New bills proposed in the US aim to give terminally ill patients better access to experimental treatments not yet approved by the Food and Drug Administration. A right-to-try bill in the House of Representatives failed to get the votes it needed to pass as fast-track legislation, though it was passed the following week in a 267-to-149 vote. The bill is now before the Senate.
But, the New York Times writes that the bills don't actually address the stumbling block, which is often the drug companies themselves. Proponents of right-to-try laws say that removing the step in which the companies ask FDA for permission will speed the process up, though the Times notes the FDA approves about 99 percent of applications it gets for compassionate use of an unapproved treatment. Meanwhile, it says that companies have a number of reasons to limit access, including because they might not have enough of the therapeutic and because it might not work.
Some companies tell the Times they'd still seek FDA permission even if the bill becomes law.
"In our view, the FDA plays a really important role," Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, tells it. She notes the agency has "information that we don't have necessarily; they see safety and efficacy information on products that may be similar."