Legal News

FDA: Stronger Guidelines Needed for Prescription Painkillers

The makers of a number of popular prescription painkillers will need to impose new guidelines and stronger restrictions to prevent abuse and misuse of the drugs, federal health officials announced this week.

On February 6, the U.S. Food and Drug Administration (FDA) sent letters to manufacturers and marketers of certain prescription extended-release pain medications called "opioids". The agency's letters ordered the companies to attend a Risk Evaluation and Mitigation Strategies (REMS) meeting to evaluate whether the benefits of opioids continue to outweigh risks of misuse, abuse and accidental overdose -- problems that have seen marked increases over the last 10 years. The New York Times reports that "[m]any doctors may lose their ability to prescribe 24 popular narcotics as part of [the] new effort to reduce the deaths and injuries that result from these medicines' inappropriate use."

The FDA's REMS invitation letters declare that the March 3 meeting is necessary "to ensure that prescribers, dispensers, and patients are aware of and understand the risks and appropriate use" of prescription opioids like fentanyl (Duragesic patch), methadone, and OxyContin.

According to CNNMoney.com, "FDA officials said they've seen reports of inappropriate prescribing by doctors amid the increase in misuse and abuse, both intentional and unintentional, of the products since they were first approved in the mid-1990s. Active ingredients in the drugs are designed to treat pain for an extended time, such as 12 hours. Drug abusers can tamper with such products and get all the effects of a drug at once, creating a heroin-like high."

• FDA News Release on Need for Meeting on Opioid Drugs
• FDA Template Letter Inviting Opioid Makers to REMS Meeting
• FDA Opioids Product Chart
• N.Y. Times: F.D.A. to Place New Limits on Prescriptions of Narcotics

Reuters: Opioid Makers Need Plan to Curb Risks: FDA

• CNNMoney.com: FDA to Implement New Restrictions for Some Pain Pills
• Duragesic Patch (fentanyl) (FindLaw)
• Pharmaceutical Drug Company Liability (FindLaw)
• Dangerous and Defective Products (FindLaw)

Full post as published by FindLaw's Common Law on February 13, 2009 (boomark / email).