Advocacy at a Glance

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.

• 21st Century Cures Passes House; Set for Senate Vote Next Week. After nearly 2 years of effort and extended negotiations with the Senate, the House passed a revised version of 21st Century Cures legislation this week. Consideration of the bill in the Senate is expected next week. Although the responsibilities given FDA are comparable to the original House Cures legislation, the amount of funding has decreased from $500 million over 5 years to $500 million over 10 years. While this will not be adequate for all of the new activities required by the legislation, it is more funding than provided in the Senate version of Cures, which would have provided no new additional funding for FDA. This chart breaks down the money by year. Monies are restricted to the purposes set forth in the Act (see House E&C summary here). The $500 million will need to be appropriated, albeit from funds that are set-aside and won’t count against the budget ceiling. This week’s Analysis and Commentary examines some of the details and why these monies are welcomed but not guaranteed.

• FY 17 Continuing Resolution Likely to Extend to Either March 31 or April 28. Congressional leaders are agreed that they will pass a long-term Continuing Resolution before the current CR runs out on December 9. The only unsettled point is whether the CR will extend to March 31 (House position) or the end of April (Senate position). The Senate expects to be particularly busy in the first quarter of 2017 with legislation and confirmation hearings, thus feeling they need more time to get to appropriations.

• Three Members Added to the HHS Transition Team – Two with FDA-related Experience. Eric Hargan, Dr. Scott Gottlieb, and Nina Owcharenko have just been announced as part of the HHS transition team. Hargan, a long-time member of the Federalist Society, is an Illinois-based healthcare attorney, who was Co-Chair and Convener of Illinois Governor Rauner’s Healthcare and Human Services Transition Committee in 2014. Previously, he was Acting Deputy Secretary at HHS. In that role, Hargan had significant influence over the FDA regulatory process. Dr. Gottlieb, who most recently was with the American Enterprise Institute (AEI), had leadership positions at CMS and FDA, including Deputy Commissioner at FDA. Gottlieb has written extensively in Forbes and the Wall Street Journal regarding FDA policy issues. Owcharenko is a health financing specialist from the Heritage Foundation.

• Alliance Board Members Pen Articles on FDA and the Trump Administration. Morning Consult published Alliance Board Member Wayne Pines’ article, entitled “The Food and Drug Administration: six important ideas." Life Sciences Leader published Alliance Board Member Nancy Myers’s article, entitled “Trump and the FDA: what to expect (and what's at stake).”