Next time your doctor writes you a prescription, ask about the drug labeling rules. They are so arcane that most doctors will mumble and demur, but your doctor is not to blame — the Food and Drug Administration’s antiquated communication rules are. These rules keep doctors from learning factual data about how medicines should be used, deprive insurance
These rules keep doctors from learning factual data about how medicines should be used, deprive insurance companies of understanding the value of new drugs, and make it harder to link drugs’ prescribed usage with recommended practice guidelines from medical experts. More importantly, the current system can keep patient’s experiences with using the drug from being included in the FDA-blessed package inserts. Why is this important? Because in an era of instantaneously available information about how and when to use everything from cars to drones, we can do better in talking about medicines. Yes, drugs are different, but not that different.
The FDA’s rules on what can be said about a prescription medicine were written 40-plus years ago — before the internet, before the Supreme Court fully recognized the First Amendment’s applicability to commercial speech, and back when third parties such as payors and pharmacy benefit managers played a minimal role or had not yet begun to need data about the on- and off-label uses of drugs. It is time for the FDA to modernize their rules to match current realities.
But change may be in the offing — recent court cases all but mandate the FDA to change rules in this area for constitutional reasons, and the new FDA Commissioner, Scott Gottlieb (a known reformer on these topics), has the smarts, drive, and support to improve the way stakeholders can talk about drug labelling. As a result, he is in a unique position to make drug labeling sensible and advance public health in the process.
Today, doctors are drowning in data about treatments, from clinical trials and other studies published in medical journals to treatment guidelines and protocols from leading professional societies. The physical limits of a 24-hour day combined with the pressures of modern medical practice make it virtually impossible for prescribers to keep up with the flow of new information. In addition, current communications rules make it difficult for doctors to know how, when, and whether to use drugs and biologics. They need clinical trial insights that are integrated with the practical, useful information from medical professional colleagues who study diseases and how best to treat them in clinical settings. Patients need to know more about therapies so they can adhere to them properly. Studies estimate that non-adherence to drug regimes, suboptimal prescribing, drug administration, and diagnosis could result in as much as $290 billion per year in avoidable medical spending.
The FDA often stands in the way of doctors and patients having the most relevant information because it has taken the narrow view that companies who sell drugs may only communicate data which are based on rigorous clinical trials. This discourages manufacturers from sharing equally-relevant information based on other types of investigations, such as real-world usage analyses and economic studies. The current FDA rules impede conversations between drug developers and insurance companies trying to establish mechanisms to pay for drugs according to their performance and value, rather than the volume sold. The problem is particularly acute when parties are discussing uses that are not yet FDA-approved. Lastly, the current rules prevent manufacturers from sharing with doctors information about how patients who have used the drug in real-world settings have fared. These “patient-reported outcomes” are worth collecting and using in the process of guiding medical practice — after all, if doctors are ultimately trying to serve patients, what is more important to patients than their own actual experience of a therapy?
The FDA has legitimate reasons to be cautious about permitted communications. The Food and Drug Act of 1906 created the FDA to deal with quack medicines and demonstrably false claims made by (literal) snake oil salesmen selling (actual) snake oil. Given its genesis, the modern FDA knows two important things about drug communications: 1. Left unregulated, charlatans will prey on the sick and unsuspecting, and 2. If unproven medicines can be commercially marketed, their manufacturers will avoid submitting them to FDA scrutiny to establish that they are safe and effective.
Although these are compelling reasons to regulate communications, the FDA has put a virtual stranglehold on the dissemination of useful, truthful clinical information that hampers both patient care and cost control efforts. Until now, the FDA’s strategy has been to conduct a protracted trench war in court to keep their old rules in place, but a long string of losses on First Amendment grounds means that it is only a matter of time before they will need a new strategy. Fortunately, there are better ways to both minimize adverse consequences and control medical marketing, and the new FDA Commissioner Gottlieb sees drug communications in a unique way and is likely to change the rules. Here’s how:
First, join the call of former FDA Commissioner Califf for a strong and privately enforceable set of standards on medical marketing by companies, agencies, journals and purchasers. The powerful pharmaceutical industry trade association — PhRMA — has shown that it can be an effective “naming and shaming” forum to point out and discourage false claims. Second, the FDA should work with professional associations representing medical specialty societies so that practice guidelines—even those that refer to “off label” uses—can be linked to product communications when done accurately, professionally and appropriately. Third, the FDA should advance an existing agenda item from the federal user fee law that requires more attention to the role of patients in drug development by securing their impact in how the product is being used and understood by patients. On this score, the FDA can adopt guidance documents on patient-reported outcomes and inclusion — when based on sound science — of more data about the patient experience of a drug regimen. Lastly, the FDA can permit serious, professional, fact- and science-based conversations between drug developers and insurers before a product is approved so that contracts can be developed that facilitate lower drug expenditures by paying for value.
With these changes, FDA’s Gottlieb can turn the page on a vexing policy issue that has been treated too long as a zero-sum game. Information that can be shared about drugs must be based on sound science and be truthful. Useful information that is based on competent and reliable scientific evidence, a standard followed by the Federal Trade Commission, should be eligible for inclusion on a drug. The competent and reliable standard also is more consistent with First Amendment jurisprudence.
Patients and their doctors need more than litigation and posturing. They deserve solutions that improve outcomes by providing better guidance for doctors based on professional practice guidelines, more evidence about patient experiences to support better compliance and adherence, and economic data about new drugs’ health care value.
David Beier is a senior fellow and advisory board Mmember of the Schaeffer Center for Health Policy and Economics at the University of Southern California.
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