HR 2026 — Pharmaceutical Information Exchange Act

Summary

Pharmaceutical Information Exchange Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow information about a new investigational medication or the investigational use of a medication approved by the Food and Drug Administration to be provided to health care entities if the information is based on reliable scientific evidence.

Bill Text

• Introduced Introduced in House Current html April 06, 2017

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill clarifies the scope of permitted health care economic and scientific information communications by adding provisions that protect certain communications from being deemed false or misleading.

• 21 U.S.C. 352(a)

  (2) → (2) Health care economic information or scientific information provided 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 for coverage, reimbursement, or other population-based health care management, shall not be considered false or misleading or any other form of misbranding under this paragraph, or a violation of section 505 of this Act or section 351 of the Public Health Service Act, or otherwise prohibited pre-approval promotion of a drug, if it is based on competent and reliable scientific evidence and relates to an investigational new drug or an investigational use of an approved drug. In order for information relating to an investigational use of an approved drug to be provided pursuant to this subparagraph, there must have been submitted to the Secretary a supplemental application for approval of such use, or the study or studies needed to support the submission of a supplemental application for such use must have been completed with the intention that a supplemental application will be submitted to the Secretary for approval of the use. For purposes of this subparagraph, scientific information includes 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.

  This addition provides legal protection to certain communications about investigational drugs from being classified as misbranding, as long as specific conditions are met.

• 21 U.S.C. 352(a)

  (A)

  This change redesignates the existing subparagraphs for better organization.

• 21 U.S.C. 352(a)

  clause (B)

  This change removes the existing definition of health care economic information from the statute, streamlining the text.

Action History

1. April 06, 2017

   Introduced in House

2. April 06, 2017

   Introduced in House

3. April 06, 2017

   Referred to the House Committee on Energy and Commerce.

4. April 07, 2017

   Referred to the Subcommittee on Health.

5. January 17, 2018

   Subcommittee Consideration and Mark-up Session Held.

6. January 17, 2018

   Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 18 - 14 .

Sponsors

• Brett Guthrie · Primary

Subjects