The result is a "predicate creep," the report said, in which devices are approved based on information from older devices that often bear little resemblance to each other.
One contentious provision, for example, directs the FDA to assess whether new drug uses, or indications, could be approved based on "real-world evidence", such as observational studies.
Will the agency have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up studies?
While there is no evidence that any of the drugs stem the underlying disease, they were approved based on studies showing temporary improvement or stabilization in some patients with Alzheimer's.
Schumer also cited the case of an African-American woman who filed suit after being denied a home-equity loan, even after the loan application was conditionally approved based on her credit report.
But Comcast was confident that its merger with Time Warner would be easily approved, based on the argument that the two companies have a fundamentally different relationship than similarly large companies in other industries.
In 1936, a docudrama called "I Was a Captive of Nazi Germany" was reluctantly approved — "based solely," according to Breen, "upon the picture's technical conformity to the Production Code" — but it had trouble getting distribution.
Avastin had been approved based on a trial that showed it delayed the worsening of tumors by 5.5 months — almost as big a gain as seen now with pertuzumab.
One of the earliest materials, Mr. Mulley said, was a product called Thermo-lag, which the commission approved based on what turned out to be fraudulent lab tests submitted by an obscure company.
"However, per the FDA definition, it is approved based on evidence of safety and probable benefit".
