US “right to try” legislation passes after initial defeat

pharmafile | March 22, 2018 | News story | Medical Communications, Research and Development, Sales and Marketing FDA, House of representatives, Right to try, US, pharma 

The controversial and much-discussed “right to try” bill has been passed in the US House of Representatives, quickly rebounding after an earlier vote last week which saw the legislation narrowly rejected.

The decision means that terminally ill patients can circumvent the FDA to request access to experimental therapies which have only passed Phase 1 trials, despite the fact that such a pathway already exists through the US regulator, and drug companies are still under no obligations to comply to the request under the new bill.

The legislation had a much easier time of passing this time around. In the previous vote, because it was rushed to the House floor through a fast-track procedure which did not allow for amendments, a two-thirds majority vote was required to score a win. However, in the most recent vote, only a straightforward majority was needed. In the end, the legislation passed with a vote of 267 to 149, easily passing the required threshold. Though the vote was mostly along party lines, 35 Democrats voted in favour of the bill while two Republicans opposed it.

It is a victory for prominent supporters of the legislation, which include the Koch Brothers and libertarian think tank the Goldwater Institute, which has been instrumental in securing versions of the legislation in 38 states so far, in addition to being accused of pushing an anti-regulatory agenda to weaken the authority of the FDA.

Given the debate over the legislation’s true efficacy in actually helping patients, it’s a victory that is seen by some as more symbolic than anything else, and could be the first major step on a longer journey.

“I think this is the first step, for sure. Tear down as many regulations as possible, take away all oversight, and let it be the Wild West of medicine,” remarked Andrew McFadyen, Executive Director of the Isaac Foundation, a rare disease patient organisation. “Republicans know this doesn’t give access to patients. But they opened the door to Koch brothers and Goldwater to rip apart the FDA, and then other government bodies after that.”

The next stop for the bill is the Senate, where it was originally cleared in an earlier draft form, which has since been amended to better protect patient safety and encourage the involvement of drug firms. While the office of Senate Majority leader Mitch McConnell did not comment on the likelihood that the bill will passed, it is widely expected to do so, though it is not known when. The hope of supporters is that it will swiftly reach the desk of President Trump, who has strongly backed the legislation in his public appearances, most notably his State of the Union address at the end of January.

Matt Fellows

Related Content

FDA approves ANDA of 20mg generic Nitisinone capsules

Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has …

FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has …

Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) …

Latest content