The FDA publishes warning letters and inspection reports on its websites. It issues public recalls and drug label warnings. However, it is not feeling in such a sharing mood when it comes to its proposed letter grades for manufacturing plants on the quality of their manufacturing. It intends to keep those under wraps.
|Janet Woodcock, director of CDER|
The FDA's Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), for several years has been pushing drugmakers to establish a "culture of quality" in their manufacturing. The push came as the agency has upped its plant inspections, issued more warning letters and repeatedly banned plants that it found fall short on GMP standards. Out of her concerns came the FDA's new Office of Pharmaceutical Quality and from it has come draft guidance on plans to establish benchmarks that will tell it which plants need to be more closely monitored. This week the FDA huddled up with industry members to take comments on that proposal.
The agency intends to collect quantitative information to replace the more general ideas the agency has had about the state of manufacturing quality and allow the FDA to track processes through a product's life cycle. And from all of that it will create grades on how each plant is doing.
But Woodcock said this week that it has no plans for those grades to be made public, the Washington Examiner reports. She said that the metrics might be "misinterpreted" by the public. "Because they can be gamed and are not straightforward to understand it would be a disservice to release them to the public," the newspaper quoted her saying.
Using biologics manufacturing as an example, Woodcock pointed out that it is more complex than small-molecule tablet production and might result in a higher rate of rejection from a processing line. "If they have a higher [batch] rejection rate does that mean they are a bad production line or a good production line?" Woodcock said. "The public isn't in a position to interpret all of that."
Officials from two of the largest industry lobbying organizations, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Generic Pharmaceutical Association (GPhA), said they generally support the FDA's efforts, Regulatory Focus reports. But they raised concerns that the guidance may not be enough to get some drugmakers to comply. They questioned whether the agency needs legislative authority to require the metrics be provided, otherwise the effort might fall short.
Those guidance is not final, however, and the industry, and ostensibly the public, still have an opportunity to chime in. Regulatory Focus points out that the FDA extended the deadline for comment by 60 days to Nov. 27.
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