This past month, the House of Representatives convincingly passed the 21st Century Cures Act. This bill contains important provisions related to how life science companies can communicate information about their products to patients, doctors, and payers. As the Senate contemplates a similar measure, it is important that legislation includes provisions that are needed to update the current regulatory constraints on communicating the latest medical information to those most in need.
The Coalition for Healthcare Communication provided a great writeup of a recent congressional briefing, sponsored by the Medical Information Working Group, that addressed the limitations and challenges of the current legal and regulatory framework, how this affects patient access to critical therapies, and how Congress can improve regulatory oversight of medical information.
During the hearing, Sandra Raymond, CEO and president of the Lupus Foundation of America, spoke to the importance of open channels of communication for doctors looking to best treat patients with lupus. She stated that for patients with lupus, current treatments primarily are off-label uses of drugs approved for other purposes, such as immunosuppressants, anti-malarials and steroids. Without a steady flow of information from companies about these uses, physicians are “uninformed about the current treatments for a disease they don’t understand well,” she said. “The result? Patient care is impacted.” Raymond told congressional staffers that regulators need to balance patient benefit and risk to determine appropriate healthcare communications, permit adequate directions for use on approved and alternative uses, and encourage approval for additional instructions.
Alan Bennett, senior counsel at Ropes & Gray. and co-leader of the Medical Information Working Group, also weighed in from the legal perspective. Currently, the regulation of medical information seems trapped in the past, with a promotional system that was “designed in the 1970s for 1970s conditions” that do not account for significant changes in reimbursement, technology, and evolving case law regarding free speech, according to told the Coalition for Healthcare Communication that MIWG wants to work with the FDA on making the regulation of medical information communication more clear and expansive.
“This would be a major change in the way the agency regulates, and major changes tend to take a lot of time, but recent First Amendment developments and marketplace factors, such as reimbursement and technology, are causing the FDA to pay attention,” Bennett said.
At the briefing Bennett highlighted three recent cases — Sorrell v. IMS Health Inc., U.S. v. Caronia, and Amarin Pharma Inc. et al. v. U.S. Food and Drug Administration et al. – that are bolstering the First Amendment right to speech or to hear a message. Although the Amarin case is still pending, Bennett noted that “if it comes out in favor of greater First Amendment rights, the agency will have to address that.”
Bennett also touched on other major issues that affect medical information communication:
- Payer communication. Congress thought that enacting Section 114 of the Food and Drug Administration Modernization Act of 1997 would allow companies to disseminate healthcare economic information to payers for formulary decision making, but in practice, the provision “remains unclear and FDA has muddied the waters further,” he said. He added that companies need a roadmap so dissemination is not ambiguous and companies can communicate with payers late in the FDA approval process to ensure that their drugs can be covered upon approval.
- Scientific Exchange. “Everyone relies on this, but no one really knows what it is,” Bennett said. “It is clear at the margins, but there are a lot of activities that go on between the poles,” he remarked.
- Definition of Labeling (and Advertising). The statute provides some definition, but that definition has been broadened by the FDA, according to Bennett. “We want the FDA to align its definition with the statute and case law,” he said.
- Substantial Evidence Standard for Claims. For comparative claims, the regulations state that claims based on any study that is not a randomized, controlled clinical trial is automatically false and misleading, even for an on-label claim, Bennett explained. “There are data today that didn’t exist in the 1970s – real-world data – that companies ought to be able to use to support claims,” he said. “The standard needs to be more flexible.”
- Intended Use. If a company knows its product is being used off-label, communicating that intended use is against the law, according to Bennett. Although the FDA is not enforcing this provision, “it is still on the books for the Justice Department to use and it needs to be clarified, especially when the standard of care for various conditions is an off-label use of an approved drug.”
- Guidelines. The FDA’s guidelines for unsolicited requests for information and textbook dissemination need to be updated and streamlined so that truthful and non-misleading information about treatments can be communicated in a timely and effective manner, Bennett told briefing attendees.
The bottom line, Bennett added, is that “a patient’s role in his or her own healthcare has become more important, so that patient and his or her physician should have access to the best information, for which companies are the most valuable source.”
Bennett also asserted that addressing this issue legislatively “is appropriate and necessary to provide the FDA with guidance to align with the statute and the Constitution,” he said. Although the House’s 21st Century Cures legislation “is a start, more comprehensive changes are essential and Congress needs to address the specific issues we have raised.”
Thanks to the Coalition for Healthcare Communication for their coverage of this important event.