Act to Collect Money From Drug Manufacturers has Bipartisan Support


The popular PDUFA for the FDA is up for its five-year reauthorization.

The Prescription Drug User Fee Act (PDUFA) is up for renewal and one leader in the Senate is predicting that it will get bipartisan support.

The act, which must be reauthorized every five years, allows the FDA to collect millions of dollars from the manufacturers of drugs, money that it uses to cover about 60% of the costs of reviewing and approving new products.

Sen. Mitch McConnell (R-KY), Majority Leader in the Senate, told Reuters that he expects to get support for the reauthorization from both parties. "It's an extremely important bill that I think we'll be able to move on a bipartisan basis," he said.

Related article: FDA Approves 800 Generics in 2016, but Legislators Think Process Should Be Faster

PDUFA was first passed in 1992, when drug makers were complaining that the review and approval process at FDA was taking too long and when FDA was understaffed and underfunded, according to the Pharmaceutical Research and Manufacturers of America (PhRMA). The quinquennial reauthorization is negotiated between industry and the FDA. This proposed reauthorization of the act is called PDUFA VI and was negotiated in 2016.

This year’s bill was approved by a Senate panel by a vote of 21 to 2. The current act expires in September. However, Reuters noted that the proposal is unlikely to be approved in this cycle.

“The PDUFA VI agreement is an important step forward in ensuring patient safety, maintaining the FDA’s high standards of regulatory review and promoting timely access to safe and effective medicines for patients,” said PhRMA in a statement on its website.

The proposed 2018 budget issued by the White House calls for the pharmaceutical industry to cover all the costs of drug and medical device reviews.

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