Updated: FDA delays collection of drug manufacturing volume data

Regulatory NewsRegulatory News | 26 August 2020 |  By 

The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical to the public health during a public health emergency,” and the active pharmaceutical ingredients of those drugs.
Drugmakers are also required to report manufacturing volume data under Section 3112(e) to FDA, including the “amount of each drug … that was manufactured, prepared, propagated, compounded, or processed … for commercial distribution.” The act also allows that this information may be required to be submitted in an electronic format and gives the secretary of the Department of Health and Human Services discretion to exempt biologics from some or all of the manufacturing volume data reporting requirements.
While the requirements established under Section 3112 are set to take effect on 23 September 2020, FDA says the electronic data submission portal it intends to use will not be ready by that date.
“FDA staff are working to define the data to be reported, create an electronic portal for the submission of this information, and determine when to begin collecting this information. We will provide further updates as our implementation planning continues,” FDA wrote in the notice.
An FDA spokesperson was unable to provide a timeline for when manufacturers would need to submit manufacturing volume data but said the agency “will provide an update at a future date on when we anticipate the collection will begin.”
The spokesperson also confirmed that the other provisions of Section 3112 would apply from 23 September, including the expansion of shortage reporting requirements under Section 3112(a) and a new requirement for manufacturers of drugs, APIs, or associated medical devices used for the preparation or administration of such drugs, to “develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug.”
Erin Fox, senior director of drug information and support services at the University of Utah Health, told Focus that while having access to such data could help FDA understand the severity of shortages, the agency does have market share data that, “Gets them to about the same place.”
“I can understand them not having the ability to set up a new data collection system right now. I think this is a ‘nice to have’ [and] not necessarily the deal breaker that will solve drug shortages,” she said.
Jonathan Darrow, assistant professor at Harvard Medical School, gave a similar assessment, telling Focus, “What is really needed is not more authority for the FDA, but a better understanding of why shortages are occurring.” Darrow suggested specific measures such as “enlarging the national stockpile or imposing inventory reserve requirements on hospitals and other healthcare facilities,” might better address some shortages caused by surges in demand.
“Congress, rather than the FDA, should be considering the market factors that have produced shortages, and how best to respond … Providing more information to the FDA is unlikely to be where the solution lies,” he said.
Editor’s note: This article was updated with additional comment from FDA.


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