Opioid Manufacturer Gets FDA Warning Letter Over Lack Of Risk Information

Federal regulators indicate that Collegium Pharmaceutical, Inc., the makers of the opioid drug Xtampza ER, failed to provide adequate warnings about risks associated with the medication, in what some see as a sign of the agency cracking down on how the powerful pain pills are marketed. 

FDA warnings to pharmaceutical companies have been few and far between so far in the Trump administration, but the agency took the time to single out Collegium in a letter (PDF) last month.

The FDA’s Office of Prescription Drug Promotion (ODPD) indicates that the company failed to warn of serious risks linked to the use of Xtampza ER at a major conference last summer.

“The exhibit booth was displayed at the American Society Health-System Pharmacists (ASHP), and viewed by an OPDP representative. The exhibit booth makes false or misleading representations because it fails to adequately communicate information about the serious risks associated with Xtampza ER use,” the letter states. “These violations are particularly concerning given the serious public health impacts of opioid addiction, abuse, and misuse that can lead to overdose and death.”

While a small infraction, compared to a warning regarding a widely used label or direct-to-consumer advertising, the letter came just days after FDA Commissioner Scott Gottlieb announced new FDA plans for combating the opioid abuse crisis. Some say the letter is a product of the agency’s new, tougher policy on opioids in action.

The letter notes that the prescribing information for Xtampza ER contains boxed warnings for addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome and interactions with other drugs, in addition to other contraindications and less serious warnings.

The agency also indicates that Collegium has a history of these types of problems, and that ODPD warned Collegium in September 2016 on presentations that, similar to the booth, failed to provide adequate risk information. There were warnings at the booth, but they were on a side panel several feet away in small text and likely missed by most observers, the letter notes.

In addition, the booth represented the drug’s abuse-deterrent properties in a misleading way, putting the benefits in prominent text at eye level, and the fact that there were still ways the drug could be abused near to the floor and behind a chair.

The FDA has called for Collegium to turn over all of its promotional materials and explain how it plans to avoid such missteps in the future.

Opioid Crisis

In the United States, evidence now suggests that drug overdoses kill more people than gun homicides and car crashes combined. In fact, between 1999 and 2015, more than 560,000 people died from drug overdoses. Even as abuse has seemingly decreased, opioid overdose deaths have increased.

In 2015, two-thirds of drug overdoses were linked to opioids, including Percocet, OxyContin, heroin, and fentanyl, which on its own is largely driving the number of opioid deaths.

Americans use more opioids than any other country in the world, with the number of prescriptions in the U.S. last year providing enough pills to medicate every American 24 hours a day for three weeks consecutively. Opioid overdoses kill more than 90 Americans every day, experts say, and the economic burden of opioid misuse costs the country $78.5 billion per year.