FDA plans overseas inspections as GDUFA goes to Congress

After years of negotiations 2011 marked a breakthrough for generic user fees and the project is now nearing reality. On Friday the US Food and Drug Administration (FDA) finished work on Generic Drug User Fee Act (GDUFA) which will give it a funding boost at a time of budgetary tightening.

“At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion​”, Margaret Hamburg, commissioner of the FDA, said.

To fund activities the FDA will collect user fees totalling $299m (€236m) a year. In spending the fees the FDA aims to ensure generic drugmakers “are held to consistent high quality standards and are inspected biennially, using a risk-based approach, with foreign and domestic parity​”.

The FDA will derive 70 per cent of the fees from inspections of generic finished dosage form and active pharmaceutical ingredient (API) facilities. Production plants located oversees will pay between $15,000 and $30,000 more than their peers in the US to account for increased inspection costs.

An estimated 2,000 finished dosage form and active pharmaceutical ingredient (API) facilities will fund the programme. Fees will be divided 80 per cent to 20 per cent between the finished dosage form and API and manufacturers, respectively.

Achieving parity​

In recent years the US Government Accountability Office (GAO) has repeatedly criticised the FDA for shortcomings in overseas inspections, leading to the agency being placed in its high-risk series. The GAO asked for adoption of risk-based inspections and parity between foreign and domestic plants.

By 2017 the FDA aims to have achieved parity. The FDA will inspect facilities in association with abbreviated new drug applications (ANDAs) and during routine surveillance. Finished dosage form facilities should be inspected every two years and API plants every three years, the FDA said.

Funds will also be used to clear the backlog of generic drug applications. In 2013 the FDA will collect one-off fees of $50m relating to ANDAs pending on October 1. The Generic Pharmaceutical Association claims the FDA has more than 2,000 ANDAs to process.

Congressional approval​

The FDA has sent its recommendations for generic, prescription and biosimilar user fees to Congress. In early February the House Energy and Commerce Health Subcommittee will meet to discuss the proposals.

“We will be working closely with Congress and stakeholders to support the reauthorisation of user fees for pharmaceutical products, and medical devices, as well as to authorise new user fees for generic drugs and biosimilars​”, Hamburg said.