FDA Gives More Time to Generic Facilities to Register, Saying Many Have Not

| 04 December 2012 | By Alexander Gaffney, RAC, 

The US Food and Drug Administration (FDA) is delaying by two weeks the implementation of its facility registration requirements under the Generic Drug User Fee Act (GDUFA), a subset of a recently passed FDA Safety and Innovation Act (FDASIA).

One of the law's main goals was to achieve parity between the way FDA collects fees from branded and generic pharmaceutical products. Under a long-standing program, FDA assesses user fees from branded pharmaceutical companies in return for it spending that money on new review staff and otherwise upgrading its capacity to regulate products efficiently. Industry is generally in favor of this, as it speeds up the time it takes for its products to be reviewed by regulators.

FDASIA extends this program to the generic drug industry under GDUFA, calling on generic drug manufacturers to pay a yearly fee to register its manufacturing facilities, among other fees and changes. The due date for those registrations to have been received by FDA was 3 December 2012, but now FDA says it will grant a two-week grace period for all remaining facility registrations to be received by agency officials.

After that grace period is up, it writes, all products manufactured by those facilities will be considered "misbranded."

A generic drug "facility" is a fairly broad term under the act, encompassing any place that manufactures products, finishes, packages, re-packages or labels the product, as well as any organization that conducts bioequivalence or bioavailability testing on generic products and other testing sites.

Those facilities should supply FDA with the name of the registrant owner, the name of the facility owner, the name of the company, the type of business operation they are running, their DUNS number, their Facility Establishment Identifier (FEI) and the address where their facility is located. Only certain facilities will be required to pay facility fees, but all are required to register with FDA.

"This self-identification information will assist in constructing an accurate inventory of facilities, sites and organizations involved in the manufacture of generic drugs," FDA wrote in a Federal Register posting on 1 October 2012. Any facilities not providing FDA with the required information are subject to prosecution, injunctions and product seizures, as well as products being denied entry into the US.

FDA said more than 1,700 generic drug facilities have already registered with FDA-"below estimates of the universe of generic drug facilities." An FDA analysis of recent Abbreviated New Drug Applications (ANDAs) and Prior Approval Supplements (PASs) found that roughly one in eight applicants had failed to self identify with FDA-a trend the agency said would "result in higher individual facility fee amounts" for those who had registered.

"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," it explained, saying it hopes the two-week grace period gives the remaining facilities time to register.