Generics Makers Concerned About FDA’s Inactive Ingredient Database, Other GDUFA Issues

September 23, 2014

The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, according to generics makers who laid out a variety of other shortfalls they see in the agency’s generic drug approval process.

The accuracy and completeness of the current database is lacking, Robert Vincent, Teva’s director of U.S. generics regulatory affairs, told FDA officials at a public hearing Wednesday on the implementation of the 2012 Generic Drug User Fee Amendments.

For example, it doesn’t indicate why certain ingredients have been withdrawn, and it doesn’t state if an inactive component was withdrawn for safety reasons, he said.

David Guagh, senior vice president for sciences and regulatory affairs at GPhA, echoed this concern and urged the FDA to work quickly to revise the database to ensure it is complete, accurate and transparent.

The database was just one of the issues raised at the hearing on GDUFA, which allows the FDA to collect fees from firms and ANDA filers to beef up resources and speed approvals.

Several companies complained about the universality of the fees themselves. Representatives of smaller manufacturers argued the fees can be prohibitively expensive for those just getting into generic drug making but have not yet earned any profit in the enterprise.

Steven Pessman, executive vice president of PureTek, suggested that companies who have not yet had any ANDAs approved be exempt from the facilities fees. Gil Roth, president of the Pharma & Biopharma Outsourcing Association, pointed out that a bill has been introduced in Congress that would exempt small manufacturers from GDUFA fees.

Another complaint centered on the FDA’s handling of controlled correspondence, including the number of communications that the agency exempted from response timelines laid out in a recent guidance.

The FDA should provide status updates on its responses to controlled correspondence rather than leave generics waiting, argued Keith Webber, head of regulatory review and regulatory affairs at Perrigo. GPhA’s Guagh added that even as the emphasis on controlled correspondence has increased, informal communications with the agency have gone down. Generic companies need more opportunities to resolve issues with the FDA over phone and email, he said.

Others argued the FDA should increase its frequency of meetings with generics firms to address the problems. Such conversations can address multiple issues at once rather than keep generics firms waiting for responses to multiple controlled correspondences, said Candis Edwards, senior vice president of regulatory affairs at Amneal.

Speakers also urged greater communication from the agency about when they can expect responses on their ANDA filings.

The FDA has committed to responding to an increasing percentage of ANDAs over the next fiscal year under its new GDUFA performance goals. But speakers at the meeting contended they’re more worried about those filings that fall outside of the response timelines. As such, generics makers have called for guidelines for response times to these filings.

Guagh pointed out that the FDA has a huge backlog of pending ANDAs. He asked for greater transparency for when filers can expect a response, arguing that generic companies can live and die on when they get approval. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.