SOURCE: MOTHER JONES, September/October 1995, “agency under attack;” Author: Leslie Weiss
SYNOPSIS: The Food and Drug Administration (FDA), sometimes criticized in the past for being too cozy with corporations, is now under attack for exactly the opposite reason. A powerful bloc of critics in the drug industry has joined hands with the Republican Congress and together they are pushing to overhaul the FDA. These critics claim the FDA is too tough on drug companies, unnecessarily inhibits innovation, and delays approval of new drugs and medical devices.
Leading the charge in Congress is Speaker of the House Newt Gingrich, who has labeled the FDA the “number one job killer” in the country, and called its head, David Kessler, “a bully and a thug.” Gingrich’s Progress & Freedom Foundation has a radical plan to privatize much of the FDA supervision of drugs and medical devices.
If enacted the Progress & Freedom Foundation’s plan will place responsibility for drug development, testing, and review in the hands of private firms hired by the drug companies themselves, while retaining a weakened FDA to rubber-stamp their recommendations. Additionally, the plan limits the liability of drug companies that sell dangerous drugs to the public.
Under the plan, government-licensed firms called DCBs (drug or device certifying bodies) would be retained by drug companies to develop, test, and review new products. According to the proposal, “competition between firms would inevitably produce a lower-cost, faster, and higher-quality development and approval process.”
FDA spokesperson Jim O’Hara charged, “What this report proposes is dismantling many of the safeguards that protect the public from drugs and devices that are unsafe or just don’t work. This is basically a proposal that says public health and safety are commodities for the marketplace.”
Though drug testing and review would be privatized under the plan, the FDA would still exist and would theoretically have the final say on new products. However, the report states there would be “a strong presumption that private certification decisions would not be overturned without substantial cause.” Further, the FDA would not be authorized to request additional testing or data, and it would “have to exercise its veto within a fixed time period (e.g. 90 days) after which the drug or device would automatically receive FDA approval.”
The Progress & Freedom Foundation plan also limits the drug company’s liability should a patient be injured or killed by a dangerous drug or medical device. According to the plan, a victim could not sue for punitive damages if the manufacturer of the product could show it met regulatory standards (no matter how weakened they were) during development and testing.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, says the plan to limit corporate liability is “hypocrisy at the very least.” Even some in the drug industry feel it goes too far.
Not surprisingly, the foundation has financial backing from some of the biggest names in the pharmaceutical industry, including Bristol-Myers Squibb Co., Eli Lilly & Co., and Marion Merell Dow. Another drug manufacturer, Glaxo, has given an undisclosed amount to the foundation, in addition to contributions of approximately $325,000 to the Republican Party and Republican candidates. As a whole, the drug industry contributed more than $1.6 million to the Republican Party in the 1993-94 election cycle.
SSU Censored Researcher: Tina Duccini
COMMENTS: Author Leslie Weiss said the plan to strip the FDA of its power did not receive sufficient coverage in the mass media. “Once I learned of the Progress & Freedom Foundation’s (PFF) proposal to gut the FDA, I was surprised at the lack of coverage it received. When PFF released the report, it received coverage only in the Wall Street Journal (and then, of course, in Mother Jones).”
When asked why the general public should know more about this issue, Weiss said, “For most of us, reliance on therapeutic drugs and devices for healing is second nature. We expect quality and depend on the FDA to ensure it. Our lives depend on it. Any discussion of altering the safeguards that protect us from potentially dangerous drugs or medical devices must take place in a public forum; otherwise, we risk falling victim — financially and physically — to what easily could become an unregulated industry.”
Weiss charged, “Drug and medical device producers, with their well-financed lobbying armies, are the only beneficiaries of limited media coverage on this subject. Reduced safety regulations and clinical testing periods reduce their costs by millions of dollars. So does reducing liability regulation.”