Compounding a crisis

In the past two weeks, 15 Americans have died of fungal meningitis and more than 200 have become infected from tainted steroid injections they received to treat problems with their spines. The "compounding" pharmacy responsible for distributing the contaminated steroid shipped nearly 18,000 vials of the product to 75 facilities in 23 states, so that many more people could have been exposed to the fungal contaminant.

Federal health agencies are rightly focused on recalling the drugs, and members of Congress are already calling for new laws with tighter controls over compounding pharmacies. New laws merit consideration, but so do existing rules that are not being enforced and policies that are driving more widespread use of these compounded products.

Among the first policy issues that should be scrutinized is the Obama administration's 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 (FDA) 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 medicines from compounding pharmacies, which are less regulated than the generic drug firms. 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.

Read the full text of this article at American.com.

 

 

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About the Author

 

Scott
Gottlieb
  • Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services. 

    Click here to read Scott’s Medical Innovation blog.


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