Towards the end of last year, the United States Food and Drug Administration (FDA) issued a draft guidance that revisited its approach to the communication of scientific information on unapproved uses of approved/cleared medical products (SIUU), requesting comments on the draft document. In response to the draft guidance, pharmaceutical companies and stakeholders pushed back on the changes in their comments.
Eli Lilly and Company
By way of example, Eli Lilly responded with a fairly comprehensive critique of the draft guidance – complete with suggestions for improvement. In its comment, Eli Lilly welcomed the overall spirit of the 2023 Draft Guidance, noting that the company appreciated the effort by the FDA to create a level playing field for industry players and to address concerns related to the sharing of scientific information on unapproved uses of approved/cleared medical products. Lilly emphasized the importance of sharing accurate and science-based information about medicines and biomedical research, and that such information helps to empower health care providers to make informed decisions and provide top-level care to patients.
However, Eli Lilly took issue with the distinction the FDA makes in the guidance between advertising, labeling, and scientific exchange, noting that the First Amendment does not differentiate between the three. Additionally, Lilly notes that the guidance creates ambiguous standards and arbitrary lines, which may potentially inhibit freedom of speech. In addition to potential First Amendment violations, Lilly notes that the draft guidance imposes operational burdens and may confuse employees and ultimately restrict the use of certain communication channels.
In conclusion, Lilly recommends that the FDA remove the concept of “clinically relevant” from the guidance, revise recommendations on SIUU communications, and address practical considerations to align the guidance with common industry practices.
PhRMA
The Pharmaceutical Research and Manufacturers of America (PhRMA) also submitted comments in response to the draft guidance, also expressing an appreciation to the agency for its continued effort to provide guidance to industry on sharing scientific information with health care professionals. However, PhRMA is concerned that the draft guidance has a limited scope and may be overly restrictive or unclear in some of the recommendations. Along those lines, and similar to the concerns Eli Lilly raised in its comments, PhRMA emphasized that all guidance published by the FDA should be careful to confirm to the First Amendment, taking care to protect truthful and non-misleading pharmaceutical communications. The comments from PhRMA also cite to the Fifth Amendment, noting that agencies must “provide notice for what behavior it intends to regulate” and that “enforcement based on vague guidance that does not provide proper notice of unlawful behavior does not comport with the Fifth Amendment.”
PhRMA also joined Lilly in taking issue with the proposed standard that source publications for SIUU communications be “clinically relevant,” as it is poorly defined in the draft guidance. PhRMA further argued against the exclusion of early-stage data from SIUU communications, as those data can be helpful in informing health care providers about new treatments – particularly in critical areas such as cancer and rare diseases.
In its comments, PhRMA points to the PhRMA-BIO Principles, noting that they “strike an appropriate balance between ensuring that a speaker’s First Amendment rights were protected and preserving a critical role for FDA in protecting the public health and safety and maintaining strong incentives for biopharmaceutical companies to seek supplemental approvals of approved medicines.” PhRMA pointed to those principles as a model for the FDA to conform its guidance to, to the extent that it is unclear or inconsistent with them.
PhRMA concluded by emphasizing the need to revise the draft guidance to enhance patient care by providing timely, education, and accurate information to health care providers and by offering to provide further information and engage in a dialogue with the FDA on how to best achieve those goals.
Medical Information Working Group
The Medical Information Working Group (MIWG) also submitted comments in response to the draft guidance, thanking the agency for recognizing the importance of SIUU communications. However, MIWG believes that the draft guidance does not adequately serve the public and individual health interests, that it exceeds statutory and constitutional limits, and is too ambiguous, all potentially leading to the limitation of communication of truthful, non-misleading scientific information and impacting patient care. MIWG notes that “most critically, we ask 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 HCPs, where SIUU may be used by them to inform clinical practice decisions.”
MIWG notes that the focus on SIUU communications in the revised draft is too narrow and does not account for the full range of benefits that can be associated with such communications, particularly in areas like oncology, dermatology, psychiatry, and rare diseases. Similar to the other comments cited above, MIWG disagrees with the FDA’s definitions of “scientifically sound” and “clinically relevant” information, arguing that the definitions are overly restrictive.
In conclusion, MIWG asks the FDA to make significant revisions to the draft document and re-issue for a new Comment Period before finalizing the guidance. Some specific revisions MIWG requests in its comments include: a broader acknowledgment of the benefits of SIUU communications, clarification on the regulatory status of SIUU communications, and clearer definitions of certain terms included in the draft guidance.
Washington Legal Foundation
The Washington Legal Foundation (WLF) also submitted comments in response to the draft guidance, as a public-interest law firm and policy center. WLF has a history of defending commercial speech rights, particularly in First Amendment cases, which as we have seen in each of the comments above, is particularly relevant here.
WLF has previously litigated against the FDA’s authority to restrict truthful manufacturer speech and in its comments also highlighted the Supreme Court’s recognition of the importance of the free flow of truthful information in medicine and public health. In doing so, WLF argued that the FDA’s revised draft guidance document is overbroad, ambiguous, and restricts important scientific speech, including debates and discussions in medicine.
WLF notes in its comments that physicians often rely on their own training, experience and judgment, as well as a variety of information sources (including manufacturer communications) when making treatment decisions – not just FDA-approved labeling. Therefore, WLF raises concerns that by being overly restrictive, the draft guidance may stop manufacturers from communicating truthful scientific information to health care providers, in violation of the First Amendment. Additionally, WLF argues that the revised draft does not provide clear guidance to drug and device manufacturers, leading to ambiguity in statutory, regulatory, and contractual obligations – possible violations of the Fifth Amendment – and with the FDA’s enforcement discretion, will create uncertainty among industry participants and potentially chill communication.