Gottlieb advises FDA after steroid infection scandal

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.

Read the full piece here

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]

For media requests please contact [email protected] or 202.862.5829.

Also Visit
AEIdeas Blog The American Magazine
About the Author

 

Scott
Gottlieb

What's new on AEI

To secure southern border, US must lead international effort to stabilize Central America
image The Ryan pro-work, anti-poverty plan: Thomas Aquinas 1, Ayn Rand 0
image Does SNAP support work? Yes and no
image Obama Democrats lose their big bet on health exchanges
AEI on Facebook
Events Calendar
  • 28
    MON
  • 29
    TUE
  • 30
    WED
  • 31
    THU
  • 01
    FRI
Tuesday, July 29, 2014 | 10:00 a.m. – 12:00 p.m.
Is Medicare’s future secure? The 2014 Trustees Report

Please join AEI as the chief actuary for Medicare summarizes the report’s results, followed by a panel discussion of what those spending trends are likely to mean for seniors, taxpayers, the health industry, and federal policy.

Friday, August 01, 2014 | 10:30 a.m. – 12:00 p.m.
Watergate revisited: The reforms and the reality, 40 years later

Please join us as four of Washington’s most distinguished political observers will revisit the Watergate hearings and discuss reforms that followed.

No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled today.
No events scheduled this day.