FDA Accepting Comment on Burden of Drug Advertising, HCEI Communications Disclosures

Aug. 10, 2021 – The FDA is finalizing the burden estimates of complying with statutory requirements and guidance documents it previously issued on prescription drug advertising and the information drug companies communicate to payers and formulary committees and will accept comments on these estimates until Aug. 23.

According a notice published in the July 23 Federal Register on prescription drug advertising, the estimated annual third-party disclosure burden for an ad prepared in accordance with 21 CFR Part 202 – which requires that an ad be submitted for prior approval before dissemination – is roughly 29.8 million hours across the industry (based on an estimate of 74,425 annual disclosures at 400 hours per disclosure). The agency also estimates that fulfilling the requirement that a drug sponsor “promptly and adequately” publicize new adverse information about the drug will take 40 hours per year (assuming a placeholder of one respondent for these disclosures).

The annual reporting burden on the pharmaceuticals industry for reporting waiver requests from “major statement” requirements, submitting ads for required prior approval, adequately publicizing adverse event information and voluntarily submitting ads is approximately 2,200 hours, with the bulk of those hours (2,180) related to voluntary submissions. Compliance with the agency’s guidance document, “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements” (issued in 2017), requires another estimated 408, 207 hours from industry each year.

A second notice in the July 23 Federal Register estimates the annual burden for medical product companies providing recommended information – consistent with FDA-required labeling – to payers or formulary committees at 38,880 hours.

In its 2018 guidance document, “Medical Product Communications That Are Consistent with the FDA-Required Labeling – Questions and Answers,” the FDA lays out the recommended information to be included when information is disseminated to payers. In its recent notice, the agency estimates the hours it takes medical product companies to disclose the following information per year:

  • Information to be included when firms disseminate health care economic information (HCEI) to payers about approved prescription drugs: 90,000 hours
  • Information to be included when firms disseminate HCEI materials to payers about approved or cleared medical devices: 47,200 hours
  • Information to be included when firms disseminate information to payers about unapproved uses of approved or cleared products: 717 hours
  • Follow-up information that is disseminated to payers regarding previously communicated information about unapproved products or unapproved uses of approved or cleared products: 1,436 hours.