The U.S. House of Representatives has passed legislation that would improve current drug safety provisions and reauthorize the Food and Drug Administrations user-fee programs.
A key component of the FDA Amendments Act of 2007 would establish a new program to monitor the safety of drugs after they have been approved and marketed, rather than focusing solely on drugs before they are approved. It would also increase the penalties for drug companies that violate safety standards and impose conflict-of-interest provisions to ensure the FDA is not making decisions based on the personal financial interests of those serving on advisory panels.
In addition, the legislation would reauthorize for five years the Prescription Drug User Fee Act, which allows the FDA to charge fees to drug companies to expedite the agencys review of drug-approval applications, as well as the Medical Device User Fee and Modernization Act, which gives the FDA permission to charge user fees as part of the medical-device approval process. A news release from Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, said it is estimated that the FDA will collect $287 million in fees from medical-device companies over five years.
And in an effort to promote drug safety, the legislation would assess a maximum penalty of $250,000 for a first offense of a false or misleading ad in direct-to-consumer advertising for prescription drugs. There would also be a penalty of up to $500,000 per day for subsequent offenses in any three-year period. Next the House bill will be reconciled with the Senates FDA Revitalization Act. -- by Jessica Zigmond