On May 22, 2018, the U.S. House of Representatives enacted a controversial bill to allow sick people to circumvent the Food and Drug Administration (FDA) to get access to unapproved medicines. The House took up a Senate-passed “right to try” bill (S. 204) and passed it by a vote of 250 to 169.
S. 204 had languished for months, despite vocal support from the White House. The House in March passed a modified version of the legislation that found no traction in the Senate; so House leaders decided to move forward with the version the Senate had previously passed, culminating in this week’s vote.
FDA Commissioner Scott Gottlieb commented that he preferred the House version (H.R. 5247), as it would be easier in some ways for the FDA to administer. The FDA had significant input into the House-passed version of the bill. However, Gottlieb recently also expressed support for S. 204 as passed by the Senate, which will now be signed into law by President Donald Trump in the coming days.
The measure would apply to drugs and biological products that are not yet approved by FDA for commercial distribution, but that have successfully completed a Phase I clinical trial. A physician would have to certify that a patient has exhausted approved treatment options and cannot participate in a clinical trial involving the experimental drug. Patients would have to provide their doctors with written informed consent regarding the treatment.
The FDA has an Expanded Access program that allows patients to use unapproved, experimental drugs if certain conditions are met. The bill would allow for broader use of those drugs by not requiring the FDA to sign off on a treatment. However, drug companies would still have to agree to provide them.
The move to take action on Senator Ron Johnson’s (R-Wis.) bill (S. 204) reverses course for some House Republicans who had worked for months behind the scenes to narrow who could get unapproved drugs.
President Trump and Vice President Pence have been vocal supporters for “right to try” legislation. Trump gave an endorsement for the legislation during his speech on drug pricing May 11, and has been working with supporters in Congress to get the legislation into law.
Senator Johnson held up passage of the FDA’s user fee authorization to get his version of a bill passed in 2017.
There was little sign the Senate would take up the House-passed version of Johnson’s bill, so supporters in Congress and Trump himself renewed efforts to pass the Senate-passed version.
Supporters have said the bill offers “hope” to those facing serious illnesses, but critics warn it could create a loophole for doctors and drug makers who don’t want to follow safety procedures created by the FDA for giving people unapproved drugs.
Author: Patrick Cooney, President of The Federal Group, Inc.