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Regulatory Focus™ > News Articles > 2020 > 7 > Unified agenda: FDA publishes lengthy to-do list

Unified agenda: FDA publishes lengthy to-do list

Posted 08 July 2020 | By Denise Fulton 

Unified agenda: FDA publishes lengthy to-do list

Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.
The importation of prescription drugs continues to be among deregulatory priorities for the Trump Administration. This Spring’s agenda notes that FDA aims to publish a final rule by December 2020, after publishing a Notice of Proposed Rulemaking (NPRM) last December.
If finalized, the rule would allow states and certain other non-federal government entities to seek FDA authorization to import certain prescription medicines from Canada. Such programs could be sponsored by a pharmacist, pharmaceutical wholesaler or a state or government below the federal level, according to the proposed rule. Certain products would be excluded, including insulins, controlled substances, intravenous drugs, drugs with Risk Evaluation and Mitigation Strategies (REMS) and drugs injected in the spine or eye.
Pharmaceutical manufacturers and industry groups and multiple Canadian pharmacist groups were among those that submitted comments opposing the proposed rule. Drugmakers cited low levels of proposed cost savings and safety concerns while Canadian commenters argued the proposal would imperil Canada’s own drug supply chain as well. (SEE RELATED: Drugmakers, Canadians Balk at FDA’s Safe Importation Plan, Regulatory Focus 16 March 2020).
The medical device de novo classification process has been on FDA’s agenda for the last several years. An NPRM was published in late 2018, with comments required by the first quarter of 2019. Under the proposed rule, FDA set out procedures and criteria for the de novo process, aiming to increase transparency and predictability for device makers. Devices using the de novo process are those for which there is no predicate device to rely on, and devices granted a de novo request can serve as a predicate device for a later 510(k) submission.
Device industry representatives expressed concerns that the proposed rule did not achieve what it set out to do, specifically “limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval,” according to the proposed rule.
Commenters noted that the proposed requirements were either identical or nearly identical to those required of the more rigorous pre-market approval (PMA) process, potentially negating any advantage to the de novo process.
FDA aims to publish a final rule on de novo device classification in September.
The agenda also notes numerous proposed rules FDA plans on issuing in the next 6 months. Among them:
  • Postmarketing Safety Reporting Requirements for Human Drug and Biological Products. Originally issued in 2003, this proposed rule aims to better align FDA requirements on postmarketing safety reporting for medicines and biological products with guidance from the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The original 2003 comment period was extended several times; this go round, FDA aims to reissue a NPRM in December.
  • Medication Guide; Patient Medication Information. In November, the agency aims to issue a NPRM that would require a new form of patient labeling for outpatient drugs and biologics called Patient Medication Information. The goal of the new labeling document would be to provide “clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.”
  • Harmonizing and Modernizing Regulation of Medical Device Quality Systems. FDA plans to revise and update the quality standards for medical devices to ISO 13485:2016. Doing so would harmonize domestic and international standards and reduce the regulatory burden on manufacturers and importers. The NRPM is due in October.
  • Biologics Regulation Modernization. This proposed rule, due in December, would clarify the requirements and procedures necessary to file a Biologic License Application and support the abbreviated pathway created by BPCIA.
  • Clinical Holds in Medical Device Investigations. This proposed rule, originally scheduled for release in February 2020, would create a regulatory framework for implementing clinical holds in medical device clinical trials. The NRPM is due in September.
  • Investigational New Drug Application Annual Reporting. This proposed rule also aims to better align FDA’s work with ICH standards. If finalized, the rule would replace the annual reports currently submitted by Investigational New Drug (IND) sponsors with an FDA development safety update report (FDA DSUR) with the same format and content as that of ICH. The NPRM originally was supposed to be issued in March 2020; the new deadline is this month.

Spring 2020 Unified Agenda


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