FDA Public Hearing to Focus on Fentanyl Patch Risks

By Emily Cox
fentanyl patch
flickr/iPredator

Federal regulators are holding a public hearing Friday to discuss the effectiveness of a seven-year-old initiative to mitigate fentanyl patch risks, as the patches have been the subject of numerous recalls due to problems with the concentrated painkiller leaking from the fentanyl patch, causing overdoses and fatalities.

The FDA will host a joint meeting of its Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees August 3. The meeting will take place at the agency’s White Oak campus in Silver Spring, Maryland. The committees will go over the results of recent assessments on the effectiveness of risk evaluation and mitigation strategies (REMS) linked to the use of transmucosal immediate-release (TIRF) drugs. These are more commonly known as fentanyl patches.

A Johnson & Johnson subsidiary originally introduced the fentanyl patch as the brand name Duragesic pain patch. Now, it is widely available as a generic. Numerous drug companies make versions of the medication, including Watson, ALZA, and Mylan Pharmaceuticals.

The painkiller patches contain powerful fentanyl gel. Hypothetically, the patch delivers this gel slowly through the skin. However, direct contact with the gel can have devastating consequences.

Since its introduction, manufacturing problems have plagued the Duragesic patch with defective products that allowed gel to leak from the fentanyl patch, posing substantial overdose risks.

In December 2011, the FDA initiated a REMS program to make the manufacturing and distribution of fentanyl patches safer. Now, the drug has become intrinsically connected with the national opioid crisis. This isn’t due to the patches themselves but synthetic fentanyl that has infiltrated the U.S. market from overseas.

Fentanyl Patch Safety Hearing Part of Agency’s Fight in Opioid Epidemic

FDA Commissioner Scott Gottlieb issued a press release August 1. Gottlieb indicates that the public meeting is an important component of the agency’s fight against opioid abuse. However, he also referred to the importance of the FDA ensuring that patients who are suffering from significant pain to be able to access necessary pain relief.

“These TIRF products are medically important but also pose serious risks,” Gottlieb wrote. “We’re seeking the advice of outside experts on the effectiveness of the REMS and whether changes to the REMS might be necessary.”

Gottlieb also noted a significant decline in fentanyl patch prescriptions since the implementation of REMS. Currently, only about 5,000 patients have prescriptions for the patches nationwide. However, even then, the data indicates that 42 percent of fentanyl patch prescriptions are to non-opioid tolerant patients.

FDA to Look Into TIRF REMS and Possible Fentanyl Patch Use Expansion

According to the release, the FDA will ask the committees to evaluate the reliability of the FDA’s current data and to look if fentanyl patches are going to patients most in need, as well as if prescribing patterns are contributing to adverse health outcomes.

Furthermore, Gottlieb said that the FDA will seek manufacturer data to get a clearer picture of how well the fentanyl patch REMS program is working. However, it appears that the agency is looking into expanding fentanyl patch use once more.

“Ultimately, we need the advisory committee experts to advise the FDA on whether the new approaches we are considering will put us on the right path to helping patients in pain by making it possible for them to get these medicines while also reducing their known serious risks,” Gottlieb wrote. “As part of our ongoing commitment to the safe use of these products, the FDA will seek the committee’s feedback on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met.”

While the advisory committees’ recommendations are not binding, they often have a significant effect on regulatory policy.

Fentanyl Patch Recalls and Regulatory Action

Numerous manufacturers have issued fentanyl patch recalls over the past decade. Consequently, many critics question if the pain patch can be manufactured safely. If the fentanyl gel leaks due to manufacturing defects or the patch delivers it through the skin at an inconsistent rate, it can cause potentially fatal overdoses.

The FDA has also issued several safety warnings about fentanyl patch risks. In September 2013, the FDA issued a drug safety communication to remind patients that the fentanyl patch can still be deadly even after use, warning users and caregivers to exercise great caution with disposal.

The fentanyl patch REMS program meeting will be August 3 from 8am to 5pm at the FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Conference Center, Room 1503 in Silver Spring, Maryland.

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