The FDA is currently not structured to ensure that drugs are safe or clinically valuable–as is its legal mission. The FDA’s focus is overwhelmingly on the approval of new drugs, and on tenaciously defending those drugs–even when they were proven unsafe and clinically useless to boot. This has resulted in hundreds of thousands of preventable deaths. Since 1993, after the enactment of the Prescription Drug User Fee Act (PDUFA, 1992) 38 drugs were withdrawn from market worldwide because of fatal risks–5 remain in the US market, including Avandia. 

Dr. Marcia Angell, former editor of the New England Journal of Medicine, has written an excellent, insightful essay in the form of a book review , in which she offers 9 recommendations to tackle specific shortcomings of FDA’s current norm and practice which is under the influence of entrenched conflicts of interest. Her recommendations include:

•  First, the Prescription Drug User Fee Act (PDUFA) should be repealed.

She points out how industry’s $400 million annual payment to the FDA in "user fees" since enactment of PDUFA has impacted the FDA’s focus, and, more importantly, the unsafe drugs that have been issued the government seal of approval.

* The imbalance in the number of FDA staff in its four divisions regulating drugs is a direct result of PDUFA:The Office of New Drugs has 930 employees assigned to speed up the drug approval process, OSE (which monitors safety) has 206, Office of Generic Drugs has 268, Marketing , Advertising Division has 83, and Manufacturing / Product Quality has just  3 employees.

•  the Office of Surveillance and Epidemiology (OSE) should have more authority and independence from the Office of New Drugs (OND)

•  Third, members of CDER’s standing advisory committees should have no financial ties to drug companies (except for research support provided under carefully restricted conditions.

•  Fourth, the FDA should see that the post-marketing studies it requires as a condition of approval are carried out in a reasonable time.

•  Fifth, approval of new drugs should be limited to three years, and during that time advertising aimed directly at consumers should be prohibited.

•  Sixth, the FDA should review generic  drugs as rapidly as brand-name drugs, and be adequately staffed to do so.

•  Seventh, 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 eighth reform concerns the “surrogate endpoints”–especially for me-too drugs or drugs for less serious conditions, there is no rush and the FDA should insist on clinical endpoints.

•  Ninth, as a condition for enrolling human subjects, all clinical trials,  without exception, should be registered at inception in a public database and the results shown when the research is completed.

Ironically, the catalyst for her thoughtful essay is a book by Daniel Carpenter, a Harvard professor of government, who, apparently doesn’t have a clue as to the significance of the vital issues involved. According to Dr. Angell, Prof. Carpenter omitted ALL of the critical issues affecting the health of consumers of prescription drugs. Many of the problems that critics have been grappling with–which Dr. Angell discusses–arise from the culture that has diverted the agency from its raison d’etre (reason for existing) which is to protect the public interest. Instead, high ranking FDA officials have put industry’s proprietary interersts ahead of the public welfare.

But as Dr. Angell notes: "The pharmaceutical industry and the FDA are not engaged in a common endeavor, and they shouldn’t be. Drug companies, of course, want to sell safe and effective drugs, but their primary purpose, like that of other investor owned businesses, is to enhance the value of their shareholders’ stock by maximizing profits. If they did not do that, their top executives would risk being fired. The job of regulators, on the other hand, is to enforce legal constraints that often moderate the profit incentive. Thus, the basic missions of industry and regulators are different, and inherently somewhat adversarial, no matter how pleasant the relationship…"

 Read complete article at:  http://www.nybooks.com/articles/archives/2010/sep/30/agency-can-be-dangerous/

             and also at: https://ahrp.org/cms/images/stories/articles/angell_fda_dangerous.pdf

Vera Hassner Sharav