Praise, Suggestions for ‘Enhanced’ Purple Book

The Association for Accessible Medicines says that by updating the Purple Book, FDA is “increasing transparency for patients, providers, payers, manufacturers, and other stakeholders. This will help close educational and regulatory gaps, and it will improve patient access and adoption of lower-cost FDA-approved biosimilars.” The association’s comment letter contains recommendations for continuing to improve the Purple Book and responses to FDA specific questions in the public docket.

In its letter, Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s creation of a searchable Purple Book database and the agency’s commitment to future enhancements and solicitation of comments on such enhancements. The letter contains PhRMA’s general comments and thoughts on the order and display of simple search results, display of advanced search results, and additional comments.