Pharmaceutical Research and Manufacturers of America

Pharmaceutical Research and Manufacturers of America (PhRMA) is an American trade association based in Washington, DC that lobbies on behalf of pharmaceutical companies. PhRMA has offices in Japan and the United Arab Emirates.¹⁾

PhRMA was founded in 1958 “to represent America’s biopharmaceutical research companies and seek essential alignment between public policy and medical research to address patient needs.”^{2) 3)}

Member companies include AbbVie, Alkermes, Amgen, Astellas, AstraZeneca, Bayer, Biogen, BioMarin, Boehringer Ingelheim, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, EMD Serono, Genentech, Gilead Sciences, GlaxoSmithKline, Incyte, Ipsen Biopharmaceuticals, Johnson & Johnson, Lundbeck, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Sage Therapeutics, Sanofi, Sunovion, Takeda, Teva, and UCB.⁴⁾

Taking back the FDA

By Marcia Angell | February 26, 2007

IT'S TIME to take the Food and Drug Administration back from the drug companies.

The agency's coziness with industry is underscored by the composition of its 18 advisory committees – outside experts who help evaluate drugs.

Incredibly, many of these advisers work as consultants for drug companies. Although they are supposed to recuse themselves if there is a direct conflict of interest, the FDA regularly grants exemptions from that requirement. Of the six members of the advisory committee that in 1999 recommended approving Vioxx – the arthritis drug pulled from the market in 2004 because it caused heart attacks – four had received waivers from the conflict-of-interest rule.

The FDA now behaves as though the pharmaceutical industry is its user, not the public. Fortunately, the user fee law is subject to renewal every five years, and this is one of those years.

Congress should let the law die this time around and substitute its own support – which ought to be increased. Other reforms recently proposed, such as administratively separating drug approval from safety surveillance, will not mean much as long as this law is in effect.

At $300 million to $400 million a year, the equivalent of about a day in Iraq, Congress can easily afford to buy this vital agency back for the public, and it should.

Dr. Marcia Angell, a senior lecturer at Harvard Medical School, is a guest columnist.⁵⁾