FDA Sets New Opioid Generics Guidelines

Scott Gottlieb, MD

The US Food and Drug Administration (FDA) has shared regulatory plans to induce the development of opioid generics formulated to prevent drug abuse.

In a statement published Tuesday, Scott Gottlieb, MD, FDA Commissioner, touched on the transition from an opioid-dominated market, to the implementation of generic products with abuse-deterrent formulations (ADFs).

The FDA must have the ability to improve access to newer formulations through generic competitors, Gottlieb said, for “appropriately selected and monitored patients.”

To date, 10 opioid drugs with ADF properties have been approved by the FDA. However, Gottlieb said there’s a need for more expediency and accessibility in getting such products onto the market.

“In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids,” Gottlieb said. “This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart.”

The FDA also intends to ease the length of regulatory process for generic ADF opioid developers and improve the review process with improved testing methodologies for evaluating features such as abuse deterrence for both brand and generic products.

New tools to expedite generic development are also being considered, Gottlieb said.

“The same features that make drugs hard to manipulate and abuse also make these formulations more complex, and therefore harder to develop generic versions of,” Gottlieb said.

The intention of these new guidelines is set to create a “more robust path” for generic ADF opioid applicants, Gottlieb said. The FDA’s goal is to make the prescription of a new-formulation opioid more commonplace than its predecessors in any even when an opioid drug is appropriate for use.

Though the guidelines are the newest among a continuing trend of FDA efforts to stifle the opioid epidemic, Gottlieb acknowledged that opioid drugs can still be manipulated for abuse in the new ADF generics regulation. The administration is therefore evaluating the actual efficacy of “abuse deterrent” products in clinical settings.

“Our goal is to decrease the rate of new addiction, and thus any unnecessary legitimate and especially illicit use of opioids,” Gottlieb said. “Rather, this is an effort designed to encourage the shift — only when opioids are clinically appropriate ‒ from existing, easily abused products to those that are harder to manipulate.”

The streamlining guidelines comes at a new boiling point in the opioid epidemic. This month, the Council of Economic Advisers estimated the cost of the epidemic to reach $504 billion in the US in the most recently available year of data, 2015. That rate is 6 times greater than previously estimated.

On Monday, the FDA granted a New Drug Application priority review to lofexidine, a treatment designed to mitigate opioid withdrawal symptoms. It could follow the NSS-2 Bridge, an electric stimulation device for reducing opioid withdrawal symptom, in the market — the device was approved just last week.

While combating addiction itself is crucial in limiting abuse rates, the administration must also begin providing better options for opioids.

“As we balance the need to effectively treat pain with the public health emergency related to opioid addiction, we must find creative ways to prevent new cases of abuse and addiction,” Gottlieb said.

A press release regarding the guidelines was made available.

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