Policy Documents

Abolish the FDA?

December 1, 2008

Why not just abolish the U.S. Food and Drug Administration?

By Maureen Martin

That may sound radical, but the Wyeth v. Levine case, due to be heard in the U.S. Supreme Court next Monday, could destroy the agency’s purpose. The issue in the case is whether the federal law establishing the FDA “preempts” state laws and shields makers of FDA-approved drugs from liability under state tort law.

Much more than that is at stake. The case could lead to a wholesale expansion of state regulation in other areas of law for any industry subject to intensive federal regulation. The case, therefore, is being closely watched.

The plaintiff is certainly sympathetic. She lost an arm to gangrene after the Wyeth anti-nausea drug Phenergan was improperly injected into an intravenous line she was hooked up to. Earlier in the day, she had received a shot in the arm, but it failed to relieve her pain, so the doctor decided on the IV.

The plaintiff claimed the drug label failed to adequately warn users about dangers of injecting the drug through IVs. But the FDA required the label to include four warnings telling providers to exercise “extreme care” in injections with IVs. Gangrene would “likely” result if done improperly, the label says.

The label also warned health care providers to stop the injection immediately if the patient complained of pain, which the plaintiff did. And it warned dosages shouldn’t exceed 25 mg. The plaintiff got twice that much. It sounds like the assistant didn’t read the label at all. That’s understandable—the “label” is two pages long.

Seven states—Arizona, Michigan, New Jersey, Ohio, Oregon, Utah, and Texas—have statutes providing an FDA defense for drug manufacturers, according to Jim Beck and Mark Hermannn’s Drug and Device Law blog.

Vermont doesn’t have such a law, but Wyeth argued preemption could be implied from FDA approval of its label and that approval barred the plaintiff’s claim of improper labeling under state law. But in closing arguments at the Vermont trial, the plaintiff’s lawyer told the jury, “The FDA doesn’t make the decision, you do.” The jury awarded a $6.7 million verdict against Wyeth. The state Supreme Court affirmed it, and Wyeth filed for U.S. Supreme Court review.

So what use is the FDA, if states can impose additional warning requirements?

FDA approval is required by law before a drug may be sold in interstate commerce. The lengthy review process evaluates health and safety data about the drugs, weighing risks and benefits. The FDA was created more than 100 years ago to eliminate conflicts between state and federal law, replacing those conflicts with one uniform national law.

The Vermont Supreme Court found federal law imposed only minimum requirements and states are free to mandate stricter ones. If the plaintiff wins and each of the 50 states becomes free to impose drug safety laws in addition to federal laws, drug makers will have to monitor state law carefully and modify labels state-by-state. This is an unworkable system that would destroy any semblance of a national product market. It endangers drug marketing and new drug development, and therefore the public’s health.

State attorneys general are clearly salivating at the prospect of preserving and expanding their authority—47 of them filed a joint amici brief supporting the plaintiff.

If the plaintiff wins, there are going to be 50 separate requirements for drug approvals, with the FDA as just the 51st. In that case, it should be abolished.

Maureen Martin (martin@heartland.org) is senior fellow for legal affairs at The Heartland Institute.