he 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.
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.”
The drug, used to combat the morning sickness that sometimes accompanies pregnancy, caused catastrophic birth defects in children born to women who used it in the late 1950s and early 1960s.
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.
“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.”
At least two of the rumored candidates for FDA commissioner have advanced nontraditional views on how the regulatory agency should approve drugs.
Jim O’Neill, a staunch libertarian who is not a physician, has called for discarding the requirement that new medicines be shown to be effective before they are given FDA approval. O’Neill has suggested undue regulation by the FDA “kills people” and hurts the economy.
He has also suggested the FDA should only require pharmaceutical companies to prove that a drug is safe before clearing its way to the market.
Another reported candidate, Dr. Joseph Gulfo, has dismissed that idea as a way to sell “safe snake oil.”
But Gulfo has argued the FDA should adopt a tiered approval system that would allow some drugs to make it to market even if they haven’t shown that they change the long-term health outcomes of people taking them.
Gulfo, who is currently executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, suggests the regulatory agency should consider whether drugs lead to positive trends in biomarkers linked to diseases.