Insurance Litigation

New FDA Commissioner Sworn in – Can He Serve Two Masters?

Dr. Scott Gottlieb was sworn in to be the 23rd Commissioner of the U.S. Food and Drug Administration (FDA) on May 11, 2017.

He previously worked for the agency as a Deputy Commissioner for Medical and Scientific Affairs and, as a medical doctor, he’s been a senior advisor to the FDA commissioner.

Most recently he served as a Resident Fellow at the American Enterprise Institute (AEI), a conservative think tank based in Washington, D.C.

The AEI promotes limited government, individual responsibility and freedom for the leaders of capitalism.

Can Dr. Gottlieb serve two masters?

Dr. Gottlieb has written extensively about FDA policy and drug companies, the same ones he’s served as an advisor and the same ones he’s invested in through venture capital firms.

The Senate voted 57-to-42 to confirm Dr. Gottlieb, a narrow vote because of Dr. Gottlieb’s many ties to the drug companies he will be regulating.

He has promised to divest himself or, at the very least, recuse himself for one year from making any decisions concerning the companies he’s entangled with.

The fear is that Mr. Trump’s latest pick to head the FDA could undo decades of drug safeguards.

Echoing Mr. Trump’s push to bring major change to the way the FDA does business, would include accelerating the process of approving new prescription drugs.

Dr. Gottlieb has already written about the FDA’s “cumbersome drug approval process.”

Writing for the American Enterprise Institute, Dr. Gottlieb has argued that speeding the drug approval process would slow the rising cost of drugs by promoting competition between manufacturers.

Bringing drugs to market without the proper vetting is not what most Americans expect from their watchdog agency.

A Consumers Union poll found Americans want safer drug and medical device reviews, not quicker.

“Dr. Gottlieb is someone who has an unprecedented web of financial ties and conflicts of interest to the pharmaceutical industry,” said Dr. Michael Carome, director of the Public Citizen’s Health Research Group.

Mesh News Desk (MND) readers already know that 95% of medical devices get to market within about 90 days, so a fast-track clearance process is already in place for most medical device manufacturers.

It’s unclear if Dr. Gottlieb will replace Jeff Shuren, MD and JD, who heads the medical device division of the FDA. Regardless, Dr. Gottlieb will be his boss and his policies will serve as the direction for the agency.

Congress toughened the way drugs were approved after the Thalidomide crisis of the 1960’s. The drug was taken by pregnant women for nausea but led to severe birth defects.

After that debacle, the FDA was more mindful of the safety of food and drugs, not medical devices.

There is currently a presidential freeze on hiring at the FDA.

Drug industry leaders tell the New York Times, if drug companies want faster and new kinds of clinical trials approved, they need to fill the estimated 1,000 staff vacancies so decisions can be made more quickly.




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