The Consolidated Appropriations Act, 2023, the federal government funding legislation signed into law at the end of 2022, amends Federal Food, Drug, and Cosmetic Act provisions regarding misbranded medical products to formally allow drug and medical device manufacturers to proactively share investigational drug and device information, including health care economic information, with payors, health plans, formulary committees and other similar entities prior to initial clearance or approval of drugs and devices or approval of a new use.

The provisions in Sec. 3630 – facilitating exchange of product information prior to approval – codify guidance that the FDA issued in 2018 and provide legal protection for those communications.

“Since the publication of the final guidance, we have witnessed internal company struggles regarding whether and how to provide this important information to payors,” Dara Katcher Levy, a director with Hyman, Phelps & McNamara, P.C. said. “We are hopeful that this critical information will facilitate earlier patient access to needed treatments once they are approved.”

The Pre-approval Information Exchange (PIE) Act (H.R. 7008) was first introduced in March 2022 by Rep. Brett Guthrie, R-Ky. After the mid-term elections, the bill was reintroduced by Guthrie and Reps. Anna Eshoo, D-Calif., Scott Peters, D-Calif., Morgan Griffith, R-Va., Doris Matsui, D-Calif., and Michael Burgess, R-Texas. Representatives Eshoo and Guthrie were the chairperson and ranking member of the House Energy and Commerce Committee’s health subcommittee.

“Having the support of Energy and Commerce health subcommittee leaders Eshoo and Guthrie gives critical momentum to PIE as we begin the ‘lame duck’ session after the election,” said Academy of Managed Care Pharmacy (AMCP) CEO Susan Cantrell when the bill was reintroduced. “Both are established leaders on health policy in Congress and worked to include the PIE Act as a provision in the House-passed version of the FDA reauthorization bill [H. R. 7667] earlier this summer.”

In reintroducing the bill, Guthrie said “the goal of the Pre-approval Information Exchange Act is to get newly FDA-approved treatments and devices to patients faster. Early communications between a payor and a drug or device manufacturer that this bill would permit under law can help reduce the time lag between FDA approval and a payor covering the drug or device so that patients can access cutting-edge medical innovation sooner.”

“Producers of newly- or soon-to-be- FDA approved medicines and medical devices are prohibited from sharing vital health care economic datapoints with insurers as they establish their coverage policies,” added Peters. “This can prolong coverage decisions, cause lengthy treatment delays, and reduce access for patients seeking innovative medical care. Ensuring payors have more accurate health care economic information will help patients access treatments more quickly by speeding up coverage decisions on FDA-approved medicines.”

The new law states that no drug or device will be deemed to be misbranded through the provision of truthful and not misleading product information to a payor, formulary committee or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved, cleared, granted marketing authorization or licensed provided the product information includes:

• a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization or licensed and that the safety and effectiveness of the drug or device for the use has not been established;
• information related to the stage of development of the drug or device involved, such as the status of any study or studies in which the investigational drug or device or investigational use is being investigated; how the study or studies relate to the overall plan for the development of the drug or device; and whether an application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the FDA and when such a submission is planned;
• in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of all material aspects of study design, methodology and results; and all material limitations related to the study design, methodology and results;
• where applicable, a prominent statement disclosing the indication or indications for which the FDA has approved, granted marketing authorization, cleared or licensed the product and a copy of the most current required labeling; and
• updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status.

In addition, the product information must not include information that represents that an unapproved product or an unapproved use of a drug or device has been approved, cleared, granted marketing authorization or licensed or has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied.

“Product information” includes:

• information describing the drug or device (such as drug class, device description and features);
• information about the indication or indications being investigated;
• the anticipated timeline for a possible approval, clearance, marketing authorization or licensure;
• drug or device pricing information;
• patient utilization projections;
• product-related programs or services; and
• factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.

The law also requires the Government Accountability Office to conduct a study on the provisions five-and-a-half years after the law is enacted to examine:

• The types of information communicated between such manufacturers and payors;
• The manner of communication between such manufacturers and payors;
• Whether manufacturers file an application for approval, marketing authorization, clearance or licensing of a new drug or device or the new use of a drug or device that is the subject of communication between such manufacturers and payors;
• How frequently the FDA approves, grants marketing authorization, clears or licenses the new drug or device or new use;
• The timeframe between the initial communications permitted under the provisions regarding an investigational drug or device or investigational use, and the initial marketing of such drug or device.