The House Energy and Commerce Health Subcommittee voted to approve the following health policy bills on January 18, 2017:
- H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act. This bill would create a safe harbor that would allow drug and medical device companies to share certain health care economic or scientific information with payers, formularies, and other coverage, reimbursement, and population-based health care decision makers prior to FDA approval. Such information – including clinical and pre-clinical data and results relating to an unapproved drug therapy, or drug indication, or other condition of use being investigated or developed – must be based on competent and reliable scientific evidence and relate to an investigational use of a new drug or device or an investigational use of an approved drug or device. The safe harbor would allow for such information to be shared only if a supplemental application has been submitted to FDA for such use or, at a minimum, the study or studies needed to support the submission of a supplemental application have been completed “with the intention that a supplemental application will be submitted to [FDA] for approval of the use.” The bill was approved by a vote of 18 to 14. If it becomes law, H.R. 2026, the PIE Act, would partly codify current FDA policy governing pre-approval communications with payors, formulary committees, and similar entities. FDA’s policy, announced in a draft guidance issued January 2017 (Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers), states that pre-approval information “may help payors plan and budget for future coverage and/or reimbursement decisions prior to FDA approval of investigational products,” The policy also clarifies that FDA “does not intend to object” to the dissemination of this information under 21 C.F.R. § 312.7(a). FDA’s policy permits the following information to be disclosed pre-approval: (1) product information (e.g., drug class); (2) information about the indication sought, such as information from the clinical study protocol(s) about endpoint(s) being studied and the patient population under investigation (e.g., number of subjects enrolled, subject enrollment criteria, subject demographics); (3) factual presentations of results from clinical or preclinical studies (i.e., no characterizations or conclusions should be made regarding the safety or effectiveness of the product); (4) anticipated timeline for FDA action and/or possible FDA approval; (5) product pricing information; (6) targeting/marketing strategies (e.g., outreach activities planned to generate prescriber awareness about the product); and (7) anticipated product-related programs/services (e.g., patient support programs, including information about copay/savings cards).
- H.R. __, the Over-the-Counter Monograph Safety, Innovation, and Reform Act. The legislation would make what many consider to be long-overdue reforms to the FDA over-the-counter (OTC) monograph program for nonprescription drugs marketed without an approved new drug application. To modernize and streamline the process, the legislation would create a system for future changes to drug monographs through an administrative order procedure with the opportunity for development meetings or other consultations, submission of comments on proposed orders, and dispute resolution procedures. To enhance public health, the legislation would create a mechanism for faster safety label changes, and establish a pathway for innovations under monographs. The bill would establish an OTC monograph user fee program to support related reforms. The bill was approved by a voice vote.
- H.R. 1876, the Good Samaritan Health Professionals Act. This bill would provide limited liability protection for health care professionals providing services as a volunteer during a federally-declared disaster. The bill was approved by a voice vote.
The bills now advance to the full Energy and Commerce Committee.