Tomorrow, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug Administration (FDA) can provide clarity for drug and device companies regarding dissemination of truthful and non-misleading data and information that is not included in their product labeling.  

This hearing comes in the aftermath of litigation and attempted regulation on off-label promotion. Notably, in March, the FDA, delayed for one year a rule that would have expanded the agency’s ability to police off-label use. Easing restrictions on off-label use resurfaced last month when the Energy and Commerce Committee marked up user fee legislation. Representative Morgan Griffith (R-VA) attempted to attach his legislation on off-label promotion to the FDA reauthorization bill, but withdrew it after committee Democrats balked and threatened to withhold support for the reauthorization.

Tomorrow’s hearing has two parts. First, the Committee will consider two discussion drafts: an amended version of Representative Griffith’s Medical Product Communications Act, and an amended version of Representative Brett Guthrie’s (R-KY) Pharmaceutical Information Exchange Act. According to a summary provided by the Committee, Griffith’s bill “would clarify 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.” Guthrie’s bill “would clarify how drug and medical device companies can share health care economic or scientific information with the previously described entities if it is based on competent and reliable scientific evidence and relates to an investigational use of a drug or device.”

In addition to the two pieces of legislation, the Committee will hear from a panel of legal and policy experts about the challenges and benefits of current off-label restrictions.

The hearing begins at 10:30 AM Eastern Time and will be webcast here.

 

Posted by Vince Sampson