Leahy Leads Bicameral Coalition of Lawmakers Urging FDA to Swiftly Adopt Proposed Rule to Protect Consumers of Generic Drugs

WASHINGTON (Friday, April 24, 2015) – Senate Judiciary Committee Ranking Member Patrick Leahy (D-Vt.) and senior Democratic leaders on the Senate and House Committees charged with overseeing the nation’s policies on health, consumer rights, budget, aging and veterans’ affairs today urged the Food and Drug Administration to support consumers by adopting meaningful safety rules for labeling on generic drugs.

The effort by 47 Senate and House lawmakers comes as the FDA closes out its public comment period on a Proposed Rule to ensure that generic manufacturers of prescription drugs can update their warning labels to provide better safety information.  Last month, the FDA held a hearing that featured injured patients, consumer groups, and medical professionals testifying in support of the Proposed Rule.

“We understand that some have raised objections about the economic impact of the FDA’s Proposed Rule on generic manufacturers,” the lawmakers wrote. “To the extent generic manufacturers object that the Proposed Rule could make them liable to injured customers if they fail to adequately update their safety information, such concerns ring hollow.  The costs of patient injuries caused by a drug company’s failure to meet its warning obligations would otherwise be borne unfairly by insurance companies, the government, and injured patients themselves.  Importantly, the Proposed Rule is designed to improve warning information, which should reduce, not increase, the number of patients needing compensation for injury.”

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 cannot be held responsible for inadequate labeling because they lack authority to update their labeling information, even if they become aware of new safety problems. 

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,” the lawmakers wrote. “The FDA’s Proposed Rule takes significant and overdue steps to achieve this goal.  We urge you to reject weakening alternatives and act swiftly to finalize the Proposed Rule.” 

Signatories on the letter serve on the Senate and House Committees charged with oversight of the nation’s policies on health, consumer rights, budget, aging, and veterans’ affairs. They include Senate Judiciary Committee Ranking Member Patrick Leahy (D-Vt.), Senate HELP Committee Ranking Member Patty Murray (D-Wash.), Senate Veterans Affairs Committee Ranking Member Richard Blumenthal (D-Conn.), Senator Al Franken (D-Minn.), Senator Dick Durbin (D-Ill.), Senator Sheldon Whitehouse (D-R.I.), Senator Chris Coons (D-Del.), Senator Sherrod Brown (D-Ohio), Senator Bernie Sanders (I-Vt.), Senator Elizabeth Warren (D-Mass.), Senator Tammy Baldwin (D-Wis.), Senator Heidi Heitkamp (D-N.D.), Senator Mazie Hirono (D-Hawaii), Senator Jack Reed (D-R.I.), Senator Bob Casey (D-Penn.), and Senator Jeff Merkley (D-Ore.), as well as Ranking Member of the House Energy & Commerce Committee Frank Pallone, Jr. (D-N.J.), House Judiciary Committee Ranking Member John Conyers (D-Mich.), House Budget Committee  Ranking Member Chris Van Hollen (D-Md.), Gwen Moore (D-Wis.), Doris Matsui (D-Calif.), Louise Slaughter (D-N.Y.), Carolyn Maloney (D-N.Y.), Jan Schakowsky (D-Ill.), Paul Tonko (D-N.Y.), Ted Deutch (D-Fla.), Filemon Vela (D-Texas), Matt Cartwright (D-Pa.), Lloyd Doggett (D-Texas), Marcy Kaptur (D-Ohio), Terri Sewell (D-Ala.), Eddie Bernice Johnson (D-Texas), Betty McCollum (D-Minn.), Gene Green (D-Texas), Sheila Jackson Lee (D-Texas), Scott Peters (D-Calif.), Barbara Lee (D-Calif.), Mark Pocan (D-Wis.), Jim McDermott (D-Wash.), Jerrold Nadler (D-N.Y.), Ed Perlmutter (D-Colo.), John Sarbanes (D-Md.), Charles Rangel (D-N.Y.), Lucille Roybal-Allard (D-Calif.), Hank Johnson (D-Ga.), Hakeem Jeffries (D-N.Y.), and Judy Chu (D-Calif.).

Leahy, Franken, Van Hollen, and other lawmakers previously sent letters to the FDA urging attention to this issue in March 2014, June 2013, and May 2012

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 have also called on the FDA to act.  Stories about injured patients whose lives have been affected by the current generic labeling rules have recently appeared in The Hill and ThinkProgress.org.

A copy of the Congressional letter to FDA Commissioner Doctor Stephen Ostroff is available online.

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