House passes 'right-to-try' bill, sending it to President Trump's desk

congress
The FDA already approves 99% of requests to access unapproved treatments under its expanded access policies, sometimes called "compassionate use." (Roberto/temprb0)

The House voted 250-169 to pass a "right-to-try" bill that would allow terminally ill patients access to experimental drugs. The bill, approved by the Senate last August, is headed to the desk of President Donald Trump, who is expected to sign it into law.

The legislation would allow patients with life-threatening conditions to ask drugmakers for medicines that have not yet been FDA-approved but that have at least completed phase 1 testing. The patient must have run out of approved treatment options and must be unable to participate in a clinical trial of the experimental drug in question. The FDA's oversight would be rolled back as the patient would only need a physician and the drugmaker to sign off on the request.

Drugmakers are not obligated to provide the treatments: "No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug," the bill says.

"The administration believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physician," the White House said in a statement Monday.

The House debated—and failed—a different version of the bill in March, with 138 Democrats and two Republicans voting against it and preventing it from reaching the two-thirds majority it needed to move on.

Objections to that bill, as well as to the version that passed, were underpinned by the belief that it would have little effect on access to medicines, while making patients vulnerable to exploitation by unscrupulous doctors and drugmakers, who would have total control if the FDA were to be cut out of the process.

As it stands, the FDA already approves 99% of requests to access unapproved treatments under its expanded access policies, sometimes called "compassionate use."

INDUSTRY RESEARCH

Veeva 2019 Unified Clinical Operations Survey

Share your thoughts in this quick survey. The first 50 qualified respondents will receive a $5 Amazon gift card, and, in appreciation for your time, all qualified survey respondents will be entered in a drawing to win a $50 Amazon gift card.