“Slow and burdensome” is how President Donald Trump has described the Food and Drug Administration’s drug approval process. His promise to speed it up by slashing regulations raised major safety concerns among scientists, regulators, and patient groups. But speed and safety do not have to be at odds. Modern tests that are physiologically relevant to humans because they are based on human biology — not on the biology of other animals — offer scientists more predictive information more quickly. FDA should focus on evaluating these technologies and work with industry to ensure they are implemented.
Dr. Scott Gottlieb, the new FDA commissioner, addressed the false dichotomy of speed versus safety in his congressional confirmation hearing. Through advances in regulatory science, he said that “we can have our cake and eat it too.” Gottlieb also said that the FDA should consider anything that can make the drug development process more predictive, such as better tools to evaluate safety and effectiveness and to bring down cost.
Implementing new test methods and protocols to assess the safety and efficacy of new drugs is essential. More than 95 percent of new drugs fail in humans after passing preclinical in vitro and animal tests. There were 25 clinical trial failures in the first quarter of 2017 alone.
Just when I thought STAT newsletters might be a good source of information, I see you get suckered by an animal rights group like PCRM. Are you just another source of “alternative facts”? You should do this story again with a credible science writer policy specialist whose agenda is to advance science, not stop animal-based research. I was almost ready to buy STAT Plus, but not until you check your sources of material to make sure they have scientific credibility.
“Scientific credibility” is a matter of making solid arguments based on good sources—not a codeword for tribal loyalty. Baker’s analysis is sound, and you can check the links if you doubt her facts.