Washington- Senator Chris Dodd, a senior member of the Senate’s Health, Education, Labor and Pensions Committee, today led seven other Democrats on the Committee to request that the Committee’s leadership postpone scheduling a markup of S. 3807, the “Enhancing Drug Safety and Innovation Act” until the Committee has held hearings while Congress is in session to give members of the Senate, as well as the public, time to consider the Institute of Medicine’s (IOM) recent report on drug safety.

“The IOM is one of the nation’s premier organizations in providing Congress and the public with scientifically informed analysis and independent guidance,” the letter to HELP Committee Chairman Mike Enzi states. “Its report on drug safety, which was nearly two years in the making, will inform the process and we believe it would be a mistake to move drug safety legislation through the HELP Committee before Congress and the public have an opportunity to consider its findings.”

“As someone who has proposed and authored, with Senator Grassley, the strongest drug safety measure in the Senate, I understand that this is a tremendously important issue.  But just as the FDA shouldn’t rubber stamp a drug without first thoroughly testing it for safety and effectiveness, we shouldn’t rush through legislation that doesn’t adequately address the scope of the problem.   The Institute of Medicine has just released a stunning report on problems at the FDA and we should conduct comprehensive hearings to thoroughly and carefully learn from it.”

In March 2005, the last time that the HELP Committee solicited public testimony and comment about drug safety and the FDA approval process, hundreds of comments were received. Senator Dodd is the co-author of S.930, the “Food and Drug Administration Safety Act of 2005,” which would set up a new, independent center inside the FDA to review drugs and biological products once they are on the market and S. 470, the “Fair Access to Clinical Trials Act,” which would ensure access to clinical trial information for patients, physicians, the broad scientific community, and the general public.

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