Letter to HHS Secretary on Pharmaceutical Research & Manufacturers of America Emergency Preparedness Task Force (HRG Publication #1600)
November 8, 2001
VIA HAND DELIVERY
Tommy Thompson, Secretary
Re: PhRMA Emergency Preparedness Task Force
Dear Secretary Thompson:
I am writing in connection with your meetings with the Pharmaceutical Research & Manufacturers of America Emergency Preparedness Task Force. This group is directed by Aventis s Richard Markham and includes representatives from 10 other pharmaceutical companies, including Pfizer, Pharmacia, GlaxoSmithKline, Merck, American Home Products, Johnson & Johnson, Bristol-Myers Squibb, Bayer, Eli Lilly, and Abbott Laboratories.
According to several news reports, the PhRMA Task Force has met with your office to provide advice and seek direction regarding tasks that HHS would like it to perform. During an October 26, 2001 meeting with representatives of PhRMA, you reportedly requested that PhRMA put together for [you] a pharmaceutical scientific technology task force. (The Pink Sheet, October 29, 2001, at 3.) In response, PhRMA created its Emergency Preparedness Task Force to provide ideas and advice to HHS, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health on matters relating to bioterrorism. Accordingly, in recent weeks, PhRMA liaisons, such as Michael Friedman, and pharmaceutical company executives have been meeting regularly with Bush Cabinet members, such as yourself.. (New York Times, November 4, 2001, Section 3, page 1.)
The PhRMA Task Force established at your behest is unquestionably a federal advisory committee subject to the Federal Advisory Committee Act (FACA). Accordingly, the HHS meetings with the Task Force violate FACA. Before a federal agency may use an advisory committee, FACA requires that the agency file a charter with the agency and with appropriate committees of Congress and provide a copy to the Library of Congress. (5 U.S.C. App. II § 9(c).) Among other things, the charter must set forth the committee s objectives and the scope of its activities, the period of time necessary for it to carry out its purposes, and a description of duties. The membership of the committee must be fairly balanced in terms of points of view represented and the functions performed. (5 U.S.C. App. II § 5(b).) In addition, timely notice of each meeting between HHS and the committee must be published in the Federal Register. (5 U.S.C. App. II § 10(a)(2)); see (41 C.F.R. § 101.6.1015(b)(1).) FACA embodies a strong presumption that all advisory committee meetings be open to the public and allow public participation and the government has the burden of proving that a meeting is exempt from this requirement. (5 U.S.C. App. II § 10(a)(1).) Moreover, advisory committee material must be made available to the public, subject to some of the exemptions of the Freedom of Information Act. (5 U.S.C. App. II § 10(b).)
We understand that HHS is taking on the difficult job of determining how to protect our nation from the threat of bioterrorism. We commend your concern about that issue. At the same time, the rule of law must be observed. Exigent circumstances do not justify ignoring applicable legal obligations. FACA recognizes that the public s ability to scrutinize the manner in which the government obtains advice from private individuals helps to ensure that proposals are not biased or based on the self-interest of committee members. (See H.R. Rep. 92-1017, reprinted in 1972 U.S.C.C.A.N. 3496.) That logic applies here. The pharmaceutical executives who make up the Task Force plainly have expertise, but they also have powerful economic self-interests in shaping government policy on this topic. Accordingly, compliance with FACA is of vital importance.
To our knowledge, HHS has made no effort to bring itself into compliance with FACA. We urge that you instruct HHS staff to do so immediately. It would be a diversion for all concerned if HHS s noncompliance with FACA forced us to bring a challenge in court.
Your prompt attention to this matter is necessary.
Sidney M. Wolfe, MD