FDARA Clears Senate; Needs President’s Signature to Become Law and more
Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.
FDARA Clears Senate; Needs President’s Signature to Become Law. HR 3240, the FDA Reauthorization Act (FDARA) passed the Senate, after previously being adopted by the House in July. From this point, It often takes a number of days before a bill reaches the White House. Accordingly, it may be mid-August before the President signs FDARA into law (which is expected, see here).
While the bill contains a number of additional provisions, it’s primary purpose is a 5-year reauthorization of the four medical product user fees (prescription drugs, generic drugs, medical devices, and user fees). In order to avoid amendments on the Senate floor -- which would have necessitated FDARA being sent back to the House for consideration -- the Senate passed three separate free-standing bills that the House can consider later this year.
This week’s Analysis and Commentary Explores: How Much of FDA’s Funding Is BA Approps? How Much User Fees?
Alliance Plans to Be on the Hill on September 19th; Please Join Us and Hold the Date on Your Calendar. Authorizers and appropriators have made FDA a priority, as reflected in the House and Senate Ag/FDA appropriations bills, as well as in FDARA. While challenges still remain (see the answer to Question 2) because FDA’s responsibilities keep growing, we need to thank Members of Congress and encourage prioritization as the final touches are placed on FY 18 and as we prepare for FY 19. More details will be forthcoming.
Likely to See Your Senators or Representatives Over Recess? If So, Talk About FDA’s Needs.Please make three points: FDA’s responsibilities are core functions of government. FDA-regulated industries are world leaders in discovery and innovation in large part because of the stability and oversight provided by FDA. FDA’s well-trained staff is indispensible to its success. For more detail on each of these points, read the answer to Question 3.