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The Friday Update — September 18, 2009

November 27, 2009


Metrics Project Update.  We have received a good number of comments from Alliance members and comments continue to come in on a daily basis.  We are currently in the process of reviewing and compiling the comments and will to have a compilation working draft document for each sub-group (drugs/biologics; devices; and food) to review in the near term. 

Working drafts of the compilation documents will be sent to sub-group participants for review upon completion and we are hoping to hold working group sessions during the first full week of October (5th to 9th of the month).  


It has been a busy week … with Senator Baucus unveiling his health reform proposal and Commissioner Hamburg on the road talking about enforcement. And progress is being made on the agriculture appropriations bill (includes FDA). It may be done before the new fiscal year starts on October 1, but certainly before October is done.

As the Alliance consolidates the significant gains of the past three years and looks ahead, two points are immediately relevant for this Fall:

The appropriations cycle is a year-round activity, even when Congress stays on schedule. If you only look at the Hill, appropriations goes from the release of the President’s budget in early February until final passage, hopefully on or before October 1.  Nobody actually gets to rest in the intervening months. Congressional staff work on program oversight, field hearings, research, meetings with the agency and preparation for the next fiscal year. The Alliance continues to prepare for the next Congressional cycle, but also goes into full gear working with the Executive Branch to get the highest  possible FDA number into the President budget request for 2011.

In the appropriations world, success doesn’t necessarily lead to further success. Every year, every dollar must be explained and defended…along with strong rationale for why it contributes to a better future.  This is why the Alliance will be devoting significant energy this Fall into the metrics project.  We have been told by veterans of the successful 5-year doubling of the NIH budget: we wish we had spent more time in the middle years worrying about justifying increases after the doubling was completed. While we can envy an agency that “gets stuck” at the $28 billion level, it took several years for Congress to get past the idea that “we have already taken care of NIH.” We don’t want Congress to think that way about FDA.  

As we ask each of you to expend more effort to help FDA, I thought it might be useful to re-cap some of the key messages:

  • FDA’S needs have been neglected for many years under both Republican and Democratic Administrations. FDA has never been funded as a public health agency. In 1984, CDC and FDA were both funded at about $400M. Twenty five years later, CDC’s appropriated budget is $6.5 billion and FDA’s is $2 billion.
  • The world that FDA regulates has become more complex.  Billions in industry and NIH funding have advanced the scientific basis for medical products. The American food supply cannot avoid an  environment where every step from field to table carries some risk. Nanotechnology, aquaculture and genomics are just three of the many new challenges that FDA is preparing for.  
  • New responsibilities are constantly being added to the FDA’s mandate.  Laws passed over the last few years cannot be fully implemented without  vastly broader and more interactive databases of suppliers, products, imports, adverse events, treatment protocols, etc. . This will cost several hundred million dollars to create and at least as much to maintain and expand. CBO has estimated that one of the leading food safety proposals being considered by Congress might require $1 billion in new appropriations by the fifth year after enactment.

Hopefully, this whets your appetite to learn and do more. Please get involved in one of the metrics task forces, integrate FDA’s resource needs into your public affairs and lobbying positions, and be the every-day advocate that the agency needs.

PS: On my blog this week, I have written about the Office of Regulatory Affairs at FDA and about how dependent CDER is on user fees. The blog is not affiliated in any way with the Alliance, but I think these columns might be of particular interest to Alliance members. Check it out.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance.


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