Label Rule Would Pre-Empt State Law

The Food and Drug Administration is reportedly preparing to declare that federally approved medication labels pre-empt state law.

The Wall Street Journal says the move could strengthen pharmaceutical makers’ defenses against lawsuits claiming injury by the companies’ products.

Plaintiffs’ lawyers oppose the policy, the newspaper said.

If the proposed changes were to be enacted, drug-product safety in the (United States) would suffer a major setback at a time when the conduct of pharmaceutical companies and the FDA have been called into question, said Thomas R. Kline, a plaintiffs’ attorney with Kline & Specter, and a key player in Vioxx litigation.

The newspaper said big companies have long fought patchworks of laws that differ from state to state, and federal efforts to assert authority in various regulatory areas have drawn testy responses from state officials.