Former Food and Drug Administration commissioner Andrew Von Eschenbach, who ran the agency from 2005 to 2009 and has now decamped to the conservative Manhattan Institute, had this advice for reforming the agency in this morning’s Wall Street Journal:
(Reform) means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.
Former Food and Drug Administration commissioner Andrew Von Eschenbach, who ran the agency from 2005 to 2009 and has now decamped to the conservative Manhattan Institute, had this advice for reforming the agency in this morning’s Wall Street Journal:
(Reform) means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.
Right. Give a drug industry that already fails to complete two-thirds of its mandated post-marketing trials a blank check to dump hundreds of unproven molecules on the market so that insurers, including Medicare, will have to pay for them. I’m surprised he didn’t also call for balancing the budget.
Now, to be fair, he also said that “the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.” In essence, he’s saying let’s abandon the gold-standard of double-blind, placebo-controlled clinical trials for determining efficacy, and substitute post-hoc epidemiological studies based on registry data.
I’m a big fan of registries. I believe their data can be used to determine efficacy. I look forward to the day when there are registries up and running for all the borderline drugs and devices that are already on the market; registries with the scope and controls that independent scientists agree are adequate for reaching conclusions about efficacy in a post-marketing setting. On that day, we can talk about extending such registries on a pilot basis to some experimental medicines that have passed their Phase I safety trials.