PhRMA Statement on Enactment of FDA L... ( WASHINGTON Sept. 27 --- Pharmace...)

PhRMA Statement on Enactment of FDA Legislation

Date:9/27/2007

WASHINGTON, Sept. 27 /PRNewswire-USNewswire/ --- Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin issued the following statement today on the enactment of the "Food and Drug Administration Amendments Act of 2007:"

"By signing into law the 'Food and Drug Administration Amendments Act,' President Bush has taken a vital step to both strengthen our nation's drug safety system -- already the world's best -- and preserve crucial incentives to help spur research and generate critical information about the use of medicines in our children.

"The law, which reauthorizes the Prescription Drug User Fee Act (PDUFA), provides FDA with additional resources it needs to promote and protect the public health. The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems.

"FDA will have the capacity to modernize its Adverse Events Reporting System, which is used to collect and aggregate safety data, enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information, and better evaluate risk communication and risk management programs.

"The law also reauthorizes the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), both of which were set to expire on September 30. BPCA has done more to spur research and generate essential information about the use of medicines in pediatric patients than any other initiative and PhRMA has supported its reauthorization without significant modifications.

"Furthermore, the law will enable FDA to hire additional employees to review broadcast drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated. It also will create strong incentives for companies to submit such advertisements to the agency before airi
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