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.

• Happy New Year -- Strap on Your Seat Belts -- FY17 Appropriations Process Begins! Congress returned to Washington this week, and we expect to see appropriators getting out of the blocks quickly on the FY17 process. Our perspective is partly informed by a pragmatic look at the legislative calendar, which includes much of the summer lost to political conventions and August recess. Also, as last year concluded, Speaker Paul Ryan (R, WI) articulated a goal of a regular order process, in which all 12 appropriations bills would be passed individually, something that hasn’t happened since the 1990s.While the process may be more straightforward for FY17 because this past Fall’s budget agreement sets the spending ceiling for FY 17, there are many skeptics who point out the complexities on arriving at agreement in an election year, internal spending debates within the Republican caucus, and a likely continued appetite for controversial policy riders (including recent gun control-related issues). Nonetheless, there are press reports that Senate majority and minority leadership are discussing how to streamline the appropriations process. Regardless of whether the appropriations process end game results in a “regular order,” we think that merely the goal of regular order combined with a limited legislative calendar will cause earlier than normal movement of sub-committee hearings and mark-ups, including potential March mark-ups.

• State of the Union Next Week. President Obama will deliver his final State of the Union (SOTU) address on Tuesday, January 12, 2016 at 9 p.m. ET. With a somewhat early SOTU, this gives the President the opportunity to release his budget in the relative near future, and allow for subcommittee hearings to begin.

• Senate HELP Schedules Vote on FDA Commissioner for January 12. The Senate HELP Committee, which held confirmation hearings last Fall, is now ready to vote on Dr. Robert Califf’s nomination to be FDA Commissioner. A favorable vote is expected. His name would then go to the Senate floor where a vote will possibly occur yet this month.

• “Another Strong Year for Patients in Need of New Drug Therapies.” So declares CDER Office of New Drugs Director John Jenkins in an FDA Blog post describing the 45 novel therapies approved in 2015. This is the highest annual total in two decades. More than just numbers, Dr. Jenkins’s column emphasizes the broad benefit to patients from new high-quality therapies becoming available.

• ICYMI: FDA Blog Explores Medical Product Innovation. Acting FDA Commissioner Stephen Ostroff has penned a lengthy analysis of FDA’s 2015 accomplishments in medical product innovation and discusses initiatives for this coming year. He places particular emphasis on patient engagement initiatives and the strong role of regulatory science in promoting innovation. This is part 1, with part 2 (on medical product safety) and part 3 (on food, tobacco, and antimicrobial resistance) having also emerged as of this morning.

• Accountability a Major Focus for FDA; Stakeholders, the Public and Congress Are Watching. FDA has seen its budget grow over the last decade (in part because of the Alliance’s efforts). At the same time, the agency’s responsibilities have grown and practically every FDA activity has become more complex. Under these circumstances, agency accountability has become more important. This theme is explored in this week’s Analysis and Commentary.