
FDA Proposes Streamlined Medication Handouts
FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.
After more than a decade of debate and discussion, FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products. A
The aim of the new program is to reduce drug misuse and adverse reactions by providing accurate information on product indications and uses to help people take prescription medicines safety and effectively,
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Costs for manufacturers
To realize such gains, sponsors of new drugs will seek FDA approval of PPIs as part of new drug applications (NDAs) or biologics licensed applications (BLAs). In addition, manufacturers of already approved medicines will have to revise existing patient information documents and file supplemental applications to gain PMI approval. The greater burden on industry will involve updating systems for printing and packaging PMIs with medicines, an undertaking that has generated objections to previous FDA proposals for revising required information for patients. To facilitate these changes, the agency outlines a five-year implementation schedule, as it calculates that sponsors would have to submit labeling supplements for more than 2600 existing drugs and more than 1600 new drug applications.
Generic-drug makers face added complexities in converting current medication information to the new format, as they will have to refer to new PMIs of their reference listed drugs, once those are submitted to and approved by FDA. The agency says it will facilitate this process by creating PMI templates for approved abbreviated new drug applications if the reference drug has been withdrawn or lacks an approved PMI.
In recognition of the issues raised from past proposals, FDA requests comments from industry on the usefulness and appropriateness of this latest patient information plan, the accuracy of the agency’s estimate of the burden and cost of providing the requested information, ways to improve the PMI proposal, and strategies for a reducing the burden of collecting the requested information. Industry has six months to submit comments.
About the author
Jill Wechsler is Washington reporter for BioPharm International.
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