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Should the FDA Be Split In Two? And Other Industry Musings

The FDA is grossly underfunded, resulting in spotty oversight and slow drug approval processes, leading some to speculate that America might be better served by two agencies instead: one for food safety and another for drug oversight.

But today industry insiders* downplayed the idea of carving up the FDA. Their reasoning? First of all, it would be too complicated to untether the two areas of oversight. Secondly, America is redoubling its preventive health efforts, including healthy eating and regular exercise as a means to reduce the chronic disease burden. Billy Tauzin, CEO of PhRMA, commented, “We are what we eat. We should keep food and drug oversight closely aligned.”

Other industry concerns voiced on the conference call included:

1. A wish for the FDA to enter the 21st century by accepting digital filing and analysis of clinical trial data. Currently, they accept paper copies only.

2. A call for an experienced executive leader to become the new FDA Commissioner. One conference participant stated that “The FDA has been a rudderless ship for too long. We need someone who has the courage to say that there’s no such thing as a risk-free drug, and then speed up the approval process based on the best science available. The FDA is the world’s leading regulatory agency but is losing respect on the international stage, while Europe’s FDA equivalent is increasing in prestige.”

3. A desire for the new FDA Commissioner to be “above politics” and objective about science. A fixed term for the position was proposed.

4. A request for transparency in the drug approval process. One call participant said, “The FDA’s decision-making process is a black box. That really slows down our ability to get effective drugs to market.”

5. A cautious approach to approving biosimilar (or follow-on biologics) treatments. “At least 14 years are needed to demonstrate the interchangeability of biologic therapies,” said one biotech industry leader. “There’s a big difference between creating generic molecules of a common drug, and reproducing safe and effective treatments derived from living organisms.”


*The conference call was called, “The Obama administration and the new congress: good medicine for the pharma, biotech, and medtech industries?” sponsored by Ernst and Young. Recordings of the conference are not yet available to the public. Participants included:

Billy Tauzin, President and CEO of PhRMA
Jim Greenwood, President and CEO of the Biotechnology Industry Organization
Brett Loper, Executive Vice President, Government Affairs from AdvaMed

Special guest:
Mark B. Hassenplug, Global Pharmaceutical Markets Leader, Ernst & Young LLP

Anne Phelps, Prinicpal, Washington Council Ernst & Young LLP
Carolyn Buck Luce, Global Pharmaceutical Sector Leader, Ernst & Young LLP

The FDA Lacks The Resources To Ensure The Safety Of America’s Food Supply

Tommy Thompson

The recent peanut butter/salmonella outbreak offers another opportunity to reflect on the underlying budget crisis and staff shortage at the Food and Drug Administration. I interviewed Tommy Thompson, former Secretary of Health and Human Services, about what the peanut butter debacle tells us about the FDA inspections of our food supply.

You may listen to our conversation by clicking on the play button, or read a summary below. Enjoy!

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Dr. Val: Has this recent outbreak influenced how the FDA tracks food ingredients?

Thompson: No it hasn’t. We have a serious food problem in America because the FDA is understaffed. There have been too many outbreaks of food poisoning – everything from listeria on cucumbers and onions to salmonella infections from ice cream and peanut butter. Approximately 82 million people experience an episode of food poisoning each year, 350,000 of them require treatment in a hospital and 8,000 die. People don’t seem to realize what a large problem food poisoning is until there is a new outbreak. The recent peanut butter contamination affected between 700-800 different food products.

Americans need to realize that the FDA is severely understaffed and cannot do the inspections necessary to protect all of our food. I’ve been harping about this for a long time. When I was Secretary of HHS I was able to increase the number of inspectors by 100%, but since I left the funding was decreased and the numbers of inspectors is back to the level when I started.

There are 64,000 venues that the FDA has to inspect, and there are only 700 inspectors. It is geographically and mathematically impossible to do all the inspections. The FDA is responsible for inspecting 80% of our food supply while the department of agriculture does the rest. The department of agriculture has 7000 employees and 6000 venues that they have to inspect. Just compare the resource differential between the FDA and the department of agriculture and you see the serious constraints under which the FDA operates.

The department of agriculture inspects every meat processing factory every day. But an FDA inspector may get to a food processing plant only once every 6 or 7 years.

Dr. Val: Wow, that’s enlightening and also terrifying at the same time.

Thompson: Yes, it really is. We inspect less than 1% of the food coming into America. The amount of imported food continues to increase as the number of inspectors decreases. We have some serious problems with our food supply and it’s about time that congress recognized this.

The FDA is doing the best job they can, and yet they are regularly criticized by the media. When you consider their limitations, they’re doing a heck of a good job with the resources they have.

Dr. Val: So what do we need to do to improve this situation?

Thompson: The FDA needs a larger budget, we need to get more inspectors out there, we need updated testing technology, but we also need a more modern law that would require food processing plants to file an affidavit with the FDA to ensure that their food is safe. There’s very little supervision of these companies.

Dr. Val: Is there anything the public can do to petition the government to increase funding to the FDA so they can inspect our food properly?

Thompson:  There’s a coalition to improve the quality of food inspections at FDA and I’m a part of that. There are people in congress who are working on introducing legislation to provide the FDA the resources necessary to hire more inspectors, and to require affidavits of safety from food processing plants.

Dr. Val: Do you think Dr. Joshua Sharfstein will become the new FDA commissioner?

Thompson: Sharfstein is being considered for a position at FDA, whether it’s commissioner, assistant commissioner, or chief of staff I don’t know.

Dr. Val: Do you have any advice for the new FDA commissioner, whoever it is?

Thompson: Yes. In addition to lobbying for increased funding to support more inspector positions, he or she should consider appointing a special commissioner of food that would report directly to the Secretary of Health and Human Services. The new FDA commissioner should focus on getting medicines and new drugs to market. In 2008 we had fewer new drugs get to market than any year since 1981. The entire FDA is overworked, the responsibilities are great, and congress meddles too much in their affairs, though that may change now that the democrats control both houses and the presidency.

The staff at FDA are becoming demoralized because every time they make a decision someone in congress criticizes them for it. Then they become reluctant to make decisions at all.

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