If It Ain’t Broke... But What if It Is?
BY JASON J. NICHOLS, OD, MPH, PHD, FAAO
As noted elsewhere in this issue, the U.S. Food and Drug Administration (FDA) recently approved the first new prescription medication for dry eye disease in ~13 years—ending the dry eye medical treatment drought. This isn’t because other companies have not tried to get medications approved for dry eye disease—they have. As practitioners, we have tremendous hope for this new treatment in helping alleviate dry eye, particularly when other therapies may not have worked in the past.
This is a good example that points to a regulatory system that is broken in many ways. The FDA is a federal agency of the U.S. Department of Health and Human Services (DHHS) and is empowered by the U.S. Congress to enforce the Federal Food, Drug and Cosmetic Act first passed in 1938. The act was passed as a result of mass poisonings around the world due to the use of diethylene glycol (a poisonous organic solvent) to solubilize sulfanilamide (an antibacterial). It is said that the FDA regulates more than $1 trillion of consumer goods on a budget of about $5 billion (much of which is generated from user fees).
Indeed, the FDA is charged with helping ensure the safety of our nation’s people relative to medical drugs and devices (in addition to food, dietary supplements, cosmetics, tobacco products, electromagnetic devices, and veterinary products). Among the medications it oversees, the FDA classifies drugs into three groups: new drugs, generic drugs, and over-the-counter drugs. In terms of approving new drugs, many would argue that the FDA has become far too conservative in doing so and tremendously bureaucratic at the same time.
So, how should such a government body balance these important functions? I recently read a very interesting article in the Wall Street Journal about this issue, which shared some perspectives as to how we might consider evolving drug and medical device approvals (http://blogs.wsj.com/experts/2016/06/29/its-time-to-radically-change-how-the-fda-approves-drugs/?mod=e2tw). In essence, the article argued that the FDA should continue to scrutinize drugs and devices via its thorough review process, but that the current “approve/not approve” system is archaic, leaving very little options for practitioners and patients who may benefit from unapproved drugs and devices otherwise. Rather, the author argued, the FDA should act more like Consumer Reports, with ratings for safety, efficacy, and degree of evidence for each compound or device.
This would leave practitioners (and patients) with more options and starting points in terms of their care—of course, shifting more responsibility and risk to them in making these decisions. While not perfect, I think that, in this data-driven era, a move along these lines could be of great benefit to the care of our patients.