This week, the House Energy and Commerce (E&C) Health subcommittee held a hearing, “Examining Medical Product Manufacturer Communications,” to discuss two bills (H.R.1703 and H.R.2026) that seek to expand off-label communication. Six witnesses testified before the committee, four presenting compelling testimony on the need to loosen off-label communication. However, Democrats on the committee expressed deep concerns that these bills would threaten public health and undermine the Food Drug and Administration (FDA). Rep. Frank Pallone, Jr. (D-NJ) claims that loosening off-label regulations would hamstring the FDA from holding bad actors who distribute dangerous drugs or medical devices accountable.
As a reminder, this hearing was in response to a deal made during the FDA user fee reauthorization package between Republicans and Democrats. Rep. Griffith’s bill, the Medical Product Communications Act (H.R.1703), which is supported by ASCRS and the Alliance of Specialty Medicine, would give drug and device manufacturers the ability to communicate truthful and non-misleading information about their products not referenced in the FDA-approved label on a medical product to physicians. Rep. Guthrie’s bill, the Pharmaceutical Information Exchange Act (H.R.2026), seeks to improve patient access to emerging medication by clarifying the scope of permitted healthcare economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers. We will continue to keep you updated.