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A Broad Public Health Commitment

September 20, 2010

ANALYSIS AND COMMENTARY

As Ladd and I meet with Alliance members and other groups, we receive many suggestions about FDA activities that can use additional resources. It usually takes the form of: “Can you make sure that policymakers know there is an important need for more resources in the x program?”

For me, this is a reminder of one of the Alliance’s central themes: the FDA is significantly underfunded for the responsibilities it has been given. A few years of good increases helps a lot, but a multi-year effort will be required to close the responsibilities/resources gap. And the gap exists in every part of the agency.

We hear a lot about the “big-ticket” items: additional monies for food safety research and enforcement … and more appropriated funding to support the approval and safety monitoring functions in drugs, biologics and devices. Two cross-cutting program areas are also mentioned often: information technology and regulatory science.

The comparatively smaller items that come up in conversation are myriad. They include nutrition labeling, cosmetic regulation, generic drugs, grants for orphan drug development, seafood safety, better consumer education, more sophisticated risk communication programs and so on. Occasionally, we are asked to be advocates for the large, but less visible programs at FDA, such as the Center for Veterinary Medicine and the National Center for Toxicological. We believe it is important to do so.  

In recent conversations, we have been urged to speak more about three areas where past efforts are building or have been newly revived:   

  • Improved cooperation with NIH. The interest/belief is that a deeper FDA/NIH relationship would improve drug development — meaning potential therapies to help patients will arrive at the NDA/PMA stage sooner and with more definitive clinical studies. While NIH has substantially more resources to contribute, a meaningful and productive relationship requires FDA to contribute monies (and not just people resources) to the effort.
  • Greater involvement with patients, clinicians and academia. With little fanfare, FDA has increased its commitment to working with those who will prescribe and use FDA-regulated medical products. This is more than just additional stakeholder meetings. There are efforts to develop biomarkers and clinical endpoints through workshops, hearings, cooperative agreements. I am particularly impressed by the multi-year effort to create an artificial pancreas.
  • Agency commitment to global harmonization. This effects both food and medical products. FDA regulates some domestic companies that don’t import or export, but the bulk of companies are domestic/global or foreign. FDA tries to inspect the world, but needs stronger alliances and monies to hold up our end of agreements and to establish more overseas offices. Medical products are rarely intended only for the US market, meaning companies are also seeking multiple country approvals and trying to conform with different regulatory requirements.

 
The role of the Alliance is circumscribed. Our 180 members are bound by a commitment to increase the total FDA appropriated budget. However, examples always help, especially if they demonstrate that FDA responsibilities — important public health responsibilities — are not limited to a handful of areas.

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

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