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Friday, March 29, 2024

US Congress confirms new drug regulator chief

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US cardiologist and scientist Robert Califf was narrowly confirmed Tuesday as commissioner of the Food and Drug Administration, despite opposition from Democrats who accused him of contributing to the country’s opioid crisis.

Califf, who briefly headed the agency under former president Barack Obama “has the experience and expertise” to lead “during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” said a White House statement at the time of his nomination. 

The FDA is responsible for regulating human and veterinary drugs, biological products and medical devices, as well as the safety of food, cosmetics and radiation-emitting products. 

Its drug review process, which has taken on a new level of visibility during Covid-19, is considered the global gold standard.

The position had been vacant for the past year, with the role of leadership falling to acting commissioner Janet Woodcock, a career official.

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Califf won a tight 50-46 vote in the Senate, with independent Senator Bernie Sanders and four Democrats including Joe Manchin of West Virginia, a state hard hit by opioid overdoses, against confirmation.

Manchin accused Califf of stoking the opioid epidemic because of his approval of a number of the drugs during his last tenure as commissioner, and expressed “extreme disbelief and disappointment” in the outcome of the vote.

More than a million Americans have died from drug overdoses since the late 1990s, when the pharmaceutical industry and health care providers began to market and prescribe pain-killing opioid drugs aggressively.

The liberal wing of the Democratic party was also leery of his close ties with the pharmaceutical industry.

Six Republicans however crossed the aisle to vote in his favor, including former presidential candidate Mitt Romney.

Most Republicans voted against, with the anti-abortion Susan B Anthony List expressing alarm at Califf overseeing an easing of restrictions around medical abortion during his last tenure.

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