Editor’s note: This post is part of a Health Affairs Blog Symposium on Health Law stemming from 4th Annual Health Law Year in P/Review conference hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Holly Fernandez Lynch wrote an introductory post in January 2016 and you can access a full list of symposium pieces here or by clicking on the “The Health Law Year in P/Review” tag at the bottom of any symposium post.
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.
Another reason that the nation has determined that drug promotion should be more restricted than promotional statements about, for example, toasters or computers, is that the consequence of getting a medication-use decision wrong can be catastrophic.
This helps explain why so many of us are worried about the growing movement to consider the promotional claims of drug makers to be in a class of commercial free speech protected under the First Amendment. While overtly fraudulent statements would not be permitted (“This pill will make you live forever”), a study used in promotional materials could be inaccurate or misleading in many ways without being overtly fraudulent. A clinical trial may be poorly controlled, an observational study of side effects may be under-powered to detect an important drug risk, studies may be cherry-picked to feature only those with the most positive findings. There certainly are precedents for such activity in the pharmaceuticals sector.
The law already considers several aspects of medical care in a privileged manner: it determines who can practice, maintains very high standards for the privacy of medical records, and strictly enforces requirements for many aspects of clinical care. This makes sense, because the life-and-death consequences of excessive permissiveness are so substantial.
The existing restrictions on what companies can say in promoting their products do not restrict what physicians can prescribe. Once a drug is approved by the FDA, doctors can use it in any way we see fit. At issue is only the question of what manufacturers can say in promoting their products.
Lessons From The Past
Recent history provides a powerful caution about what could happen if companies were given more freedom to market their products for unapproved uses. In the last decade, nearly every major pharmaceutical company has been forced to pay substantial penalties or settlements for violation of off-label promotion standards, for a cumulative total exceeding $15 billion. One salient example illustrating this concern was the 2012 settlement by Johnson & Johnson for illegal promotion of its anti-psychotic drug Risperdal to treat elderly patients with dementia in nursing homes. It was not just that the drug is usually ineffective in these patients; it also increases the risk of death by about 60 percent, a warning that the FDA features prominently at the top of the drug’s official prescribing information.
We already have clear evidence of what would result from a looser standard of companies’ communications about their drug products. That was the situation that prevailed before 1962, when drug manufacturers were permitted to advertise products later found to be poorly effective, dangerous, or both. And one need look only as far as the magazines and television commercials of today to see what happens when regulatory restraints are lifted for another drug class, the so-called nutritional supplements. Because of bad legislation passed in the 1990s that took jurisdiction for these drugs out of the hands of the FDA, the airwaves and print media, as well as the Internet, are now saturated with implausible claims for products that have little factual basis. The country does not need the same level of miscommunication for a class of drugs that is dramatically more powerful.
Thus, the central question is not Central Hudson, the classical case-law definition that has been used to determine when it is acceptable to curtail commercial free speech. The real issue is whether we as a society feel that there is something special about human illness and its treatment that warrants a different legal status than promotional statements made about refrigerators.
As convinced as I am about this from the perspective of a clinician and drug researcher, I fear that I will be on the losing side of this battle. The rampant forces of commercial free speech zealotry that are working in the service of corporate empowerment are likely to win this battle. Paradoxically, patients’ rights to the best possible medical care will be diminished in the process.
Author’s Note
On March 8, it was announced that the FDA backed down from its position forbidding the maker of a prescription fish-oil product from promoting its product for unapproved uses. The company may now do so, despite the absence of compelling evidence that this use will benefit patients. It’s not just about the fish oil: this slimy development will lubricate the slippery slope of FDA’s sliding into less and less control over companies’ promotional claims. The end is near.
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