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US House Passes Drug Safety Bill 403-16

On July 11, 2007 the United States House of Representatives passed H.R. 2900, the "FDA Amendments Act of 2007," by a vote of 403 to 16. It improves current drug safety provisions, encourages greater transparency and timeliness in the drug review process, and reauthorizes the FDA’s essential user fee programs. According to the Committee on Energy and Commerce's press release,

"This bipartisan legislation provides FDA with the resources it needs to fulfill its mission of protecting the health of American consumers,” said Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce. “By approving this comprehensive bill, Congress is striking the proper balance between new drug safety measures and consumer needs."

“Today, the House paved the way for restoring public confidence in the FDA by giving it the tools it needs to safeguard the public health," said Rep. Frank Pallone (D-NJ), Chairman of the Health Subcommittee. "We have produced a bipartisan bill that gives FDA the authority and resources it needs to ensure American consumers have timely access to safe and effective prescription drugs and medical devices."

Until today, FDA focused solely on a drug’s safety before it was approved. This legislation establishes a new program within the FDA to monitor the safety of drugs after they have been approved and marketed--drugs on the market would be subject to new FDA surveillance and safety requirements.

Other measures enhance drug safety, including increasing the penalties for drug companies that violate safety standards and imposing strict conflict-of-interest provisions to ensure FDA is not making decisions based on the personal financial interests of those serving on advisory panels. It reauthorizes for 5 years both PDUFA and MDUFMA. User fees are increased (more staffing/faster approval of drugs). It permits appropriators to provide additional funding for the drug safety program that would allow the fees to be reduced by a corresponding amount. FDA will collect an estimated $287 million in fees from medical device companies over 5 years, just over a fifth of the total cost to the FDA to review new devices.

To promote drug safety, the bill also assesses a maximum penalty of $250,000 for a first offense of a “false or misleading ad” in direct-to-consumer advertising for prescription drugs and a penalty of up to $500,000 per day for subsequent offenses in any 3-yr period.

Several provisions encourage the development of pediatric drugs/devices, intended to make more new drugs available to children, who typically represent a much smaller pool of likely consumers than adults.

HR 2900 will now be conferenced with S.1082, the FDA Revitalization Act, which passed 93-1 in the Senate May 9, 2007. PhRMA Pres./CEO Billy Tauzin's statement (July 11, 2007) says:

“...Since its original enactment in 1992, PDUFA has been a resounding success for the FDA, pharmaceutical research companies, taxpayers and, most importantly, patients. The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently, while maintaining its stringent safety and efficacy standards...The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety system. The agency will be able to hire key staff for drug safety activities and enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information. In addition, the agency will have the capacity to modernize its Adverse Events Reporting System used to collect and aggregate safety data, and better evaluate risk communication and risk management programs... The House PDUFA bill will enable the FDA to hire 27 additional employees to review 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 advertisements to the agency before airing them, in accordance with PhRMA’s Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs.Currently, FDA review times for advertising submissions are long and unpredictable. We believe this bill, like the legislation passed by the Senate, will lead to more expeditious and predictable review times, which ultimately benefits public health. PhRMA looks forward to continuing to work in a bipartisan manner with Members of the House and Senate to further improve the legislation as it moves to conference."

For some context, see the JAMA article FDA Responds to Institute of Medicine Drug Safety Recommendations—In Part,” by Bruce M. Psaty, MD, PhD and R. Alta Charo, JD. The authors provide an easy reference table summarizing IOM's Recommendations and the FDA's Response. They observe that “[u]nder PDUFA, the US has increasingly become the country of first launch, the public testing ground for new medicines, but no corresponding effort has been made to strengthen postmarketing risk surveillance, risk assessment, risk management and risk communication." They conclude that the life cycle approach recommended by the IOM will permit both rapid drug approvals and ongoing efforts to ensure the safety of the US drug supply. "The proposed bills pending in the US House and Senate offer a fresh opportunity to harmonize these important twin goals. "

See FDA :The future of drug safety: promoting and protecting the health of the public: FDA's response to the IOM’s 2006 report US Dept of Health and Human Services, January, 2007.

See also the public meeting notice on PDUFA renewal plans as published in the February 16, 2007 Federal Register.

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This page contains a single entry from the blog posted on July 15, 2007 10:45 AM.

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