17 May For the First Time, Appropriations Rider Preventing E-Labeling Removed from Legislation
WASHINGTON – Today, the House Appropriations Committee, Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies, released its Fiscal Year 2024 funding proposal. For the first time, the funding bill does not contain a policy 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 current policy requiring printed prescribing information is 61 years old,” said Richard Carbo with the Alliance to Modernize Prescribing Information (AMPI). “Today, many health care professionals prefer to receive this information digitally because it contains the most up-to-date information available. For too long, this policy rider has prevented this antiquated practice to remain in place. By allowing the FDA to move forward with this rulemaking, health care professionals are one step closer to having the option to choose how they receive this information. A broad coalition of industry stakeholders, health care, and environmental groups are supporting this commonsense effort because it not only cuts down on wasteful paper usage, but more importantly, real-time information is better to address patient safety concerns.”
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. 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paper prescribing information through the supply chain takes on average 8 to 12 months, meaning that the information is outdated by the time health care professionals receive the paper version, whereas the information online is updated in real-time.
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 19 cosponsors.
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.
The full text of the bill is available here.