Biotech Values

[DewDiligence]

US House Clears PDUFA Bill

[Along with renewal of the PDUFA funding that the FDA requires, key features of the bill are maintenance of the 6-month pediatric exclusivity period and the imposition of fees on medical-device companies.]

http://www.reuters.com/article/marketsNews/idUKN1930954820070919

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Wed Sep 19, 2007 4:58pm EDT

WASHINGTON, Sept 19 (Reuters) - The U.S. House of Representatives approved a bill on Wednesday aimed at strengthening Food and Drug Administration drug safety oversight and raising pharmaceutical industry fees that help speed product reviews.

The House voted 405-7 for the measure, which includes compromises reached by House and Senate negotiators.

The legislation must clear the Senate before going to President George W. Bush for his signature into law.

The measure gives the FDA the power to require new warnings on prescription drugs that are already on the market and to order the completion of post-approval studies of medicines. Companies that fail to comply with FDA directives could face fines.

The bill requires drugmakers to post basic results for clinical trials of approved products in a public database. Companies also must list all clinical trials, except preliminary studies, in the database. [“Preliminary” clearly includes phase-1 studies and it may also include some phase-2a and phase-1/2 studies, depending on exactly how the bill is worded.]

It also preserves a six-month period of additional market exclusivity for drugmakers that test the safety and effectiveness of products in children. An earlier Senate version of the bill had cut that time to three months for blockbuster drugs.
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