September 22, 2023
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 updated drug labeling for patients. Safety Act, legislation that allows all prescription drug manufacturers to revise drug labels to provide consumers with accurate and up-to-date warnings. Current federal law mandates that generic drug labels must match the Food and Drug Administration (FDA)-approved labels for their brand-name equivalents. This bill will allow pharmaceutical companies to independently update the labels of generic drugs – ensuring that patients have the most up-to-date information about the potential side effects and risks associated with prescribing them.
“Millions of Americans choose generic drugs over brand-name drugs for their lower prices and availability – and they should have access to the most accurate and up-to-date information available. Therefore, we must give all drug manufacturers the opportunity to update their labels to reflect the most up-to-date information. This bill will give consumers the tools they need to make more informed health care decisions.” Senator Van Hollen said.
“Consumers deserve up-to-date warning labels on all their prescriptions – whether brand or generic,” Senator Blumenthal said. “Our common sense measures allow all manufacturers to revise labels so patients are aware of potential side effects and other short- and long-term risks. Providing the transparency and information Americans need will help protect their health and well-being.
“Ohioans need to know the most up-to-date safety information and potential side effects of the medications they are taking,” Senator Brown said. “This legislation will ensure Ohioans have the most up-to-date information at the pharmacy counter, regardless of whether the drug is generic or brand name, and will hold accountable any drug company that fails to update their labels.”
“Delawareans deserve drugs that are affordable, safe to use and transparent about side effects,” Senator Coons said. “This legislation is a step forward to help ensure that generic drug manufacturers provide consumers with useful and accurate information to help Americans make timely and informed decisions about their health care.”
You can view the invoice text here.
While FDA regulations allow brand-name manufacturers to independently update their labels if they identify new risks or side effects, generic drug manufacturers can only adopt approved changes made by brand-name drug manufacturers. A key problem with this arrangement is that brand-name drug manufacturers have little incentive to quickly update labels after generic competition enters the market, as sales of the brand-name drug tend to slow significantly thereafter. As a result, many Americans are at risk of taking drugs with outdated safety information.
Furthermore, these Americans have no legal recourse if they are harmed by a generic drug that is not accompanied by up-to-date information on side effects. In a 2013 Supreme Court case Spit v. Mensing, the court ruled that federal law precluded generic drug manufacturers from independently changing their labels and therefore could not be held liable for failing to add or increase warnings on their products. The Patient Safety and Generic Labeling Improvement Act addresses this issue by allowing generic drug labels to be revised using the same procedures currently available to brand-name manufacturers.
The updated law on drug labeling for patient safety is approved according to AARP, AARP Maryland, American Association for Justice (AAJ), Public Citizen, National Center for Health Research, Consumer Federation of America, Consumer Action, National Association of Consumer Advocates, US Public Interest Research Groups (PIRG), and Maryland PIRG.
“AARP MD believes it is vitally important that consumers have the right to know information about the medications they are taking,” said Hank Greenberg, AARP Maryland state director. “Outdated labels can be confusing or even dangerous. This important legislation will ensure that consumers receive accurate and up-to-date information.”
“AARP believes that generic drugs are one of the most effective ways for consumers to reduce prescription drug costs, and we encourage our members to talk to their doctors about what generic drugs may be helpful to them whenever possible.” said Bill Sweeney, AARP senior vice president of government affairs. “This bill will ensure that the consumer has 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 put at unnecessary risk because the labels on their prescriptions fail to warn them of newly discovered potential risks. It is important 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 the known risks,” said Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group. “Allowing generic drug manufacturers to make safety updates to their product labels, as this bill aims to do, would close the safety gap and better protect public health.”
“Patients deserve to know about all the possible risks when they take medication. Generic drug manufacturers are currently not allowed to update their warning labels, which is unfair to everyone – patients and companies alike. We greatly appreciate Senator Van Hollen’s leadership in addressing this dangerous issue.” said Dr. Diana Zuckerman, president of the National Center for Health Research.
“Consumers must have access to accurate safety information about their medicines,” said Courtney Griffin, director of consumer product safety at the Consumer Federation of America. “Consumers have little control over whether their medications are branded or generic. It is inherently unfair that consumers may not have accurate and up-to-date information when their drug is a generic version.”
“Sen. Van Hollen’s bill will put brand-name and generic patients on a level playing field by ensuring that both, and in this case, generic users, will not only benefit from updated safety labeling, but will also be able to assert their state laws and seek liability against manufacturers if they are harmed,” said Christine Hines, legislative director of the National Association of Consumer Advocates.
“Generic medicines are essential to help patients save money on the medicines they need,” said Patricia Kelmar, US PIRG’s senior director of health care campaigns. “This bill will ensure that patients can rely on the information provided on the labels of their less expensive, therapeutically equivalent generic drugs. Patients need the most up-to-date and accurate labels for all FDA-approved drugs.”
“We thank Senator Van Hollen for his leadership on the updated Patient Safety Drug Labeling Act. This bill will help ensure that patients enjoying generic drug savings have the most up-to-date information on their prescription drug labels.” said Maryland PIRG Director Emily Scarr. “The best health care is high value health care – low prices and high quality.”
Companion House legislation was introduced earlier this year by U.S. Reps. Adam Schiff (D-Calif.) and Annie Kuster (DN.H.).
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