Immediately before the government shutdown, the Energy and Commerce Health Subcommittee held a markup to advance three health care bills, including a measure designed to give drug and medical device companies more freedom to discuss off-label information, one that would overhaul how the Food and Drug Administration (FDA) regulates over-the-counter (OTC) drugs, and another that would shield a health care professional from liability related to “an act or omission” that occurs as a volunteer in response to a disaster.
Opening Statements
Opening statements were provided by E&C Committee Chairman Greg Walden, E&C Committee Ranking Member Frank Pallone, Jr., and Health Subcommittee Chairman Michael C. Burgess, M.D.
E&C Chairman Greg Walden briefly summarized each of the bills, beginning with H.R. 1876, the Good Samaritan Health Professionals Act, which provides limited liability protections for health practitioners providing care to those in a federally declared disaster, such as the recent wildfires in Oregon and the West or even in a horrific event such as the Boston Marathon bombing.
He then spoke about the Pharmaceutical Information Exchange (PIE) Act of 2017, H.R. 2026. This bill attempts to facilitate communication between medical product developers and payors prior to FDA approval, based on the clinical data those developers will rely on for FDA approval.
Lastly, the Committee discussed the “Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018” legislation that attempts to “modernize the arcane process by which over-the-counter (OTC) health products are made available to consumers.” Walden noted that the OTC Monograph was established over forty years ago and it still remains incomplete today.
He closed by encouraging bipartisan support for these “critical bills.”
Volunteer Liability Protection
The Good Samaritan Health Professionals Act of 2017 (H.R. 1876), introduced by Representative Marsha Blackburn, was passed by voice vote. Full passage of the bill would shield health care professionals who serve as volunteers and believe in “good-faith” an individual is in need of health care services for which they are certified to perform. Health care professionals are not currently protected under the Volunteer Protection Act, passed in 1997. The bill’s liability protections do not apply to health care professionals who cause harm through willful or criminal misconduct, or who perform health care services while under the influence of alcohol or drugs.
Off-Label Communications
The Pharmaceutical Information Exchange (PIE) Act of 2017 (H.R. 2026), sponsored by Representative Brett Guthrie, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow information about an alternative use for FDA-approved pharmaceuticals and devices to be provided to health care entities under the premise that the information is based on “trustworthy, non-misleading scientific evidence.” Under the bill, the pharmaceutical/device company and physician must clearly differentiate between FDA-approved uses for the drug or device and off-label information if the therapy is approved for other uses.
Guthrie noted that this bill has been revised since last year based on technical assistance from FDA. A new version was introduced during the markup as a substitute amendment. The updated version of the legislation broadens the scope of the original bill to include devices and adds that the information that is shared must be “truthful and non-misleading.” Republican supporters argued that although physicians are legally allowed to prescribe pharmaceuticals for off-label uses, manufacturers are at risk of prosecution and criminal penalties for discussing and promoting alternative use.
The bill passed on a party-line vote, with some Democrats raising concerns that the bill could undermine the FDA and put patient health at risk. Full Committee Ranking Member Frank Pallone noted his belief that the legislation could lead to “the coverage of wholly unapproved drugs and would limit FDA’s ability to act against inappropriate actions by manufacturers.” Additionally, Representative Anna Eshoo observed that the bill does not require manufacturers to share health care economic information (HCEI) and scientific information with FDA, even if FDA requests the information.
The Committee rejected two Democratic amendments: one that would prevent communication about a product that had not yet been approved by the FDA and another that would require companies to provide the FDA off-label communication requested by the FDA respectively.
Over-the-Counter Regulation
The bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act would overhaul FDA regulation practices for OTC drugs and supply an increase in available resources to the FDA to oversee non-prescription medicines. Successful passage would lead to the first changes to over-the-counter regulation in more than 40 years and would direct the creation of a mechanism for faster safety label changes, establish pathways for innovation, and authorize a new user fee program that could bring in $120 million in funding through 2022. Thirty FDA employees currently devote their time to over-the-counter issues; the increase in funding through this legislation would allow the FDA to hire 100 additional staff.
Under the bill, FDA would be able to update OTC monographs without going through the rule making process, which is so cumbersome that products can remain on the shelves for decades before FDA can require updated labeling or formulation changes.
The legislation passed by voice vote, despite the concerns expressed by some Democrats on the Committee.