FDA outlines plan to incentivize high-quality manufacturing

Regulation of pharmaceutical manufacturing generally involves more stick than carrot. While a production misstep will result in a regulatory slapdown, the reward for doing well is simply avoidance of punishment. Now this could be changing, with the FDA looking into how it can offer incentives to manufacturers.

The FDA's interest in what it can do to promote and sustain manufacturing and product quality improvements forms part of its 40-page strategic plan to end and prevent drug shortages. The document contains scant details on how the incentives would work--and the FDA admits it is yet to fully flesh out the idea--but it still reveals an interest in more carrot-based regulation. The FDA is limited in its ability to offer economic rewards, but it suggests payers are better positioned to provide economic encouragement of high-quality, shortage-preventing manufacturing.

While the FDA is unclear on how it can incentivize manufacturers, it knows which sort of initiatives it wants to reward. "[We are] looking at ways FDA, using our existing authorities, can recognize manufacturers that do a particularly valuable job, whether it's creating a new product to relieve a shortage, or bringing a product that had formerly been marketed back," FDA deputy director of regulatory programs Dr. Douglas Throckmorton told reporters on a call attended by FiercePharmaManufacturing. The idea is to reward manufacturers who help the FDA overcome drug shortages.

The FDA made several other proposals that affect drug manufacturers. The agency is looking into how it can share information on manufacturing quality more widely, and in doing so help companies improve their processes. A new FDA office focused on manufacturing quality is also under consideration. The office would give manufacturers a focal point for quality discussions and lead FDA initiatives in the area. Throckmorton expressed an interest in risk-based approaches that can help the regulator detect shortage-causing quality problems earlier. The FDA is also extending early notification requirements to biologics and advising manufacturers on how to avoid shortages.

The initiatives are intended to build on what the FDA described as a successful push to end and prevent drug shortages. The FDA said last year there were 117 shortages, less than half the number in 2011. While recognizing the improvement, observers are concerned about the persistence of the remaining shortages. "The number of new drug shortages is declining, and that's good news. But the ones we have already are not going away. The current status is we're really stuck, and it's almost getting worse," Erin Fox, manager of the University of Utah's Drug Information Service, told The Wall Street Journal.

- view the FDA plan (PDF)
- read the WSJ article
- here's FiercePharma's take