One in 8 generic drug or API plants missed Monday's deadline to register with the FDA as required by the new generic drug user fee law. But rather than begin hammering companies with penalties, the agency has extended an olive branch, pushing the deadline to Dec. 18.
According to a notice posted on the FDA website, only about 1,700 plants have registered so far and the agency has an idea of which manufacturers have not turned in the paperwork. The agency says that number is not only below industry estimates but does not sync up with an analysis of Abbreviated New Drug Applications and Prior Approval Supplements submitted since Oct. 1. The law also extends to facilities that fill and finish, repackage and even some testing facilities, according to an explanation document from the FDA, which tells how to register.
Companies that don't get signed up risk having their drugs considered "misbranded" by the FDA, which can lead to warning letters and agency actions. Also, when companies don't register, everyone suffers, the agency points out. "The two week grace period should enable facilities who have not yet registered to do so. FDA does not want to penalize companies that have already complied with this new requirement by setting higher annual facility fee rates based on an artificially low industry reporting base."
The registration is required under the new Generic Drug User Fee Amendments of 2012, which for the first time include generic and active pharmaceutical ingredient makers in its user fee program. The extra money generated through the provision is slated to help the FDA extend its inspections, particularly of foreign plants, which it historically got into far less than U.S. facilities.
Generic drugmakers who are lagging also got a nudge from Generic Pharmaceutical Association. In an emailed statement, a spokesman said, "GPhA urges all generic facilities to self identify as soon as possible, as required by law, so that FDA can continue its implementation of the new generic drug user fee program
- read the FDA notice