U.S. Food and Drug Administration News

On August 1, 2014, the U.S. Food and Drug Administration (FDA) announced the fiscal year 2015 user fees for pharmaceutical and medical device companies. These rates will be effective from October 1, 2014 through September 30, 2015. For medical devices, a premarket application (PMA) will cost $250,895 and a 510(k) premarket notification submission will be $5,018.

Prices will increase for both a new drug application with clinical data and a biosimilar application with clinical data — each will now cost $2.1 million. Fees for foreign active pharmaceutical ingredient (API) facilities will increase to $56,926. This will affect almost 700 FDA-approved foreign API plants. Fees for foreign facilities producing finished dosage forms (FDFs) will rise to $262,717.  This will affect 410 FDA-approved foreign plants — including more than 150 in India. A facility that makes both FDFs and APIs would need to pay both facility fees. Abbreviated new drug application (ANDA) fees will be reduced to $58,730. Drug master file fees will be reduced to $26,720.

Also on August 1, 2014, the FDA also released a proposal to deregulate a number of Class I and Class II digital health medical devices. Although just a proposal, the FDA has said that it no longer plans to enforce 510(k) requirements for the devices on the list. However, a device manufacturer may still need to comply with other regulations, such as product registration.   The list of deregulated mobile medical devices and smartphone-enabled or connected devices includes hearing aids, ophthalmic devices, thermometers, fertility diagnostic devices and stethoscopes.

In late July 2014, the FDA also released a guidance document for the 510(k) pathway. The guidance provides details on the evaluation of 510(k) applications and what the FDA looks for in terms of substantial equivalence — including predicate and reference devices. And on August 5, 2014, the FDA released a draft guidance for biosimilar products. The draft expands the number of products eligible for reference product exclusivity.