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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/

By The Health Law Firm|2024-03-14T10:00:30-04:00June 1, 2018|Categories: Department of Health, Health Care Industry, In the News, Pharmacy, The Health Law Firm Blog|Tags: CDC, compounding, drug recall, emergency suspension order, ESO, eye infections, FDA, florida, Franck's. Franck's pharmacy, fungal eye infections, Ocala, pharmacist, pharmacy|Comments Off

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/

By The Health Law Firm|2024-03-14T10:00:31-04:00June 1, 2018|Categories: In the News, Pharmacy, The Health Law Firm Blog|Tags: CDC, compounding, drug recall, eye infections, FDA, florida, Franck's. Franck's pharmacy, fungal eye infections, Ocala, pharmacist, pharmacy|Comments Off

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.

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.

By The Health Law Firm|2024-03-14T10:00:32-04:00June 1, 2018|Categories: In the News, Pharmacy, The Health Law Firm Blog|Tags: criminal fraud, drugs, enforcement, FDA, FDA compliance, federal securities law, Food and Drug Administration, inspections, investigation, investors, KV Pharmaceuticals, lawsuit, pharmacy, securities fraud class action, shareholders|2 Comments

Settlement Reached in GlaxoSmithKline Healthcare Fraud Case

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

GlaxoSmithKline (GSK), a prescription drug manufacturer, will pay $3 billion in fines to resolve allegations of healthcare fraud. The settlement was announced by federal prosecutors on July 1, 2012, and in a press release from the Florida Attorney General on July 2, 2012. This is the largest healthcare fraud settlement in U.S. history.

Settlement Resolves Allegations Against GSK Related to Healthcare Fraud.

The settlement resolves allegations that GSK:

Marketed the depression drug Paxil for off-label uses, such as use by children and adolescents;
Marketed the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages;
Marketed the asthma drug Advair for off-label uses, including first-line use for asthma;
Marketed the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions;
Marketed the nausea drug Zofran for off-label uses, including pregnancy-related nausea;
Made false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
Offered kickbacks to healthcare professionals to induce them to promote and prescribe certain prescription drugs; and
Submitted incorrect pricing data for various prescription drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.

GSK Will Also Plead Guilty to Criminal Charges as Part of Settlement.

As part of the settlement, GSK has will plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (FDCA). Allegedly, GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs contained labels that were not in accordance with their FDA approvals. Additionally, GSK allegedly failed to report certain clinical data regarding Avandia to the FDA.

Florida to Receive Over $56 Million In Settlement.

Florida will receive more than $56 million as part of the settlement with GSK. Florida Attorney General, Pam Bondi, announced the state’s participation in the settlement on July 2, 2012.

Settlement Stems From Whistleblower Actions.

The settlement is based on four qui tam, or whistleblower, actions brought by individuals pursuant to state and federal false claims. To view the federal False Claims Act, click here. A National Association of Medicaid Fraud Control Units team, along with several other federal agencies, investigated the matter and conducted settlement negotiations with the defendants. Florida’s civil investigation was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is part of the Medicaid Fraud Control Unit.

Contact Health Law Attorneys Experienced in Healthcare Fraud Cases.

The Health Law Firm represents physicians, medical practices, pharmacists, pharmacies, and other health providers in healthcare fraud cases, including investigations, regulatory matters, litigation, and audits involving government health programs (Medicare, Medicaid, TRICARE).

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:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Historic Healthcare Fraud Settlement.” Florida Office of the Attorney General. (July 2, 2012). Press Release. From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/E494FDADFF113AC885257A2F0068F790

Schmidt, Michael S. and Katie Thomas. “GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement.” New York Times. (July 2, 2012). From: http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

By The Health Law Firm|2024-03-14T10:00:32-04:00June 1, 2018|Categories: In the News, The Health Law Firm Blog|Tags: Attorney General, audit, false claims act, FDA, florida, Florida Medicaid, fraud defense attorneys, fraud schemes, GlaxoSmithKline, GSK, healthcare fraud, medicaid, medicaid fraud control unit, medicare, mfcu, qui tam, realtor, settlement, whistleblower|Comments Off

Fake Doctor in Texas Accused of Injecting Patients with Silicone Instead of Botox

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

A South Texas woman was charged on October 31, 2013, for allegedly injecting people with silicone, that she claimed was Botox. The phony health professional, described in some media reports as an “unlicensed plastic surgeon,” has been charged with practicing medicine without a license. According to Reuters, the unlicensed health professional could also be facing charges of manslaughter if investigators confirm that a woman’s death was related to treatments received from the imposter.

Click here to read the entire article from Reuters.

If convicted, the fake health care professional could spend up to ten (10) years in prison and have to pay up to $10,000 in fines.

Investigators Looking for More Victims.

Investigators say this phony health professional would travel to different spas and massage parlors along the Texas-Mexico border offering her services and leaving advertisements. She allegedly made injections in patients’ lips, buttocks and legs. The advertisements seized by authorities touted collagen treatments for $250.

According to Fox News, investigators learned of the underground practice when a victim allegedly received a series of injections in her legs in August 2013. The victim has allegedly been hospitalized since October 9, 2013. Authorities also say they are investigating the death of a woman who may have been a victim of the treatments. So far around 30 victims have been identified, but investigators say there could be more, according to Fox News.

To read the Fox News story, click here.

Underground Injections Happen All Over the Country.

This is by no means the first report we’ve heard of phony health care professionals injecting people with toxic chemicals.

In February 2013, a South Florida man was arrested for allegedly injecting people with silicone in a West Palm Beach motel room. According to police, this fake physician injected his patients with buttocks-enhancing silicone injections. He would then allegedly seal up the skin wounds with Krazy Glue. To read more on this, click here to read my previous blog.

As far as we know, there is no relationship between the Florida fake doctor and the Texas fake doctor. However, they could have attended the same medical school.

Practicing Without a License Is a Crime.

Practicing medicine without a license is a crime. Additionally, so is helping someone practice medicine without a license. As a practitioner, you may be asked to supervise or join a practice. Remember that your license may be at stake with any wrongdoing by your subordinates. Before you join a practice or agree to supervise others, check first with the Department of Health (DOH) that the other providers are legitimate. You can verify a license for free on the DOH’s website.

Also, remember that a license to practice medicine in Venezuela, Cuba, Mexico or anywhere else, is just that: a license to practice in that country. It does not allow a person to practice medicine in the United States. A specific license from the State of Florida is required to practice in Florida, except for certain military and federal physicians. Always check a physician’s license.

More Stories on Fake Physicians and Other Phony and Fraudulent Professionals to Come.

In the near future on this blog we will include additional articles on fake doctors and health care professionals.

To see a blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

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, 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?

What do you think of all of these news stories of phony health care professionals? Please leave any thoughtful comments below.

Sources:

Taylor, Jared. “Phony Plastic Surgeon Accused of Using Silicone for Botox.” Reuters. (October 31, 2013). From: http://www.reuters.com/article/2013/10/31/us-usa-crime-texas-idUSBRE99U1CT20131031

Associated Press. “South Texas Woman Charged for Allegedly Injecting Client; Authorities Seek More Victims.” Fox News. (October 31, 2013). From: http://www.foxnews.com/us/2013/10/31/south-texas-woman-charged-for-allegedly-injecting-clients-authorities-seek-more/

“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.

FDA Issues New Warning for Popular Type 2 Diabetes Drug

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new class of frontline treatment for type 2 diabetes. It was approved in 2013 and quickly gained popularity among health care providers and patients. Other drugs in the class include Invokament, Jardiance, Xigduo XR, Farxinga and Glyxambi. These drugs, known as SGLT2 inhibitors, are intended to improve glycemic control in patients with type 2 diabetes by blocking the absorption of glucose in the kidneys.

The Problem.

According to the FDA’s warning, SGLT2 inhibitors can lead to the development of diabetic ketoacidosis, a serious condition that can result in cerebral edema, pulmonary edema, heart attacks, strokes, cardiac dysrhythmia, nonspecific myocardial injury, diabetic retinopathy, severe dehydration, coma and death. The FDA recently took notice of these significant health risks and issued a safety announcement that warned of the serious side effects potentially resulting from treatment with SGLT2 inhibitors. To read the FDA’s warning, click here. To read one of our blogs on a similar case, click here. Click here to find out how The Health Law Firm can help you with a situation such as this.

Comments?

Did you develop ketoacidosis after taking a SGLT2 drug such as Inkovana? If you or a loved one took Invokana or another type 2 diabetes drug that resulted in ketoacidosis, you may have legal options. Please leave any thoughtful comments below.

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.

KeyWords: Food and Drug Administration, FDA, defense attoryney, defense lawyer, defense counsil, Inkovana, Type 2 Diabetes Drug, SGLT2 inhibitors, products liability attorney, products liability lawyer, ketoacidosis, safety announcement, recall, safety warning, drug side effects, plaintiff products liability attorney, health care attorney, health care lawyer, health law, The Health Law Firm

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 © 1996-2015 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:01:18-04:00May 15, 2018|Categories: Pharmacy Law Blog|Tags: defense attoryney, defense counsil, defense lawyer, drug side effects, FDA, Food and Drug Administration, health care attorney, health care lawyer, health law, Inkovana, ketoacidosis, plaintiff products liability attorney, products liability attorney, products liability lawyer, recall, safety announcement, safety warning, SGLT2 inhibitors, the health law firm, Type 2 Diabetes Drug|Comments Off

Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases

Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal

Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application).

Federal preemption stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling. This interpretation was affirmed by the U.S. Supreme Court in 2011 in the Pliva, Inc. v. Mensing case. The Court, however, left the door open when it added “Congress and the FDA retain the authority to change the law and regulations if they so desire.”

In November 2013, the US Food and Drug Administration (FDA) began the process to do just that when it published a proposed rule that will require generic drug companies to update the labeling of their drugs in light of new safety risks even though the RLD labeling for those products has different information on warnings, precautions, contraindications, adverse reactions and the like.

Under the proposed regulation, when the ANDA holder has “newly acquired information” that presents “sufficient evidence of a causal association” between the unlabeled warning and the approved generic drug, the generic manufacturer must submit a Changes Being Effected (CBE-0) supplement to its ANDA and immediately change its label. Also, the ANDA holder will be required to send the NDA holder both the labeling change and a copy of the information supporting the change. Any changes ultimately approved by FDA would affect both the generic label and the RLD holder’s labeling.

The FDA has noted that “if this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.”

Interested parties wishing to provide input on the proposed rule must submit comments by January 13, 2014. The full text of the proposed rule is available at this link.

The Pliva v. Mensing, 131 S.Ct. 2567 (2011) decision is available at this link: http://www.supremecourt.gov/opinions/10pdf/09-993.pdf.

About the Author: Alina Denis Jarjour is a business attorney, corporate governance / compliance professional and mediator. In addition to being a private practitioner, Alina has served in executive level legal, operational and governance/compliance roles within life sciences, telecommunications and technology companies. Her firm, Jarjour | Legal, works closely with clients engaged in the life sciences, tech / telecom, media, healthcare, consumer products and non-profit activities in and outside of the United States. Alina is an alumna of the University of Pennsylvania Law School, is bilingual (English/Spanish) and speaks frequently on business development, regulatory, compliance, conflict resolution and legal topics.

This article was originally published in the Florida Bar December 2013 Health Law Monthly Updates.

By The Health Law Firm|2024-03-14T10:01:40-04:00May 15, 2018|Categories: Pharmacy Law|Tags: abbreviated new drug application, ANDA, brand name drug company, brand name prescription drugs, drug label, failure to warn, FDA, Food and Drug Administration, Generic Drug Cases, Generic Drug Labeling, generic drugs company, generic manufacturer, generic pharmaceutical manufacturer, generic prescription drugs, NDA, new drug application, prescription drugs, product liability, product liability action, reference listed drug, RLD|Comments Off

DEA Offers New Prescription Drug Return Policy

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

Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.

Hopefully this will help to eliminate many of the problematic situations that pharmacists and physicians found themselves in when they accumulated returned or unused medications from patients for destruction.

This move intends to address the rising number of injuries and deaths associated with controlled substance drugs, particularly opioids. Reducing the stockpile of unneeded prescription drugs from American homes will limit teenagers’ accessibility to their parents’ medications and reduce burglaries for such substances. According to The New York Times, this demographic is known to be the most prevalent abuser of such controlled substances.

To read the full story from The New York Times, click here.

Prior Methods of Prescription Drug Disposal.

Under the Controlled Substances Act, patients were only allowed to dispose of unused drugs themselves or surrender them to law enforcement. Personal disposal of controlled substances typically means flushing pills down a toilet or throwing them in the trash. Because this can pose a risk toward animals and clean drinking water, these methods are frowned upon by environmentalists and the Environmental Protection Agency (EPA).

Drug “take back” programs are another option when it comes to disposing of unused prescription drugs. These events are organized by the DEA and are held twice a year at local police departments across the country. During these programs, citizens can anonymously drop off any unused prescription drugs. According to The Wall Street Journal, the Department of Justice (DOJ) reported that a nationwide event in April 2014 brought in 390 tons of prescription drugs at more than 6,000 sites. In the past four years, these collection events have removed from circulation more than 4.1 million pounds of prescription medication from across the country.

Although these events prove successful, many healthcare professionals are optimistic for the bigger impact the pharmacy “take back” programs may have. Providing consumers convenient year-round access to medication disposals will be positive reinforcement to regularly dispose of unused prescription medications. This method is believed to be more likely to accomplish the mission of shrinking the pool of unused and potentially fatal controlled substances in American homes.

To read the full article from The Wall Street Journal, click here.

Ironing Out Details of the New Plan.

There are many logistics to consider to ensure these pharmaceutical “take back” programs will be successful. The programs will not be mandatory, as the decision to take part will be the under the sole discretion of each company. The pharmacies must voluntarily choose to register with the DEA in order to start receiving the leftover prescriptions. In the past, pharmacies have not generally wanted to accept the hassle of offering such a program. However, the DEA expects many pharmacies to jump on the bandwagon to showcase good-faith effort of keeping drugs out of the wrong hands.

DEA-approved organizations collecting the unused drugs will include hospital pharmacies, narcotic treatment programs, and companies contracted by other collectors to destroy controlled substances.

There are concerns circling the initiative. Some pharmacies do not have the resources required to accommodate incinerators, thus limiting the locations available to consumers. In addition, professionals are concerned with the lack of regulations listed in the new plan. There are no set requirements on how the prescriptions should be destroyed. The rules simply mandate that the drugs are altered into a permanent, irreversible state.

The burden of payment has also not been discussed or outlined in the new plan. Who will cover the cost of packaging and disposal has yet to be decided. Also, to be considered is the challenge of keeping the returned prescriptions safe until destruction. An unsecured, unmonitored return site containing stock piles of addictive drugs would be a gold mine for many addicts and criminals. Should a theft occur at one of these drop-off receptacles, who would be held liable? The American Pharmacists Association has already expressed concern of pharmacy legal liability.

The biggest obstacle of all, however, may be convincing the general public that returning unused pills is a necessary moral obligation.

Comments?

Would you participate in this type of prescription drug return program? As a pharmacist or someone who works at a pharmacy, what are your concerns with this take back program? Please leave any thoughtful comments below.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals. We can review business referral arrangements and provide legal counsel on whether they are not in violation of federal and state anti-referral laws. The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings.

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

Sources:

Barrett, Devlin. “U.S. to Allow Pharmacies to Take Back Unused Prescription Drugs.” The Wall Street Journal. (September 08, 2014). From: http://online.wsj.com/articles/u-s-to-allow-pharmacies-to-take-back-unused-prescription-drugs-1410186602

Saint Louis, Catherine. “D.E.A. to Allow Return of Unused Pills to Pharmacies.” The New York Times. (September 08, 2014). From: http://www.nytimes.com/2014/09/09/health/unused-pills-return-to-pharmacies.html?_r=0

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.

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