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# House Hearing to Review FDA Off-label Enforcement
- URL: https://www.fdaweb.com/house-hearing-to-review-fda-off-label-enforcement/
- Published: 2017-07-10T12:00:00.000Z
- Updated: 2026-09-14T22:33:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139078

The House Energy and Commerce Subcommittee on Health has announced a 7/12 hearing on “Examining Medical Product Manufacturer Communications.” It is planned to provide “members an opportunity to better understand how medical products are often prescribed and administered for uses that are not included in the labeling approved by the Food and Drug Administration (FDA) as well as how product manufacturers are limited in their ability to communicate about such ‘off-label’ uses,” a hearing [background memo](http://docs.house.gov/meetings/IF/IF14/20170712/106225/HHRG-115-IF14-20170712-SD002.pdf?ref=fdaweb.com) says. “Some have argued that prohibiting manufacturers from proactively disseminating truthful and non-misleading off-label information has hindered health care providers’ from receiving the latest scientific and medical data that could inform patient care. In addition, a lack of regulatory clarity has prevented payors, formulary committees, and similar entities from receiving adequate information from drug and device companies about their products prior to FDA approval to help them accurately budget and forecast.”

It appears the hearing will also examine FDA’s off-label enforcement actions, which are pursued on the basis that a medical product in question has become “misbranded” and the agency’s determination that a new intended use has been established, the briefing document says. “The type of evidence the government can cite to determine that a new intended use has been established has been the subject of significant debate,” it says. “Some have argued that FDA’s current regulatory and enforcement posture has stifled medically beneficial information exchange.”

Additionally, the hearing will review Rep. **Morgan Griffith**’s (R-VA) amended version of HR 1703, the Medical Product Communications Act. The measure would “clarify in statute that a new intended use may not be determined by reference to actual or constructive knowledge that a product is being used in a manner that varies from the approved labeling, non-public statements to that effect, or communications that fall within a scientific exchange safe harbor established by the legislation,” according to the briefing document.

  
The hearing will also discuss an amended version of HR 2026 offered by Rep. **Brett Guthrie** (R-KY) that would clarify how drug and medical device companies can share health care economic or scientific information with certain entities if it is based on competent and reliable scientific evidence and relates to an investigational use of a drug or device. “In order for information relating to an investigational use of an approved or cleared product to be provided under this statutory provision,” the notice says, “the study or studies the manufacturer anticipates could be sufficient to support the approval of the new use must have been conducted; the manufacturer must intend that a supplemental application will be submitted to FDA for such use; and information must include a conspicuous and prominent statement describing any material differences between the information provided and the FDA-approved product labeling.”