GOP senator presses FDA on 'right to try' implementation

GOP senator presses FDA on 'right to try' implementation
© Greg Nash

The Republican author of the new “right to try” law is calling on the Food and Drug Administration to enforce it as written.

In a letter sent Thursday to the FDA, Sen. Ron JohnsonRonald (Ron) Harold JohnsonKavanaugh, accuser to testify publicly on Monday Kavanaugh furor intensifies as calls for new testimony grow House panel advances DHS cyber vulnerabilities bills MORE (R-Wis.) said the right to try law “intends to diminish the FDA’s power over people’s lives, not increase it.”

Johnson was the primary author of the bill, which was signed into law by President TrumpDonald John TrumpTrump rallies in Nevada amid Supreme Court flurry: 'We're gonna get Brett' Trump: 'Good news' that Obama is campaigning again Trump boosts Heller, hammers 'Wacky Jacky' opponent in Nevada MORE Wednesday.

The law is intended to let terminally ill patients request access to drugs the FDA hasn’t yet approved without going through the agency.

Patients can request the drugs from manufacturers if the medicine has gone through a small-scale clinical trial and is still under FDA consideration.

FDA Commissioner Scott Gottlieb has not spoken against the law, but Johnson took issue with some of his recent comments and statements.

On Wednesday, Gottlieb in a statement said FDA stands ready to implement the legislation “in a way that achieves Congress’ intent to promote access and protect patients.”

Johnson also pointed to a recent news article where Gottlieb was quoted saying the agency may need to write guidance or regulation in order to best achieve the goals of the law.

“Given your comments, and as the law’s primary author, I would like to make this legislation’s intent absolutely clear,” Johnson wrote. “It is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments. “

Johnson said the law “gives patients with a life-threatening condition ... a right to hope.”

The law was opposed by most House Democrats and many public health advocates.

They argue it will put patients in danger and will give many a false hope about chances of a successful treatment, since drugmakers aren’t actually required to give unapproved medicines to patients who ask for them.