Taking A Data-Driven, Patient-Centric Approach To Pharmaceutical Company Communication With Health Care Professionals

This new post by James M. “Mit” Spears appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

This post is based in part on a debate which took place between Jerry Avorn and Mit Spears. After reading this piece, check out the counter argument. You can also watch a video of the debate.

The ability of pharmaceutical companies to provide information about medicines to health care professionals beyond that which is contained in the Food and Drug Administration (FDA)-approved labeling is a topic that has generated a great deal of discussion, particularly in light of the August 2015 Amarin decision rendered by a US District Court in the Southern District of New York, and the FDA’s recent settlement of the case.

In Amarin, Judge Paul Engelmayer ruled that the FDA’s regulation of information provided by pharmaceutical companies violated the First Amendment’s Commercial Speech doctrine to the extent that they prohibited the communication of truthful and non-misleading speech, even where the information provided went beyond the FDA-approved labeling. On March 8, FDA and Amarin settled the case in a way that preserves Amarin’s ability to share truthful, non-misleading information about its medicine. In fact, the FDA even agreed to provide advisory review of two such communications per year with a 60-day timeline.

This case followed on the heels of the Second Circuit’s 2013 decision in Caronia and the Supreme Court’s 2011 ruling in Sorrell v. IMS Health, Inc., in which the Courts affirmed that the First Amendment’s protections of commercial speech extended to pharmaceutical companies and their employees. […]

Read the full post here.

The First Amendment And Pharmaceutical Promotion

This new post by Jerry Avorn appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

This post is based in part on a debate which took place between Jerry Avorn and Mit Spears. After reading this piece, check out the counter argument. You can also watch a video of the debate.

Traditionally, communication about medications has been granted a privileged status different from that accorded to other forms of communication. This makes sense for several reasons.

Unlike other marketplace transactions, most consumers are not able to acquire all the information they need to make appropriate purchasing decisions. This is obviously true of patients, but it is also true of doctors. Most physicians simply do not have the expertise or the time to review the voluminous information that a manufacturer submits to the Food and Drug Administration when it applies for approval of a new product. Even more important, a great deal of information provided to the FDA by a manufacturer is considered proprietary to that company. As a result, although this data is evaluated by FDA scientists, it is simply not accessible to physicians or patients outside of the agency.

Large teams of FDA scientists with expertise in pharmacology, clinical trials, epidemiology, statistics, and several other disciplines take six to 10 months to review the massive dossiers submitted by manufacturers to win drug approval. The idea that unfettered “commercial free speech” would make it possible for prescribers to come up with equally useful determinations on their own is simply implausible. […]

Read the full post here.

The Amarin Settlement: Watershed or Sinkhole?

By Joan H. Krause

The latest development in the simmering war over off-label drug promotion came on March 8, when Amarin Pharma reached a proposed settlement with the FDA that would allow the company to market its cardiovascular drug, Vascepa, for certain unapproved uses.  While the settlement must be approved by the district court, it already has fueled speculation about ever-broader challenges to off-label restrictions.  The unique set of facts at issue in Amarin, however, likely will limit the ability of other pharmaceutical companies to follow suit, at least in the short term.

Amarin sued the FDA in May 2015, relying on the Second Circuit’s 2012 opinion in United States v. Caronia, which held that the Food, Drug and Cosmetic Act did not prohibit a pharmaceutical sales representative’s truthful statements about off-label use of his company’s drug, Xyrem.  Procedurally, the Amarin dispute was unusual.  Vascepa was approved in 2011 for the treatment of patients with very high triglyceride levels.  Before the approval, Amarin entered into a special protocol assessment (SPA) with the FDA under which Vascepa would be studied (the ANCHOR study) in patients with slightly lower triglyceride levels, with the expectation of additional approval if the drug met study benchmarks.  In 2013, Amarin filed for such approval.

Subsequent to the SPA, however, studies of other cardiovascular products suggested that reducing triglyceride levels in high-risk patients did not lead to real clinical benefits for patients in terms of reducing events such as heart attack and stroke.  An FDA Advisory Committee found “substantial uncertainty” as to whether Vascepa would reduce such real-life risks, and the agency rescinded the SPA.  While acknowledging that the drug had met the ANCHOR study goals, the agency refused to approve the new indication until a second study confirmed Vascepa was able to reduce major cardiac events in such patients.  The FDA refused to allow Amarin to add the ANCHOR study results to Vascepa’s label, and warned that the drug might be misbranded if marketed for the new use.

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