ADVOCACY

• $170 Million in New Money for Regulatory Science. As detailed in last week’s Friday Update, Secretary Sebelius announced results of HHS’ evaluation of efforts to increase the number of approved medical countermeasures (MCMs) — drugs to protect our population in case of a bioterror attack and from naturally occurring emerging infectious diseases.  As a result, FDA will receive significant funding ($170 million, available until expended) for regulatory science related to MCMs. The transfer of funds to FDA can be accomplished administratively, but the use of the funds for this broader purpose must be approved by Congress. Attached is a copy of the budget amendment sent by OMB to the Speaker of the House.
• Resource Implications of the Egg Crisis. With significant media attention focused on the Salmonella outbreak in eggs, the Alliance issued a press release and talking points about the resource implications of the crisis.
• Transparency and Measurements at FDA.  FDA will announce next Tuesday its further steps in the process on its FDA-TRACK initiative, which is meant to provide transparency and measurements at FDA. A contingent from the Alliance will be at the meeting, and we will report back to the full Alliance on how this meeting goes.

ANALYSIS AND COMMENTARY

When the Alliance issues press releases in successive weeks, you would normally assume the President has announced his budget request or the appropriations committees are marking up FDA funding bills. August seems a most unlikely time. Yet last week’s announcement about new funding for regulatory science and medical countermeasures was followed by this week’s deepening of public debate about the egg recall. This is a time when the importance of FDA and its funding needs are receiving heightened attention and the Alliance is working hard to turn this into new resources for the agency.

One of the most interesting articles this week tied the egg recall to one of our major themes: the need to invest in information technology at FDA. Some of FDA’s responsibilities cannot be accomplished without new data collection, sophisticated databases and analysts to translate the resulting information into useful knowledge. Other responsibilities are carried out in inefficient and often ineffective ways for the lack of good IT system.

The article can be downloaded at: “Better use of IT could minimize the next salmonella egg-idemic.” The author, Daniel Castro, is a senior analyst at the Information Technology and Innovation Foundation and a former analyst at the General Accounting Office. He usually writes about cybersecurity, e-Government, health and privacy. He recognizes the possible impact of the new FDA rule on eggs and salmonella and notes the potential for upgraded enforcement in the future. He then analyzes all the ways that IT can help. It is worth reading.

He concludes: “Is more IT the only solution to Salmonella outbreaks? Of course not. But policymakers should remember that IT has an important role to play in monitoring, detecting and responding to public health threats and protecting the safety of our food supply.”

The Alliance would add only that IT is also critical to safe and effective drugs, biologics, devices, veterinary drugs, over-the-counter medications and so on. No single thing would help FDA more than a large infusion of monies to build the IT system that supports a 21st Century FDA. We will keep working on it.

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

MEDIA ACTIVITIES/RELEVANT DOCUMENTS

• FDA Commissioner Dr. Margaret Hamburg tells TODAY’s Matt Lauer that her organization needs additional resources and authority to better combat food safety issues.
• FDA says they need more help
• Alliance advisor William Hubbard appeared on a KQED (San Francisco) radio program covering the egg recall. Inadequate resources was a prominent theme.
• Des Moines Register op-ed: “Fix cracks in food safety system;” resource shortfalls highlighted.

ADVOCACY

HHS Secretary Kathleen Sebelius announced a new regulatory science initiative yesterday. We understand the program consists of $170 million for FDA but are trying to determine more specifics.

ANALYSIS AND COMMENTARY

It’s hot in DC and Congress is gone until September 13. It would be boring except the Executive Branch always seems willing to absorb the extra column inches that are freed up by Congressional recess. Thus, the report released yesterday by HHS Secretary Sebelius drew a lot of attention, but I didn’t read a single article that included a quote from a Member of Congress. The Alliance’s press release and our viewpoint can be viewed here.

Yesterday, the Secretary released the findings and recommendations from a top-to-bottom review of the Department’s efforts with regard to national security and the development of medical countermeasures (MCM). This means products that will decrease morbidity and mortality from a bioterror attack or from naturally occurring emerging infectious diseases. Think anthrax or radioactivity from a dirty bomb for the first; think H1N1 influenza for the second. Scientifically and medically, these are difficult products to discover and develop. Financially, they won’t ever be developed without: federal assistance to promising research, and a strategic national stockpile and government contracts that will buy MCMs once they are proven.

As with the larger promise of moving medical therapies from “bench to bedside,” there is no progress without FDA. The agency is supposed to encourage companies by helping them to define appropriate safety and efficacy endpoints for their particular MCM and work with them to resolve questions of animal models, lab standards, statistical plans, quality manufacturing, etc.

Then, the agency is charged with evaluating the results of testing and determine whether to approve the product. This work has an additional wrinkle. With most MCM’s (maybe all) it is unethical to do human efficacy trials (e.g., intentionally expose a human being to anthrax to see if the MCM works). Instead, the agency (and the company) must make the difficult evaluation as to whether efficacy in animals is a sufficient surrogate for efficacy in humans.

What is notable for us is that the Secretary (and the underlying report) found that there was insufficient funding of FDA’s efforts in this area. Perhaps for the first time, there was a more global recognition of FDA’s central role in making us safer from bioterrorism and naturally occurring emerging infectious diseases. There was also a recognition that FDA couldn’t do this job with its current resource level.

Even better, the Administration placed a price tag — $170 million for FY 10 and FY 11 — on the size and scope of the monies needed to upgrade FDA’s efforts in this area.  This is a substantial amount of money that will greatly increase FDA ability to fulfill its mission in the coming fiscal year (FY 11). We have been cautious in announcing this number because of uncertainties about where the money will come from and the degree to which Congress must still have its say.

What we know so far is that the Administration plans to transfer the $170 million to FDA from the funds previously appropriated to HHS to deal with pandemic flu. Apparently, HHS and OMB have agreed that the monies can be transferred as long as they retain their original purpose of helping to deal with pandemic flu. It seems likely they can do this, but there is no immediate way to determine if Members of Congress agree.

It is clear that the transferred funds cannot be used for non-pandemic medical countermeasures. To accomplish this will require a budget amendment to broaden the permitted uses of these funds. How likely is it that Congress will approve this? We probably won’t know for sure until after September 13.

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

MEDIA ACTIVITIES/RELEVANT DOCUMENTS

• Venture fund needed to fight bioterrorism, pandemics, U.S. scientists say

The Alliance for a Stronger FDA issued a media release this morning praising HHS Secretary Kathleen Sebelius for her forthright advocacy for regulatory science at FDA.

At a press conference this morning, the Secretary highlighted regulatory science as one component of the proposed new federal approach to medical countermeasures needed to address health emergencies.

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

• Top Dems press for more FDA funding (accessible by subscribers to InsideHealthPolicy.com only)
• Health innovations for Maryland’s future