Act Amendment Allows Generic Label Changes, But Open Manufacturers to Lawsuits

Pharmacy TimesOctober 2012 Diabetes
Volume 79
Issue 10

The American Medical Association (AMA) has added its support to an amendment to a congressional act that would change the process by which generic manufacturers adjust product labels. It joins the ARRP, National Association of Consumer Advocates, and other consumer organizations in support of the amendment.

Physicians and patients turn to drug label warnings for information on reactions or adverse side effects, according a supporting letter sent by the AMA on August 29, 2012. The AMA noted its support in a September 17, 2012, news brief posted on its American Medical News website.

“Doctors without resources to survey the safety of every drug they use rely on manufacturers to provide medicines that are safe and effective, subject to the Food and Drug Administration’s oversight and approval,” James C. Madara, AMA executive vice president and chief executive officer, wrote in support of the amendment. “When a physician now prescribes a generic alternative to a brand drug, neither the physician nor the patient may assume that the label accurately reflects new risks known to the generic manufacturer.”

Rep. Chris Van Hollen (D, MD) introduced the amendment, known as the Patient Safety and Drug Labeling Improvement Act, in the House on April 18, 2012, and Patrick Leahy (D, VT) introduced it on the same date in the Senate. It was assigned to the House Committee on Energy and Commerce’s Health subcommittee, and the Senate Committee on Health, Education, Labor and Pensions. The committees will read and discuss the act and decide whether to refer it to the House or Senate as a whole.

The act, which was introduced in the House as HR 4384 and in the Senate as S2295, amends section 505j of the Federal Food, Drug and Cosmetics Act. The amendment would require label changes on generic medications if there is a change in the labeling on the brand-name drug. In particular, the amendment is meant to cover additional warnings or updates that may be added to brand name drug labels independently but can only be added to already marketed generics if the FDA approves the changes, according to a statement on Rep. Van Hollen’s website.

The amendment would counter a June 2011 Supreme Court decision, Pliva v Mensing, determining that generic drug manufacturers are not responsible for updates to product labels. The decision stated that changing labels to comply with individual state laws contradicts federal laws requiring generic drug labels to be the same as the brand-name product, and that generic manufacturers would need to apply to a federal agency in order to meet those state requirements.

According to Rep. Van Hollen’s statement, the decision permits no legal recourse for patients who have adverse reactions from taking or being administered generic medication, even if the same reactions occurred in patients on the brand-name drug.

“Consumers have the right to know the truth about the safety of the drugs they are taking—both brand and generic,” Van Hollen said on his website. “We must ensure that all manufacturers have the ability to update their labels to reflect newly discovered risks and side-effects of their products.”

According to, which tracks congressional activities, the act has a 1% chance of being enacted. The tracker states that just 4% of house bills introduced from 2009 to 2010 were enacted. In addition, the sponsor and cosponsor’s membership with a minority party could contribute to it being shuttered.

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