Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come.
Early 2017 has been one of the most interesting and challenging times for anyone concerned with medication regulation and evidence-based prescribing — as well as for the patients and health care professionals who will be so heavily impacted recent policy changes.
The 21st Century Cures Act
In December 2016, Congress passed and then-President Obama signed the “21st Century Cures Act.” Its numerous sections relating to drug regulation offered a flawed solution to a problem that doesn’t really exist — the idea that the U.S. Food and Drug Administration is very slow in making its drug approval decisions, and has unreasonably high standards for approval. As a result of these failings, the reasoning goes, Americans are being denied timely access to needed drugs, and have to pay more for them once they are approved.
Fortunately for all of us, that isn’t even close to the truth. The FDA’s evaluation times are among the fastest on earth, and the agency can turn around an approval decision within as little as six months. Further, its rate of approval is very high, and for years the agency has supported the idea that drug-induced changes measured solely by a laboratory test can be sufficient grounds for approving a new medication, rather than requiring that the new drug demonstrate an improvement in patients’ clinical outcomes.
Nonetheless, in response to the pharmaceutical industry lobby and many patient groups, Congress passed the law encouraging FDA to widen its reliance on improvements in laboratory tests, imaging studies, or other “surrogate measures” as a sufficient basis to speed the approval of new medications, instead of demanding clinical trial evidence of the drug’s impact on study subjects’ health. If embraced fully by the agency, this could well result in its approving drugs simply on the basis that they have modest effects on such biomarkers, while benefitting patients minimally or not at all.
Marketing Claims, Right-To-Try, And Other Challenges To Look Out For In 2017
Meanwhile, FDA’s authority over what statements drug companies can make in promoting their products is being eroded in the courts, through First Amendment challenges arguing that marketing claims by drug manufacturers constitute a kind of “commercial free speech” that the government must not limit. These cases, making their way through the federal court system for several years, supported by the drug industry and libertarian “action tanks,” had developed serious momentum even before the November election.
A new FDA Commissioner will soon be dropped into this swirling mix of counter-regulatory fervor and the new administration’s overall anti-government animus. Fittingly, the current nominee, Scott Gottlieb, once argued in an op-ed for The Wall Street Journal that the agency is a key barrier keeping much-needed drugs and medical devices from Americans. Meanwhile, in state legislatures throughout the nation, advocacy groups have been attacking FDA’s legitimacy at the local level by demanding the adoption of “right-to-try” laws, which would enable severely ill patients to use medications that have not been approved (or even fully evaluated) by the FDA. As it turns out, the government is not usually the main barrier to accessing such untested drugs. FDA is almost always open to approving these requests; it’s usually the manufacturers themselves who are reluctant to make such products available.
There is some good news dotting this otherwise depressing landscape. To combat the erosion of drug approval standards and the likely lifting of limits on pharmaceutical companies’ promotional statements, there is growing interest in programs that provide evidence-based counterweights to these deficits. Prominent among these is “academic detailing,” an approach in which university-based physicians synthesize the best available evidence on medication benefits, risks, and economic value, format it in an engaging and clinically relevant manner, and then “market” it interactively to practicing physicians in their offices, much as pharmaceutical sales reps have done for decades to increase sales of their companies’ products.
These programs are generally funded by health care systems or governments, with the goal of reclaiming the informational space about prescription drugs, rather than allowing the discourse to be dominated by companies whose main goal is simply to maximize their own revenues. I first began developing and evaluating this approach in the 1980s; it has now been shown to improve medication use in over 100 randomized controlled trials of its effectiveness. (I currently serve as an unpaid volunteer in this work with the non-profit Alosa Health organization in Boston.)
As we witness the ongoing degradation of public-sector control over how drugs are approved and then promoted, such non-commercial programs are likely to prove increasingly useful in restoring the role of solid science in the informing prescription drug use decisions, whatever happens in our increasingly worrisome political environment.
