Compounding: BIO Comments on FDA Request for Nominations: Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

  Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Request for Nominations: Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.”
BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
 
Introduction
BIO and its member companies work closely with FDA to ensure that the United States’ drug supply is safe, secure, and reliable, and that Americans can be confident that when they use an FDA-approved prescription drug or biologic, the medicine will be safe and effective, and work as intended. FDA’s regulatory standards for drugs and biologics are among the most rigorous in the world and BIO’s members strictly comply with the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA or the Act) that ensure the safety of prescription drugs, including Good Manufacturing Practices (cGMPs).
 
BIO recognizes that compounding, as specified under FFDCA Sections 503A and 503B, can play a useful role in personalizing a treatment for an individual patient with a unique medical need, such as by changing the dosage or formulation, on a case-by-case basis. We are troubled, however, when compounding pharmacies cross the line into large-scale manufacturing of prescription drugs and do not comply with the same rigorous standards for FDA pre-marketing approval, including rigorous cGMP standards for quality required of manufacturers by FDA. Such an approach fundamentally undermines patient safety and product quality safeguards. It also creates an uneven competitive playing field for responsible drug manufacturers that have made enormous investments in compliance with FDA regulations.
 
Accordingly, BIO urges FDA to use its full range of regulatory and enforcement authorities to ensure compounding activities do not endanger the public health. Without adequate regulation (and vigilant oversight and enforcement), compounding under both 503A and 503B may undermine patient safety, and also the integrity of the traditional New Drug Application (NDA), supplemental New Drug Application (sNDA), and Abbreviated New Drug Application (ANDA) approval processes, by providing a far less regulated alternative pathway for less responsible companies.