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A recent speech by the head of the Food and Drug Administration (FDA) — which regulates nearly a quarter of all consumer products sold in the U.S. — once again highlighted the fact that the agency has grown much too cozy with the industries it regulates, particularly pharmaceutical and medical device companies.
According to The Boston Globe, on April 4, FDA Commissioner Margaret Hamburg, speaking to a group of drug company executives, “called for more regulatory flexibility and ‘a new...
A recent speech by the head of the Food and Drug Administration (FDA) — which regulates nearly a quarter of all consumer products sold in the U.S. — once again highlighted the fact that the agency has grown much too cozy with the industries it regulates, particularly pharmaceutical and medical device companies.
According to The Boston Globe, on April 4, FDA Commissioner Margaret Hamburg, speaking to a group of drug company executives, “called for more regulatory flexibility and ‘a new era of partnership’ with the biopharmaceutical industry in bringing new treatments to patients.”[1] The audience of more than 300 pharmaceutical industry executives was attending the annual meeting of the Massachusetts Biotechnology Council, an association representing more than 600 biotechnology companies, universities and academic institutions.[2] Hamburg was quoted as saying that such a partnership promised “swifter, more efficient product development and product review.”
Such statements by the leader of one of the most important regulatory agencies within the U.S. Public Health Service reflect the seriously distorted mindset within the FDA’s senior leadership regarding the agency’s relationship with the industries it regulates. In particular, the FDA’s leaders seem blind to the fact that the relationship that must exist between a regulator and a regulated entity is fundamentally different from a partnership.
As the regulatory agency charged with ensuring the safety and effectiveness of drugs, medical devices and many other consumer products, the FDA must retain as its primary mission the protection of public health. Fulfilling this public health mission routinely requires that the agency take actions that are not aligned with the commercial interests of the industries it regulates. As such, the agency must treat these regulated industries with a reasonable amount of skepticism and, in extreme cases, must view regulated companies as adversaries.
In stark contrast, a partnership involves close cooperation between two or more entities seeking to advance shared interests and objectives. The dynamics of a partnership are incompatible with the relationship that must exist between a regulatory agency and regulated industry.
The FDA’s view of itself as a partner with the industries it regulates has developed gradually over the past two decades, and this viewpoint is now more entrenched than ever. In the context of the FDA’s partnership with industry, “regulatory flexibility” too often is a euphemism for lowering standards for approval of drugs and medical devices. The result is that, with increasing frequency, the FDA has failed to follow the precautionary principle necessary for ensuring public health and instead approved medical products that are unsafe, ineffective or both.
References
[1] Weisman R. FDA chief urges ‘new era of partnership.’ April 5, 2014. The Boston Globe. http://www.bostonglobe.com/business/2014/04/04/fda-commissioner-calls-for-new-era-partnership-with-biopharma-industry/8676GZuMw8oEqaXt2HmkmK/story.html. Accessed April 10, 2014.
[2] MassBio website. About page. http://www.massbio.org/about. Accessed April 10, 2014.
