The five-week long Congressional recess arrived on August 1 and the fate of any drug safety legislation in this current Congress was still in doubt as the two chambers left Washington. As expected, the House Energy & Commerce Committee moved ahead on both of their priority measures prior to the recess – a reauthorization of the Animal Drug User Fee Act (ADUFA) and a package of health information technology legislation. However, they did not take up the draft measure on drug safety.
The Committee has begun very preliminary work on the food section but nothing on devices or cosmetics. There remains a remote possibility that the House might move just the drug safety title this year but most observers believe that it cannot be moved without a similar effort on food safety. As of this date Energy and Commerce has no further plans for hearings on the Food and Drug Administration set for the remainder of this Congress. The Senate is apparently not any further ahead. These facts point to the Congress not acting this year and a new, comprehensive measure to be crafted for introduction when the next Congress begins in January 2009.
ACRP and APPI will continue to monitor this very fluid and uncertain situation and advise on progress of relevant legislation as we continue working with key Members and Congressional staff to continue our role in educating them about effects on clinical trials and on our membership.