Drugs

Drug Use Software Guidance Analyzed by Attorneys

Four Foley Hoag attorneys say a recent FDA draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, both answers and raises questions as it proposes a regulatory framework for software disseminated by a drug sponsor that supplements or relates to a prescription drug. Writing in an online post, the attorneys say prescription drug use related software (PDURS) may be regulated as a component of a drug’s labeling, as a medical device, or as a component of a combination product depending on the drug and the software’s functionality.

“The draft guidance’s discussion on FDA-required labeling and promotional labeling leaves sponsors with questions regarding how some materials might be regulated for PDURS and other contexts,” the attorneys write.

Their post says FDA was silent on the topic for many decades but now has provided an expansive definition of “promotional labeling” in the PDURS draft guidance. “This latest overture from FDA could be a sign that potential regulations governing promotional labeling may be on the horizon,” it says.

The draft adds a more concrete definition for PDURS and provides general commentary on prescription drug labeling, the attorneys write, which raises a few questions that reach beyond the scope of the PDURS guidance. They caution that the “expansive interpretation” in the draft “could subject virtually any communication a sponsor makes about its drug to FDA’s promotional labeling requirements. As the draft guidance explains, a drug sponsor must ensure that a drug’s promotional labeling is truthful and non-misleading, conveys balanced information about the drug’s efficacy and its risks, and discloses material facts about the drug, including facts about the consequences that can result from use of the drug as suggested in a promotional piece.”

Factors FDA says it will consider when ascertaining whether outputs from PDURS are considered FDA-required or promotional labeling are:

whether the software provides a function that is essential to the safe and effective use of the product;
whether evidence is provided to support a clinical benefit when the software is used; and
whether the software relies on data directly transferred from the device constituent part of a combination product.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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