September 22, 2023

Van Hollen, Blumenthal, Brown, Coons Introduce Bill to Protect Consumers Using Generic Medications

Today, U.S. Senators Chris Van Hollen (D-Md.), Richard Blumenthal (D-Conn.), Sherrod Brown (D-Ohio), and Chris Coons (D-Del.) announced the introduction of the Updated Drug Labeling for Patient Safety Act, legislation to allow all prescription drug manufacturers to revise medication labels to provide accurate, up-to-date warnings to consumers. Current federal law mandates that generic drug labels must match those approved by the Food and Drug Administration (FDA) for their brand-name equivalents. This bill will enable drug companies to update labels for generic medications independently – ensuring patients have the latest information about the potential side effects and risks associated with their prescriptions.

“Millions of Americans choose generic medication over brand-name for their lower prices and accessibility – and they should have access to the most accurate and up-to-date information available. That’s why we need to provide all drug manufacturers the ability to update their labels to reflect the most current information. This bill will ensure consumers have the tools they need to make better-informed health care decisions,” said Senator Van Hollen.

“Consumers deserve up-to-date warning labels on all of their prescriptions – name brand or generic,” said Senator Blumenthal. “Our common sense measure allows all manufacturers to revise labels so patients can be aware of potential side effects and other short and long-term risks. Giving Americans the transparency and information they need will help protect their health and wellbeing.”

“Ohioans need to know the most current safety information and potential side effects of the drugs they take,” said Senator Brown. “This legislation will ensure Ohioans have the most up to date information at the pharmacy counter, regardless of whether the drug is generic or branded, and hold any drug company that fails to update its labels accountable.”

“Delawareans deserve medication that is affordable, safe to use, and transparent about its side effects,” said Senator Coons. “This legislation is a step forward that will help ensure generic medication manufacturers are providing helpful, accurate information to consumers that will help Americans make up-to-date and informed decisions about their health care.”

Bill text can be viewed here.

While FDA regulations allow brand name manufacturers to independently update their labels if they identify new risks or side-effects, generic drug makers can only adopt the approved changes made by the brand-name drug manufacturers. The key problem with this arrangement is that manufacturers of brand-name medications have little incentive to promptly update their labels after generic competitors enter the market, since sales of the brand-name drug tend to slow significantly after that point. As a result, many Americans are at risk of using medications with outdated safety information.

Furthermore, those Americans have no legal recourse if they are harmed by a generic drug that is not accompanied by the latest side-effect information. In the 2013 Supreme Court case Pliva v. Mensing, the Court ruled that federal law precludes generic drug makers from independently changing their labels and therefore they cannot be held liable for failing to add or strengthen the warnings on their products. The Patient Safety and Generic Labeling Improvement Act resolves this matter by authorizing generic drug labels to be revised using the same processes that are currently available to brand-name manufacturers.

The Updated Drug Labeling for Patient Safety Act is endorsed by AARP, AARP Maryland, the American Association for Justice (AAJ), Public Citizen, National Center for Health Research, Consumer Federation of America, Consumer Action, National Association of Consumer Advocates, U.S. Public Interest Research Groups (PIRG), and Maryland PIRG.

“AARP MD believes it is vital that consumers have the right to know information about the drugs they are taking,” said Hank Greenberg, State Director of AARP Maryland. “Out of date labels can be confusing or even dangerous. This important legislation will require that consumers receive accurate, up-to-date information.”

“AARP believes generic drugs are one of the most effective ways for consumers to lower their prescription drug costs, and we encourage our members whenever possible to speak with their doctors about what generic drugs may be helpful to them,” said Bill Sweeney, AARP Senior Vice President for Government Affairs. “This bill will ensure that consumer have access to the most up-to-date safety information about the generic drugs they intend to take.”

“So many Americans rely on generic prescription drugs, but their health is needlessly jeopardized because the labels on their prescriptions don’t warn them about newfound potential risks. It’s critical that Congress act now,” said Linda Lipsen, CEO of the American Association for Justice.

“No drug is safe in all situations; a drug is safe when used in accordance with labeling that accurately reflects known risks,” said Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group. “Allowing generic drug companies to make safety updates to their products labeling, as this bill aims to do, would fill a safety gap and better protect public health.”

“Patients deserve to know about all possible risks when they take medication. Makers of generic drugs are not currently allowed to update their warning labels, which is unfair to everyone – patients and companies. We greatly appreciate Senator Van Hollen’s leadership to fix this dangerous problem,” said Dr. Diana Zuckerman, President, National Center for Health Research.

“Consumers must have access to accurate safety information about their medications,” said Courtney Griffin, Director of Consumer Product Safety at Consumer Federation of America. “Consumers have little control over whether their drugs are the brand-name or generic versions.  It is inherently unfair that consumers may not have accurate, up-to-date information when their medication is a generic version.”

“Sen. Van Hollen’s bill will put patients using brand-name drugs and generic drugs on a level playing field, by ensuring that both, and in this case, users of generic drugs, will not only benefit from updated safety labeling, but they will also be able to enforce their state laws and seek accountability against manufacturers if they are harmed,” said Christine Hines, legislative director at the National Association of Consumer Advocates.

“Generic drugs are essential to help patients save money on their needed medications," said Patricia Kelmar, Senior Director of U.S. PIRG’s health care campaigns. “This bill will ensure that patients can rely on the information provided by the labels of their lower-cost, therapeutically-equivalent generic drugs. Patients need the most up-to-date, accurate labels for all FDA-approved drugs.”

“We thank Senator Van Hollen for his leadership on the Updated Drug Labeling for Patient Safety Act. This bill will help ensure that patients who enjoy the cost-savings of generic drugs have the most updated information on the prescription drug labels,” said Maryland PIRG Director Emily Scarr. “The best health care is high value health care – low prices and high quality.”

The House companion legislation was introduced earlier this year by U.S. Representatives Adam Schiff (D-Calif.) and Annie Kuster (D-N.H.).