The month of July will be critical to the fate of any drug safety legislation in this current Congress as it is the second to last full month that the House and Senate are likely to be in session prior to the November elections. As noted earlier, both the food and drug safety legislation are currently being pulled together to address the many concerns of elected officials about the Food and Drug Administration’s (FDA) operations and capabilities. According to staff familiar with the process, it is hoped that these bills can be readied for committee markups during this month and be readied for consideration by the House shortly.
However, at least two other legislative priorities for the House Energy & Commerce Committee stand in the way of the food and drug safety bills already. One is the reauthorization of the Animal Drug User Fee Act (ADUFA) which governs the use and fees paid by makers of pharmaceuticals for use on farm animals and pets. This legislation’s authorization runs out this year and, like last year’s FDA reauthorization, must be renewed to ensure that this vital funding stream remains available for FDA’s operations. Secondly, the Energy & Commerce Committee is also working on a package of health information technology (HIT) legislation which will help physicians to deploy modern computer and electronic records technology in their care of patients in order to improve the quality of care and avoid medical mistakes which harm and kill many Americans each year. The Committee has begun the markup sessions on the ADUFA bill and will continue to move ahead on the HIT issue. But with the month-long August recess quickly approaching, it is quite likely that the food and drug safety bills may slip into September and push up against Congress’s desired break to campaign for the last six weeks prior to the election on November 4.
ACRP 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.