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Two Pix Are Worth …

August 6, 2010

ADVOCACY

Meetings.  We are pleased to report that the Alliance is scheduled to meet next week with Ellen Murray, HHS Assistant Secretary for Financial Resources.

Waxman-Harkin Letter to Secretary Sebelius Regarding FY 2012 Funding.  As indicated in a press release issued by the Alliance yesterday, Chairmen Waxman and Harkin along with Representatives Dingell, Stupak, and Pallone wrote a Congressional letter to HHS Secretary Kathleen Sebelius urging her to make FDA a priority as the Administration’s FY 12 budget is being put together. The Alliance greatly appreciates the above mentioned members for their leadership and hard work.

Alliance Membership Letters to HHS Secretary Sebelius.  We continue to urge Alliance members who have not written letters to please do so and to please share with us your letter when it is complete as we are continuing to post them on our website.

ANALYSIS AND COMMENTARY

One of the Alliance’s most effective messages this year has concerned the number of FDA staff paid for with appropriated funds, as opposed to user fees. In FY 10,  FDA has the same number of full-time equivalent employees (FTEs) as it did in 1994, which was the previous high point.  We have talked about the many new responsibilities that FDA was assigned in those 16 years, as well as the shift toward globalization and increased scientific complexity. We haven’t been challenged on these points — it is fairly obvious that the FDA’s job has grown larger and more difficult during those years. Sometimes we have been asked to provide more details and we have done so with success.

All this has been very effective. Yet, we are always looking for some different and dramatic ways to draw our comparison between 1994 and 2010. This week, I have found two:  

These images were widely used in the legislative battle over biosimilars, but FDA is also using them now. On the left is the  molecular structure of aspirin. On the right is a compressed version of the molecular structure of a monoclonal antibody.

Although biotechnology was important in 1994, the bulk of drugs under review and in the marketplace were of similar — or somewhat greater — complexity than the aspirin molecule shown here. In 2010, there are many more complicated drugs and the market has shifted strongly toward biologic therapies. The FDA needs to be a leader in hiring and retaining scientists who can handle the challenges represented by the complexity of a monoclonal antibody. This is just a pair of images, but it is a story in itself about why FDA is in continuous need of more resources to do its job well.

The second example comes from comments made by the CEO of Google at a conference on Wednesday. Specifically, he said that every two days in 2010, we create as much new information as was created from the dawn of civilization to 2003. The operative number is five exabytes of new data or five followed by 18 zeros created every 48 hours.  The amount of new and old information in 1994 was just a fraction of what it is today. Not all of it concerns FDA, but the agency needs more resources and better data systems to keep up with the amount and pace of new information.

We would welcome additional examples that are intuitive, impactful, and close to self-explanatory. They should demonstrate — directly or indirectly — how FDA’s responsibilities are more complicated and the world we live in has become so much more difficult than 16 years ago.

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

MEDIA ACTIVITIES/RELEVANT DOCUMENTS

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