FDA denies making a promise on opioids

Share this article:
Rep. Harold Rogers
Rep. Harold Rogers

Contrary to a claim by a Kentucky Republican congressman that he was assured by FDA that it would not approve new opioids unless they had abuse-deterrent formulations, the agency says it never made such a commitment. Rep. Harold Rogers made his claim in commenting to the New York Times on the agency's Oct. 25 approval of Zogenix's single-ingredient hydrocodone bitartrate analgesic Zohydro ER, the day after it said it had agreed to support regulatory restrictions on combination hydrocodone products.

The approval had “dismayed” public health advocates, the newspaper reported, noting that an advisory panel last December had voted 11-2 against it because it could lead to the same type of abuse and addiction as OxyContin before it was reformulated to deter abuse.

FDA Press Office spokesperson Morgan Liscinski said the agency's Office of Legislation “has reached out to Rep. Rogers' office regarding his comments.”

In an earlier statement on the controversy, FDA said it was “committed to ongoing efforts to reduce opioid misuse and abuse while seeking to ensure that patients in pain continue to have appropriate access to these products. We consider the development of opioid analgesics with abuse-deterrent properties to be a public health priority and are actively supporting product development in this area, but the science is still in its early stages and abuse-deterrent formulations are not available for most ER/LA analgesics. Accordingly, the FDA does not believe it is feasible at this time to require that all new solid oral dosage form opioids have abuse-deterrent properties.”

Share this article:
You must be a registered member of MMM to post a comment.


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...