Dear Research Advocate,
Congress is making progress in reauthorizing the FDA user fee programs, which is good news. According to officials at FDA, if the July 31 deadline for the “UFA” reauthorizations is missed, “reduction in force” (RIF) notices will be sent to one-third of the staff who review medical devices and a full 70% of those who review “small molecule” prescription drugs. The impact would probably be at least that dramatic for CBER, the center that reviews biologics. If the process stalls (or looks likely to), we’ll let you know and provide advocacy options!
During his confirmation hearing before the Senate HELP committee yesterday, FDA Commissioner nominee Dr. Scott Gottlieb said that he would uphold the “gold standard” FDA applies when evaluating medical products. In other words, he would not — as other potential nominees have suggested they might — eliminate FDA’s role in assessing product efficacy. He thus cleared one hurdle to bipartisan support. While some Senators remain concerned about Dr. Gottlieb’s industry affiliations, the HELP Committee and full Senate will likely approve his nomination in late April or early May.
Not surprisingly, Dr. Gottlieb was also asked about two hot button issues: the opioid crisis and the continuing controversy surrounding vaccines and autism. On the former, he said addressing the opioid crisis should be a top priority for FDA. A recent survey we commissioned shows that Americans, too, appreciate the magnitude of this crisis: a full 60% support increased federal funding for research to better understand and combat opioid addiction. On the latter, he indicated that we have reached a point where further research would be purely redundant and it is time to conclude that vaccines do not cause autism.
Congress is about to head home for a two-week recess without passing a final FY17 appropriations bill. As the April 28 deadline approaches, there are several ways this might play out. The most detrimental: no deal is reached and the government shuts down. A more likely, but unwanted, outcome is that Congress defaults to a year-long continuing resolution (CR), which would extend flat funding until FY18. We are fighting hard for option three, an omnibus bill that provides new funding levels for FY17. The pending omnibus reportedly includes increases for NIH, FDA, NSF and CDC, but unfortunately, a modest reduction for AHRQ. If funding tracks with the 12 appropriations bills crafted last year, most other science agencies will fare better under the omnibus than under a CR.
If you haven’t had a chance to weigh in on FY17, or even if you have, contact your representatives now. Write a letter to the editor and/or reach out to the editorial board of the newspaper(s) in your region. Members of Congress will listen to you, their constituent, and they will listen to local media. If we can assist your media outreach efforts, contact Suzanne Ffolkes at firstname.lastname@example.org.
While Congress is in recess, and a week before the CR is set to expire, scientists and science enthusiasts will gather in Washington, D.C. and in more than 400 cities across the country and around the world to March for Science. As I noted in a recent LTE, if we are to ensure our elected representatives place an appropriately high priority on science, those who care must show up and speak up. Not only will Research!America be celebrating science in D.C., we will have staff on-the-ground at satellite marches in Oklahoma, Utah and Los Angeles. The AAAS is helping prepare advocates for the march. Check out their Force for Science website to learn more.
With so much at stake, we will have lots to discuss at next week’s Research!America Alliance Members Meeting. Join us in person or by phone on Thursday, April 13 from 9:00 AM-10:00 AM (ET) at our office in Crystal City. We will be joined by David Reich, Senior Fellow at the Centers on Budget and Policy Priorities (CBPP) and a veteran of the House Appropriations Committee. Contact Jacqueline Lagoy (email@example.com) for location or call-in details.