WHO director: Deregulating FDA would 'lower scientific standards'

Margaret Chan, director of the World Health Organization, on Wednesday warned against deregulating the Food and Drug Administration while speaking at a conference at the University of Washington in Seattle, reports STAT.


President Donald Trump has been very vocal about stripping down the FDA's approval process to bring drugs to the market faster and stimulate competition — a strategy Dr. Chan warns against.

"We must not let anything, including economic arguments or industry pressure, lower our scientific standards or compromise our integrity," said Dr. Chan. "This is an absolute duty."

She also encouraged politicians, the pharmaceutical industry and the public to not "forget the lessons of the thalidomide disaster," reports STAT.

Thalidomide was a morning sickness drug given to women in the late 1950s and early 1960s — a time when far less safety and efficacy data was required to approve a drug. While the FDA did not approve Thalidomide in the U.S., the drug caused serious birth defects for more than 10,000 children in 46 countries, according to the report.

"Regulatory agencies everywhere must resist the push to replace randomized clinical trials, long the gold standard for approving new drugs, with research summaries provided by pharmaceutical companies," Dr. Chan said. "As some argue, making this change would speed up regulatory approval, lower the costs to industry, and get more products on the market sooner. This kind of thinking is extremely dangerous."

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