US Senate Committee on Health, Education, Labor, & Pensions

Bicameral Coalition of Lawmakers Supports FDA’s Proposed Rule to Protect Consumers of Generic Drugs

Wednesday, March 05, 2014

WASHINGTON, D.C.– Senate HELP Committee Chairman Tom Harkin (D-IA), Senate Judiciary Committee Chairman Patrick Leahy (D-VT), House Energy & Commerce Committee Ranking Member Henry A. Waxman (D-CA), House Judiciary Committee Ranking Member John Conyers (D-MI), Senator Al Franken (D-MN), House Budget Committee Ranking Member Chris Van Hollen (D-MD) and Rep. Bruce Braley (D-IA) led a bicameral coalition of 17 Senators and 24 Members of the House in submitting Congressional comments to support the Food and Drug Administration’s Proposed Rule to ensure that generic manufacturers of prescription drugs can update their warning labels to provide better patient safety information to consumers.

The 41 lawmakers serve on the Senate and House Committees charged with oversight of the nation’s policies on health, consumer rights, aging, and veterans’ affairs.

The FDA’s Proposed Rule follows a 2011 Supreme Court case in which a patient who was gravely injured by a prescription drug was unable to seek relief from the drug’s manufacturer because the drug was a generic. The Court held that generic manufacturers could not be held responsible for inadequate labeling because they lack authority to update their labeling information, even if they become aware of new safety problems. Supporters of the Proposed Rule note that since generics now fill 80 percent of all prescriptions, generic manufacturers should be able to update their warning labels to reflect new safety information they receive.

"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." 

The letter continues: 

"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." 

The Congressional comments were submitted by Senate HELP Committee Chairman Tom Harkin (D-IA), Senate Judiciary Chairman Patrick Leahy (D-VT) , Senator Al Franken (D-MN), Senator Richard Durbin (D-IL), Senator Sheldon Whitehouse (D-RI), Senator Richard Blumenthal (D-CT), Senator Chris Coons (D-DE), Senator Mazie Hirono (D-HI), Senator Patty Murray (D-WA), Senator Bob Casey (D-PA), Senator Tammy Baldwin (D-WI), Senator Elizabeth Warren (D-MA), Senate Veterans Affairs Committee Chairman Bernie Sanders (I-VT), Senator Sherrod Brown (D-OH), Senator Jack Reed (D-RI), Senator Jeff Merkley (D-OR), Senator Mark Pryor (D-AR), Ranking Member of the House Energy & Commerce Committee Henry Waxman (D-CA), Ranking Member of the House Judiciary Committee John Conyers (D-MI), Ranking Member of the House Budget Committee Chris Van Hollen (D-MD), Representative Bruce Braley (D-IA), Ranking Member of the House Subcommittee on Health Frank Pallone (D-NJ), Ranking Member of the House Committee on Veterans Affairs Mike Michaud (D-ME), and Representatives Gwen Moore (D-WI), Jerrold Nadler (D-NY), Matt Cartwright (D-PA), Debbie Wasserman Schultz (D-FL), Diana DeGette (D-CO), Louise Slaughter (D-NY), Paul Tonko (D-NY), Hank Johnson (D-GA), Eddie Bernice Johnson (D-TX), Joe Garcia (D-FL), Carolyn Maloney (D-NY), Jan Schakowsky (D-IL), Lloyd Doggett (D-TX), Doris Matsui (D-CA), Sheila Jackson Lee (D-TX), Jerry McNerney (D-CA), Ted Deutch (D-FL), and Hakeem Jeffries (D-NY).

Harkin, Leahy, Franken, Waxman, Van Hollen, Braley and other lawmakers previously sent letters to the FDA urging attention to this issue in June 2013, May 2012 and April 2012.  Several signatories also introduced related bicameral legislation last Congress. 

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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