FDA Director Responds to Drug Pricing Concerns

September 16, 2016

Pharmaceutical Executive

September 16, 2016

Drug pricing has become a hot topic after recent scandals about drug price increases, including the recent EpiPen price hike, have shocked consumers. In a Sept. 14, 2016 FDA Voice blog post, Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, clarified the agency’s role in the pricing of medications. Woodcock affirmed that while FDA is committed to ensuring that drugs are safe and effective, the agency does not regulate drug prices. The agency does, however, encourage the development of new and innovative therapies.

Woodcock specifically addressed the EpiPen price hike, stating that patents on the EpiPen, which extend to 2025, would delay the availability of generic versions of the drug.  FDA is aware, Woodcock stated in the blog post, that the agency’s approval of generic versions of brand therapies may encourage competition and affect pricing.

“The good news is that the FDA has already approved four epinephrine auto-injectors to treat anaphylaxis in an emergency, and two are currently marketed,” she said. “The EpiPen does not have any FDA-rated therapeutic equivalents. But like EpiPen, these alternative products are approved by the FDA as safe and effective for treating anaphylaxis.” 

Because the agency is aware of the potential benefit of generics, FDA looks to review applications quickly. “To speed along the process, our Office of Generic Drugs prioritizes and expedites our review of applications for first generics, making sure that the first applicants to make a generic are moved to the head of the queue and given priority review,” Woodcock stated.

FDA has also created a “roadmap” to help develop new auto-injectors and provided manufacturers with technical information and guidance about designing and testing auto-injectors. “The FDA is committed to ensuring that consumers can trust the products that are available. Anaphylaxis is a condition some people can’t avoid, but cost should not be the reason someone cannot access care,” Woodcock stated.

Source: FDA