June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders about how they learn about new treatments for their diseases or conditions, a discussion that is likely to fuel the debate over whether and how companies can disclose information about off-label uses for their products.
The House launched the “21st Century Cures” initiative to bridge the gap between the number of diseases and the number of available treatments and with a goal of “accelerating the cycle of discovery, development, and delivery of promising new treatments and cures.” A document issued through the initiative quotes FasterCures Executive Director Margaret Anderson, speaking at the initiative’s May 6 Roundtable: “There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do.”
In its call for public comments, the House Committee poses a series of questions to which it would like answers. Some of those questions touch upon the hot-button issue of the communication of new treatments – some of which are off-label uses. These questions are as follows:
- How can we work together to better translate advances in science into safe and effective new therapies for patients?
- How do you learn about new treatments and cures? How do you communicate with other patients regarding treatments and cures?
- What is the role of government in your work, including any barriers to achieving your goals and advancing breakthroughs?
- How should regulators evaluate benefit-risk? How do you work with regulators regarding benefit risk? Can this process be improved?
“The Commerce Committee docket provides a great opportunity for interested parties to highlight the value of off-label information,” said Coalition for Healthcare Communication Executive Director John Kamp. “The topic is under active discussion at the FDA and elsewhere in light of recent court decisions based on the right of doctors and patients to hear this information under the First Amendment,” he continued. “While the First Amendment decisions have made the issue ripe at the FDA, the critical value of off-label information in the delivery of healthcare has yet to be fully discussed in the Congress and in other policy venues.”
The Coalition recommends that commenters consider the following off-label communication issues that could be addressed in a comment to the House Commerce Committee:
- Observational data and real-world evidence
- Sub-population data
- Observational and comparative data
- Pharmacoeconomic information
- Information on medically accepted alternative uses of medicine
Interested parties can send submissions and comments to email@example.com by June 13.