The nay votes must be in bed bigtime with Big Pharma. Patients are not stupid. They should be given the choice that Right To Try will afford.

Thursday, 15 March 2018
By Donna Young

After House Republicans failed to clear a bill aimed at giving critically ill patients greater access to experimental drugs, it did not take long for House Majority Leader Kevin McCarthy, R-Calif., to keep his promise that his chamber would try again.

House Republican leaders have set a March 19 hearing for the so-called right-to-try legislation at the Rules Committee, hoping the second try at advancing the bill will yield a win.

The House rejected the bill March 13 in a 259-140 vote. The legislation failed to garner two-thirds of the 435 House members needed to pass the bill under the expedited process, known as suspension of the rules.

Republicans, who control the House, skipped the regular-order procedure of taking the bill through the committee process to be scrutinized and voted on before sending the measure, sponsored by Rep. Brian Fitzpatrick, R-Pa., to the House floor for consideration.

That decision proved to be fatal for the legislation.

But in reviving the bill, Republicans will try to pass it this time using a simple majority a process under which it is expected to be adopted, given more than half the House voted in favor of the legislation on its first try, including 32 Democrats.

First, though, it is set to go to the Rules Committee, which dictates how a piece of legislation gets to the floor, how many amendments will be considered and how much time will be permitted for debate.

After the legislation, known as the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018 named after a group of patients who had sought access to unapproved treatments failed to pass the House, McCarthy vowed his chamber would "not let this be the end" and would "try and try again" to adopt the measure.

The majority leader insisted "bureaucratic hurdles" were getting in the way of terminally ill patients accessing medicines that had not gone through the Food and Drug Administration's regulatory process of verifying safety and efficacy.

"Their desire to live and to beat the odds is more important than checking all the boxes," McCarthy said.

Fitzpatrick and other Republicans have complained that the FDA's process for allowing patients to try experimental drugs, known as expanded access, and often called compassionate use, is too slow and burdensome.

The FDA, however, approves 99% of the compassionate-use requests it receives, according to the agency's commissioner, Scott Gottlieb.

No guarantees

On the House floor on March 13, Frank Pallone, D-N.J., ranking member of the Energy and Commerce Committee, argued that the right-to-try bill delivers "false hope" that patients and families will receive a cure.

He noted that nothing in Fitzpatrick's bill compels a drug manufacturer to grant access to its experimental therapy on request.

Other critics of the legislation emphasized that about 90% of experimental drugs end up not working, and exposing patients to those thoroughly untested products could potentially worsen their illnesses or quicken their deaths.

In addition, opponents warned that the bill would cut out the FDA as a gatekeeper, leaving desperately ill patients potentially exposed to "snake oil" salesmen peddling false hopes.

"It is just a dangerous pathway for bad actors to exist," Rep. Jan Schakowsky, D-Ill., said on the House floor.

She also noted there are no guaranteed protections in the bill against losing hospice or home healthcare services for patients who use unapproved treatments.

Others like former biotech executive Michael Becker, president and founder of MDB Communications LLC, who has been diagnosed with terminal cancer, argued the right-to-try bill was nothing more than a "libertarian Trojan horse designed to weaken the FDA."

"And once this dangerous precedent is set, I fear it could easily be expanded to include patients with less severe diseases," Becker wrote in a March 13 blog.

False hope is better than none

But lawmakers like Rep. Joe Barton, R-Texas, insisted giving "false hope is better than none at all" and questioned why a dying patient must wait for the FDA.

Rep. Morgan Griffith, R-Va, added: "If I had a terminal diagnosis, I would even consider injecting monkey urine if I thought it would give me a few more months, a few more years with my children."

The bill is backed by President Donald Trump and Vice President Mike Pence.

While Gottlieb had expressed concerns about the initial bill, he recently said the FDA was "committed to working closely" with lawmakers to advance the legislation.

If the bill passes the House, it would need to return to the Senate for consideration, since the legislation differs from a measure the upper chamber adopted in August 2017.

Senate Majority Leader Mitch McConnell, R-Ky., however, indicated March 13 that his chamber's floor schedule was already jam-packed with other legislation that needed to be considered before lawmakers depart Washington for their spring recess, including an omnibus spending bill that must be completed before March 24 or the government will shut down.

Article amended at 9:05 a.m. ET on March 16, 2018, to remove a reference to Michael Becker being a doctor.