NAPM Defines Its Position On FDA User Fees

After inclusion of an unexpected cut in the US Food and DrugAdministration's Abbreviated New Drug Application office funding in Washington DC's proposed budget, the National Association of Pharmaceutical Manufacturers met with FDA officials to propose a user fee plan aimed at speeding approval of ANDAs.

The NAPM board of directors said in January it was willing to sit down and negotiate a user fee program with the FDA "providing we could get certain things" in return from the agency to help improve the ANDA approval process, an NAPM spokesman told the Marketletter. Then, he added, the government unexpectedly came out with a budget calling for cutting the funding of the ANDA office, replacing the expected funds with user fees.

"It was the exact opposite of what we wanted," the NAPM spokesman said; the hope had been to keep the expected ANDA budget as a floor and then add user fees, if necessary, to help the ANDA approval process - to speed it up and improve its efficiency.