WHO Rebukes Trump’s FDA Critics. It’s Not a Question – It’s a Statement! | Pharma Industry Regulation | Scoop.it

The director of the World Health Organization issued a thinly veiled rebuke of critics suggesting that the Food and Drug Administration should be overhauled, including several candidates reported to be in consideration to head the agency (read “Who Is the Most “Fantastic” Person Trump Has in Mind to Lead the FDA?”; http://sco.lt/514yv3).

 

Speaking at a conference in Seattle on Wednesday, Dr. Margaret Chan warned against loosening the rules governing the safety and effectiveness data that drug companies must supply to win marketing approval from the FDA.

 

“We must not let anything, including economic arguments or industry pressure, lower our scientific standards or compromise our integrity. This is an absolute duty,” Chan said in a speech at the University of Washington. Her remarks were circulated by the WHO on Thursday.

 

The highest standards of scientific integrity must be applied, Chan insisted, warning that politicians, the pharmaceutical industry, and the public must not “forget the lessons of the thalidomide disaster” (read “Frances Kelsey Was No Hero, Says @DrBobGoldberg, the Donald Trump of #Pharma Bloggers”; http://sco.lt/6kfno9).

 

At the time, far less safety and efficacy data were required to bring a drug to market in the US. Despite that, the FDA did not approve the drug. However, more than 10,000 children from 46 countries were affected.

 

In the wake of the thalidomide episode, Congress approved the Kefauver Harris Amendment, a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It required drug companies to provide proof of the effectiveness and safety of their drugs in order to gain approval.

 

“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,” Chan said in her speech.