Drugs

Stakeholders Take Shots at FDA SIUU Communication Guide

David McFarland

— 2 min read
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The Washington Legal Foundation (WLF) says an FDA draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses (SIUU) of approved/cleared medical products “threatens to undermine public health” and also “disregards the Constitution.” The WLF comment letter says the draft would chill truthful, non-misleading scientific speech. “If challenged in federal court,” it says, “FDA would need to show that it has a compelling governmental interest in suppressing genuine scientific speech. FDA cannot possibly satisfy that test.”

The letter makes these points:

  • dissemination of scientific speech is fully protected by the First Amendment;
  • the revised draft threatens to chill manufacturers from communicating truthful scientific information to healthcare providers, in violation of the First Amendment; and
  • the revised draft fails to provide manufacturers with fair notice of what conduct violates the law.

In its response, Pharmaceutical Research and Manufacturers of America (PhRMA) says that as a matter of public health policy and as a matter of law, “it is critical that FDA provide guidance to ensure it does not inappropriately restrict the communication of emerging scientific and medical information about treatments…. The revised draft guidance sets out recommendations that in important aspects could unduly restrict the exchange of SIUU and in other respects are ambiguous and potentially improperly limiting. PhRMA urges FDA to revise those aspects of the recommendations in the revised draft guidance that are overly restrictive or unclear.”

The Medical Information Working Group (MIWG) says it agrees with FDA that SIUU communications should be based on materials that have been subject to robust review by organizations and individuals with relevant scientific expertise, under processes addressing conflicts of interest. “The recommendations in the revised draft, however, far exceed these appropriate parameters,” it says. “In so doing, they fail to serve the applicable public and individual health interests and exceed the statutory and constitutional limits on the agency’s authority to restrict the communication of truthful, non-misleading scientific information. Moreover, certain concepts, standards, and definitions introduced in the revised draft are ambiguous and untethered to the applicable statutory and regulatory authorities.”

The MIWG calls on FDA to “acknowledge the full range of public and individual health interests served by SIUU communications and to reconsider its attempt to dictate what studies and analyses may be considered ‘scientifically sound’ and ‘clinically relevant’ by practicing healthcare providers, where SIUU may be used by them to inform clinical practice decisions.” It says the revised draft raises these overarching issues:

  • failing to serve the applicable public and individual health interests;
  • exceeding the statutory limitations on FDA’s authority because it incorrectly posits that FDA has authority over SIUU communications, which do not constitute “labeling,” “advertising,” or evidence of a new “intended use;” and
  • raising serious First and Fifth Amendment concerns.

The Advanced Medical Technology Association generally praises and appreciates FDA efforts to produce a useful guidance on SIUU communication. Its letter says that scientific exchange is particularly integral to medical devices. “As medical device technology evolves in an iterative progression with continued, incremental improvements over time, new scientific information is particularly important as access to medical devices, versus other therapies, typically requires substantial interaction and discussion with highly trained healthcare professionals prior to determining whether a device is appropriate and for receipt of truthful, non-misleading scientific information to benefit patient care….,” it says. The association offers specific comments in several areas that it believes require further elaboration to “improve clarity and better tailor the guidance to support public health goals without diminishing the agency’s regulatory purpose of safeguarding the public health.”

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