Drugs

Suggestions for FDA Drug Software Framework

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA recognition of the potential of digital health and supports agency efforts to provide clarity about its approach to regulating software associated with prescription drug products. In a comment on the agency’s proposed framework for prescription drug-use-related software (PDURS), PhRMA says it agrees with several principles underlying the proposed framework, but is concerned that specific policies outlined in it “could discourage the development of digital health solutions, hinder collaborations between drug sponsors and other digital health innovators, and ultimately hold back innovation in digital technologies that benefit patients.” It says the definition for PDURS is unduly broad and proposes a narrower definition. PhRMA recommends:

FDA apply the same regulatory framework for software associated with prescription drugs, regardless of who disseminates it;
FDA clarify the PDURS definition and narrow the scope of PDURS output considered to be labeling;
subjecting a narrower scope of drug-associated software output to the CDER Office of Prescription Drug Promotion and CBER Advertising and Promotional Labeling Branch submission process;
adopting a more flexible standard for including software output in FDA-required drug labeling;
FDA reconsider its proposal to require a sponsor to disclose that the agency has not evaluated certain software functions; and
FDA provide guidance on other issues around drug-associated software such as regulating drug and digital health technology as a combination product, requirements for use of digital health technologies in drug development, review standards for digital health technologies when reviewed by CDER or CBER, and differentiating digital products for proper prescribing, dispensing, and reimbursement.

Novartis said the “proposed framework would provide more assistance to sponsors if it provided more detail regarding when the output of PDURS will not be required to undergo FDA review.” It also provided line-by-line comments and suggestions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome