‘Right To Try’ Measure Loosening Experimental Drug Access Sails Through House On Second Attempt

The New York Times: House Passes Bill That Would Give Patients Access To Experimental Drugs
The House, spurred on by President Trump, passed a bill on Wednesday that would give patients with terminal illnesses a right to try unproven experimental treatments. The measure, which was approved by a vote of 267 to 149, appears to have a good chance of becoming law. The Senate approved a similar proposal last year. (Pear, 3/21)

The Washington Post: House Approves ‘Right-To-Try’ Bill Giving Seriously Ill Patients Access To Experimental Drugs
The legislation failed March 13 after Republicans brought it to the floor under suspension of the rules, an approach typically reserved for noncontroversial bills that requires two-thirds support for passage. The vote was 259 to 140, prompting the Wall Street Journal’s GOP-friendly editorial board to blame Republicans for “political malpractice.” Wednesday’s vote required only a simple majority for passage. The bill now needs approval from the Senate, which passed its own “right-to-try” legislation over the summer by unanimous consent. Thirty-eight states have approved similar measures, according to a national “right-to-try” advocacy group. (Viebeck, 3/21)

The Wall Street Journal: House Passes Bill Giving The Terminally Ill Easier Access To Unproven Drugs
Proponents say the bill is necessary because desperately ill patients need help getting investigatory drugs. But critics say the measure could undermine clinical research into new prescription drugs. They also point to FDA data that show the regulator already approves more than 99% of such requests. The Senate version of the legislation carried a broad definition of which patients could qualify for such unproven drugs. It would allow access by a patient “diagnosed with a life-threatening disease or condition.” Critics of the legislation contend such language could potentially jeopardize much of FDA law by allowing unapproved drugs for non-terminal disease. (Burton, 3/21)

Politico: House Passes Right-To-Try On Second Try
With a final law all but assured, health policy advocates who have vigorously opposed the idea are now looking toward the broader anti-regulatory health agenda being pushed by the Goldwater Institute. Arizona-based Goldwater has a handful of other ideas that could dramatically weaken the authority of the FDA to oversee the safety and effectiveness of medicines and has already made progress getting one of those ideas — giving drug companies more freedom to market their products — on state lawmakers' agenda. Goldwater spearheaded passage of a law in Arizona's legislature last year that allows companies to promote non-FDA-approved uses of their products to doctors without fear of repercussions by state officials. It helped get similar bills introduced in Colorado and Missouri's legislative sessions this year and expects other states to follow suit soon. (Karlin-Smith, 3/21)

Stat: House Approves 'Right-To-Try' Bill, Sending Legislation To Senate
It’s not clear what’s next for the legislation, which has been a priority for President Trump and Vice President Mike Pence. The Senate unanimously passed a broader right-to-try bill last fall, but did so largely to satisfy the demands of the bill’s sponsor, Sen. Ron Johnson (R-Wis.) as he held up another priority law. A single senator could similarly choose to block or hold up consideration of the now House-passed bill. (Mershon, 3/21)

The Hill: House Passes 'Right To Try' Drug Bill
Opponents of the bill also point to the FDA’s compassionate use program, saying the agency approves 99 percent of requests to let a patient use an experimental drug. They argue the legislation provides “false hope,” as drug manufacturers aren’t required to provide the drug to patients who ask. (Roubein, 3/21)