Drug Shortages: BIO Comments on FDA Proposed Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

 Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Proposed Rule: Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products.”
BIO represents more than 1,100 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.
Drug shortages can create significant concerns for patients seeking to maintain a treatment regime for their disease or condition and can even delay or halt clinical trials necessary to bring new therapies to market. The biotechnology industry is committed to the discovery and development of new, novel treatments for serious and life-threatening diseases, and drug shortages that prevent patient access to needed treatments stands counter to our driving mission to extend and enhance the lives of patients.
BIO supports FDA efforts to implement sections 506C and 506E of the Federal Food Drug and Cosmetic Act (FFDCA) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), including the general application of the drug shortage notification provision to biological products, taking into account the unique considerations around the manufacture and distribution of therapeutic biologics and vaccines.
BIO supports advance notification, which allows FDA to work with all stakeholders and exercise regulatory flexibility to prevent and minimize the impact of drug shortages. BIO appreciates and acknowledges the dedicated, hard-working individuals at the FDA who have partnered collaboratively with industry to prevent and mitigate drug shortages.
Actions taken by FDA in the years 2011 through 2013 clearly support the value of advance reporting and coordination between industry and FDA in the prevention and mitigation of drug shortages. While shortages of biotechnology products represent only a small minority of overall drug shortages, BIO recognizes there have been shortages of a handful of biological products in recent years due in part to the challenges associated with the manufacturing these products. In the experience of many biotechnology companies, FDA staff work constructively and collaboratively with the manufacturer in the event of a shortage to help resolve the problem and restore patient access to needed FDA-approved therapies as soon as possible.
Furthermore, BIO strongly believes that permitting widespread compounding of drug products deemed in shortage is not an appropriate solution to any one drug shortage. The public health consequences of increased availability of drug products that are not FDA approved, thus calling into question their quality, safety, and effectiveness, solely replaces one patient risk with another. Compounding exposes patients to unapproved products made in facilities not subject to FDA pre-approval inspection or governed by FDA Good Manufacturing Practices (GMPs).
We ask the Agency to consider our specific comments below, and BIO looks forward to continuing to work with the Agency, manufacturers, and other key public health stakeholders to further prevent and mitigate drug shortages.