One step forward, two steps back.
By Ajay K. Singh, MBBS, FRCP, MBA
January 3, 2017
The 1962 Drug Amendments Act put the last nail in coffin—or so it seemed—for drug manufacturers/pharma companies in making outlandish claims on the effectiveness of their drug in promoting and marketing it. The process generated confidence that drugs were being marketed only after being shown to be effective. This put an end to the “tonic” industry that marketed liver tonics and kidney tonics and the like without much, or any, evidence.
A Perspectives article in the New England Journal of Medicine by Christopher Robinson and Aaron Kesselheim, centers around the controversy about whether a drug can be promoted and marketed based on an “individual’s right to free speech.” It discusses the impact of recent court decisions on whether pharma companies and their representatives can promote or market their drug without an express indication approved by the FDA.
A 2012 decision by the U.S. Court of Appeals for the Second Circuit (which includes New York, Connecticut and Vermont) overturned an earlier decision. Tamara Frazier, writing in Pharmaceutical Compliance Monitor, nicely summarizes the details of the court case:
“Alfred Caronia was a pharmaceuticals sales representative for Orphan Medical who, together with a physician in Orphan’s speaker program, promoted the drug Xyrem for off-label uses. Xyrem, known as the date rape drug, is approved for treatment of narcolepsy. Caronia and the physician were caught on tape promoting its use for treatment of insomnia, fibromyalgia, restless legs, Parkinson’s disease, and multiple sclerosis, and in unauthorized patient populations. Orphan and the physician pled guilty. After a trial on the merits, Caronia was acquitted of misbranding, but convicted of conspiracy to introduce a misbranded drug into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a) (2) of the Federal Drug and Cosmetic Act (“FDCA”). On December 3, 2012, the Second Circuit Court of Appeals overturned Caronia’s conviction, citing his first amendment rights. It declared, unequivocally, that the government “cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” “
The fundamental issue is this: under the umbrella of free speech can someone—the company sales representative or the company itself—claim benefits for a drug that are not proven and not approved by the FDA?
Since the Caronia decision, the US Government has tended to succeed in litigation regarding off-label use drugs with one notable exception. In a 2015 case, Amarin Pharmaceuticals was able to ultimately prevail on off-label promotion of it’s fish oil-derived cardio drug Vascepa, despite not having obtained an approved indication from the FDA.
As discussed earlier, The Drug Amendments of 1962, passed unanimously by the Congress, “recognized that no drug is truly safe unless it is also effective, and effectiveness was required to be established prior to marketing—a milestone advance in medical history.” This built on the 1938 Federal Food, Drug, and Cosmetic Act, a law enacted in the aftermath of 100 deaths following treatment with sulfanilamide.
The courts re-interpreting the role of the FDA is unfortunate. Robinson and Kesselheim write, ” Rather than acceding to the views of two judges in one federal circuit, we hope that the FDA continues to stand on principle. The U.S. Constitution should not be misconstrued in such a way as to undermine the primary functions of federal regulation in this area: to protect patients and to create a high-quality market for drugs and devices that is driven by science rather than hype.”
Understanding Addiction, the first in a three-part, accredited opioid use disorder program, is open for enrollment. Each of these self-paced, online CME courses is produced by Harvard Medical School’s Global Academy, and is free of charge with funding from the National Institute of Drug Abuse. These courses are intended for nurses, nurse practitioners, physician assistants, physicians, and other health care providers collaborating to treat patients with substance use disorders.
Dr. Ajay K. Singh is the Senior Associate Dean for Global and Continuing Education and Director, Master in Medical Sciences in Clinical Investigation (MMSCI) Program at Harvard Medical School. He is also Director, Continuing Medical Education, Department of Medicine and Renal Division at Brigham and Women’s Hospital in Boston.