Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software

Regulatory NewsRegulatory News
| 02 April 2019 | By Ana Mulero 

The US Food and Drug Administration’s (FDA) regulation of prescription drug-use-related software (PDURS) behooves alignment across relevant centers, industry comments on FDA’s proposed framework argued.

From pharmaceutical companies and trade associations to digital health companies and coalitions, the agency’s November 2018 proposed framework for the future regulation of PDURS drew comments from a range of stakeholders. The proposed framework on PDURS is largely seen as step in the right direction for the pharmaceutical and medical devices sectors to harness the potential seen in the digital health space. FDA solicited comments on its proposal to inform the development of a pending draft guidance.

Submitted comments already show common threads. Several commenters argued for clarity around the role of the proposed PDURS framework within the broader context of review standards and regulatory initiatives both within and across FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH).

PhRMA encouraged FDA guidance on CDER and CBER review standards for digital health technologies and close collaboration between CDER, CBER and CDRH for policy alignment. CDRH’s work to develop a new framework for digital health regulation via its Pre-Certification (PreCert) program was cited by some of the commenters as an initiative that lacked discussion in the agency’s proposed framework.

The agency “should consider the regulatory issues that can occur between CDER/CBER and CDRH since they have different regulatory frameworks that are not always aligned with each other” as part of the proposed framework’s development, Novartis said. The National Center for Health Research (NCHR) recommended FDA describe “if and where” PDURS tools would fit within FDA initiatives such as PreCert.

At the center of the argument for alignment across the three FDA centers lies the approach to how risk is defined for regulatory purposes. CDRH has adhered to the International Medical Device Regulators Forum’s (IMDRF) approach on determining risks in software as a medical device (SaMD) in developing not just its SaMD guidance, but also creating PreCert in collaboration with nine FDA-selected companies.

CDER should take an approach similar to CDRH’s with IMDRF’s SaMD framework, Omada Health argued.

“Processes for consistent cross-center engagement align with the overarching intent in the 21st Cures Act of 2016, where Congress authorized FDA Intercenter Institutes and enhanced center coordination around combination products,” PhRMA noted. “Such cross-center coordination also aligns with the FDA’s FY 2019 budget that proposed a Center of Excellence for Digital Health—a proposal presumably akin to the agency’s successful Oncology Center of Excellence that works across FDA centers.”

The roles of FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB) are also reportedly in need of further clarifications. FDA should “make clear that use of the OPDP or APLB advisory comments process for PDURS is voluntary, rather than expected or recommended,” the Medical Information Working Group (MIWG) requested. The MIWG is comprised of 11 firms, including Amgen, Bayer, Bristol-Myers Squibb, Eli Lily and GlaxoSmithKline, among others.

Other issues commenters raised relate to broadness in the interpretation of how the terms PDURS and PDURS output, labeling and promotional labeling, benefit claim and intended use are defined, the proposal for mandatory disclosures and the need for expedited review timelines specific to PDURS.


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