Food and Drug Administration (FDA) | The Health Law Firm Blog

Hydrocodone Combination Drugs Could Be Reclassified to Schedule II Category of Controlled Substances

By Lance O. Leider, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs from schedule III into the more restrictive schedule II category of controlled substances. According to a number of different sources, on January 25, 2013, the committee presented this recommendation to the FDA. If approved, hydrocodone combination drugs, such as Vicodin, will be harder for physicians to prescribe.

The advisory committee met because the Drug Enforcement Administration (DEA) is requesting the FDA to approve the reclassification of hydrocodone combination products. The DEA wants to help curb the growing number of people across the country addicted to painkillers.

Click here to read an FDA briefing document given to the advisory committee.

It is now up to the FDA to decide whether or not to implement the advisory committee’s decision as to whether hydrocodone combination drugs will stay labeled as schedule III controlled substances or move to schedule II controlled substances. If medications containing hydrocodone are moved to schedule II, they will be in the same category as the widely abused oxycodone.

Hydrocodone Abuse is Serious.

Currently, hydrocodone products are the most widely prescribed drugs in the U.S., according to an article on MedPage Today. Records show that painkiller abuse kills more people in America than heroin and cocaine combined. The DEA argues that since these drugs are so frequently abused, they should be more tightly controlled.

To read the MedPage Today article, click here.

What You Need to Know as a Health Care Provider.

This change would have wide-spread consequences for health care professionals, especially doctors and pharmacists. Under the schedule II category of controlled substances, physician assistants (PAs) and nurse practitioners would no longer be legally allowed to prescribe hydrocodone combination drugs.

If the recommendation is accepted, it would be more difficult for patients to obtain refills on hydrocodone combination drugs. Refills without a new prescription, faxed prescriptions and prescriptions called in by telephone would all be banned. Only written prescriptions from a doctor would be allowed.

If the recommendation is adopted, much stricter scrutiny on the purchasing, prescribing, retailing and use of these medications can also be expected. Prosecutions and administrative actions can also be expected to follow.

The FDA is also debating the DEA’s request to limit prescriptions of hydrocodone combination pills to a 90-day supply instead of the current regulations which permit five refills within six months.

Arguments Heard Against the Reclassification.

According to an article in The New York Times, many opponents spoke against the recommendation. Advocates for nursing home patients argued that weak and elderly residents with chronic pain would have to make a difficult trip to see a doctor just to get a prescription refilled. Click here to read The New York Times article.

Some committee members questioned if there was another option to consider versus changing the scheduling. They questioned whether greater use of e-prescribing and Prescription Drug Monitoring Programs, as well as better education efforts for clinicians and patients would be better solutions for the drug abuse epidemic.

Now it remains to be seen how the FDA will interpret the advisory committee’s recommendation.

Florida’s Prescription Drug Abuse Epidemic.

Florida law enforcement including the DEA, the Federal Bureau of Investigation (FBI), and Department of Health (DOH) all seem to be having a hard time keeping up with prescription drug abuse in Florida.

We have written a number of blogs on the abuse of narcotics in Florida. See our blog on a fake prescription ring busted in Osceola County, and a Central Florida nurse accused of illegally obtaining prescriptions for painkillers, for example. Check our website for similar blogs.

Pharmacists, pharmacies, legal distributors and physicians are often too caught up in the frenzy to stem prescription drug abuse and to eliminate “pill mills.”

Call Experienced Health Law Attorneys for Your Legal Needs.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.
Sound Off.

As a health care professional, do you think hydrocodone products should be labeled as a schedule II controlled substance? What are the positive and negative effects of this decision? Please leave any thoughtful comment below.
Sources:

Fiore, Kristina. “FDA Panel Votes for Tighter Controls on Vicodin.” MedPage Today. (January 25, 2013). From: http://bit.ly/X8qlsu

Tavernise, Sabrina. “F.D.A. Likely to Add Limits on Painkillers.” The New York Times. (January 25, 2013). From: http://www.nytimes.com/2013/01/26/health/fda-vote-on-restricting-hydrocodone-products-vicodin.html?_r=0
About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2024-03-14T10:00:45-04:00June 1, 2018|Categories: Administrative law, Department of Health, In the Know, Pain Management, The Health Law Firm Blog|Tags: administrative hearings, defense attorney, defense lawyer, Department of Health (DOH), doctors, Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Food and Drug Administration (FDA), hydrocodone, license defense counsel, nurse practitioner, pharmacists, physician assistants (PAs), physicians, schedule II controlled substances, schedule III controlled substances|Comments Off

Two National Recalls Prompt Food and Drug Administration (FDA) to Update Metal-on-Metal Hip Implant Safety Concerns

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm

On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a metal socket, or metal-on-metal hip devices. This comes after two recent hip replacement recalls that are sparking thousands of lawsuits. Click here to read the FDA communication.

In August 2010, Johnson and Johnson’s DePuy Orthopaedics implemented a DePuy ASR hip recall, withdrawing more than 93,000 hip implants from the market. (Click here to read the press release on the recall from DePuy.) In July 2012, Stryker Orthopaedics implemented a similar recall on the Rejuvenate and ABG II modular neck components. (Click here to read the Stryker recall press release.)

Updated Information on Metal-on-Metal Hip Implants From the FDA.

According to the FDA, in metal-on-metal hip implants, metal can be released into the body when two connecting components slide against each other. This can happen during daily activities. Metal release will cause some tiny metal particles to wear off of the device and into the space around the implant. Wear and corrosion at the connections may also occur. Some of the metal ions from the implant can enter the bloodstream. If this happens, patients can suffer from muscle, nerve and bone damage.

Click here to read more on metal-on-metal hip implants from the FDA.

Second Trial Over DePuy Hip Implant in Progress.

The president of DePuy testified during the second DePuy ASR hip trial. According to an article in Bloomberg News, the DePuy president said that the metal-on-metal hip implants were recalled because of a high rate of corrective surgeries required in patients, not because the device’s design was defective. Click here to read the Bloomberg article.

You may remember on March 8, 2013, in the first ASR hip recall trial, a California jury awarded the plaintiff $8.3 million in compensation damages after finding the ARS’s design defective. This result will have significant impact in the 10,750 other lawsuits against DePuy. Click here to read a previous blog on the first trial over the DePuy hip implants.

Stryker Orthopaedics Facing Similar Lawsuits.

As of February 2013, more than 80 lawsuits against Stryker have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey. Stryker is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on any patient who had implants installed. Click here to read a previous blog on the Stryker lawsuits.

We’ve also learned some Stryker patients are being contacted by Broadspire. This company is trying to discuss settling with these patients. We want to encourage any metal-on-metal hip implant recipients to contact and experience attorney first, because there is still time to file a claim for injuries.

Contact an Attorney Experienced in Products Liability Litigation.

Although The Health Law Firm represents predominantly physicians and other health care providers, we are involved in products liability litigation. The Health Law Firm has recently undertaken plaintiffs’ products liability cases against the manufacturers of defective hip implants. We are now representing plaintiffs in a number of products liability cases involving both the DePuy hip and the Stryker hip implants. We are able to combine our knowledge of the health law industry with our litigation experience for the benefit of patients.

If you received a DePuy or Stryker hip replacement and have experienced pain, swelling, high levels of metal in your blood, a corrective revision surgery, or other complications, we may be able to help you.

To learn more about your legal rights, contact The Health Law Firm for a consultation by calling (407) 331-6620 or (850) 439-1001 or visit our website at www.TheHealthLawFirm.com.

Comments?

What are your thoughts on these recalls? Are you a Stryker or DePuy hip implant recipient? Please leave thoughtful comments below.

Sources:

Harris, Andrew and Voreacos, David. “J&J’s Ekdahl Says Hip Recalled for Clinical Reaons.” Bloomberg. (March 13, 2013). From: http://www.bloomberg.com/news/print/2013-03-13/depuy-chief-questioned-over-records-calling-asr-defective.html

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.pdf

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2024-03-14T10:00:46-04:00June 1, 2018|Categories: In the Know, In the News, Products Liability Cases, The Health Law Firm Blog|Tags: ABG II modular-neck stems, artificial hip implant, Broadspire, Broadspire Services, dangers of metal-on-metal hip implants, defense attorney, defense lawyer, DePuy, DePuy hip implant, DePuy lawsuits, DePuy recall, Food and Drug Administration (FDA), health care attorney, health lawyer, hip implant lawsuit, hip implant recipient, Inc., lawsuits, mass-tort cases, metal-on-metal hip implants, multicounty litigation (MCL), recall, Rejuvenate, Sktryker Orthopaedic, Stryker, Stryker hip implant, Stryker lawsuits, Stryker recall|Comments Off

Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries

By Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Colorado surgeon allegedly faces 14 counts of unprofessional conduct associated with the use a robotic arm used during surgeries, according to the formal administrative complaint. The Colorado Medical Board filed the complaint on April 2, 2013, alleging that from 2008 until 2010, the surgeon cut and tore blood vessels, left sponges and other instruments inside of patients, injured patients through padding and positioning, subjected some patients to overly long surgeries and had to abort kidney donation procedures because of mistakes. The surgeon is also accused of not documenting the mistakes in patient charts.

According to the Colorado Board of Medicine’s administrative complaint, the surgeon was using the da Vinci robot, manufactured by Intuitive Surgical, Inc., for surgeries.

Click here to read the formal complaint from the Colorado Medical Board.

This complaint was filed around the same time as the U.S. Food and Drug Administration (FDA) launched a review of the robotic procedures.

A Number of Patients Speak Out On Surgeries.

The complaint lists 11 patient cases allegedly mishandled by the surgeon.

In one case, a 22-year-old woman wanted to donate a kidney to her brother. She was informed by the surgeon that the robot was the “gold standard” for kidney removals and transplants. During the surgery, the surgeon allegedly injured the patient’s aorta. To stop the bleeding, the surgeon allegedly converted to an open surgery, then aborted the kidney removal. After the attempted surgery, the patient allegedly went into post-operative distress and an X-ray showed a sponge that had been left inside the patient. The patient also alleges she was left with nerve damage after being improperly padded.

In another case, the surgeon allegedly used the robot on an 86-year-old man with metastatic cancer. The surgeon allegedly injured the patient’s aorta, and the robot arm moved when it should not have, causing another tear. The patient suffered kidney failure after the operation, and the family withdrew the patient’s life support.

Surgeon Suspended for Performing Robotic Surgeries.

In the complaint, the Colorado Medical Board is asking an administrative law judge to discipline the surgeon’s license to practice medicine. An article in The Denver Post states that the surgeon had his robotic-surgery privileges suspended for three months in 2010. The hospital would not say whether or not the surgeon received new training before allowing him to use the robotic arm after his suspension.

To read the entire article from The Denver Post, click here.

FDA and Other Medical Societies Leery of Robotic Procedures.

In March 2013, the FDA began interviewing surgeons about issues with the robotic surgery units, according to Fierce Health IT. The agency is allegedly trying to figure out why there has been an uptick in adverse event reports, including damaged organs and device failures, and whether these are a result of error or design problems.

For a list of other sources discussing possible adverse outcomes from robotic surgery, please see “references” below.

The American Congress of Obstetricians and Gynecologists and the Massachusetts Quality and Patient Safety Division are also warning health care professionals about the risks associated with robotic surgeries, according to Fierce Health IT. The American Congress of Obstetricians and Gynecologists said that these types of surgeries should not be the first or second choice for women undergoing routine hysterectomies. The Massachusetts Quality and Patient Safety Division sent a letter advising doctors of the safety concerns regarding robotic surgery.

Click here to read the entire article from Fierce Health IT.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a health care professional, does your facility use robotic arm surgeries? Do you believe they are the safer option? Do you think the FDA should take a closer look at these machines? Please leave any thoughtful comments below.

Sources:

Booth, Michael. “Colorado Charges Doctor in Problem-Plagued Robo-Surgeries at Porter.” The Denver Post. (April 10, 2013). From: http://www.denverpost.com/breakingnews/ci_22998041/colorado-charges-doctor-botched-robo-surgeries-at-porter

Hall, Susan. “Robo-Surgery Mistakes Land Physician in Hot Water.” Fierce Health IT. (April 15, 2013). From: http://www.fiercehealthit.com/story/robo-surgery-mistakes-land-physician-hot-water/2013-04-15

Colorado Medical Board v. Warren J. Kortz, M.D. Case Number ME 2013. Formal Complaint (April 2, 2013). From:http://www.thehealthlawfirm.com/uploads/Colo%20v.%20Warren%20Kortz%20MD.pdf

Gold, Ashley. “Health Officials Warn Complications Robotic Surgeries.” Fierce Health IT. (March 26, 2013). From: http://www.fiercehealthit.com/story/health-officials-warn-complications-robotic-surgeries/2013-03-26

Hall, Susan. “OBGYN Group: Robotic Surgeries Not Best Choice for Routine Hysterectomies.” (March 15, 2013). From: http://www.fiercehealthit.com/story/obgyn-group-robotic-surgery-not-best-choice-routine-hysterectomies/2013-03-15

Garde, Damian. “FDA Echoes Questions Over Intuitives’s Surgical Robot.” Fierce Medical Devices. (March 1, 2013). From: http://www.fiercemedicaldevices.com/story/fda-echoes-questions-over-intuitives-surgical-robot/2013-03-01

Bird, Julie. Much of Robo-Surgery Marketing ‘Unsubstantiated.’” Fierce Health IT. (July, 24, 2012). From”
http://www.fiercehealthit.com/story/much-robotic-surgery-marketing-unsubstantiated/2012-07-24

About the Authors: Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:00:47-04:00June 1, 2018|Categories: Administrative law, Board of Medicine, Health Care Industry, In the News, Licensing issues, Medical License, The Health Law Firm Blog|Tags: administrative complaint, administrative judge, administrative law, Colorado law, Colorado medical board, da Vinci-brand surgery units, discipline license to practice medicine, discipline to medical license, doctor, Food and Drug Administration (FDA), formal complaint against surgeon, health care attorney, health care lawyer, health law, license to practice medicine, malpractice lawsuit, medical board, medical board complaint, medical board hearing, medical errors, physician, robotic surgery, robotic surgery arm, standard of care, surgeon, unprofessional conduct|Comments Off

Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

– “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

– “One who makes such a payment may be unable to explain and to justify it.”

– “Such a firm or individual may well possess market power derived from the patent.”

– “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

– “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:00:49-04:00June 1, 2018|Categories: Appeal, Health Care Industry, In the Know, In the News, Pharmaceutical Drugs, Pharmacy, The Health Law Firm Blog|Tags: AARP, American Medical Association, brand name drugs, brand name prescriptions, brand-name drug manufacturers, defense attorney, defense lawyer, Federal Trade Commission (FTC), florida attorney, Florida lawyer, Food and Drug Administration (FDA), generic drug manufacturers, generic drugs, generic medications, generic prescriptions, health law, medicaid, medicare, Pay-for-Delay Drug Agreement, pay-for-delay practices, pharmaceutical industry, pharmacist, pharmacy, pharmacy law, prescription, supreme court, the health law firm|Comments Off

More Than 7,000 Patients of Oklahoma Dentist Are Being Asked to Get Tested for HIV and Hepatitis

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The unsanitary practices of an Oklahoma dentist may have exposed more than 7,000 patients to HIV and hepatitis, according to a number of media sources and the Oklahoma Department of Health (DOH). Currently officials with the Oklahoma DOH are contacting all of the dentist’s patients since 2007, and urging them to get tested for blood-borne diseases. Since the news broke on March 28, 2013, the dentist has voluntarily closed his two offices and surrendered his dental license for 30 days.

Click here to read a copy of the letter from Oklahoma DOH warning the dentist’s patients to get tested.

We want to point out that these are just allegations made against the dentist at this point in time and have not been proven by the state.

Dentist Accused of Being a “Menace to the Public” in Complaint.

According to the complaint filed with the Oklahoma Board of Dentistry, the dentist is allegedly facing 17 allegations from The Board due to the violations against his practice.

Alleged charges against the dentist include:

1. A patient testing positive for HIV and hepatitis C;

2. The dental practice being unsafe, unsanitary and lacking of sterilization checks;

3. Committing gross negligence related to decisions related to the dental health care of patients;

4. Practicing dentistry without the proper display of licenses and certifications;

5. Violation of provisions of the State Dental Practice Act by failing to keep a suitable record of dangerous drugs;

6. Unlawful practices in authorizing dental assistants to practice dentistry; and

7. Having open vials of medications and unsanitary dental materials in an unclean environment.

Click here to read the complaint.

Dentist Admitted to Not Handling Sterilization and Drugs Procedures.

According to the complaint, a device in the dentist’s office used to sterilize dental instruments wasn’t working properly. An inspector also found two separate sets of instruments. Each set was cleaned differently, one set of instruments was for patients known to have infectious diseases, and one set was for those not believed to have such diseases. Oklahoma DOH officials said the proper approach is for all instruments to be handled as if they contain viruses and infectious diseases.

According to an article in The New York Times, the dentist allegedly told officials during one inspection of his office that his staff handled all sterilization and drug procedures. Click here to read the entire article from The New York Times.

Dentist Faces Hearing at State Board of Dentistry.

According to the Oklahoma DOH, the dentist has been a state-licensed dentist since 1974, and an oral surgeon since 1977. He faces the possibility of having his license revoked, after a hearing on April 19, 2013, at the state Board of Dentistry in Oklahoma. This investigation is ongoing.

Contact Health Law Attorneys Experienced with Department of Health Investigations of Dentists.

The attorneys of The Health Law Firm provide legal representation to dentists in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com.

Comments?

What do you think of this dentist’s story? Are you curious as to how the practice got so bad? Please leave any thoughtful comments below.

Sources:

Oklahoma Board of Dentistry State of Oklahoma v. Wayne Scott Harrington, D.M.D. Case Number 13-005. Statement of Complaint. (March 28, 2013). From: http://www.thehealthlawfirm.com/uploads/OK%20Dentist%20Complaint.pdf

Ball, Brandi. “Tulsa County Dentist May Have Exposed 7,000 Patients to HIV, Hepatitis.” News on 6. (March 28, 2013). From: http://www.newson6.com/story/21820518/tulsa-county-dentist-may-have-exposed-patients-to-hiv-hepatitis

Oklahoma State Department of Health. “Tulsa Health Department, Oklahoma State Department of Health and Oklahoma Board of Dentistry Investigate Tulsa Dentist.” (March 28, 2013). From: http://bit.ly/ZwRhRT

Fernandez, Manny. “Tests Start for Patients of Dentist in Inquiry.” The New York Times. (March 29, 2013). From: http://www.nytimes.com/2013/03/30/health/dental-patients-in-oklahoma-warned-of-disease-risk.html

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:07-04:00May 15, 2018|Categories: Board of Dentistry, Dental Law, Dentist Defense attorney, Dentistry Law, Dentists|Tags: administrative complaints, administrative law, attorney administrative law, attorney for dentists, Board of Dentistry, Centers for Disease Control and Prevention (CDC), common deficiencies in inspections, defense attorney, defense lawyer, dental practice, dentist, dentistry, Department of Health (DOH), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), H.I.V., health and safety violations, health investigation, health law attorney, health lawyer, health officials, hepatitis B, hepatitis C, infection control guidelines, lawyer for dentists, legal defense for administrative complaints, license revoked, Oklahoma DOH, oral surgeon, State Board of Dentistry in Oklahoma City, surrendered dental license, voluntarily surrendered license|1 Comment

Supreme Court to Determine if Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers are Legal

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Supreme Court is currently looking into whether brand name drug manufacturers may pay generic drug manufacturers to keep the generic drugs off the market. These payments, often called pay-for-delay, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court’s decision may be worth billions to pharmaceutical companies and consumers.

In January 2013, the American Medical Association (AMA) teamed up with the American Association of Retired Persons (AARP) and other organizations seeking to eliminate pay-for-delay agreements. The groups filed a friend-of-the-court brief in the Supreme Court case.

Click here to read the friend-of-the-court brief.

History of Pay-For-Delay Agreements.

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

The Impact of Pay-For-Delay Agreements.

It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs.

According to an article on National Public Radio (NPR), the number of pay-for-delay agreements is increasing. Click here to read the entire NPR article.

Legalized Extortion Causes Patients to Pay High Drug Prices.

This type of legalized extortion does nothing more than drive up drug prices for all patients by keeping generic drugs off the market. On the other hand, it vastly increases the profits made by big name pharmacy companies who are able to derive even more money from expired patents.

AMA Fights to Get Rid of Pay-for-Delay Agreements.

According to a press release, AMA, AARP, the National Legislative Association for Prescription Drug Prices and the U.S. Public Interest Research Groups all signed onto the friend-of-the-court brief filed in the Supreme Court.

The AMA is concerned that pay-for-delay agreements extend patent monopolies, increase health care costs and restrict doctors’ ability to treat patients. To read the entire press release from the AMA, click here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a health care professional, how do you feel about pay-for-delay agreements? Please leave any thoughtful comments below.

Sources:

Mills, Robert. “AMA Joins Other Groups Seeking to Overturn Pay-for-Delay Drug Agreement.” American Medical Association. (January 30, 2013). From: http://www.ama-assn.org/ama/pub/news/news/2013-01-30-amicus-brief-ftc-vs-watson-pharmaceuticals.page

Federal Trade Commission v. Watson Pharmaceuticals, Inc. Case Number 12-416. Brief for AARP, American Medical Association, National Legislative Association for Prescription Drug Prices and U.S. Public Interest Research Groups as Amici Curiae in Support of Petitioner. January 29, 2013. From: http://www.thehealthlawfirm.com/uploads/2013-01-29-amicus-brief-ftc-vs-watson-pharmaceuticals.pdf

Purvis, Leigh. “Pay-for-Delay Agreements and Prescription Drug Costs.” AARP. (May 13, 2013.) From: http://blog.aarp.org/2013/05/13/pay-for-delay-agreements-and-prescription-drug-costs/

Totenberg, Nina. “Supreme Court Hears ‘Pay to Delay’ Pharmaceutical Case.” National Public Radio. (March 25, 2013). From: http://www.npr.org/2013/03/25/175043758/supreme-court-hears-pay-to-delay-pharmaceutical-case

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Generic Drug Maker Ranbaxy Pleaded Guilty to Claims of Adulterated Drugs-Must Pay $500 Million Fine

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Generic drug maker Ranbaxy USA Inc., pleaded guilty to drug safety violations and will be responsible for paying $500 million in criminal and civil fines, according to the Department of Justice (DOJ). The fines will resolve claims that the manufacturer sold inferior drugs and made false statements to the U.S. Food and Drug Administration (FDA) about manufacturing practices at two factories in India. This announcement was made by the DOJ on May 13, 2013. This settlement is the largest drug settlement to date involving a generic drug manufacturer and drug safety.

To read the entire press release from the DOJ, click here.

Ranbaxy USA Inc., is a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited. The entities listed in the settlement include: Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories, Inc., Ohm Laboratories, Inc., and Ranbaxy USA, Inc. (collectively “Ranbaxy”).

Criminal Fine and Forfeiture.

Ranbaxy admitted to not conducting proper safety and quality tests of several drugs manufactured at two of its plants in India, according to the DOJ. Under the settlement the company pleaded guilty to three felony counts of violating the federal drug safety law. Ranbaxy agreed to pay $150 million in criminal fines and forfeitures.

False Statements Made to FDA.

According to the DOJ, Ranbaxy also pleaded guilty to four felony counts of knowingly making false statements to the FDA in annual reports. To settle civil claims under the False Claims Act and related state laws, Ranbaxy agreed to pay $350 million. This fine was to resolve false claims that were submitted to government health care programs such as Medicare, Medicaid, TRICARE and the Department of Veterans Affairs. The settlement was entered into by all 50 states, the District of Columbia and the federal government.

Florida Will Receive $3 Million from Settlement.

According to the Florida Attorney General (AG), Florida will receive more than $3 million as a result of the settlement. AG Pam Bondi stated that the Medicaid Fraud Control Unit (MFCU) will not allow Florida taxpayers to pick up the tab for pharmaceutical companies that manufacture, distribute and sell adulterated pharmaceutical drugs.

Click here to read the settlement agreement between the State of Florida and Ranbaxy.

Example of Florida’s Civil Forfeiture Act.

This is an example of Medicaid fraud through the use of adulterated and “counterfeit” drugs, as well as the use of Florida’s Civil Forfeiture Act in a Medicaid case. To learn more on civil forfeiture and defending against seizures of property, click here for a previous blog.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of this settlement agreement? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA.” Department of Justice. (May 13, 2013). From: http://www.justice.gov/opa/pr/2013/May/13-civ-542.html

Meale, Jenn. “Attorney General Bondi Enters $350 Million National Settlement with Ranbaxy Resolving Adulterated Drug Claims” Florida Office of the Attorney General. (May 14, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/505E50CA109D827885257B6B006BA668

Settlement Agreement between the State of Florida and Ranbaxy Laboratories Limited. Case No. 10-05-01. (May 14, 2013). From: http://www.thehealthlawfirm.com/uploads/Ranbaxy%20Settlement%20agreement.pdf

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:14-04:00May 15, 2018|Categories: Pharmacy, Pharmacy Law|Tags: adulterated drugs, Civil forfeiture, defense attorney, defense lawyer, Department of Justice (DOJ), false claims act, false statements, Florida Office of the Attorney General (AG), Food and Drug Administration (FDA), forfeiture, generic drug manufacturer, generic pharmaceutical manufacturer, Medicaid Fraud Control Unit (MFCU), pharmacist attorney, pharmacist lawyer, pharmacy attorney, pharmacy lawyer, Ranbaxy USA Inc., the health law firm, U.S. Food and Cosmetic Act|Comments Off

Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies

By Lance O. Leider, J.D., The Health Law Firm

On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click here to read a previous blog on the meningitis outbreak.

This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over compounders, but creates significant safeguards.

This particular piece of legislation passed the House of Representatives in September of 2013, passed in the Senate in November 2013, and President Obama signed it into law on November 28, 2013. To read a summary of the Drug Quality and Security Act, click here.

Under Law, Registration with the FDA is Voluntary.

The goal of the Drug Quality and Security Act is to enact greater controls, tracking, and oversight of the compounding pharmacy industry. Presently, the U.S. Food and Drug Administration (FDA) only regulates manufacturers of medications, leaving compounding pharmacies to be regulated by state boards of pharmacy.

However, this two-part regulation left large compounding operations like the NECC in somewhat of a gray area. Large compounding labs like NECC that mass produce products to ship across state lines have come under fire from state boards of pharmacy.

At a recent meeting of the Florida Board of Pharmacy’s Compounding Committee, the panel members expressed concerns over the lack of inspections and oversight of pharmacies shipping drugs into Florida. In general, the Committee supported the efforts to strengthen regulations, whether by the FDA or state boards.

Overview of the Law.

Under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose to register as outsourcing facilities. The pharmacies that register would then be regulated by the FDA rather than by state boards of pharmacy. The hope is that compounding pharmacists will want to register with the FDA because physicians will prefer using compounding pharmacies that are federally regulated, and therefore considered safer.

The law also creates a national system for tracking prescription drugs from the manufacturer to retail pharmacies, first this is done through serial numbers on bottles and later through electronic codes. Drug makers will be required to add serial numbers to all drug packages within four years, and within 10 years drug makers must implement electronic codes that can be used to track medicine from the factory to the pharmacy.

Issues with Previous Inspections.

As mentioned above, the issue of large-scale compounding and nonresident pharmacies was recently discussed by the Florida Board of Pharmacy.

Florida has more than 700 nonresident pharmacy permits outstanding. According to the Board of Pharmacy, approximately half of those are shipping compounded sterile products into Florida.

Prior to the events at NECC, state boards of pharmacy were under the mistaken assumption that their sister boards were appropriately regulating and inspecting these pharmacies. However, it turns out that many of the inspections were conducted by inadequately trained staff, or the staff was misled as to exactly what was going on at the pharmacy.

Many of the pharmacies wrongly informed the state inspectors that they were registered with the FDA as a manufacturer and did not have to provide prescriptions during inspections. This led to largely unregulated production of compounded sterile medications and eventually the meningitis outbreak of 2012.

Florida Board of Pharmacy to Have More Oversight.

Frustrated with the general lack of oversight and the potential harm to Floridians, the Board is preparing to take additional steps to ensure that compounders are appropriately regulated.

Among the possible steps to be taken are:

1. Outsourcing nonresident pharmacy inspections to organizations like the National Association of Boards of Pharmacy (NABP);

2. Require personal inspection by a Florida Board-approved inspector prior to issuing or renewing a license (costs of the inspection would be paid by the permittee);

3. Training specialized compounding pharmacy inspectors; and

4. Creating a Verified Pharmacy Program in conjunction with the NABP and other state boards.

Ultimately, the result of the additional regulations will mean more rigorous compliance standards on both in and out-of-state compounding pharmacies.

New Permit Law for Florida Pharmacies that Compound Sterile Products.

The Florida Board of Pharmacy also recently announced a new law which will be required for pharmacies that compound sterile products. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014. To read more, click here.

These new standards will make it easier for authorities to quickly spot where tainted batches of medications were produced. It is important to regularly review the Board of Pharmacy rules and USP guidelines to ensure your facility is compliant.

Contact Health Law Attorneys Experienced with Investigations of Pharmacies and Pharmacists.

The attorneys of The Health Law Firm provide legal representation to pharmacies, pharmacists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Have you heard of these new possible pharmacy regulations? How will this affect you or your pharmacy? Please leave any thoughtful comments below.

Sources:

Lee, Jaimy. “Bill Boosting FDA Authority Over Compounding Pharmacies Heads to Obama.” Modern Healthcare. (November 18, 2013). From: http://www.modernhealthcare.com/article/20131118/NEWS/311189973/bill-boosting-fda-authority-over-compounding-pharmacies-heads-to?utm_source=frontpage&utm_medium=newsitem309&utm_campaign=carousel-traffic

Perrone, Matthew. “Pharmacy Bill Set for Test Vote in Senate.” Washington Post. (November 11, 2013). From: http://www.washingtonpost.com/politics/pharmacy-bill-set-for-test-vote-in-senate/2013/11/11/a961c958-4b25-11e3-9890-a1e0997fb0c0_story.html

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Categories: Compounding pharmacy, Florida Board of Pharmacy, Pharmacy Law|Tags: Board of Pharmacy rules, compounded sterile medications, compounding labs, compounding manufacturing, compounding medications, compounding pharmacy, compounding pharmacy oversight, compounding pharmacy regulations, defense attorney, defense lawyer, FDA inspection, FDA regulation, Florida Board of Pharmacy Compounding Committee, Food and Drug Administration (FDA), health law, health law firm, meningitis, office-use compounding, outbreak, pharmacist, pharmacist attorney, pharmacist lawyer, pharmacy, pharmacy attorney, pharmacy deficiencies, pharmacy inspections, pharmacy lawyer, state board of pharmacy, state inspectors, sterile products, the health law firm, traditional compounding, USP guidelines|1 Comment

Compounding Pharmacies Urged to Sign Up for U.S. Food and Drug Administration Oversight

By Lance O. Leider, J.D., The Health Law Firm

It is estimated there are 3,000 compounding pharmacies in the United States, 14 of which have signed up to be regulated by the U.S. Food and Drug Administration (FDA) under the Drug Quality and Security Act. On January 8, 2014, the commissioner of the FDA sent thousands of letters to hospitals and other medical providers that may buy medicines from the compounding pharmacies. The letters urged providers to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public. The letters also mentioned last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). To read a previous blog on the meningitis outbreak, click here.

In November 2013, the Drug Quality and Security Act was passed. Under the law, the FDA does not have absolute authority over compounders, but it creates significant safeguards. To read a previous blog on the Drug Quality and Security Act, click here.

Registering with the FDA is Voluntary.

The goal of the Drug Quality and Security Act is to enact greater controls, tracking, and oversight of the compounding pharmacy industry. Previously, the FDA only regulated manufacturers of medications, leaving compounding pharmacies to be regulated by state boards of pharmacy. However, this two-part regulation left large compounding operations like the NECC in somewhat of a gray area. Large compounding labs mass producing products and shipping across state lines have recently come under fire from state boards of pharmacy.

Overview of the Drug Quality and Security Act.

Under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose to register as outsourcing facilities. The pharmacies that register are regulated by the FDA rather than by state boards of pharmacy. The hope was that compounding pharmacies will register with the FDA because physicians will prefer using facilities that are federally regulated, and therefore considered safer.

The law also creates a national system for tracking prescription drugs from the manufacturer to retail pharmacies, first this is done through serial numbers on bottles and later through electronic codes. Drug makers will be required to add serial numbers to all drug packages within four years, and within 10 years drug makers must implement electronic codes that can be used to track medicine from the factory to the pharmacy. To read a summary of the Drug Quality and Security Act, click here.

What Registered Compounding Pharmacies Must Agree To.

Compounding pharmacies registering with the FDA must agree to routine inspections, and to report adverse events associated with their products. Registered compounding pharmacies must also pay a fee for the privilege. The FDA is listing on its website the companies that have already registered. Click here to see the list.

Ultimately, the result of voluntary federal oversight will mean more rigorous compliance standards for both in and out-of-state compounding pharmacies. However, the purported benefits (more business and a better reputation) may far outweigh the burden.

If your pharmacy is considering FDA registration it would be best to consult with an experienced health attorney to guide you through the process.

Contact Health Law Attorneys Experienced with Investigations of Pharmacies and Pharmacists.

The attorneys of The Health Law Firm provide legal representation to pharmacies, pharmacists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think about the number of compounding pharmacies that have signed up to be regulated by the FDA? As a provider, would you consider using compounding pharmacies that have not signed up? Please leave any thoughtful comments below.

Sources:

Palmer, Eric. “Compounders Start to Sign Up for FDA Oversight.” FiercePharma. (January 10, 2014). From: http://www.fiercepharma.com/story/compounders-start-sign-fda-oversight/2014-01-10

Associated Press. “States Urged to Register Compounding Pharmacies.” ABC News. (January 10, 2014). From: http://abcnews.go.com/US/wireStory/states-urged-register-compounding-pharmacies-21489538

Burton, Thomas. “FDA Urges Compounding Pharmacies to Register.” Wall Street Journa. (January 10, 2014). From: http://online.wsj.com/news/articles/SB10001424052702303754404579312680341438784

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement is in response to allegations of misrepresenting the regulatory status of an ointment used to treat skin conditions and submitting false Medicaid claims. Florida’s Medicaid program will receive almost $900,000 of the settlement.

Click here to see the press release from the AG’s office.

Pharmaceutical Company Allegedly Submitted False Claims to Medicaid.

According to the Department of Justice (DOJ), Healthpoint launched the ointment for the treatment of nursing home patients with bed sores. The settlement resolves allegations that Healthpoint marketed the ointment, Xenaderm, without the approval of the Food and Drug Administration (FDA) by modeling it on a pre-1962 drug that the FDA never reviewed. The DOJ states that the main ingredient in Xenaderm was determined by the FDA to be less-than-effective for its intended use. The government contends those determinations render the ointment ineligible for Medicaid reimbursements. Healthpoint is accused of knowingly submitting false claims to Medicaid programs.

To read the press release on the settlement from the DOJ, click here.

The settlement is th result of litigation by the United States Attorney’s Office for the District of Massachusetts, the DOJ and fifteen (15) states, including Florida.

Responding to a Medicaid Audit.

Should you find yourself, your facility or your health practice the subject of a Medicaid audit by your state Medicaid agency or audit contractor, there are a few things you should know.

The most important thing is that just because you are being audited, it does not mean that you or your business has done anything wrong. State and federal governments conduct audits for many different reasons. Typical ones include: special audits of high-fraud geographic areas, auditing of particular billing codes, randomly selected provider auditing, and complaints of possible fraud.

Click here to see a complete list of steps you should take in order to compile and provide a set of records that will best serve to help you avoid any liability at the conclusion of the audit process.

Contact Health Law Attorneys Experienced in Handling Medicaid Audits, Investigations and other Legal Proceedings.

Medicaid fraud is a serious crime and is vigorously investigated by the state MFCU, the Agency for Healthcare Administration (AHCA), the Zone Program Integrity Contractors (ZPICs), the FBI, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health attorney familiar with medical billing and audits today. Often Medicaid fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.

The Health Law Firm’s attorneys routinely represent physicians, dentists, orthodontists, medical groups, clinics, pharmacies, assisted living facilities (AFLs), home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions. We also represent health professionals and others who know of Medicare and Medicaid fraud to file whistleblower and qui tam cases.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of this settlement agreement? Please leave any thoughtful comments below.

Sources:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Settlement with Pharmaceutical Company.” Florida Office of the Attorney General. (February 25, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/D69C285712F6FF9185257B1D004D275D

Department of Justice. “Healthpoint Ltd. to Pay up to $48 Million for False Medicaid and Medicare Claims for Unapproved Prescription Drug.” Department of Justice. (December 6, 2013). From: http://www.justice.gov/opa/pr/2012/December/12-civ-1459.html

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2024-03-14T10:01:39-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law, Whistleblower|Tags: Department of Justice (DOJ), false claims, false claims act, Federal Food Drug and Cosmetic Act, Florida defense attorney, Florida defense lawyer, Florida health care law, florida health law, Florida Medicaid fraud, Food and Drug Administration (FDA), Healthpoint, Healthpoint Ltd., medicaid, Medicaid fraud, medicaid fraud control unit, nursing homes, Office of Attorney General (AG), overpayment, pharmaceutical company, pharmaceutical drugs, quit tam, whistleblower|Comments Off