FDA Allows Rehearing Deadline to Pass in Misbranding Case

The Food and Drug Administration (FDA) did not file a motion for rehearing with the U.S. Court of Appeals for the Second Circuit by the January 16, 2013 deadline in the case of United States v Caronia. In so doing, the appellate court’s setting aside of the conviction of pharmaceutical sales representative Alfred Carornia’s stands. The FDA charged Caronia with: (1) conspiracy to introduce a misbranded drug into interstate commerce; and (2) introducing a misbranded drug into interstate commerce, both involving violations of 21 U.S.C. secs. 331(a) and 333(a)(2). Observers speculate that the FDA will not pursue any further action on this case as it might set a precedent across the country that would prohibit prosecution of these types of cases.

Conviction

At trial, Caronia was found not guilty of introducing the drug Xyrem® into commerce. The jury did find Caronia guilty of conspiracy to market Xyrem while it was misbranded, but not marketing with knowledge that the labeling and warnings were inadequate. Xyrem is a central nervous system depressant that the FDA approved in 2002 for the treatment of narcolepsy patients with cataplexy, a condition involving weak or paralyzed muscles. The FDA required a “black box” warning label for Xyrem stating that: (1) it was approved only for patients between the ages of 16 and 65, (2) there was limited experience with use for patients over 65, and (3) it had not been tested on children. The FDA claimed that Caronia and a codefendant made statements to a physician posing as a prospective customer promoting the use of Xyrem to treat fibromyalgia, muscle disorders, chronic pain, and chronic fatigue syndrome. Caronia stated that the drug had been used with patients as young as 14 and, more frequently, with patients over 65.

Strategy

By letting this decision stand, the FDA is not risking a ruling by the U.S. Supreme Court that would apply throughout the country. Allowing this conviction to be set aside would allow the FDA to pursue these types of action in other judicial circuits, as this ruling only applies to the Second Circuit, which is comprised of New York, Connecticut, and Vermont. Richard Samp, chief counsel of the Washington Legal Foundation, which filed a brief in support of Caronia, said in an article published at Pharmalot.com, “It indicates to me that rather than fight, they’re interested in finding a way to conduct business as they have.”

Ability to Prosecute

In addition, the FDA does not believe that the current ruling of the Court of Appeals for the Second Circuit will impact how it enforces the law. According to Pharmalot, an FDA spokeswomen said, “The FDA does not believe that the decision will significantly affect the agency’s enforcement of the drug misbranding provision of the Food, Drug & Cosmetic Act.” She continued, “The decision does not strike down any provisions of the FD&C Act or its implementing regulations, nor does it find a conflict between the act’s misbranding provisions and the First Amendment or call into question the validity of the act’s drug approval framework.” The appellate court noted that free speech protections do not extend to false or misleading statements.

The FDA has until March to seek a hearing before the U.S. Supreme Court, according to the Pharmalot report. In addition, the FDA could seek a 60 day extension to make its filing.

New York City Gets Inventive in Its Crackdown on Opioid Abuse

The growing problem of prescription drug abuse, particularly in relation to opioids, has been a hot topic for federal and local government officials over the past year. In the summer of 2012, a citizen petition signed by more than 30 leading pain-addiction experts was sent to the FDA, asking for clarification and guidance to physicians on how to use extended-release painkillers. In the same time frame, the FDA released a Risk Evaluation and Mitigation Strategy (REMS) for a class of opioid medications, known as extended-release (ER) and long-acting (LA) opioid analgesics, used in pain treatments. In October of 2012 the FDA released a briefing on hydrocodone in anticipation of its Drug Safety and Risk Management (DSaRM) Advisory Committee meeting, and recently the FDA released a draft guidance relating to the development of abuse-deterrent opioids.

According to a recent report by the Substance Abuse and Mental Health Services Administration (SAMHSA), “prescription drug misuse is second only to marijuana as the nation’s most prevalent illicit drug problem, with approximately 22 million persons nationwide initiating nonmedical pain reliever use since 2002.” Officials are looking for inventive ways to combat this growing problem, and New York City has created a task force to tackle prescription drug misuse. According to the Partnership for Drug Free America, this initiative began in December of 2012 after officials identified 21 pharmacies that account for about one-fourth of the city’s oxycodone Medicaid reimbursements.

On January 10, 2013, New York City Mayor Michael Bloomberg announced that under a new city policy, emergency departments: (1)  will not prescribe long-acting opioid painkillers; (2) may prescribe no more than a three-day supply of opioids; and (3) will not refill lost, stolen or destroyed prescriptions. According to Deputy Mayor Gibbs:

“Changing practice by front line providers is key to changing the course of this epidemic…While prosecutors and the law enforcement community rightly focus on those who illegally prescribe, dispense or procure painkillers, health leaders need to focus on encouraging well-meaning doctors and pharmacists to prescribe and dispense these medications safely and judiciously. Our work will proceed on all fronts to curtail the harms that come from painkiller misuse.”

The mayor also released the new task force’s interim report on prescription pain killer abuse. The report noted that under new legislation, by the end of 2014, physicians will only be able to prescribe controlled substances electronically, which will circumvent the problem of forged prescriptions written on stolen prescription pads. The report also discussed a proposed regulation, initiated by the task force that would “require specific training for providers who prescribe more than 100 morphine equivalent doses (MED) per day to any patient not receiving end-of-life or cancer-related palliative care.” According to the report, the city’s next steps include:

  • Make naloxone more widely available.
  • Petition the FDA to modify the labels of prescription painkillersContinue to promote clinical guidelines on preventing misuse of prescription painkillers.
  • Support creation of standards for prescription drug monitoring systems by the federal government that allow for linkages between states.
  • Promote disposal of excess opioid painkillers.
  • Implement a temporary system that would prevent prescription forms from being activated until a doctor confirms that he or she has received the prescription pads.
  • Introduce a new education campaign for public high school students and parents.
  • Expand access to and use of all effective treatments for opioid dependence.

At a recent conference in California, New York City’s Police Commissioner, Raymond Kelly, announced “Operation Safety Cap” where GPS-enabled “bait bottles” will be stocked in pharmacies within their supply of regular prescription drug supplies. In the event of a robbery or theft, the bait bottles could lead officials to “stash locations” in the city, where drug dealers are storing large amounts of stolen prescription pain pills.

It remains to be seen what effect these policies and programs have on the growing problem, but if they are successful, keep your eyes open for similar programs in cities across the United States.