The legal matters involving pharmacies and pharmacists are many. Learn more about pharmacist involvement in investigations by the Department of Health, local investigative agencies, the Medicaid Fraud Control Unit (MFCU) and the Drug Enforcement administration (DEA)concerning complaints, including allegations of license violations, prescription fraud, and other types of disciplinary infractions.

Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak

The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S.

The CDC reports that eye drops and injections traced back to the lab caused the infections. These ophthalmic products contained multiple fungal and bacterial species, according to the CDC. The products have now been recalled, but were in use for over a year before the recall. The CDC has also issued a warning to avoid any product labeled sterile from Franck’s.

The patients impacted by the contaminated products had all undergone some type of eye procedure in which the Franck’s products were used. 23 patients have allegedly suffered some vision loss as a result of the infection.

The Florida Department of Health (DOH) has stated that it cannot divulge if Franck’s or any other pharmacy is being investigated at this time. If the pharmacy is believed to pose an immediate threat to patient safety, the DOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.

Franck’s has released a statement saying that the pharmacy is fully cooperating with the DOH and FDA. Franck’s says it is currently cooperating to conduct product recalls and will assist in post-recall inspections to prevent future occurrences.

This is not the first time that this Central Florida pharmacy has made headlines. In 2009, the pharmacy was blamed for the deaths of over twenty polo horses in south Florida. This was also allegedly caused by a contaminated compound. Because of this case, the FDA tried to stop Franck’s from compounding veterinary products.

However, Franck’s won in U.S. District Court when United States v. Franck’s Lab, Inc. was decided in December 2011. In this case, the federal court ruled that the FDA does not have the authority to regulate the practice of pharmacists compounding veterinary prescriptions from bulk substances. The decision in favor of the pharmacy can be found here.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. It’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.

Sources Include:

Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012). From
http://www.foxnews.com/health/2012/05/04/cdc-links-eye-infections-to-troubled-florida-pharmacy/#ixzz1tvHCA4yg

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012). From:
http://www.cbsnews.com/8301-504763_162-57427915-10391704/rare-fungal-eye-infections-tied-to-fla-pharmacy-cdc-warns/

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012) From
http://www.gainesville.com/article/20120503/ARTICLES/120509811?tc=ar

United States v. Franck’s Lab, Inc., No. 5:10-cv-147-Oc-32TBS (M.D. Fla., Sept. 12, 2011).

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012). From
http://www.wftv.com/news/news/local/ocala-pharmacy-blamed-dozens-people-suffering-visi/nNWCR/

Number of Oxycodone-Related Deaths Down in Florida

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

It looks like Florida’s prescription drug legislation, the statewide prescription drug monitoring database and the prescription drug crackdowns by law enforcement may be working, according to the Florida Department of Law Enforcement (FDLE). The FDLE states in its semi-annual report, oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. A look at the national numbers shows that the number of people abusing prescription drugs is also down.

Florida and National Numbers.

In the first half of 2012, there were 759 oxycodone-related deaths in Florida, according to the Orlando Sentinel. That number is down from 1,058 during the same time period a year before. The Orlando Sentinel states that nationwide 7 million people abused prescription drugs in 2010. By 2011, that number had dropped to 6.1 million. Studies also show prescription drug use among young adults ages 18 to 25 is also on the decline. The Metropolitan Bureau of Investigation Director believes these numbers are down because young people are realizing these drugs are dangerous and can be deadly.

Click here to read the entire article from the Orlando Sentinel.

Florida Cracks Down on Prescription Drug Abuse.

Previously, Florida was known as a state where drug addicts and dealers could easily find a pill mill or go doctor shopping to get prescription drugs. In the past two years, Florida state leaders and law enforcement officials have stepped up regulations and made serious crackdowns on doctors, pharmacists and pharmacies.

In April 2013, a Lake Mary doctor was sentenced to 25 years in prison for trafficking prescription drugs. Click here to read that story. In December 2012, a fake prescription drug ring was busted in Osceola County. To read that story, click here. In June 2012, the Drug Enforcement Administration (DEA) and Florida law enforcement announced operation “Pill Street Blues” targeting doctors and clinic owners across Florida. Click here to read more.

Health Care Professional Must Stay Ahead of Patients with Chronic Pain.

Even though the number of people abusing prescription drugs is down, state regulatory boards, private certification boards and federal agencies are not going to ease up. Many physicians in practice today are eschewing multi-disciplinary approaches to treating chronic pain in favor of monotherapies with narcotic medications.

These physicians do this at their own peril. In our practice we see many physicians in trouble with state medical boards and law enforcement officials because of their prescribing practices. If you treat patients with chronic pain it is imperative that you stay ahead of them. Click here to read a blog on legal tips for health care professionals to manage pain patients.

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?

Do you think the new legislation, the state prescription drug monitoring database and the crackdowns by law enforcement are making a difference in the war against prescription drugs? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “‘We Can Stop This Epidemic,’ CDC Boss Says at Rx-Drug Abuse Summit in Orlando.” Orlando Sentinel. (April 2, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-prescription-drug-abuse-summit-20130402,0,4693169.story

Pavuk, Amy. “Drug-Related Deaths Plunge in First Half of 2012.” Orlando Sentinel. (March 25, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-drug-deaths-down-20130325,0,6750345.story

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.

Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

Franck’s Pharmacy Urges Physicians to Assist in Recall Efforts.

Franck’s Pharmacy is seeking the assistance of physicians in alerting patients who may be impacted by the recall. Franck’s Pharmacy is also advising physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Any adverse events should be reported to Franck’s Pharmacy and the FDA’s MedWatch program.

Franck’s Pharmacy Ceases Production of Sterile Compounds.

Franck’s Pharmacy also announced that it will stop producing sterile compounds at its Ocala lab facility for the present. Franck’s Pharmacy made the announcement via e-mail on May 23, 2012. The e-mail also confirmed that several employees had been laid off. Allegedly, these employees were terminated due to the sterile compounding shutdown. Franck’s Pharmacy will continue to compound non-sterile human and veterinary medicine.

Franck’s Pharmacy Recently Linked to Eye Infection Outbreak.

Franck’s Pharmacy decided to cease sterile compounding after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used. For additional information on this, click here.

Prior Deaths of 30 Polo Ponies.

In an earlier unfortunate incident in 2009, Franck’s Pharmacy’s compounding of veterinarian prescriptions allegedly led to the deaths of approximately 30 expensive polo ponies here in Florida. Click here for details. In the aftermath of that case, the FDA attempted to prevent Franck’s Pharmacy from any further compounding of pharmaceuticals for veterinary purposes. The FDA eventually lost the case heard by the U.S. District Court, Middle District of Florida, which ruled in favor of Franck’s Pharmacy. The decision can be seen 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.

Sources Include:

Franck, Paul. “Urgent: Compounding Prescriptions Recall.” Franck’s Pharmacy. Press Release. (May 23, 2012). From
http://www.francks.com/

Medina, Carlos E. “Franck’s Ceases Sterile Compounding Service.” Ocala.com. (May 23, 2012) From
http://www.ocala.com/article/20120523/ARTICLES/120529872/-1/entertainment02?template/

Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Drug Enforcement Administration (DEA) agents along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic on June 14, 2013. According to the Orlando Sentinel, agents searched for evidence at the clinic associated with multiple doctors. DEA agents stated the clinic was operating as a “pill mill” and allegedly diverting legal prescriptions for illegal purposes. No one was arrested during the raid. Longwood is a suburb of Orlando.

Investigation Spreads to South Florida.

According to WESH-TV, during the raid agents took everything from the clinic that could help them build a criminal prosecution. This included paper records, computer equipment and prescription drugs. DEA agents would not say how many people they were investigating, but they did say this raid was the result of a two-year long investigation.

In addition to the Longwood pain clinic, DEA agents said they are also searching locations in Brevard County, Florida, where associates of the Longwood clinic allegedly live.

To watch the WESH-TV report, click here.
Two Doctors Associated With the Longwood Clinic Allegedly “Blacklisted” by Pharmacy.

According to the Orlando Sentinel, two doctors associated with the Longwood clinic were allegedly “blacklisted” in 2011, by CVS Pharmacy. This means that CVS notified those physicians that the pharmacy chain would no longer fill prescriptions they wrote for certain drugs such as oxycodone, due to suspiciously high prescribing rates. To read a previous blog on the CVS blacklist, click here.

Click here to read the entire Orlando Sentinel article.

The Longwood pain clinic is currently closed. Whether this will be temporary or permanent is unknown at this time.

Different Clinic, Similar Storyline.

This raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. To read a blog on two Orlando-area pharmacists recently arrested on charges of alleged drug trafficking, click here. Even the biggest pharmacy chains are not immune to investigations. Walgreens just agreed to pay $80 million to settle a DEA investigation into the chain’s dispensing practices of prescription drugs. To read more, click here.

Contact Health Law Attorneys Experienced with DEA Cases and Licensing Actions.

The Health Law Firm represents physicians, pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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 all of these raids on pharmacies and pain clinics? Please leave any thoughtful comments below.

Sources:

McDaniel, Dave. “Agents Raid Longwood Pain Clinic.” WESH-TV. (June 14, 2013). From: http://www.wesh.com/news/central-florida/seminole-county/agents-raid-longwood-pain-clinic/-/17597106/20572512/-/item/0/-/afpnwwz/-/index.html

Pavuk, Amy. “Agents Raid Longwood Pain Clinic.” Orlando Sentinel. (June 14, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-professional-pain-care-raid-20130614,0,3826330.story#tugs_story_display
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.

The DEA’s War on Pain Management

The Health Law Firm George F. Indest III HeadshotWithin the last few years, raids on pain management clinics, as well as pharmacies, have been increasingly commonplace. The doctors, pharmacists, nurses and other health care professionals involved are carted away in handcuffs and must defend their practice.

According to the St. Petersburg Times, a South Florida pain management clinic has recently been shut down under emergency action by the Florida Department of Health (DOH). Several health care professionals at the clinic were arrested, their licenses revoked.

In this instance, the charges against these health care employees are not completely unwarranted. Patients confessed to authorities that members of the clinic knew they were shopping for drugs, and an employee revealed that he was asked to recruit patients by promising powerful drugs.

However, it is not uncommon for a pain management clinic or related practice to face investigation, especially in Florida. Federal and state agencies are doing everything and anything they can to prevent drug farming, which means a crackdown on health care providers. Dubbed “Operation Pill Nation,” this strict enforcement means more worries for health care professionals, who now must monitor patient needs under the DEA’s close watch.

If your medical practice specializes in pain management or a similar area, have a plan in place in the event that the DEA comes knocking on your door. Be aware of health lawyers that are familiar with these cases and can defend you in the event of a DEA raid. These proceedings are often very complicated, and you’ll want an experienced team of health law attorneys to properly defend you from criminal charges.

At The Health Law Firm, our team of lawyers specialize in the representation of doctors, nurses, pharmacists, physicians assistants, nurse practitioners and other health care professionals involved in Department of Health, Diversion Control and Drug Enforcement Administration in Florida and throughout the United States. For more information about our knowledge in the practice of health law and DEA cases read our article on Pain Management and the DEA.

Investors can Continue to Bring Claims Against KV Pharmaceutical

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

The U.S. Eighth Circuit Court of Appeals ruled that investors can continue to bring claims against KV Pharmaceutical Co. (KV) for making false or misleading statements to the U.S. Food and Drug Administration (FDA). The ruling was reached on June 4, 2012.

To view the appeals court ruling in Public Pension Fund Group v. KV Pharmaceutical Company, click here.

Appeals Court Ruling Revives Securities Fraud Class Action Lawsuit.

The appeals court has revived a securities fraud class action that was dismissed by a trial court in 2010. Investors pursued the fraud claims in a case filed in 2009 in U.S. District Court in St. Louis. In the lawsuit, investors allege that they suffered $1.5 billion in losses. The investors claim that the loss was suffered because KV allegedly misled the FDA in its compliance reports. KV then shut down its manufacturing operations in 2009.

Investors Allege KV Was Not Honest About FDA Compliance.

The lawsuit focused on FDA inspections of KV facilities over a six-year period. Results of those inspections were reported to the company’s management on a document called a Form 483. Investors alleged that information on the forms about KV’s compliance with FDA regulations contradicted statements KV made to investors. Allegedly, the forms stated that KV was not in compliance with FDA regulations.

However, KV said that the forms did not show the FDA’s final determination. The district court agreed with KV and dismissed the suit.

Appeals Court Decision May Have Ramifications for Other Drug Manufacturers.

The appeals court reversed the dismissal of the lawsuit. According to the appeals court, investors could have considered the Form 483 reports significant given the company’s assurance that it was in compliance.

The appeals court decision could have implications for other drug manufacturing companies. The decision represents the first time a federal appeals court has determined that FDA’s issuance of a Form 483 can be considered material under federal securities laws.

KV Has Recently Experienced Several Setbacks in Addition to the Investor Lawsuit.

The appeals court decision is the latest setback for KV. Starting in 2008, the generic drug manufacturer was subject to a series of recalls and investigations by the U.S. Department of Justice and the FDA. The investigations were related to KV’s manufacturing and distribution of oversized morphine pills.

In 2010, KV’s former subsidiary Ethex Corp. pleaded guilty to two felony counts of criminal fraud. Ethex Corp. agreed to pay $27.6 million in fines and restitution related to the charges. To view a press release from the U.S. Department of Justice regarding the charges against Ethex, click here.

In 2011, KV’s former chief executive pleaded guilty to misdemeanor violations of the Food, Drug and Cosmetic Act. He was sentenced to 30 days in jail and ordered to pay $1.9 million in fines and forfeitures.

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.

Sources Include:

Harris, Andrew. “KV Pharmaceutical Must Face Suit Over Quality Assurances.” Bloomberg News. (June 4, 2012) From: http://www.businessweek.com/news/2012-06-04/kv-pharmaceutical-must-face-suit-over-quality-assurances

Raymond, Nate. “U.S. Court Revives KV Pharmaceutical Investor Suit.” Reuters. (June 4, 2012). From: http://www.msnbc.msn.com/id/47681167/ns/health/t/us-court-revives-kv-pharmaceutical-investor-suit/

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.

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

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.

New Florida Drug Database Aimed at Preventing Drug Abuse

Recently, Florida pharmacists, physicians and pain management clinics have received negative attention over frequent Drug Enforcement Administration (DEA) raids. Now, Florida is once again in the spotlight as the state has launched a drug database in an attempt to reduce drug abuse perpetuated by visits to the doctor.

According to the Orlando Sentinel, this database will allow physicians and pharmacists to review a patient’s prescription history before issuing prescriptions for painkillers like OxyContin and other powerful drugs.

These preventative measures are not new to Florida health care providers. After garnering a reputation for frequent drug trafficking, proliferated by pain management clinics, the state passed legislation banning many doctors from dispensing dangerous controlled substances in their offices.

Currently, use of the database is not mandatory, but legislators are hoping to make it a requirement in the future. Both the Florida Medical Association and the Florida Osteopathic Medical Association are urging members to retrieve information from the database before writing prescriptions.

With this new database, physicians, pharmacists and pain management clinics can help prevent visits from the DEA and Department of Health (DOH). Instead of writing prescriptions for powerful painkillers every time a patient comes calling, doctors can now judge whether a patient is really in need or abusing drugs. Being able to see every instance that a patient has filled a prescription for drugs like OxyContin and Valium will allow physicians and pharmacists to understand the whole picture If a patient is shopping around for drugs, it will be made apparent.

Keep the DEA from your practice by taking every precaution, including querying the database before writing or administering a prescription. For more information on DEA cases see this article about defending yourself in the event of an investigation. Pharmacists can learn about more legal matters concerning their profession here.

Franck’s Pharmacy Closes; Compounding Lab is Now Wells Pharmacy Network

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

July 31, 2012, marked the end of an era for Franck’s Pharmacy in Ocala, Florida, as the retail location closed its doors for good. According to an Ocala Star-Banner article, in July 2012, Franck’s Compounding Lab, which was one of the largest compounding labs in the country, was bought by Wells Pharmacy Network. The deal included Franck’s Lifestyles, which sells supplements and wellness products, but did not include the retail pharmacy location.

Click here to see the official press release from Wells Pharmacy Network.

Closed Pharmacy Comes After a U.S. Food and Drug Administration (FDA) Finding of Fungal Growth in Pharmacy’s Clean Room.

In May of 2012, Franck’s Pharmacy Inc., issued a recall for its compounded prescriptions. The prescriptions impacted by this recall included all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. 

The recall was apparently prompted by an action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy recalled its sterile compounds to prevent any possible risk of infection.

To see the FDA recall, click here.

Eye Infection Outbreak Linked to Franck’s Pharmacy Products.

Franck’s Pharmacy ceased sterile compounding in its Ocala lab after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used.

I previously blogged about this story, click here to read the entire post.

Franck’s Trouble in the Past.

According to the Ocala Star-Banner, the eye preparation case was the second time Franck’s faced claims of improper compounding. In 2009, Franck’s veterinary division allegedly improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died.

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.

Sources:

Medina, Carlos. “Franck’s Pharmacy Closes its Doors.” Ocala Star-Banner. (July 31, 2012). From: http://www.ocala.com/article/20120731/ARTICLES/120739961?p=3&tc=pg

Ulbricht, Christopher. “Wells Pharmacy Network Expands to Ocala, Florida.” Franck’s. (July 5, 2012.) From:  http://www.francks.com/

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.

New Details Released on Drug Enforcement Administration’s Investigation of Central Florida Pain Management Clinic

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Drug Enforcement Administration’s (DEA) investigation into a Longwood, Florida, pain management clinic continues. More details are being revealed about the case. DEA agents along with local police and sheriffs’ deputies raided the pain management clinic on June 14, 2013. Agents believe the evidence they have gathered suggests the clinic was operating as a “pill mill,” according to the Orlando Sentinel. Officials allegedly seized evidence at the clinic associated with at least ten (10) doctors and other clinic employees. No one has been arrested yet, but documents filed in federal court in Orlando suggest charges could be coming.

I previously blogged about this raid. Click here to read that blog.

Details of the Investigation.

According to the Orlando Sentinel, the DEA began surveying the alleged pill mill in January 2011, while investigating a doctor shopper. From July 2011 through May 2013, agents monitored the clinic. During the investigation, agents observed long lines outside the clinic, out-of-state license plates and groups of “patients” arriving at the clinic together. All of this behavior, according to authorities, is associated with pain clinics.

More concrete evidence against the pain management clinic, according to police officials, includes:

–  Patients stating that employees discussed selling pain pills and fake MRIs;

–  DEA agents observing drug deals made by patients coming from the clinic, in the vicinity of the clinic;

–  Used needles were found in nearby parking lots; and

–  Two of the clinic’s patients allegedly died from overdoses during the investigation.

Pain Management Clinic Physicians Made Millions.

It’s reported that the pain management clinic hired ten (10) doctors to write illegal prescriptions and employed others to falsify documents. For their willingness to participate in the illegal activity, the physicians allegedly made millions of dollars.

According to the Orlando Sentinel, the bank accounts of the clinic managers were analyzed as part of the investigation. From 2011 to 2013, more than $5.5 million in cash was deposited into the bank accounts of the clinic managers and physicians.

To read the entire article from the Orlando Sentinel, click here.

Keep in mind, at this point, these are just allegations made against the clinic and its employees and nothing has been proven by the state or federal government.

Be Mindful of the Prescription Drug Monitoring Database.

DEA agents used Florida’s prescription drug monitoring database to find out what types of pills and how many pills physicians at the Longwood pain clinic were prescribing. The prescription database was not intended to be used for criminal prosecution or law enforcement purposes. Yet it is routinely being used to prosecute physicians, pharmacists and pharmacies among others.

If You are a Health Care Professional Involved with Pain Management, Keep These Tips Handy.

The raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. I have represented a number of physicians who have been accused of “overprescribing.”  Some of these were criminal investigations by local law enforcement authorities, such as a county sheriff’s office. Some were investigations by the DEA. Some were investigations by the state licensing agency, such as the Florida Department of Health (DOH).

It is important physicians know how to protect themselves and their licenses from drug-seeking patients.  Click here to read tips I give to physicians I advise on this issue.

Contact Health Law Attorneys Experienced with DEA Cases and Licensing Actions.

The Health Law Firm represents physicians, pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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 all of these raids on pharmacies and pain clinics? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Rx for Danger: Pain Clinic Owners Made Millions, Hired 10 Doctors to Write Illegal Scripts, Feds Say.” Orlando Sentinel. (June 24, 2013). From: http://www.orlandosentinel.com/health/os-professional-pain-care-longwood-20130624,0,1172890.story

Indest, George. “Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic.” The Health Law Fir. (June 17, 2013). From: http://thehealthlawfirmblog.wordpress.com/2013/06/17/drug-enforcement-administration-agents-raid-central-florida-pain-management-clinic/

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.

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