Tired of dealing with constant, but avoidable, lapses in drug manufacturing, the FDA’s CDER Director Janet Woodcock several years ago decided having drugmakers regularly report quality metrics would help the agency to focus on problem plants before matters got out of control. But even after winning significant revisions to the proposal, the industry is now asking the agency to hit the “pause” button on enactment.
In a letter to the agency, the Cross-Industry Quality Metrics Collaboration Group said, “We believe that the burden of FDA metrics collection far outweighs the benefits, at least as currently proposed.” It says the agency needs to hold off on taking additional steps until there can be “further public dialogue between industry and the Agency...”
The group is made up of various organizations representing different pieces of the supply chain, but includes PhRMA, the big dog of drug industry lobbying.
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The FDA issued draft guidance in 2015, with the idea of pushing even reluctant drugmakers toward quality manufacturing, and established a risk-based method for setting inspections. The plan was to have drugmakers provide 10 baseline quality metrics, things they were already collecting such as the number of lots rejected for specification-related issues during or after manufacturing. By getting that and other info before inspections, the FDA believed it could help drugmakers avoid problems that result in FDA actions.
After industry complaints that the process was onerous and 10 metrics too many, the FDA last year revised the draft guidance, cutting the number of metrics to be reported to three: lot acceptance rate, product quality complaint rate and invalidated out-of-specification (OOS) rate. But the industry said even with revisions the plan poses legal and practical issues.
There is also the chance that with a new president pledging to cut regulations and a new FDA director coming on board with the mandate to speed drugs to the market, a delay might be what the industry needs to get the plan killed altogether.
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Trump has nominated Scott Gottlieb, an FDA deputy director in the last Bush administration. While he has been slammed by Democrats for being too cozy with the industry, he has gotten significant support from within the industry for his views that regs should be cut and approvals speeded up.
On the other hand, some of his views might run counter to the push to halt the FDA metrics move. He has said that the FDA should publish the now-private complete response letters sent by the FDA to drugmakers which stop drug approvals.
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That kind of disclosure is one of the things that drug manufacturers would like to prevent with the FDA proposal for metric-based reports. In its letter to the FDA, the pharma firms said, they preferred a “gated” phased-in approach.