FDA announces new rules for prescription painkillers industry

by Michael Heygood

The U.S. Food and Drug Administration has this month introduced new safety measures for extended-release and long-acting opioid medications, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

The drug companies that market powerful painkiller medications will be required to train U.S. doctors, nurses and other health professionals in the safe use of the drugs, which are blamed for thousands of fatal overdoses each year.

“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”

The new rules affect more than 20 companies that manufacture these opioid analgesics. Under the new REMS, companies will be required to make education programs available to prescribers as well as make available FDA-approved patient education materials on the safe use of these drugs.

According to the FDA. the drugs in question—extended-release and long-acting opioid medications—are associated with serious risks of overuse, abuse, misuse and death and the numbers continue to rise. The Centers for Disease Control and Prevention has reported that 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications—nearly four times as many deaths compared to 1999.

Key components of the new measures include:

  • Training for prescribers: Re-educational programs for prescribers of these opioid medications will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, the education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction, and general and specific drug information for these opioid analgesics.
  • Updated Medication Guide and patient counseling document: These materials contain consumer-friendly information on the safe use, storage and disposal of these opioid analgesics. Included are instructions to consult one’s physician or other prescribing health care professional before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.
  • Assessment/auditing: Companies will be expected to achieve certain FDA-established goals for the percentage of prescribers of these opioids who complete the training, as well as assess prescribers’ understanding of important risk information over time.

It is expected that the first continuing education activities under the program will be offered to prescribers by March 1, 2013.

Some health care experts stressed that training should be required for all prescribers. But FDA officials said the programs will be optional for now because making them mandatory would require a new law by Congress.

The new FDA plan covers about 30 opioid drugs, including Purdue Pharma’s OxyContin, Johnson & Johnson’s Duragesic fentanyl patch and Pfizer’s Embeda. A complete list of the drugs involved can be found by visiting the FDA’s website.

The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions. We have the resources and experience to protect a person’s rights and the rights of their loved ones against irresponsible pharmaceutical companies and physicians.

If you or a loved one has experienced the tragedy of losing a family member as a result of prescription narcotics usage, you and your family deserve answers to your questions. If your loss was as a result of a defective drug or perhaps a physician’s negligence, you have the right to demand that the drug company or negligent physician be held responsible.

Contact the law firm Heygood, Orr & Pearson for a free consultation so we can help you determine the best way to protect your legal rights and interests. You can reach us by calling our toll-free hotline at 1-877-446-9001, or by filling out our free case evaluation form.

by Michael Heygood

Michael Heygood is a licensed attorney and partner at HO&P who focuses on insurance and corporate litigation, and other civil arenas. Michael has been named multiple times to the Super Lawyers List.