Regulatory Focus™ > News Articles > New Bill Would Standardize Package Inserts

New Bill Would Standardize Package Inserts

Posted 29 May 2012 | By Alexander Gaffney, RAC 

A new bill introduced in the Senate on 22 May would require the US Food and Drug Administration (FDA) to propose new regulations regarding the Patient Medication Information (PMI) received by patients.

The proposed legislation, S.3212-Cody Miller Initiative for Safer Prescriptions Act, was introduced by Sen. Kristen Gillibrand (D-NY), and deals with PMI patients receive when obtaining drug products from a physician or pharmacist. PMI commonly includes package inserts, which provide extensive information about how products are to be used by patients.

The bill specifically would amend section 505D of the Federal Food, Drug and Cosmetic Act (FD&C Act) to require all prescription PMI be scientifically accurate, nontechnical, understandable and written in plain language. Further, the legislation would establish minimum requirements for information contained within drug PMI, including direction for use, contraindications, measures to counteract side effects and risks, situations requiring the intervention of a healthcare professional and known drug-drug interactions (DDIs).

Gillibrand's legislation would also require regular updates to drug information contained within the PMI "as new drugs and new information becomes available," would require standardized presentation of information across drug classes and similar products to "avoid patient confusion and harm," and develop means to analyze patient understanding of PMI.

While the fate of the legislation in the Senate is as-yet unknown, it could receive the support of the US Food and Drug Administration (FDA), which previously said "it sees merit in adopting use of a single document that is standardized with respect to content and format."

Read more:

S.3212-Cody Miller Initiative for Safer Prescriptions Act

FDA - Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing

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