Energy and Commerce Health Subcommittee Explores Need for More Robust Communication about Real World Uses of Medicines
Committee Members and Witnesses Acknowledge FDA Prohibitions a Barrier to 21st Century Cures
07.25.14 | By Mit Spears
As part of the 21st Century Cures initiative, the House Energy and Commerce Subcommittee on Health discussed barriers to evidence development and communication for medicines and devices. The hearing reflected stakeholder input on the need to reduce barriers to communicating important scientific information about medicines and devices beyond what is in the labeling approved by the Food and Drug Administration (FDA).
During the hearing, a number of Subcommittee members discussed communications about “off-label” uses of medicines. In his opening statement, Subcommittee Chairman Joe Pitts (R-PA) commented that the FDA’s prohibition of off-label communication has been mentioned as a barrier to 21st century cures and that the discovery of the risks and benefits of a drug or treatment does not end with FDA approval. It is often just the beginning, given what can be learned in a realworld setting about the different uses for medicines and medical devices.
Echoing Rep. Pitts’ comments, Gregory Schimizzi, M.D., a member of the board of directors and past president of the Coalition of State Rheumatology Organizations (CSRO), testified that “current practices at both the FDA and CMS may be inappropriately hampering the exchange of information and making it difficult for physicians to receive the information they need to make valuable treatment decisions.”
Dr. Schimizzi, speaking on behalf of the Alliance for Specialty Medicine, also urged the FDA to “develop standards for qualifying realworld data through a public process to expand the current process of review of materials beyond what is included in the package insert,” to cover areas such as subpopulation data and comparative cost data.
Treating patients with rare diseases was frequently mentioned as a primary reason for physicians to have greater access to information about additional uses of medicines. Dr. Schimizzi said biopharmaceutical companies can glean information from clinical trials that a drug may be useful in a rare disease, but they aren’t incentivized to further investigate because of the high cost of clinical trials. According to Dr. Schimizzi, access to such information could guide physicians in a way that would increase efficacy as well as safety and potentially even decrease costs.
Energy and Commerce Committee Chair Fred Upton (R-MI) called the hearing, “a great opportunity to learn how we can encourage and reward ongoing evidence development and not unduly limit how such evidence is discussed or communicated to patients and providers.”
We agree. FDA’s outdated regulatory framework must be modernized to ensure healthcare providers are armed with truthful, scientifically accurate, and data-driven information to prescribe the most effective treatments for their patients.
Tuesday’s hearing is one in a series of discussions to hear from stakeholders across from the health ecosystem on how to accelerate the discovery, development and delivery of new treatments and cures for patients. PhRMA will closely monitor future discussions, and we look forward to reviewing the recommendations the Energy and Commerce Committee brings forward later this year.