AAJ Calls on FDA to Finalize Proposed Rule on Generic Drug Safety Labeling | The American Association For Justice
For Immediate Release: April 27, 2015

AAJ Calls on FDA to Finalize Proposed Rule on Generic Drug Safety Labeling

23,000 Sign Petition Calling for Agency to Protect Consumers

Washington, D.C. — The FDA should move to promptly finalize a rule that will improve the safety and accountability of generic drugs, the American Association for Justice (AAJ) said in comments submitted to the agency today. The Proposed Rule goes a long way to promote consumer safety by ensuring that generic drug companies are responsible for the warning labels on their products and can update the warning information, as brand manufacturers can.

“We urge the FDA to finalize the Proposed Rule, without significant change, as quickly as possible,” Lisa Blue, AAJ President, said in the comments. “In addition to ensuring timely warnings to consumers, the Proposed Rule serves another equally important purpose: reinstating consumers of generic drugs the ability to seek recourse for their injuries through the justice system.”

The Proposed Rule would require generic drug manufacturers to promptly update safety labeling to include new safety information using the “Changes Being Effected” (CBE) process. This change will promote timely communication of safety information to patients and physicians. Current rules that preclude generic drug manufacturers from updating their safety information through the CBE process have a detrimental impact on consumers.

The AAJ comments call on FDA to reject an “alternative proposal” from the generic drug industry (GPhA) and name-brand pharmaceutical companies (PhRMA), which would drastically limit the situations in which a manufacturer is permitted to update a drug’s safety labeling and would inevitably result in significant delay before consumers are made aware of important information about the safety of their medications. It would also eliminate all accountability for both brand name and generic drug manufacturers for their products, leaving neither generic drugmakers nor brand name drugmakers responsible for the safety labels on their products.

“The alternative proposed by GPhA and PhRMA would be a major setback in consumer safety regulation and would pose an unacceptable risk to the public’s health and wellbeing,” Blue said in the comments.

AAJ’s public education and grassroots campaign, Take Justice Back, spearheaded a petition calling on FDA to finalize the rule as proposed, which has garnered more than 23,000 signatures. The petition was submitted to FDA on Monday afternoon by Tammy Gilbert, an Ohio woman who lost her 22 year old daughter after she took a generic form of the painkiller Darvon and died days later. The petition is available at:


AAJ’s comments to FDA are available here.


The American Association for Justice works to preserve the constitutional right to trial by jury and to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations. Visit http://www.justice.org