Life Science Compliance Update

August 29, 2017

Industry Responds to Communication Guidances


In early 2017, FDA issued draft question and answer documents detailing how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well as in ways that are consistent with the FDA-required labeling. Industry offered many comments on the draft guidances outlining the FDA’s policies on industry communications with payers and claims that are on a drug’s label. We note a number of interesting comments from the Federal Register docket:


In BIO’s comments, the trade association points out:

“While there are many sources of clinical and scientific information available to payors

and HCPs, biopharmaceutical companies often possess the most detailed and up-to-date information about a given product, based on the company’s clinical trials to support approval and ongoing studies. Being able to proactively communicate truthful and non-misleading current information about their medical products would allow companies to ensure that: (1) payors have the comprehensive information needed to make well-informed and timely coverage and reimbursement decisions to ensure patients have access to the treatments their physicians prescribe; and (2) HCPs have the information they need to tailor treatment courses to the specific patient.”

Merck points out:

“Even with access to these new data, we expect that population health decision‐ makers will continue to be interested in the evidence pharmaceutical companies generate to support the value of their medicines for new uses.  As a research‐driven pharmaceutical company, we believe that FDA‐approved labeling will continue to be used as a primary data source for developing formularies, making coverage decisions, and creating clinical guidelines.  Data from randomized controlled clinical trials will remain the gold standard and be heavily relied upon as part of this process.   Merely because other data is available does not diminish the need, and desire, for high‐quality clinical trial data.  Pharmaceutical companies will continue to have a strong incentive to generate data for inclusion in an FDA‐approved label, considering the greater weight given to such evidence, and their need to communicate about approved uses of their products to health care professionals, patients, and caregivers.

Moreover, an FDA regulatory approval continues to have follow‐on impact globally, which would remain an additional strong incentive for pharmaceutical companies to pursue regulatory approval for new uses of approved medicines. Numerous countries across the world recognize, review and advise their own decisions with the information from an FDA regulatory review.

In short, this desire for more evidence creates not only the need for the robust dialogue between population health decision‐makers and pharmaceutical companies, but also the continued generation of high quality clinical data by pharmaceutical companies.”

From PhRMA’s comment in response to one of the specific questions posted by the FDA:

“PhRMA generally agrees with FDA in Q. A.7./A. A.7. that disclosures providing appropriate context are important to ensure that communications are truthful and non-misleading for their intended audience. Indeed, providing such contextual information is consistent with PhRMA-BIO Principle 3, which states that ‘[t]o help ensure that [sophisticated audiences] can appropriately weigh data that are not contained in the FDA-approved labeling for a drug, companies should make appropriate disclosures.’ However, the full slate of required disclosures in the Draft Guidance would recommend that manufacturers provide payors with disclosures that provide much more information than is necessary to ensure payors have appropriate context for the communicated information and suggests a level of paternalism inconsistent with First Amendment jurisprudence.”

Additionally, Eli Lilly and Anthem came together to submit a joint comment on the payer question and answer document, noting that changes to the existing FDA regulations and policies "are necessary in order to mitigate the challenges associated with the limited information that currently exists during insurer rate development and stakeholder budgeting timelines."

August 28, 2017

Is FDA Building its Talent Pool?


We recently reported on the Senate’s passage of the FDA Reauthorization Act (FDARA) which renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. Without these fees, FDA was expected to issue employee layoffs, but FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any layoff notices to user fee-funded staff “unless and until September 30 had passed without reauthorization.” We now have an interesting story that outlines how the FDA plans to build—rather than layoff—its talent pool.

FDA Recruiting Talent

According to the Endpoint News article, Gottlieb is fielding a new team of recruiters to start scouting top talent for the agency. It is being reported that the Commissioner is rolling out a pilot program to start a talent hunt, looking to better match new hires with the many jobs they have open. And the agency plans to start by recruiting new staffers for the PDUFA-related positions in the drugs and biologics programs.

“To take on this new effort, we’re establishing a dedicated group of full-time staff with the responsibility to ensure that we reliably and predictably identify, recruit, and efficiently hire the scientific personnel the Agency needs,” noted Gottlieb in a recent FDA blog post.

“Professional staff from our centers with experience recruiting specialized scientific and medical staffing will be key members of this new pilot effort. Staff from the Office of Operations will assist with the identification of potential candidates from key scientific disciplines.”

The article further outlines that Gottlieb has asked CDER’s Melanie Keller to take charge of the initiate. She’ll be running the pilot from a newly-created position inside the Office of Medical Products and Tobacco.

Drug Development and Industry Support

The article notes that the agency has been plagued by hundreds of positions long left open at the agency, making recruitment a key issue for Gottlieb. His plan to accelerate a wave of new drugs to the market will be hampered by a lack of regulators to help clear the backlog of generic applications. Better expertise will also help Gottlieb adopt new technologies to more quickly and efficiently promote drug development.

The article concludes by noting the popularity of this within the biotechnology industry, so it should be an interesting development to follow in the coming year.

A Murky Future for Off-label Promotion: New Leadership at the FDA Brings Change


On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time, there has already been various regulatory changes and shifts, in terms of policy guidance, as well as a new focus toward easing the Agency’s rules and regulations pertaining to off-label uses. The article will explore those changes and the Agency continues to refine the “intended use” rules.

The U.S. Food and Drug Administration’s (“FDA”) Twenty-Third Commissioner, Dr. Gottlieb, is a man of many talents. He is a physician, medical policy expert, and public health advocate. As a practicing physician, he was previously a Resident Fellow at the American Enterprise Institute, and a Clinical Assistant Professor at the New York University School of Medicine in Manhattan, where he also practiced medicine. Dr. Gottlieb also has deep FDA experience, having previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and as a senior advisor to the FDA Commissioner.

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