Gottlieb Asserts FDA Authority in Considering Opioid Risks

Last week the FDA made a bold move by requesting that Endo Pharmaceuticals remove its opioid pain medication, reformulated OPANA® ER (oxymorphone hydrochloride), from the market, stating the agency’s concern that “the benefits of the drug may no longer outweigh the risks.” This action – the first time the FDA has taken steps to remove a currently marketed opioid product from the market because of potential abuse – shows that new FDA Commissioner Scott Gottlieb is not hesitating to position the FDA as a force to be reckoned with in the nation’s ongoing opioid crisis.

“This is a bold step by Commissioner Gottlieb to push the limits of FDA jurisdiction to advance the public health,” said Coalition for Healthcare Communication Executive Director John Kamp. “It’s the leadership I expected from Gottlieb, and while controversial in some sectors, it shines new light on what can be done from the Commissioner’s office.”

Specifically, Gottlieb stated that the opioid epidemic is a public health crisis and that the FDA “must take all necessary steps to reduce the scope of opioid misuse and abuse.” He noted that the agency “will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

A June 8 statement from the FDA noted that the FDA’s decision is based on a review of all available postmarketing data, which represents a shift in the abuse of the product from nasal to injection following the product’s reformulation, which has been associated with a serious outbreak of HIV and hepatitis C and cases of a serious blood disorder. In March 2017, an FDA advisory committee voted 18-8 that the benefits of Opana ER “no longer outweigh its risks.”

According to Center for Drug Evaluation and Research Director Janet Woodcock, “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.” Woodcock added that this action “will protect the public from further potential for misuse and abuse of this product.”

The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency said it intends to take steps to formally require its removal by withdrawing approval.

In a June 8 press release, Endo stated that it is reviewing the FDA’s request “and is evaluating the full range of potential options as we determine the appropriate path forward.” Endo also stated that “Despite the FDA’s request to withdraw OPANA® ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed.”