Fifteen Americans have already died from of fungal meningitis from tainted steroid injections in the past two weeks, and over 200 more have been infected. Amidst calls for more regulation from politicians, former Federal Drug Administration (FDA) official and AEI scholar Scott Gottlieb, MD, explains in a just-published piece what can–and should—be done by the FDA.
Gottlieb points out:
- Need new laws? Members of Congress are calling for tighter controls over compounding pharmacies. New laws merit consideration, but we also need to better enforce existing rules and address issues that have created shortages of FDA-approved versions of these medicine.
- Nudged towards compounding: Among the first policy issues that should be scrutinized is a recent tightening of oversight of the manufacturing of generic versions of sterile injectable drugs. This tightening was rooted in some legitimate concerns that the Food and Drug Administration had about the reliability of the manufacturing facilities. But it has prompted shortages of these drugs. In some cases, the shortages have forced doctors to seek these drugs from more lightly regulated compounding pharmacies.
- Cost v. Quality: At the same time, the administration has created a contradictory set of policies that has diluted the regulatory authority required to ensure the safety of these compounded medicines. On the one hand, the compounded drugs have been favored for their lower costs, even as there was occasional concern about the drug quality.
Scott Gottlieb is is a practicing physician and resident fellow at the American Enterprise Institute. He served in several senior positions at the FDA and as a senior adviser at the Centers for Medicare and Medicaid Services. He is available for interviews and can be reached at [email protected]
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