Standards at the US Food and Drug Administration are being rolled back, Vox writes, with the passage of the 21st Century Cures Act, which is to be signed into law by President Barack Obama.
Vox's Julia Belluz notes that the bill alters the level of evidence FDA requires to approve a drug for a new indication or for post-market review. The bill urges the agency to accept 'real-world evidence' such as observational studies from drug companies that Belluz says won't be as rigorous as data from randomized clinical trials. In addition, she says it allows FDA reviewers to rely solely on "summary-level reviews" from drug companies when making these decisions.
"It's a lower level of evidence than the gold standard, which is randomized controlled trial," the Public Citizen's Health Research Group's Michael Carome tells her. "Real world evidence is easier to do, less expensive, less onerous. It's easy for that type of research to be designed in a way that leads to biased results."
The move is to speed up the pace of drug approvals, Belluz says, adding that critics are also concerned that the agency's oversight will only continue to weaken as President-elect Donald Trump has expressed support for increased deregulation. His current top contender to lead FDA, Jim O'Neill, has called for the agency to allow all drugs that pass safety, though not efficacy, testing on the market.