The US Food and Drug Administration (FDA) is reminding all manufacturers of generic drug products, including active pharmaceutical ingredients used in generic drug manufacturing, that they need to re-register with the agency under the terms of a 2012 law.
In the lead-up to the 2012 passage of The Food and Drug Administration Safety and Innovation Act (FDASIA), FDA regulators highlighted a growing problem: Many generic drug manufacturers were moving their operations overseas, making it difficult for FDA to inspect facilities and, worse, determine where drug products were being manufactured in many cases.
The Generic Drug User Fee Act (GDUFA) of FDASIA, modeled off similar user fee provisions long enacted for pharmaceuticals and medical devices, aimed to remedy this situation in part by instituting two main requirements.
The first were user fees, levied on companies with pending applications, new abbreviated new drug applications (ANDAs), manufacturing facilities and active pharmaceutical ingredient facilities, as well as yearly maintenance fees.
The second involved registration requirements, meant to ferret out companies and manufacturing facilities not yet known to FDA to make sure that regulators could both inspect those facilities and make sure they knew which ingredients and products they manufactured.
Each year, FDA requires generic drug manufacturers to register with it between 1 May and 1 June, during which time the companies must submit, update or reconfirm all information previously reported to FDA.
Entities required to register with FDA include:
- manufacturers, producers or finishers of generic pharmaceutical products
- manufacturers or active pharmaceutical ingredients used in generic drug products
- labelers, packagers, repackagers of generic pharmaceutical products
- clinical research organizations conducting bioequivalence and bioavailability testing for generic drug products
As of FY 2014, 3,905 facilities had self-identified themselves as generic facilities to FDA. (List-PDF) Several dozen were cited by FDA as not having paid their appropriate user fees.
All required entities should provide FDA with information in Structured Product Labeling (SPL) format, including:
- name of the registrant/owner
- name of the facility owner
- name of the company
- type of business operation
- DUNS number
- Facility Establishment Identifier
- facility address
(Additional information may be found in Regulatory Focus' 23 August 2012 story, "FDA Releases Guidance on Facility Registrations, Payments Under GDUFA.")
Facilities have until 1 June 2014 to register or re-register with FDA for the 2015 fiscal year, FDA wrote in a 28 April 2014 email to industry.
However, FDA explained in an email to industry that registration under Section 510 of the FD&C Actis in fact a different process than self-identification. That section refers to the registration of all drug-producing or -affiliated facilities, regardless of the type of drug substance they produce. The GDUFA legislation, by contrast, is supposed to allow FDA to identify which ones specifically produce generic drugs.
As FDA explained, the effect will be that many manufacturers will need to submit information separately to each respective system, though Section 510 registration occurs between 1 October and 31 December each year.
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.