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. […]

By |2024-03-14T10:01:40-04:00May 15, 2018|Pharmacy Law|

Florida Board of Pharmacy Approves Change to Destruction of Controlled Substances Rule

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

At its meeting held in Orlando, Florida, on February 12, 2014, the Florida Board of Pharmacy approved final changes to Rule 64B16-28.303, Florida Administrative Code. This rule governs the destruction of controlled substances by Class II Institutional Pharmacies.

The focus of the new rule changes is to ensure that either the prescription department manager (PDM) or the consultant pharmacist of record signs off on all destruction of controlled substances. Further, the rule requires that a copy of the destruction documents be mailed to the Drug Enforcement Administration (DEA) within one business day of destruction.

According to the Board’s statement, the purpose of the […]

DEA Offers New Prescription Drug Return Policy

3 Indest-2009-2By 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 […]

By |2024-03-14T10:01:40-04:00May 15, 2018|Pain Management, Pharmacist, Pharmacy, Pharmacy Law|

Pharmacies May be Liable for Filling Valid Prescriptions

Lance Leider headshotBy Lance O. Leider, J.D.

Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing the medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to […]

The 25 Biggest Mistakes Pharmacists Make After Being Notified of a Department of Health Complaint

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

The investigation of a complaint which could lead to the revocation of a pharmacist’s license to practice and the assessment of tens of thousands of dollars in fines, usually starts with a simple letter from the Department of Health (DOH). This is a very serious legal matter and it should be treated as such by the pharmacist who receives it. Yet, in many cases, attorneys are consulted by pharmacists after the entire investigation is over, and they have attempted to represent themselves throughout the case. Often, the mistakes that have been made […]

37 Central Floridians Charged with Illicit Pharmaceutical Drug Trafficking

By Dr. Thu Pham, O.D., Law Clerk, The Health Law Firm

Attorney General Pam Bondi along with special agent Mark R. Trouville of the Drug Enforcement Administration (DEA) and Longwood Police Chief Troy Hickson announced, on June 20, 2012, the execution of 37 arrest warrants stemming from state drug charges.  The defendants all reside in Central Florida.

Click here to read the entire press release from the Florida Attorney General.

The Defendants’ Charged with Felonies.

The charges for the defendants ranged from first degree to third degree felonies.  The defendants have been charged with acts, such as conspiracy to traffic Oxycodone, solicitation to deliver Oxycodone, and possession of Hydromorphone with intent to […]

Two Pharmacists and One Dentist in Central Florida Arrested for Prescribing and Dispensing Prescription Drugs

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

The Lakeland Ledger reports that Polk County Sheriff’s Detectives arrested a dentist and two pharmacists on September 5, 2012, in three unrelated cases dealing with illegally prescribing and dispensing painkillers. The sheriff’s office said the three arrests are part of its efforts to target prescription drug abuse.

To read the entire Lakeland Ledger article, click here.

The Arrest of the Dentist’s Daughter Led to His Investigation and Arrest.

In May 2012, the dentist’s daughter was arrested for allegedly forging more than 500 […]

Two Central Florida CVS Pharmacies Get Controlled Substance Licenses Pulled by Drug Enforcement Administration (DEA)

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

The U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida, on September 12, 2012, according to a number of sources. The two pharmacies will no longer be able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision is in response to a government crackdown on the distribution of painkillers. Sanford is in Seminole County, a suburb of the greater Orlando area.

To see the court records from this case, click here.

We’ve […]

Filling Phony Prescriptions for Pain Killers Lands Orlando Pharmacist Behind Bars

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

Another pharmacist was led away in handcuffs during a September 25, 2012, raid on an Orlando-area pharmacy, according to a number of sources. The pharmacist is accused of filling prescriptions for oxycodone, even though he allegedly knew the prescriptions were not legitimate.

Click here to see video of the arrest from WFTV in Orlando.

Investigation by Narcotics Agents Led to Arrest.

In December 2011, narcotics agents searched the same pharmacy and found 22 prescriptions that were suspected to be fraudulent, according to the Orlando Sentinel.

Agents […]

Key West Pharmacy Blows Whistle on Medicaid Fraud and Comes Out on Top

By Danielle M. Murray, J.D.

On September 27, 2012, Public Citizen, a watchdog group, reported whistleblowers have initiated $6.6 billion in penalties against drug manufacturers in 2012. Most of these penalties are for fraudulently overcharging government programs. The report names a small Key West, Florida, pharmacy as one of the top whistleblowers in the country. The pharmacy noticed and reported that drug manufacturers were charging highly inflated prices to Medicaid.

To read the entire report on from Public Citizen, click here.

Whistleblowing Can Pay Off Big.

The study shows that the government collected billions of dollars, just in 2012, as a result of whistleblower efforts.

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