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July 7 — The FDA is releasing a final rule (RIN 0910-AG88) that requires drug manufacturers to report any supply chain disruptions that could lead to drug shortages, according to a notice to be published July 8 in the Federal Register.
Specifically, the final rule requires notification to the FDA at least six months prior to the date of the permanent discontinuance or interruption in manufacturing, or, if six months' advance notice isn't possible, as soon as possible, but no later than five business days after the permanent discontinuance or interruption in manufacturing occurred, the notice said. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) (Pub. L. No. 112-144).
The final rule also specifies the minimum information that must be included in the notification and codifies the FDA's current practice of publicly disseminating information on shortages and maintaining public lists of drugs in shortage, the FDA said. Under the final rule, the FDA will issue a noncompliance letter to a manufacturer for failure to notify the agency.
The agency said it believes the final rule will improve its ability to identify potential drug shortages and to prevent and mitigate the impact of these shortages.
The final rule is effective Sept. 8. The proposed version of the rule was published in the Federal Register Nov. 4, 2013 (78 Fed. Reg. 65,904, Nov. 4, 2013) and comments were due Jan. 3, 2014. In comments on the proposed rule, generic and brand drug companies said they had some concerns. For instance, the Generic Pharmaceutical Association (GPhA) said it was concerned that the rule would require a manufacturer to report a manufacturing interruption before having sufficient information to determine that an interruption is likely.
The rule imposes annual reporting costs of up to $16,827 on those manufacturers affected by the rule, and up to $441,000 on the FDA in review costs, the notice said. Undertaking mitigation strategies, as measured by labor resources, is estimated to cost the FDA between $1.85 million and $5.94 million, and industry between $2.97 million and $9.55 million.
The FDA also said it estimates annual costs for industry between $9.57 million and $30.97 million associated with increasing production. Estimated total annual costs of the interactions between industry and the FDA range between $14.54 million and $46.92 million, the notice said.
“The public health benefits, mostly nonquantified, include the value of information that would assist FDA, manufacturers, health care providers, and patients in evaluating, mitigating, and preventing shortages of drugs and biological products that could otherwise result in delayed patient treatment or interruption in clinical trial development,” the agency said.
In a statement provided to Bloomberg BNA, the Biotechnology Industry Organization (BIO) said that “while we have not yet fully reviewed the final rule, we believe that drug shortages can create significant concerns for patients seeking to maintain a treatment regime for their disease or condition.”
“We support advance notification, which allows FDA to work with all stakeholders and exercise regulatory flexibility that might mitigate the impact of a drug shortage or the impending removal of a drug from the market,” BIO said. “We appreciate and acknowledge FDA’s commitment to partner collaboratively with industry to prevent and mitigate drug shortages.”
GPhA and the Pharmaceutical Research and Manufacturers of America didn't respond to a request for comment.
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