FEDERAL QUALITY RATING PROGRAM FOR PHARMACEUTICAL MANUFACTURERS

To advocate that the Food and Drug Administration (FDA) assign quality ratings to pharmaceutical manufacturers based on the quality of their manufacturing processes, sourcing of active pharmaceutical ingredients and excipients, selection of contract manufacturers, and business continuity plans; further,

To advocate that the FDA consider offering incentives for manufacturers to participate in the program.

Rationale

Shortages of critical drug products in hospitals and health systems continue to pose a significant threat to public health, and pharmacists and other clinicians are often challenged with locating supplies of life-saving or life-sustaining drug products at a moment’s notice and with very few options to choose from. While the number of new shortages has fallen considerably since 2011, a number of drug products remain in short supply. Drug product shortages are often caused by a manufacturing problem (e.g., contamination) that halts production until the problem is resolved. To address the issue of quality in drug product manufacturing, the FDA has considered creation of a manufacturing quality initiative that would highlight companies that employ the best quality manufacturing processes by establishing a rating system that would assign a rating to companies based on their level of quality in the manufacturing process. This rating system could be made public to enable prospective customers to see which companies employ the best quality practices. Further, the rating system could serve as a basis for FDA to offer incentives to companies who consistently rate higher than competitors.