Life Science Compliance Update

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June 06, 2016

House Energy and Commerce Ask FDA for Update on Off Label Guidance

The House of Representatives, through the Energy and Commerce Committee, are questioning the United States Food and Drug Administration's (FDA) current approach to regulating off-label communications. Committee Chairman Fred Upton and Health Subcommittee Chairman Joseph Pitts recently sent a letter to the Department of Health and Human Services (HHS) that not only questioned the current approach, but also expressed a willingness of the Committee to work with the agency to help craft workable policy solutions.

The letter referenced "recent litigation" that has "raised significant questions about FDA's authority to restrict" certain communications made by medical product manufacturer communications, specifically "the proactive dissemination of truthful and non-misleading information that is outside the scope of a product's FDA-approved labeling."

The House leaders mentioned that while discussing the 21st Century Cures Act, the Committee was able to hear how new data and analyses on real-world usage of medical products is continuously being generated after FDA approval and they believe that ensuring physicians and others who are involved in influencing treatment decisions are informed about scientifically accurate "off label" information is critical to optimizing patient care. They noted one testimony in particular, that of a rheumatologist in July 2014, which stated, "By limiting the sharing of information, physicians are hampered in their ability to access all available sound medical evidence and firm scientific rationale necessary to treat patients with difficult problems." Mr. Upton and Mr. Pitts believe that preventing manufacturers from proactively providing such information is not only unsound public policy, but also constitutionally impermissible.

In the letter, Upton and Pitts state that ire the pharmaceutical companies are having toward the FDA for dragging its feet on new off-label marketing guidelines is misdirected. Instead, that frustration, according to Mr. Upton and Mr. Pitts, should be aimed toward the HHS. In the letter, the Representatives state,

As FDA's authorizing committee, we are increasingly perplexed by the agency's unwillingness or inability to publicly clarify its current thinking on these issues in a coherent manner. If FDA continues to remain silent, settlement agreements will be the only means by which policy is formulated—and it will be in an ad hoc manner lacking any semblance of consistency and cohesiveness. It has come to the committee's attention that such inaction may be the result of disagreements between FDA and HHS leadership. Specifically, despite being on FDA's guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible 'scientific exchange.' While comprehensive guidance would be a welcome step in the right direction, we still question whether non-binding policy statements would satisfy due process concerns.

The letter continues on, stating that the Committee raised these concerns – even before Amarin and Pacira – and proposed targeted statutory changes to clarify key terms and concepts within the FFDCA to establish clearly defined ways that manufacturers could disseminate scientifically accurate information while preserving the FDAs approval standards for drugs and devices.

The letter concludes with a willingness to get creative, with the Representatives stating that "the committee is open to considering alternative approaches to address such an important issue. However, Congress needs a willing partner that will engage seriously in modernizing law to reflect the intersection of off-label use and 21st century medicine."

Upton and Pitts also attached a copy of the proposed bill to their letter. While it is impossible to know what the FDA – or HHS – is thinking, until the proposed guidelines come out, or Congress takes legislative action, pharmaceutical companies will continue to have to deal with the uncertain status quo and uncertain future.






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