Radical Plan from Newt Gingrich's Think Tank to Gut FDA

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.