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Advocacy at a Glance

December 20, 2013

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.

  • Alliance Sign-on Letter. We had circulated a draft letter to go to appropriators urging higher funding for the FDA for FY 14. Appropriators are inclined to be supportive of the FDA … and we needed to show Congress that the whole community supports the agency, so hopefully your company or organization has already signed on.
  • Senate Sends Budget Deal to President. By a vote of 64-36, the Senate on Wednesday passed a measure establishing a federal budget for the remainder of FY 14 and for FY 15.  The budget deal marks an achievement for a divided Congress which last passed a budget in 2009. The budget measure, passed in the House of Representatives last week by an overwhelming margin, provides an overall FY 14 discretionary spending level of $1.012 trillion. Now that the topline spending number has been set, the next step is for congressional appropriators to divide up the available money amongst federal agencies. To avoid a government shutdown, appropriators must pass appropriations legislation by January 15. The Alliance will be working to make sure there is a strong voice for FDA funding in this process.
  • Senate Appropriations Chair Barbara Mikulski Describes Tight Schedule for FY 14 Appropriations. With the Ryan-Murray budget agreement finally passed in both Houses, Senator Mikulski outlined the timeframes for work to be done in an article in CQ (that is only available to subscribers to that publication). First, she and House Appropriations Committee Chair Hal Rogers will decide how to divide the $1.012 trillion in discretionary spending among the 12 appropriations subcommittees and their bills. These are known as 302(b) allocations, referring to the section in the Budget Act that sets out this process. The subcommittee staff will then negotiate over the holidays and are expected to report any remaining disagreements on January 2. The two chairs and their ranking members (Representative Nita Lowey and Senator Richard Shelby) will try to resolve these on January 6 and 7. The goal is to have the finished omnibus appropriations bill on the House floor on January 10 and the Senate floor by January 13.
  • FY 15 Passback Delayed While Congress Works on FY 14 Appropriations Bills. In anticipation of the President’s State of the Union Address on January 28 and the release of the President’s budget request the following week, the Office of Management and Budget (OMB) usually “passes back” the near-final numbers to each agency in December and considers final agency appeals for more funding.   The exact date for the passback can be changed for practical and political reasons. This year, OMB has delayed the passback until January as they are waiting to see how things progress related to FY 14 appropriations bills.
  • Special Holiday Thanks to the Veep. FiercePharma reported that Vice President Joe Biden was able to secure agreement from the Chinese Government to add 19 FDA inspectors to the nine that currently are located in China. These were positions for which the Alliance had worked to make sure there was funding, and it is great to see the inspectors will be able to get on the ground and do their important work.  Adding to the mission size of the embassy is always a delicate issue, and we appreciate the Vice President taking personal interest in making this happen.
  • FDA Working with European Counterpart to Better Leverage Resources. As we talk to Members of Congress about the importance of FDA funding, one of the questions we often get is, “How is FDA working to become more efficient and better use its existing resources.” This is a fair question, and we know FDA is constantly trying to innovate and better leverage its resources. Over the years, we have encouraged FDA to communicate its efforts in this area. Based on that, we wanted to highlight a recent effort by FDA to leverage its work with its European equivalent, the EMA. FDA announced a joint initiative with the EMA to coordinate inspections and evaluations of bioequivalence data generic drugs. You can read the agreement here
  • Congressional Holiday Recess. Once the Senate leaves Washington today, both chambers of Congress will be on a several-week-long recess. Lawmakers are scheduled to return to Washington on January 6th. President Obama is expected to hold his last press conference of the year today, before he fuels up Air Force One and heads to Hawaii for the holidays.  He will return to Washington the weekend of January 4th. Advocacy at a Glance and our weekly Analysis and Commentary will resume on January 3rd. Wishing everyone happy holidays.

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