27 Sep First Ever Senate Authorization Bill on E-Labeling Legislation Introduced
WASHINGTON – Today, Senators Cory Booker (D-NJ) and Markwayne Mullin (R-OK) introduced the Prescription Information Modernization Act. The bipartisan bill will allow the Food and Drug Administration (FDA) to move forward with a proposed rule allowing drug manufacturers to transmit prescribing information electronically, as opposed to a printed copy, as currently required.
The first ever Senate authorization bill follows the removal of the appropriations rider that prevented the FDA from promulgating rules that allow for the distribution of prescribing information to pharmacies and health care professionals in solely electronic form. The release of the Fiscal Year 2024 funding proposal from the House Appropriations Committee, Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies, marked the first time the funding bill does not contain the policy rider.
“Our health care system has been slow to adopt the latest technology that can help make our health care more efficient,” said Senator Booker. “By ensuring our healthcare system embraces digital innovation, we can help reduce waste and prioritize access to accurate information. I am proud to introduce this bipartisan legislation that will modernize our health care practices and help improve patient outcomes.”
“Current prescription information distribution is outdated for the digital age,” said Senator Mullin. “Electronic prescriptions will simplify how providers access and manage prescription data, improving efficiency without compromising patient care quality. I am confident this change will help medical professionals provide the most up-to-date, accurate care to their patients.”
In March, U.S. Representatives Diana Harshbarger (R-TN) and Mikie Sherrill (D-NJ) introduced bipartisan, standalone legislation to remove the policy rider, allowing the FDA to move forward with its rulemaking process. The legislation currently has 23 cosponsors.
Under the current policy, which has not been updated since 1962, prescribing information sent to providers that contains important information related to a specific drug must be printed, running an average of 45 pages per prescription. This information is not intended for patients but rather contains the drug’s chemical makeup and information that informs a healthcare professional on the drug’s interaction with other drugs. In 2014, the FDA proposed a rule that would allow the electronic distribution of prescribing information. Since then, Congress has used the appropriations process to prevent the agency from finalizing that rule, requiring the bulky paper labels to be printed and distributed, even though many are immediately discarded by healthcare professionals for being outdated. Developing, printing, and distributing updates to paper prescribing information through the supply chain takes on average 8 to 12 months, meaning that the information is outdated by the time health care professionals receive the paper version, whereas the information online is updated in real-time.
This effort to remove the policy rider is supported by the AMPI, the American Pharmacists Association (APhA), and a coalition of stakeholders from across the country, including the Academy of Managed Care Pharmacy (AMCP), Asthma and Allergy Foundation of America, Association for Accessible Medicines, BioNJ, CivicaRX, the Environmental Paper Network, the Healthcare Distribution Alliance, HealthCare Institute of New Jersey, the LUNGevity Foundation, the North Carolina Biosciences Organization, and the Texas Healthcare and Biosciences Institute.