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)
It raises funds through the PhRMA Foundation.
History
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)
Membership
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)
PhARMA Lobbying Impact
1992 Prescription Drug User Fee Act
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)
Bioshield Two
Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S. 1873), nicknamed “Bioshield Two” and sponsored by Senator Richard Burr (R-North Carolina), aims to shortcut safety testing for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. Co-sponsored by Bill Frist (R-TN), Mike Enzi (R-WY), and Judd Gregg (R-NH), by voice vote, despite Democratic objections.
How many lawyers and lobbyists does it take to define pandemic as anything at all to anyone on the public dime and an assigned parking space near the door? In 2005 Bill Moyers reported 35 lobbyists per Member of Congress. Just counting sponsors 4×35= 140 lobbyists potentially helping. That's PhARMA teamwork!
Senate Bill
Oct 17, 2005 · Biodefense and Pandemic Vaccine and Drug Development Act of 2005 - (Sec. 3) Amends the Public Health Service Act to establish the Biomedical Advanced Research and Development Agency (BARDA) within the Department of Health and Human Services (HHS) to coordinate and oversee activities that support and accelerate advanced research and development of qualified countermeasures to exposure to hazardous agents or infectious diseases or qualified pandemic or epidemic products.
Establishment.–There is established within
the Department of Health and Human Services, the Biomedical Advanced Research and Development Agency.</DELETED> <DELETED> ``(2) Purpose.--It shall be the purpose of the BARDA to coordinate and oversee activities that support and accelerate qualified countermeasure or qualified pandemic or epidemic product (referred to in this section as `countermeasure or product') advanced research and development by--</DELETED> (8) Person.--The term `person' includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local agency or department. SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AGENCY.</DELETED>
<DELETED> ``(a) Definitions.–In this section:</DELETED>
<DELETED> ``(1) BARDA.--The term `BARDA' means the Biomedical Advanced Research and Development Agency.</DELETED> <DELETED> ``(2) Fund.--The term `Fund' means the Biodefense Medical Countermeasure Development Fund established under subsection (d).</DELETED> <DELETED> ``(3) Other transactions.--The term `other transactions' means transactions, other than procurement contracts, grants, and cooperative agreements, including transactions for prototypes, as provided to the Secretary of Defense under section 2371 of title 10, United States Code. ((https://web.archive.org/web/20160402133240/https://www.congress.gov/bill/109th-congress/senate-bill/1873/text))