FDA releases plan to expedite, promote generic drug development

As part of its effort to increase competition in the prescription drug market, the FDA released a list of drugs that are off-patent and off-exclusivity without approved generics and produced a revised manual of policies and procedures for review of abbreviated new drug applications, including prioritization for generic products.

“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Scott Gottlieb, MD, commissioner of the FDA, said in an agency press release. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”

The list includes approved new drug applications that are off-patent, off-exclusivity, lack a generic competition and do not have FDA approval of an abbreviated new drug application. Part one of the list identifies products for which the FDA could immediately accept an abbreviated new drug application without prior discussion, while part two identifies products involving potential legal, regulatory or scientific issues that would require the agency to address prior to submission of an abbreviated new drug application. The FDA will update the list every 6 months.

“Ninety percent of all medicines given to patients are lower cost generic alternatives,” Andrew Powaleny, director of public affairs at PhRMA told Healio.com/Hepatology. “Enhancing competition for generic medicines can help lower health care costs while continuing to incentivize the development of new treatments and cures for patients.”

The updated manual of policies and procedures includes prioritization of review for generic products that have fewer than three abbreviated new drug applications approved for the reference listed drug and have no blocking patents or exclusivities. The FDA will not consider approval of abbreviated new drug applications for expedited review if submitted within one year of the last applicable patent expiration date or exclusivity date.

These steps are a part of the FDA’s Drug Competition Action Plan, recently announced by commissioner Gottlieb.

“I am committed to continuing to pursue additional policy steps, under the FDA’s current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need,” Gottlieb said in the release.

The FDA will hold a public meeting on July 18, 2017, to solicit input regarding ways in which the FDA’s standard and procedures related to generic drug approval may be in use to create obstacles to generic access. – by Talitha Bennett

Reference: www.fda.gov

Editor's Note: This item was updated to include comments from Andrew Powaleny, director of public affairs at PhRMA.