03.27.15

Leahy Joins Marshfield Resident Diana Levine And Other Patient Advocates In Urging FDA To Protect Consumers Of Generic Drugs

WASHINGTON (FRIDAY, March 27, 2015) – Senate Judiciary Committee Ranking Member Patrick Leahy (D-Vt.) Friday led a coalition of 28 lawmakers in a letter urging the U.S. Food and Drug Administration (FDA) to support consumers by adopting meaningful safety rules for labeling on generic drugs.

The letter comes as Marshfield, Vt., resident Diana Levine and other patient advocates testified at a day-long FDA hearing in Silver Spring, Maryland, in support of a proposed FDA rule that would ensure that generic manufacturers of prescription drugs can update their warning labels to provide better safety information.  Ms. Levine, a musician who was forced to have her arm amputated below the elbow after being injured by a mislabeled drug, testified to the importance of strong labeling rules to protect patients and consumers.

In her testimony, Levine said:  “I had nausea.  Now I don’t have a hand.  Allowing both the brand and the generic manufacturer to update their safety labels when they have new safety information gets safety information to consumers, doctors, nurses and other health professional sooner and that information is critical to patient safety.  Ensuring all drug manufacturers are accountable to consumers is an important part of drug safety.  When drug manufacturers have immunity, Americans suffer.”

The FDA’s Proposed Rule follows a 2011 U.S. Supreme Court case in which a patient who was gravely injured by a prescription drug was unable to seek recourse from the drug’s manufacturer because the drug she had taken 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.  In contrast, patients who are injured by a brand-name drug may seek compensation for their injuries, following a 2008 Supreme Court case in which Ms. Levine was the lead plaintiff.  Leahy and other senior lawmakers raised concerns about this inconsistent treatment for consumers, who often have little choice whether they take the generic or brand-name version of a drug.

Leahy and the other lawmakers wrote:  “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 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.” 

Leahy has urged the FDA to act on this issue since the 2011 Court decision came down, including in letters he sent in March 2014, June 2013, and May 2012

In the letter Friday he was joined by senior Democratic members of the Senate and House committees charged with oversight of the nation’s policies on health, consumer rights, budget, aging, and veterans’ affairs. 

Signatories include 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.) and Senator Tammy Baldwin (D-Wis.), as well as by 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 (Md.), and Reps. Gwen Moore (D-Wisc.), 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) and Betty McCollum (D-Minn.).

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. 

# # # # #

Press Contact

Press Contact
David Carle: 202-224-3693