Regulatory Focus™ > News Articles > Senators Press FDA to Explain Regulation of Generic Opioids

Senators Press FDA to Explain Regulation of Generic Opioids

Posted 02 May 2014 | By Alexander Gaffney, RAC

A group of senators are pressing the US Food and Drug Administration (FDA) to provide a more predictable pathway to market for generic opioid painkillers in the hopes of ensuring that new versions of the drug will retain the abuse-deterrent qualities of the existing products.


FDA's policies on generic opioid painkillers have always been a bit wonky on account of the agency needing to balance two competing factors: policy and law.

On one hand, the agency wants to reduce levels of painkiller misuse and abuse, and has also expressed a preference for consumers and patients having access to affordable medicines. On the other, the agency is bound to approve drugs that meet its regulatory requirements and do not pose a heightened risk to consumers.

But in between these two policy goals lie opioid-based painkillers, and a question: Just how effective are various different abuse-deterrent technologies?

Past FDA actions and policies seem to indicate that while FDA prefers products which make use of the technologies, they're not the panacea some branded drug manufacturers make them out to be.

For example, in June 2013, FDA finalized a decision permitting the sale of non-abuse-resistant versions of the painkiller Opana ER after it said that the original versions of the drug had not been withdrawn from the market for reasons of safety or efficacy. Endo Health Solutions, Opana's manufacturer, had argued that non-abuse-deterrent versions of the drug would introduce a public health crisis. FDA, meanwhile, had found Endo's deterrence data unconvincing.

But just months earlier in April 2013, FDA highlighted the other side of that same enforcement approach. Specifically, if companies could provide data indicating that its drugs were withdrawn for reasons of safety or efficacy, and that the new versions of the drug were more abuse-resistant, then FDA would keep non-abuse-deterrent versions of the drug off the market.

At that time, FDA said it would not approve any non-abuse resistant forms of Purdue's Oxycontin, citing the effectiveness of Oxycontin's abuse-deterrent effects.

(Note: In both cases, generic manufacturers were seeking to market their generic drugs based the original, non-abuse-deterrent formulations of the drug, which were no longer marketed by either Purdue or Endo. If FDA determined that the drugs were removed from the market because they were unsafe, the generic companies' applications would have been automatically rejected, as they were in the case of Oxycontin.)

New Policies

Beyond case-by-case decision-making, FDA has also been releasing broader policies on opioid resistance as well.

In January 2013, it released a draft guidance document intended to require manufacturers to provide it with specific data on the abuse-deterrent qualities of each drug before FDA will allow them to label a drug as being resistant to abuse.

And in September 2013, the agency said it would require all sponsors of long-acting and extended-release opioids to conduct new clinical trials assessing how their products are actually misused and abused-data which might be used to assess the effectiveness of abuse-deterrent qualities.

Senators: What's the Deal with Generic Opioids?

But with the October 2013 approval of Zohydro, a pure hydrocodone pill devoid of abuse-deterrent properties (and, for that matter, liver damage-causing acetaminophen), FDA's abuse-deterrence framework is once again becoming subject to intense congressional scrutiny.

FDA has fought back against this pressure, calling legislative meddling in its approvals "extremely troubling," and has been vigorously defending its decision to approve the drug in recent weeks in TV appearances, speeches and on its website.

Now a group of four Republican senators is taking a slightly different approach to the controversy and asking the agency about its policies on abuse deterrence in general.

In their 1 May 2014 letter to FDA Commissioner Margaret Hamburg, the senators note their "concern" that FDA has yet to finalize its January 2013 draft guidance document on abuse deterrence, and urged Hamburg to finalize that document as soon as possible.

But as the senators explain, that document was targeted at new opioid products-not generic opioid products. "The same concerns are of no less importance to the generic market," the senators write. "It is essential to preserve the incentives for innovators to develop and improve their products, while providing generic manufacturers with a clear understanding of what standards will be applied to their products as they go through the review process."

"It is important to ensure that the FDA does not apply a less stringent abuse standard for generic products," they added.

The senators go on to list six questions for Hamburg, primarily focused on when FDA's abuse-deterrence guidance will be finalized, the work that has gone into finalizing it at the agency, and whether the public will be able to weigh in on the issue.

The senators also pressed Hamburg to explain how the agency plans to "approach the review of [generic opioid] products from now until the issuance of [the] final guidance to ensure regulatory certainty and consistency," and how it plans to ensure the guidance document's consistency with the Hatch-Waxman Act of 1984.

The letter is co-signed by Sens. Tom Coburn (R-OK), Michael Enzi (R-WY), Richard Burr (R-NC) and Kelly Ayotte (R-NH).

Read the Letter

Regulatory Focus newsletters

All the biggest regulatory news and happenings.