Increased Authority, Funding Needed To “Fix The FDA,” Coalition Says
This article was originally published in The Tan Sheet
Executive Summary
An ad campaign targeting inside-the-Beltway audiences seeks to pressure Congress for increased FDA funding
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An ad campaign targeting inside-the-Beltway audiences seeks to pressure Congress for increased FDA funding. A print ad urging Congress to "fix" FDA appeared in The Washington Post, The Washington Times and Roll Call March 4 with the tagline, "Congress is playing a deadly shell game with FDA." The ad features a picture of three shells titled "food," "drugs" and "medical devices"; a hand is lifting the medical devices shell to reveal a nut. FDA "is supposed to assure the safety of what goes into our bodies," the ad states. "Unfortunately, FDA is broken. The public's health is being compromised to the point of negligence," the ad states. "The current Vioxx controversy is just the latest symptom of a system in crisis," the ad says, referring to Merck's withdrawal of its COX-2 inhibitor due to cardiovascular safety concerns. "It's not all the agency's fault. Congress has reduced FDA's authority, slashed enforcement budgets and weakened its legal powers," the ad declares. "We shouldn't have to gamble with the safety of our food, medicines or medical implants." "Congress has an opportunity to fix this problem now," the ad continues, "or else continue the FDA shell game, with lax enforcement here, loopholes there, and the next deadly scandal just waiting to be uncovered." The ad campaign is sponsored by FixTheFDA.org, a coalition comprising the Center for Medical Consumers, Center for Science in the Public Interest, Command Trust Network, National Research Center for Women & Families, National Women's Health Network and U.S. PIRG. FixtheFDA.org was established over the past few weeks, U.S. PIRG said. The affiliated groups timed the ad run with the period of heightened agency scrutiny following the Feb. 16-18 advisory committee meeting on COX-2 safety. The ads also followed two Senate Health Committee hearings on drug safety March 1 and 3 (1 (Also see "Drug Safety Review Needs Continued Input From OND Experts – Woodcock" - Pink Sheet, 7 Mar, 2005.), p. 13). A TV ad appeared during Meet the Press March 6 and ran on CNN, MSNBC and Fox News Channel during the week of March 7, U.S. PIRG said. The corresponding 2 website calls for Congress to "give the FDA what it needs to protect our health." "Congress is holding hearings to examine problems with FDA's process for approving drugs, and the Institute of Medicine is conducting a review of the FDA's drug safety procedures," the website says. "However, that's not enough." FDA's oversight for medical devices and food also needs to be fixed, the site declares. The site includes results from a survey that show a majority of respondents "would oppose any candidate who voted to limit the FDA's inspection and enforcement capabilities." The poll, funded by the Center for Medical Consumers and other groups, found that two-thirds of participants supported appointing an independent body to review FDA practices and procedures (3 (Also see "FDA Needs Stronger Postmarket Reporting Process For Approved Drugs – Poll" - Pink Sheet, 7 Mar, 2005.), p. 16). "Congress should expand its examination of problems at the FDA to include the dangers posed by inadequate procedures for ensuring the safety of food and medical devices, as well as drugs," the website says. "Congress must give the FDA the authority and resources it needs to keep us safe." The "Fix the FDA" ad campaign falls in the same vein as efforts by the FDA Council, an industry/ professional/research lobbying organization that sought increased agency funding ahead of the Prescription Drug User Fee program. The FixtheFDA.org website gives users the option to send a letter to a senator or congressman urging additional funding for the agency. |