1:36 PM
Mar 12, 2018
 |  BC Extra  |  Politics & Policy

House to vote Tuesday on right-to-try bill

The U.S. House of Representatives will vote Tuesday on its right-to-try legislation, a revised version of a bill passed by the Senate in August 2017. Both bills seek to authorize using investigational treatments for terminally ill patients (see BioCentury Extra, Aug. 3, 2017).

The House's bill narrows the scope to patients with a "stage of a disease or condition in which there is a reasonable likelihood that death will occur in a matter of months," adopting language FDA Commissioner Scott Gottlieb recommended in a written statement at a House Energy & Commerce Committee meeting in October. It also proposes eligibility for patients with "a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death" (see BioCentury Extra, Oct. 2, 2017).

The Senate bill -- the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (S. 204) -- described patients with a "life-threatening disease or condition" as eligible.

While both bills stipulate that sponsors submit annual usage and adverse event reports to the HHS Secretary, the House bill further requires sponsors to include any suspected serious adverse events and to notify the HHS Secretary within seven days of providing the investigational drug. The House bill also requires physicians to "immediately" report to a sponsor or manufacturer any serious adverse effects.

Both versions would prohibit FDA from using safety or efficacy data associated with the use of an investigational drug administered outside a clinical trial to “delay or adversely affect the review or approval of the drug.”

FDA spokesperson Sandy Walsh told BioCentury the agency has been providing technical assistance to Congress on the legislation.

In an open letter on Feb. 5, more than 300 academics urged the House E&C committee not to pass right-to-try legislation that would remove FDA from the initial authorization process for accessing unapproved therapies outside of a clinical trial. The letter was addressed to Energy and Commerce Committee Chairman Greg Walden (R-Ore.) and committee ranking member Rep. Frank Pallone (D-N.J.) (see BioCentury Extra, Feb. 5).

Pallone said in a statement Monday that he "strongly oppose[s]" the bill, citing concerns that the legislation would remove FDA oversight and put patients at risk.

In his Jan. 30 State of the Union address, President Donald Trump called on Congress to pass right-to-try legislation (see BioCentury Extra, Jan. 30).

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

Purchase this article for limited one-time distribution and website posting

$750 USD