Federal lawmakers urge FDA to change rules to allow design-flaw lawsuits against generic drugmakers

In the wake of Monday's Supreme Court decision that blocked the ability of patients to sue generic drugmakers for design flaws in their medicine because it would conflict with Food and Drug Administration rules, members of Congress and consumer groups renewed their plea to the FDA to change those rules.

A link to Tuesday's Inquirer story is here.

Three senators and four representatives - all Democrats - sent a letter to FDA Commissioner Margaret Hamburg, urging her to make the changes happen so that patients who think they are harmed can seek redress in state courts.

Karen Bartlett was the plaintiff in the case that was decided Monday. The New Hampshire woman took a generic painkiller made by Philadelphia's Mutual Pharmaceutical Co., which is now part of Sun Pharmaceutical Industries, Ltd. Her adverse reaction included terrible skin reactions, near blindness, 12 operations and the need for a medically-induced coma.

Mutual had argued that FDA rules prevent a generic manufacturer from changing the composition of, or official label for, a drug once it is approved by the FDA because it is based on the brand-name drug.

Rep. Henry Waxman (Calif.), who was among the authors of the transformational legislation passed in 1984 that helped boost the generic drug industry, joined Congressmen Chris Van Hollen (Md.), Bruce Braley (Iowa), and Matthew Cartwright (Pa.) in signing the letter. Cartwright's 17th district runs from Pottsville to the Delaware River, then shifts north to touch Wilkes-Barre and Scranton. The senators were Tom Harkin (Iowa), Patrick Leahy (Vermont) and Al Franken (Minn.)

"We write to urge the Food and Drug Administration (FDA) to expedite its consideration of revisions to the FDA’s drug labeling regulations to enable manufacturers of generic drugs to update patient safety labeling in appropriate circumstances," the letter to Hamburg said in part. "These changes are critically important to ensure that the public is adequately informed of the risks and benefits of prescription drugs, and that consumers who are injured by generic drugs have the same legal rights as those who are injured by the brand-name versions of the same drugs."

Waxman and Harkin had filed an amicus brief in the case, Mutual Pharmaceutical Co., v. Bartlett, 12-142, urging the court to find in favor of Bartlett.

Monday's decision mirrored an earlier Supreme Court decision that said generic drugmakers can't be sued in state court over failure to adequately warn patients because changing the official label for a drug would violate FDA rules. Those rules say generic products have to follow the official label of the brand-name drug.

Allison Zieve of the consumer advocacy group Public Citizen was the lead attorney who wrote the brief and she was dismayed by Monday's decision.

“This creates situation in which generic manufacturers have no responsibility or accountability for product design or labeling, a unique and disturbing situation for a consumer product in our country,” Zieve said.

Meanwhile, Mira Desai, a spokeswoman for Mumbai-based Sun Pharma said in an overnight email that the company was pleased with the ruling.

The decision, she wrote, "preserves the exclusive authority of the FDA’s scientific experts to determine the safety and efficacy of pharmaceutical products. We are pleased that the Supreme Court has recognized the importance of ensuring that affordable generic drugs remain available to citizens in all 50 states."

A link to the Supreme Court decision is here. Justice Samuel Alito wrote the majority opinion.

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