PhRMA Responds to FDA Letter in First Amendment Dispute

The Pharmaceutical Research and Manufacturers of America last week submitted an amicus brief relating to the FDA's response to a drug company's suit challenging limits on truthful communications about off-label uses of a drug. See Amarin Pharma, Inc. v. FDA,  No. 15-cv-03588 (S.D.N.Y)(amicus brief filed 6/11/15).

Readers will recall that the case involves FDA interpretations that potentially make a drug manufacturer criminally and civilly liable for providing truthful and non-misleading scientific and medical information to well-trained health care professionals regarding unapproved uses of FDA-approved drugs or data that are not contained in the FDA approved labeling for such medicines. (Our friends over at the Drug and Device Law Blog have covered this issue extensively.)

PhRMA said in the amicus brief filed June 11th in the U.S. District Court for the Southern District of New York that FDA's recent maneuver -- a regulatory letter to the plaintiff, Amarin Pharma  --did not “cure the constitutional defects in FDA's content-based restrictions on protected speech.” In the letter, the FDA said it now all of a sudden doesn't object to many of the "off-label statements" the company might consider making about its cholesterol treatment drug.  So, the agency wouldn't necessarily consider the dissemination of some of that information to be false or misleading.

Because doctors routinely lawfully prescribe FDA-approved drugs for unapproved uses, informed patient care relies upon doctors having access to accurate, comprehensive, and current information about such uses. Biopharmaceutical manufacturers are an important source of this knowledge, said the brief. Amarin has a First Amendment right to provide such truthful and non-misleading  information. Doctors have a First Amendment right to receive it. And patients have a strong health-related interest in an affirmation of those rights. 

FDA’s recent made-for-litigation “regulatory letter” to Amarin does not cure the constitutional defects in FDA’s content-based restrictions on protected speech. The brief argued that instead FDA exacerbates and reinforces them in a footnote which reiterates in broad strokes the Agency’s 
longstanding position that the FDCA and FDA’s implementing regulations prohibit manufacturers from speaking to healthcare professionals about unapproved uses. Beyond that, the letter purports to be an exercise of enforcement discretion, relies on “draft” guidance documents that FDA itself contends do not bind the Agency, and contains significant caveats that preserve the Government’s option to pursue criminal and civil enforcement based on manufacturers’ protected speech.

For example, “under these circumstances,” FDA stated in the letter, it does not intend to object to the proposed communications “if made in the manner and to the extent described below.” FDA thus seeks to create a one-off discretionary exception, applicable to this case and nowhere else -- precisely the type of case-by-case determination regarding the legality of speech that the First Amendment forbids. Moreover, the letter relies exclusively on guidance documents that FDA itself contends are non-binding. Even if they would be deemed binding, many of the guidance documents cited in FDA’s letter remain in “draft” form.  PhRMA and others have submitted comments to FDA objecting to many aspects of these draft guidance documents, because, among other things, they continue to censor and burden protected speech based on both its content and the identity of the speaker.

The brief points out that FDA’s letter is not the first instance of a discretionary modification of ostensibly nonbinding guidance infringing on First Amendment rights. When manufacturers have
challenged FDA’s approach to speech about unapproved uses in Court, FDA has previously made ad hoc statements backing off of certain of those policies as a matter of enforcement discretion and with carefully vague caveats. FDA should not be permitted, argued the amicus, to avoid judicial scrutiny of its published regulations restricting protected speech on the basis of such non-final and potentially nonbinding “guidance” and such revocable assertions of enforcement discretion. 

Certainly one to watch.

PhRMA Issues New Principles on Clinical Trials

Readers of MassTortDefense know how the conduct and results of clinical trials can reach out and affect later product liability litigation: plaintiffs frequently assert that drug makers missed or ignored safety signals present in those trials. 

In reality, developing new therapies to treat disease and to improve quality of life is a long and complex process. And a critical part of that process is clinical research -- without clinical research studies, no new medicines could be made available to patients.

Last week PhRMA issued revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results with a goal of helping assure that the clinical research conducted by pharmaceutical research and biotechnology companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients.

Among the key changes in the updated Principles: Increased transparency about clinical trials for patients and healthcare professionals; enhanced standards for medical research authorship; and improved disclosure to better manage potential conflicts of interest in medical research.

PhRMA members have indeed had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. And actually, many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulatory agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.

The key issues addressed are:
• Protecting Research Participants
• Conduct of Clinical Trials
• Ensuring Objectivity in Research
• Providing Information About Clinical Trials

Of particular note to my readers may be the document's call for consistency with standards of the International Committee of Medical Journal Editors as journal guidelines for authorship;  under these, anyone who: (1) provides substantial contributions into the conception or design of a study, or data acquisition, or data analysis and interpretation; and/or (2) writes or revises the manuscript involving important intellectual content; and/or (3) has final approval of the version to be published, should receive appropriate recognition as an author when the manuscript is published. Conversely, individuals who do not contribute in this manner do not warrant authorship. We have posted about this issue before.

As always, the guidelines are purely voluntary, and even member companies are free to adopt their own best practices and mold general guidance to their particular situations.

 

PhRMA Revises Marketing Code Regarding Interactions With Healthcare Professionals

The Pharmaceutical Research and Manufacturers of America (PhRMA) has just adopted measures to enhance the PhRMA Code dealing with Interactions with Healthcare Professionals. (PhRMA represents research-based pharmaceutical and biotechnology companies.) Attacks on the marketing practices of drug makers is a common feature in pharmaceutical mass torts, including criticisms of the relationships between healthcare providers and pharmaceutical companies.

Informative professional relationships between healthcare providers and pharmaceutical research companies are instrumental to effective patient care. While plaintiffs frequently malign interactions between the companies and prescribers, doctors appropriately rely on information about new medicines in order to enhance the quality of care they give patients. Providing doctors with up-to-date information on the medicines they prescribe improves patient care. Thus, reasons for interaction include:

• inform healthcare professionals about the benefits and risks of products to help advance appropriate patient use,
• provide scientific and educational information,
• support medical research and education, and
• obtain feedback and advice about our products through consultation with medical experts.

The new code will take effect in January, 2009. The code is voluntary, reflecting the fact that different companies may approach the issues differently, all well within the range of choices available to a reasonable manufacturer in a competitive environment.