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Nov. 28 — The FDA is giving drug manufacturers an early holiday present.
The agency's newly revised draft guidance on quality metrics ( 81 Fed. Reg. 85,226) makes the quality metrics program voluntary, backing away from the Food and Drug Administration’s original 2015 draft guidance that considered companies out of compliance if they didn’t submit the metrics.
“The biggest thing is that FDA is making this voluntary for the foreseeable future, " James R. Johnson, a partner with the Washington office of Hogan Lovells US LLP, told Bloomberg BNA in a Nov. 28 phone call.
The voluntary program, the first phase of which won’t be completed until 2018, and the reduced number of metrics to be collected appear to respond to concerns the industry expressed over the FDA’s original draft of the quality metrics guidance, released in July 2015 (80 Fed. Reg. 44,973).
Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and improve drug manufacturing. The FDA wants to use the metrics to help identify which companies are lower risk and which ones merit more FDA attention and inspections. The agency also hopes metrics will encourage state-of-the-art, innovative quality management systems.
The carrot for submitting the metrics is fewer FDA inspections, Johnson said, and the stick is getting more frequent inspections. Before joining Hogan Lovells, Johnson was associate chief counsel for enforcement in the FDA's Office of Chief Counsel.
The latest version of the quality metrics guidance is “a kind of redo” of the 2015 version, Johnson said. The 2015 version was broadly criticized by the drug industry.
“I absolutely think this guidance is an indication of FDA wanting to jump on the brakes a bit with regard to quality metrics,” Johnson said. The new guidance recognizes that questions exist about whether the agency has the legal authority to require companies to create new documents and also recognizes that the program will require extensive agency resources.
“They were right to walk it back,” Johnson said. The FDA may have recognized its “original guidance was a bit too aggressive,” he added.
The drug industry had extensive issues with the 2015 draft guidance, including concerns the FDA didn’t have the legal authority to require companies to create additional documents for the program.
Under the 2015 guidance, the FDA could treat a company’s refusal to submit the metrics as an inspectional refusal, with the attendant consequence of deeming the company’s products as adulterated.
“There’s no mention of that in the new guidance,” Johnson said.
Comments on the revised draft guidance are due Jan. 24, 2017.
The drug industry also worries it will have to devote immense resources to creating data metrics documents at the expense of quality oversight. The newest guidance tries to address that burden.
The FDA asks for fewer metrics under the revised guidance, but collection still will require substantial company resources and time, Johnson said.
“The FDA draft guidance streamlines a lot of what they’re asking for, Johnson said. “They’re really trying to make it as easy as possible, but even then, it’s still going to be burdensome.”
Participating in the new program is voluntary, but the agency will publish companies’ submissions. If a company isn’t listed as participating, it may raise an underlying question of why the company isn’t submitting the data, Johnson said.
The revised guidance also clarifies quality metrics data definitions, adds comment fields and further defines reporting considerations.
“What the guidance really doesn’t talk about,” he said, “is how metrics can vary by product type.”
Ideally, metrics would be product-specific, Johnson said.
The FDA will have to analyze how best to use the data and put the data in context, he said. Comparing metrics for different kinds of products, such as biopharmaceuticals and solid oral tablets, may not be useful in determining whether one product is riskier than the other, Johnson said.
“The context isn’t exactly clear here,” he said. “The FDA is really going to have to have metrics come in first before they can streamline the process.”
After the first phase of the guidance is completed, the FDA intends to initiate notice and comment rulemaking.
“The FDA wants to get a feel for things and then put out a proposed rule,” Johnson said. “That is how it should be done,” he said. “If you’re going to enforce it as law, you should make it law.”
“That’s going to be a long process,” he said.
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The revised draft guidance is available at //src.bna.com/kig.
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