Healthcare / Regulation

More Regulation is Not the Answer

In response to the deadly meningitis outbreak, attention has been cast on compounding pharmacies, as their product of steroid injections has produced 119 illnesses and 12 deaths. Compounding pharmacies are in business to provide specific prescriptions of drugs that are not available commercially. According to the FDA, these entities should only be mixing drugs on an individual basis, for instances when physicians need a certain substance omitted or added to better suit the patient. The special pharmacies can also help in the event of a drug shortage, which is a common reason used for their mass production. With the compounding industry making up 1-3% of the U.S. pharmaceutical market, they are licensed and regulated by State Boards of Pharmacy. So although the compounds are not subject to FDA approval, strong regulation exists on a smaller scale since the nature of the work is so situation specific. Standards are also set by the United States Pharmacopeia and accreditation is required by the Pharmacy Compounding Accreditation Board, with interests represented by the International Academy of Compounding Pharmacists.

With the growth of compounding pharmacies, Congress passed a law in 1997 that put compounded drugs under FDA jurisdiction, and banned advertisement. The constitutionality was questioned on the advertising ban, and the Supreme Court ruled in 2002 that this indeed was unallowable, yet the other provisions of the law including standards for production and labeling are still up for interpretation. In light of the recent public health emergency, Democratic Representatives Rosa DeLauro and Edward Markey have already called for a revaluation of the 1997 law, and stricter oversight power for the FDA to regulate the compounded medicines. Yet, is more regulatory burden the right solution for the problem? As always, liberal legislators have run to the easy fix of more rules, more oversight, more control. It is agreed that compounding pharmacies represent a sensitive industry with severe consequences, but limiting the companies’ mission to create drugs that better health is not the answer. The industry has indeed grown to create a need for significant attention and updated standards, but putting yet another responsibility on the FDA will not foster effective improvements.   Instead of adding more obstacles to pharmaceutical innovation, we should work to reform the existing state oversight, to create an environment for safer and improved products. Compounding pharmacies have become a crucial way to address patient centeredness, and it is important to continue the trend of finding new ways to adapt therapies for specific people.