Leahy Leads Bicameral Coalition of 41 Lawmakers In Support of Proposed Rule to Protect Consumers of Generic Drugs

WASHINGTON (WEDNESDAY, March 5, 2014) – Senator Patrick Leahy Wednesday led a coalition of 17 senators and 24 members of the House in support of a proposed regulation by the Food and Drug Administration that will improve the labeling on generic drugs and secure equal treatment for consumers who take generics.

Leahy has worked closely on this issue since he became involved in the case of Marshfield, Vt., musician Diana Levine, who was forced to undergo amputation of her arm after being injected with a mislabeled drug. Leahy filed an amicus brief in the United States Supreme Court in support of Mrs. Levine’s case against the drug manufacturer in 2008. Mrs. Levine won her case, but two years later the Court ruled against a similarly-situated victim, Gladys Mensing, who was injured by the generic version of a prescription drug. The court held that the generic drug company could not be held liable for a mislabeled product — and Mrs. Mensing could not seek redress for her injuries — because generics lack the ability to improve their labels even if they become aware of new safety problems.

Leahy introduced legislation to address the Mensing decision in 2012, and led letters in May 2012 and June 2013 urging the FDA to ensure that generic manufacturers of prescription drugs can update their warning labels to provide better patient safety information to consumers. The FDA issued its Proposed Rule in November. The congressional comments submitted Wednesday strongly support the rule.

Leahy said, “A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug. I welcome this FDA action to ensure that generic manufacturers can improve their patient safety labels. Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries.” 

The congressional coalition includes senior lawmakers from the Senate and House committees charged with oversight of the nation’s policies on health, consumer rights, aging, and veterans’ affairs.

In addition to Leahy, who chairs the Senate Judiciary Committee, the signers include Senate Health, Education, Labor & Pensions Committee Chairman Tom Harkin (D-Iowa), Senator Al Franken (D-Minn.), Senator Richard Durbin (D-Ill.), Senator Sheldon Whitehouse (D-R.I.), Senator Richard Blumenthal (D-Conn.), Senator Chris Coons (D-Del.), Senator Mazie Hirono (D-Hawaii), Senator Patty Murray (D-Wash.), Senator Bob Casey (D-Pa.), Senator Tammy Baldwin (D-Wisc.), Senator Elizabeth Warren (D-Mass.), Senate Veterans Affairs Committee Chairman Bernie Sanders (I-Vt.), Senator Sherrod Brown (D-Ohio), Senator Jack Reed (D-R.I.), Senator Jeff Merkley (D-Ore.), Senator Mark Pryor (D-Ark.), Ranking Member of the House Energy & Commerce Committee Henry Waxman (D-Calif.), Ranking Member of the House Judiciary Committee John Conyers (D-Mich.), Ranking Member of the House Budget Committee Chris Van Hollen (D-Md.), Representative Bruce Braley (D-Iowa), Ranking Member of the House Subcommittee on Health Frank Pallone (D-N.J.), Ranking Member of the House Committee on Veterans Affairs Mike Michaud (D-Maine), and Representatives Gwen Moore (D-Wis.), Jerrold Nadler (D-N.Y.), Matt Cartwright (D-Pa.), Debbie Wasserman Schultz (D-Fla.), Diana DeGette (D-Colo.), Louise Slaughter (D-N.Y.), Paul Tonko (D-N.Y.), Hank Johnson (D-Ga.), Eddie Bernice Johnson (D-Texas), Joe Garcia (D-Fla.), Carolyn Maloney (D-N.Y), Jan Schakowsky (D-Ill.), Lloyd Doggett (D-Texas), Doris Matsui (D-Calif.), Sheila Jackson Lee (D-Texas), Jerry McNerney (D-Calif.), Ted Deutch (D-Fla.), and Hakeem Jeffries (D-N.Y.).

Action on this issue has been supported by a broad coalition of patient safety and consumer groups, including Public Citizen, Breast Cancer Action, National Consumers’ League, and the National Women’s Health Network.

A copy of the congressional comments to FDA Commissioner Doctor Margaret Hamburg is available online.

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Excerpts from the letter:

“Current rules that preclude generic drug manufacturers from updating their safety information through the CBE process have a detrimental impact on consumers—and, specifically, on our constituents,” the lawmakers write. “The Proposed Rule is critically important to ensure that the public is informed as soon as possible when new safety information becomes available, and to ensure that labeling for a prescription drug remains up-to-date even when the branded drug is no longer being marketed or has not undergone a labeling update to reflect newly discovered risks.” “Consumers who are injured by the generic version of a prescription drug have been foreclosed from seeking any remedy for inadequate labeling, even though consumers who take the brand-name version of the drug may seek recourse for their injury. This disparate outcome for consumers who take generic and brand name drugs is directly counter to the intent of the Hatch-Waxman Act and to generic substitution laws that have been implemented across the country.

We share a common objective of ensuring that safe, affordable generic drugs are available to all consumers. At the same time, we believe strongly that all drug makers, including generic manufacturers, should be able to take appropriate steps to enhance warning information given to doctors and consumers.”

Once finalized, the Proposed Rule will take a significant step towards improving consumer safety information and ensuring equal protection for the millions of Americans who take generic drugs.”

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