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Congress has passed legislation which will reauthorize a program allowing the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies in order to conduct drug approvals. The bill will also dramatically expand FDA’s regulatory authority in response to recent controversy. President George W. Bush is expected to sign the bill into law soon.

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA gives the FDA the authority to collect fees from pharmaceutical companies for the safety review and approval of new drugs. Under the original legislation, Congress must reauthorize PDUFA every five years. PDUFA is set to expire Sept. 30.

The Food and Drug Administration Amendments Act of 2007 (H.R. 3850) will renew and expand the user fee program. FDA will increase the amount of user fees it collects to almost $400 million, up from approximately $300 million. User fees will fund approximately half of the agency’s drug review program and a fifth of the agency’s overall budget.

See the full article here: Congress Expands FDA User Fee Program, Reforms Drug Safety Process .