Enhancing Drug Safety

Today, Senator Edward M. Kennedy, Chairman of the Health, Education, Labor, and Pensions (HELP) Committee, and I are re-introducing the “Enhancing Drug Safety and Innovation Act.

Our bill will raise the bar to ensure that drug safety is not an afterthought, but an integral part of the process throughout the life of a drug.  It requires drug makers and FDA to engage in better safety planning from the very beginning, before a drug is approved for release to the public, in order to improve both the understanding of and response to risks that arise after a drug is on the market.

The Drug Safety legislation reflects the comments and input of dozens of stakeholders, including the FDA, patient and consumer groups, industry trade associations, individual companies, and scientific experts.