FDA Overreach? Treating your cells as drugs

In today's Wall Street Journal, American Enterprise Institute (AEI) resident fellow and former Food and Drug Administration (FDA) deputy commissioner Scott Gottlieb, MD explains that the FDA's attempt to regulate cells as drugs could halt one of the most promising areas of medical research.


Gottlieb explains:

  • FDA wants to regulate cells: "At issue are cells taken from our own bodies and then re-implanted with the purpose of treating medical problems. The most inspiring work involves adult stem cells, although the court's ruling in principle extends FDA oversight into things as common as in-vitro fertilization--basically turning reproductive cells into "drugs" under the law." Two weeks ago, a United States District Court ruled that adult stem cells are drugs, and thus subject to FDA regulation.
  • FDA regulations hamper unique procedures: "Doctors will now try to convert procedures into products that can fit FDA's regulatory rubric….Not every cell procedure will lend itself to this sort of revision. How, for instance, would you run a large-scale, randomized trial and ensure consistency from one use of a drug to another, where the "drug" is really a medical procedure that must vary from one patient to the next because it involves their own unique cells?"
  • Pushing innovation outside of the Untied States: The company involved in the court case, Regenerative Sciences, has moved some labs to the Cayman Islands. Most of the adult stem cell science research is being done in Britain, Singapore, and Israel "precisely because of the FDA's bent to hold with misgiving anything novel in medicine."



"The FDA is perennially complaining to Congress that it lacks the resources to do its day job of regulating products that fall squarely in its purview. Yet in chorus, the agency is always seeking novel authority to insert itself into new areas of science where its mandate is shaky…[this goal] can be deadly when it comes to the agency's impulse to regulate, and thus forestall, cell therapies used to help repair damaged body parts."


Scott Gottlieb is a practicing physician and resident fellow at the American Enterprise Institute. He was deputy commissioner of the FDA and a senior adviser at the Centers for Medicare and Medicaid Services. He can be reached at [email protected].


For additional help, other media inquiries, or to reserve AEI's in-house TV studio or ISDN facilities, please contact:


TV Jesse Blumenthal [email protected] / 202.862.4870


Radio Michael Pratt [email protected] / 202.862.5823


Print or Web Jesse Blumenthal [email protected] / 202.862.4870, Michael Pratt at [email protected] / 202.862.5823, or Veronique Rodman at [email protected] / 202.862.4871


Follow @AEInews

Also Visit
AEIdeas Blog The American Magazine
About the Author

 

Scott
Gottlieb

What's new on AEI

Defeating ISIS: AEI experts weigh-in before the president’s address on Wednesday
image Degrading, defeating, and destroying the Islamic State
image Wealth Building Home Loan: Building wealth through homeownership and retirement savings
image The $3 iPhone
AEI on Facebook
Events Calendar
  • 15
    MON
  • 16
    TUE
  • 17
    WED
  • 18
    THU
  • 19
    FRI
Tuesday, September 16, 2014 | 5:00 p.m. – 6:00 p.m.
The Constitution as political theory

Please join us for the third-annual Walter Berns Constitution Day Lecture as James Ceasar, Harry F. Byrd Professor of Politics at the University of Virginia, explores some of the Constitution’s most significant contributions to political theory, focusing on themes that have been largely unexamined in current scholarship.

Wednesday, September 17, 2014 | 8:10 a.m. – Thursday, September 18, 2014 | 1:30 p.m.
Third international conference on housing risk: New risk measures and their applications

We invite you to join us for this year’s international conference on housing risk — cosponsored by the Collateral Risk Network and AEI International Center on Housing Risk — which will focus on new mortgage and collateral risk measures and their applications.

Event Registration is Closed
Thursday, September 18, 2014 | 2:15 p.m. – 3:00 p.m.
Speaker of the House John Boehner on resetting America’s economic foundation

Please join us as Speaker John Boehner (R-OH) delivers his five-point policy vision to reset America’s economy.

Event Registration is Closed
Friday, September 19, 2014 | 9:15 a.m. – 11:00 a.m.
Reforming Medicare: What does the public think?

Please join us as a panel of distinguished experts explore the implications of the report and the consumer role in shaping the future of Medicare.

Event Registration is Closed
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.