Legislation purporting to grant terminally-ill Americans easier access to unapproved therapies cleared the Senate on Thursday, despite concerns that it could lead to unsafe drugs creeping onto the market.
The upper chamber unanimously approved of the FDA Reauthorization Act, including an amendment that contained Sen. Ron Johnson’s (R-Wisc.) “Right to Try” law.
Similar laws have already been passed in 37 states, allowing those facing life-threatening illnesses to use medication that hasn’t been approved by the Food and Drug Administration. The laws stipulate that the therapies must have already been tested on humans and are currently being evaluated by the FDA, and that the patient has exhausted all other options.
The measure approved by the Senate Thursday would expand right-to-try to all 50 states.
Worrisome to public health advocates and medical researchers, however, is language in the law that would also hamstring FDA efforts to monitor the safety of experimental drugs that could eventually hit the approved market.
It states that any outcome of an experimental therapy conducted under this law—including the patient dying from the drug or device—cannot be used by the FDA later to adversely impact the approval of the drug.
Even drug manufacturers were wary of the oversight blind spot created by the legislation. Their primary interest group, the Pharmaceutical Research and Manufacturers of America, issued a statement in March saying: “any legislation should protect the integrity of clinical trials and the FDA oversight of expanded access to maintain the best interests of patients.”
The Washington Post reported that terminally-ill patients already have little trouble accessing experimental therapies, supporting arguments by opponents of the legislation who say that it is unnecessary, and is being used to weaken FDA oversight.
The paper noted that, in 2016, “99 percent of the almost 1,800 requests were approved, many in just hours or days.” In the more than three dozen states where the law has already been implemented, it has almost never been invoked by a patient seeking non-approved care.
Politico reported that Sen. Johnson threatened to hold up reauthorization of user fees paid by industries to the FDA, in order to get his right-to-try law passed. He managed to get unanimous consent to have it added as an amendment to the FDA reauthorization bill, which was then approved by the chamber in a 94-1 vote.
A companion bill introduced by Rep. Andy Biggs (R-Ariz.) is being considered in the House.
