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Last Updated : Jun 28, 2019 05:51 PM IST | Source: Moneycontrol.com

Why revolving door at USFDA raises ethical concerns?

A revolving door is a practice where people in highly influential positions in the government move to jobs in the private sector and vice-versa.

Viswanath Pilla @viswanath_pilla
 
 
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US-based drug giant Pfizer on June 27 announced the appointment of Scott Gottlieb to its Board of Directors with immediate effect.

Gottlieb will also be part of Pfizer board's crucial Regulatory and Compliance Committee and the Science and Technology Committee that will oversee company's status of compliance with laws, regulations, and internal procedures and also reviews management's direction and investment in the company's pharmaceutical research.

Analysts said getting Gottlieb on board is a big catch for Pfizer.

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"I am proud of the affiliation. I have never been shy about my belief that America has the best biopharmaceutical sector in the world," said Gottlieb.

If this would have been any other person, people wouldn't have batted an eyelid, but given the person named was Gottlieb, who stepped down in April as USFDA Commissioner there was lot of flurry on social media, where people started raising ethical questions on the so-called revolving door practice at USFDA.

Revolving door

A revolving door is a practice where people in highly influential positions in the government move to jobs in the private sector and vice-versa.

To be sure, Gottlieb isn't the first high profile USFDA bureaucrat to enter industry, and he is not serving the industry for the first time.

In fact the revolving door between USFDA and Big Pharma is well documented.

Two researchers - Dr. Vinay Prasad and his colleague Dr. Jeffrey Bien at the Oregon Health & Science University - have analysed in a study published in BMJ in September 2016, about the issue of revolving door between USFDA and industry.

The researchers tracked 55 USFDA reviewers in the narrow hematology-oncology field from 2001 through 2010, and found that of the 26 reviewers who left the FDA during this period, 15 of them, or 57 percent, later worked or consulted for the industry.

The big reason for USFDA staffers leave for industry is money.

Media reports say Gottlieb may possible paid multiples of his USFDA earning, which was around $150,000 a year.

The second one is having USFDA former staffer on its side, will help companies to guide applications and get a wind of the agency's direction.

The USFDA maintains that it has sufficient safeguard to protect public from any conflict of interest.

Concerns

The developments at USFDA, not just affects US, but goes beyond borders.

Despite its own flaws, USFDA is more or less accepted as the gold standard of drug regulation in the world.

Most drug regulators and physicians who prescribe medicines, take comfort of a USFDA approval of a particular drug.

The revolving door practice at highest levels raises conflict of interest and other ethical concerns.

The New York Times taking a strong view compared revolving door to "appointing the fox to guard the henhouse".

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First Published on Jun 28, 2019 04:38 pm
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