FDA: Can This Agency Be Dangerous?

FDA Dangerous Agency

Academics Duel Over FDA & Drug Regulation

How dangerous is FDA? One of the most articulate critics of the pharmaceutical industry and FDA’s oversight of drug regulation has been Dr. Marcia Angell, the past editor of the New England Journal of Medicine and currently a Senior Lecturer in Social Medicine at Harvard University. She is also the author of the “must read” book, The Truth About the Drug Companies. She maintains that the agency has not lived up to its mission of approving safe and effective drugs. She has taken the occasion of the publication of the book Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, by Daniel Carpenter (Princeton Studies in American Politics: Historical, International, and Comparative Perspectives), to write a scathing review in the September 30 edition of the New York Review of Books. Carpenter, a Professor of Government, is also at Harvard. Dr. Angell does not like this book and makes it very clear. And her negative review sparked a not-so-pleasant exchange between them in the October 28, 2010 edition where Angell accuses Carpenter of writing a “waspish letter” responding to her review. When Harvard academics flourish charges of being “waspish,” you know its serious.

Update: I am putting in a link for a memo by Dr. Carpenter responding to Dr. Angell’s review below.

I had been warned against tackling Dr. Carpenter’s 800 + page, rather dense history of FDA. I am leaving that to the good professor Sid Olufs, who periodically writes book reviews for GxP Perspectives (see the page at the top). However, Dr. Angell’s critique is harsh indeed. She faults Dr. Carpenter for the failure to bring out shortcomings with offices within FDA’s Center for Drug Evaluation and Research (CDER) and nine reforms that she considers important points about drug regulation in the United States and just how dangerous an agency FDA is. They are:

1. The Prescription Drug User Fee Act (PDUFA) should be repealed. I happen to agree, although I don’t think it was Dr. Carpenter’s intention to offer a polemic against the pharmaceutical industry. My experience in conducting PDUFA inspections for the agency for 10 years is that they are ineffective. We need public health inspections based on public health needs, not pharmaceutical dollars.

2. The Office of Surveillance and Epidemiology (OSE) should have more authority and independence from the Office of New Drugs. This involves Agency politics that is over my head. You can read Angell’s argument on the link below.

FDA agency dangerous

Conflicts of Interest on Advisory Committees

3. Members of CDER’s standing advisory committees should have no financial ties to drug companies (except for research support provided under carefully restricted conditions). I think that many of us are worried about the extent of drug company influence and the amount of money spent on that influence.

4. FDA should see that the post-marketing studies it requires as a condition of approval are carried out in a reasonable time period. This is a long overdue reform.

5. Approval of new drugs should be limited to three years, and during that time advertising aimed directly at the consumer should be prohibited. I’m not sure about the three years but I oppose direct-to consumer advertising.

6. FDA should review generic drugs as rapidly as brand name drugs and be adequately staffed to do so. A common sense reform.

7. In pre-marketing trials me-too drugs should be compared with an existing drug to treat the same condition, not just with a placebo. The debate over placebo controls in clinical trials is worthy of an entire book, maybe two. The Blog isn’t taking a position. Yet.

8. Dr. Angell’s eighth reform involves surrogate endpoints.
You will need to read her arguments on the link below.

9. As a condition for enrolling human subjects, all clinical trials, without exception, should be registered at inception in a public database at inception in a public database and the results shown when the research is completed. This might be easier said then done but greater transparency is a must in the future of clinical research.

FDA Agency dangerous

FDA Has a Long Ways To Go

GxP Perspective: This is a summary of Dr. Angell’s critique of FDA. I am not so sure. FDA is a very large agency and change will take time. I believe that change has been taking place incrementally and that FDA is doing a good job under difficult circumstances. While I agree with many of the points Dr. Angell raises, and highly recommend her book on the pharmaceutical industry, I think we need to look at the bigger picture. FDA is a much better agency than the one I left in January 2005. Let’s give some credit where credit is due. We’re lucky they are on the job.

The NY Review of Books Article by Dr. Angell on FDA: This Agency Can Be Dangerous

How Dangerous is FDA? An Exchange Between Daniel Carpenter and Marcia Angell

Dr. Carpenter’s Response Memo


In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA. (and again in January 2012)

Please join GxP Perspectives on LinkedIn at:

GxP Perspectives LinkedIn Group


Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents. Let me know!

In the Blogosphere: The nice folks at imarc have noted Mikki O’Neal’s Guest Commentary on IRB Training. Please check out their site: imarc

7 Responses to FDA: Can This Agency Be Dangerous?

  1. Sarah says:

    Hi Carl,
    Your blog keeping us inform of FDA and other related current happenings is greatly appreciated. In reference to number 4, I think oversight of the post marketing process should be looked at. I’ve audited several post marketing studies over the past few years and there is no or very little monitoring and I fear adverse events are not adequately captured and reported. What has been your experience with this?

    • GxP Perspectives says:

      So right you are (as usual). I found that out when I was at FDA that Phase IV studies just don’t receive the appropriate oversight.

  2. Count me as a skeptic, or an agnostic, or an atheist when it comes to believing any drug company claims. It takes many thousands of years for our bodies to evolve to handle new substances. New drugs do not meet that evolutionary standard in a few tears of testing. I have quit taking all medications, and my health has improved greatly simply by following an evolutionary diet of real foods.

  3. […] and Pharmaceutical Regulation at the FDA, by Daniel Carpenter that was discussed in a recent post: Can This Agency be Dangerous? John Avellanet, a compliance consultant and author of Compliance Zen on the blogroll, and Anne […]

  4. Hey this is a attractive looking site, is this wordpress? Forgive me for the foolish question but if so, what theme is? Thanks!

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