October 28, 2015

Gillibrand, Warren Introduce the Cody Miller Patient Medication Information Act

Inconsistencies, Inaccuracies Result in Medication Mistakes and Overdoses

New Legislation Would Require Standardized, Consumer-Friendly Information to be Provided with Prescriptions

Fact Sheet

Bill Text

Washington, D.C. - Today, United States Senators Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-Mass.) introduced the Cody Miller Patient Medication Information Act, to require the information that is given to patients when they pick up their prescriptions to be standardized and consumer-friendly. Currently this information is not subject to any binding standards, which often results in inconsistencies and incomplete, confusing information that makes it difficult for patients to understand. The new requirements would ensure patients are better informed about how to use their drugs, and about potential adverse side effects. Senators Debbie Stabenow (D-MI), Sherrod Brown (D-OH), and Richard Blumenthal (D-CT) are original co-sponsors of the legislation.

Senator Gillibrand introduced previous versions of this legislation in the 112th Congress and the 113th Congress following the death of Cody Miller, a Queensbury teenager who died by suicide after switching prescription allergy medications. After Cody's death in 2007, drug manufacturers began to carry a black box warning on certain allergy medications with information about neuropsychiatric events, such as depression and suicidal thoughts and actions, that had been reported in some patients.

"When patients and their families are fighting an illness, they need good, clear information about dangerous drug interactions and side-effects. Consumers should know the risks associated with their prescription medications, and this bill would help ensure that pharmacies and drug companies are communicating those risks with accuracy, in language that is easy to understand," said Senator Gillibrand.

"When families go to the pharmacy, they should be guaranteed clear, complete, and accurate information about their prescriptions," Senator Warren said. "This bill would help ensure that patients know how to use their medication safely and are better informed about any risks and side effects."

"We have long awaited this very important consumer safety issue," said Kate and Dave Miller, the parents of Cody Miller. "We feel it gives every person a personal role in truly knowing their prescription information is current and accurate."

"AARP is pleased that Senators Gillibrand and Warren recognize the value of providing written information for consumers about their medication when they fill their prescription," said Joyce Rogers, Senior Vice President of Government Affairs. "This legislation would strengthen the quality, timeliness, and scientific accuracy of this patient information which would help people use their medicines safely, minimize risks, and get the most value out of them."

"Consumer Reports supports this bill because consumers need better information about the prescription drugs they are taking. Our own studies have found concerning omissions and incomplete inserts. After so many years of inaction, we're pleased that this legislation would put a hard timeline in place and require the FDA to issue its final rules to improve the information consumers receive with their medications," said Doris Peter, Ph.D., Director of the Consumer Reports Health Ratings Center.

"Patients should be made aware of potential adverse events or side effects when they are prescribed a medication," said Phyllis Greenberger, MSW, president and CEO of the Society for Women's Health Research (SWHR). "This legislation will help to facilitate the conversation on how best to inform patients on how to safely use their medications and raise awareness of those issues."

"The Cody Miller Patient Medication Information Act is a catalyst for change to improve transparency, patient safety, and health equity in biomedical research. While we know men and women metabolize drugs differently and that drug safety and effectiveness vary by sex, many of the drugs routinely prescribed to women have not been adequately tested on them. Not only does this bill empower women with information to make better informed decisions about their health, it is also fosters their inclusion in drug trials by bringing this inequity to light," said Dr. Paula Johnson, Director, Connors Center for Women's Health and Gender Biology at the Brigham & Women's Hospital.

While the FDA strictly regulates the prescribing information meant for doctors and requires Drug Facts on over-the-counter medications, patient information about prescription medication is largely unregulated. In 1980, the FDA finalized requirements for manufacturers to provide FDA-approved medication information meant for consumers, but these regulations were revoked two years later. The FDA attempted to issue regulations again in 1995 that would have set standards for the content and format of medication information, but in 1996, Congress prevented finalization of these regulations and instead required a market-based plan. A 2008 study found that the quality of medication information provided at the pharmacy did not meet the FDA's expectations, as the length, consistency, and quality varied widely between pharmacies.

The Cody Miller Act would require the Secretary of Health and Human Services to issue regulations on the content, format, and distribution of Patient Medical Information (PMI) in easy-to-understand language for consumers. The content would include approved uses, common side effects, serious risks, when a patient should contact a health care professional, and how to properly store the medication. PMI would also include information about whether data has been collected about the use of the product by specific subpopulations, including women, seniors, and racial and ethnic minorities. Regardless of what drug store or prescription mail order company a family uses, the information would be uniform, accurate, and up-to-date.

The Cody Miller Patient Medication Information Act is supported by AARP, Consumers Union, the Society for Women's Health Research, and the Connors Center for Women's Health and Gender Biology.

A fact sheet on the bill is available here.