$170m of "No-Year" Monies for MCMs
ADVOCACY
FDA Regulatory Science Meeting.
This past week the Alliance had the opportunity to meet with Dr. Luciana Borio, who is directing FDA’s Medical Countermeasures (MCM) initiative. More details on FDA’s MCM initiative appear below in the "Analysis and Commentary" section.
Annual Membership Meeting.
Wednesday, October 27th at 2:00 p.m. Special Guest Speaker, Dr. Lu Borio, FDA, Office of the Commissioner.
ANALYSIS AND COMMENTARY
FDA has a new initiative and the potential for new monies. A recent review of HHS’s involvement with homeland security revealed a number of deficient areas. Notable among them was approving medical products that would be used to protect our population in the event of a chemical, biological or nuclear attack. Such products are known as medical countermeasures (MCMs).If all goes as planned, FDA’s MCM initiative will get $170 million of already-appropriated, "no-year" monies (i.e., available until expended) to provide more direction and support for development and approval of MCMs. This will not be a regulatory science initiative (RSI) project because it is product-oriented. However, the MCM initiative is expected to stimulate a lot of new policies and new science that will contribute to RSI. The implementation will be on a matrixed, cross-center basis, rather than centralizing staffing and funds in a particular center or creating a new center.The $170 million has been shifted to FDA’s accounts from monies appropriated by Congress to HHS to fund a national response to last year’s pandemic flu. As it currently stands, the transferred monies are not affected by the limitations in the continuing resolution, but can only be used for pandemic flu projects at FDA. Congress must approve a re-purposing of the monies to include MCMs. Congress will likely take this issue up, along with the rest of the FY11 Federal budget, in November, when they will be working against a December 3 deadline for passing the next Continuing Resolution. Because the pandemic flu money was appropriated in the Labor-HHS appropriations bill, it will be that subcommittee that will be making the decision on the re-purposing.
Some of the key staff on the initiative are already in place through re-assignment. Hiring can start for individuals who will be working on pandemic flu projects. Once the funds become available for the larger purpose, there will be a combination of new hires and existing staff who will be working on MCMs — some full-time and others half or quarter-time. If implemented as planned, there will be funding for about 375 slots, including 100 individuals each for CDER and CBER and 75 for CDRH.An important question is whether this is a sustainable initiative. The current money is "no year" money, which means it can be spent over multiple years. However, FDA plans to spend most of the money in 2011, and believes the President and Congress will want to fund this initiative each year to make it a meaningful investment. However, these are decisions that have not been publicly announced and rely on what additional funds are in the President’s budget request for FY 2012, which will be released after the State of the Union in late January. Congress will have the final say.Also unknown is the impact of this initiative on other requested increases in FDA funding. Our position is that the MCM initiative monies are going to a very specific program and do not lessen the need for the agency to receive the President’s FY 11 request. Even better would be for FDA to receive the House subcommittee mark, which was $55 million above the President’s request.For more on the MCM initiative, the RSI initiative and the status of FDA funding requests, please remember to come to the Alliance’s quarterly member’s meeting. It is at 2 p.m. on Wednesday, October 27. A highlight of the meeting will be a presentation by Dr. Lu Borio, who is running the MCM initiative.
Note: This week’s column was written by Tony Curry and Steven Grossman of the Alliance staff.
Update on hiring at FDA. We have been told that there is no FDA-wide policy on hiring under the Continuing Resolution. Some offices will be able to proceed to fill vacancies or new slots. Others may not. It will depend on their staffing and funding levels relative to FY 10.