Omnibus Bill Includes Changes to Pharmaceutical and Device Investigational Pre-Market Communications
The omnibus spending bill that passed Congress shortly before Christmas 2022 included legislation that was previously introduced as the Pre-Approval Information Exchange Act of 2022. The legislation will amend provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) regarding drugs and devices that are misbranded, formally allowing drug and medical device manufacturers to proactively share investigational drug and device information with payors, health plans, formulary committees, and other entities before the clearance or approval of the drug or device (or the new use of the drug or device).
President Joe Biden signed the spending bill into law on December 29, 2022.
Background
In 2018, the Food and Drug Administration (FDA) finalized guidance that allowed pharmaceutical and device companies to provide details about investigational products or investigational uses of marketed products to payors, health plans, formulary committees, and similar entities prior to approval or clearance of the product or its new use. However, the guidance was non-binding, and therefore, the passage of this legislation will officially establish a statutory pathway for both pharmaceutical and medical device companies to engage in pre-market communications about health care economic information with payors, formulary committees, and other similar entities.
Omnibus Spending Bill
Language Expansion to Include Devices
The legislation expands the current language of the FDCA, making the language regarding health care economic information applicable to both drugs and devices, as opposed to just drugs as it was previously written.
Health care economic information is (and has been) defined as any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes. The change made by this legislation, as noted above, is that drugs and devices can now share health care economic information with payors, formulary committees, and other similar entities with knowledge and expertise in the area of health care economic analysis, to help them select drugs and devices for coverage or reimbursement without being considered false or misleading if the health care economic information: relates to an indication approved for the drug or device, is based on competent and reliable scientific evidence, and includes a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device (when applicable).
Health care economic information does not include any analysis for an indication that is not approved for any drug or device.
Drug and device manufacturers have largely been supportive of preapproval information exchanges, but have had concerns that any legislation would go beyond the scope of guidance from the FDA. The legislation allows that information to be shared, but does not mandate it.
GAO to Conduct Impact Study
The omnibus spending bill also directed the Government Accountability Office (GAO) to conduct a study and publish a report in 5.5 years on the various aspects of preapproval information exchanges, including the types of information shared; the way in which the information is shared; whether manufacturers seek approval for the drug or device that is the subject of the information exchange; how frequently the FDA approves drugs, devices, and/or indications that are the subject of the information exchange; and the timeframe between the initial communication and the marketing of the drug, device, or indication.