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House right-to-try experimental drugs bill succeeds on 2nd attempt


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House right-to-try experimental drugs bill succeeds on 2nd attempt

A bill to give critically ill patients greater access to experimental drugs beyond the U.S. Food and Drug Administration's current compassionate-use process succeeded in the House on the legislation's second attempt — a week after it had failed in the chamber.

The March 21 late-night vote on the right-to-try legislation was 267-149, with 35 Democrats joining 232 Republicans to pass the measure. Two Republicans and 147 Democrats voted against the bill.

The measure failed on its first go when Republican leaders tried to speed it through the chamber under an expedited process, known as suspension of the rules, which required two-thirds of the 435 House members to pass. It only garnered 259 in favor on that March 13 vote, though that was enough to make it clear the Republicans could easily succeed if they tried again using a simple-majority process.

And they did — not wasting any time by immediately scheduling the legislation to go to the Rules Committee, which cleared it on March 19 using a closed-rule maneuver, meaning no amendments were permitted.

Rep. Frank Pallone, R-N.J., ranking member on the House Energy and Commerce Committee, however, made a last-ditch attempt on the House floor to try to change the bill. But his measure was defeated, 233-182.

The right-to-try bill now goes to the Senate for consideration — a vote that will not come until after Congress returns from its spring recess in April, though the timing for the chamber to take it up remains unclear. The Senate adopted a different version of the legislation in August 2017 by a voice vote.

The legislation was backed by President Donald Trump — who insisted in his Jan. 30 State of the Union address that lawmakers must pass the bill — and Vice President Mike Pence.

Second chance at life?

For terminally ill patients, the right-to-try legislation "may be a second chance at life," giving them access to the innovations and scientific breakthroughs that have not yet completed the FDA's application process, Rep. Michael Burgess, R-Texas, chairman of the House Energy and Commerce Health Subcommittee, said on the House floor.

He noted that more than three dozen states have passed their own right-to-try bills.

"The aim was to open the door to innovative experimental drugs for terminally ill patients without necessarily compromising the vital work and the mission of the Food and Drug Administration," Burgess said.

Rep. Brian Fitzpatrick, R-Pa., who sponsored the House right-to-try legislation, said that even though the FDA approves 99% of the requests it receives for access to experimental drugs through its compassionate-use program, the agency's application process was too "complicated, time consuming and expensive" and did not help enough people.

The 1,200 compassionate-use requests approved by the FDA last year paled in comparison to the 12,000 people in France who gained access to experimental treatments, Fitzpatrick argued.

But a medical ethics working group from New York University Langone Health disputed Fitzpatrick's claim, noting in a March 15 analysis that many of the drugs that are considered experimental in France have already gained approval in the U.S.

In addition, many of those patients who are obtaining the experimental treatments in France come from other nations in Europe, the group said.

No guarantees

Other right-to-try critics argued that the House legislation would cut the FDA out as a gatekeeper — leaving desperately ill patients potentially exposed to charlatans peddling false hopes.

"It creates a dangerous backdoor for modern-day snake oil salesmen, a backdoor around the FDA approval process for people who may be preying on desperate people and ignores that there actually is a safe pathway for terminally ill patients to get treatment," said Rep. Jan Schakowsky, D-Ill.

The legislation could put patients at risk of losing their hospice and home healthcare coverage if they use experimental medicines outside the FDA approval process, Schakowsky said.

Patients also could become targets of financial fraud since insurers likely would not be involved in the process.

"It is just a dangerous pathway for bad actors to exploit" vulnerable patients, Schakowsky said.

She noted that 78 medical groups and 110 patient advocacy organizations opposed the bill.

In addition, four former FDA commissioners — two appointed by Republicans and two by Democrats — came out against the bill, stating there was no evidence it would meaningfully improve access for patients, but would remove regulators from the process and "create a dangerous precedent that would erode protections for vulnerable patients."

Former biotech executive Michael Becker, president and founder of MDB Communications LLC, who has been diagnosed with terminal cancer, argued that there was an easy fix to the right-to-try legislation — "keep the FDA involved, exactly as it is under the current expanded-access program."

Supporters of the bill "have yet to explain exactly why removing the FDA from the process is beneficial, when the agency approves 99% of expanded access applications," he told S&P Global Market Intelligence.

In a March 13 blog, Becker said the bill was nothing more than a "libertarian Trojan horse designed to weaken the FDA."

On the House floor, Pallone asserted that the bill was an "egregious attempt" to "undermine the FDA" by the libertarian Goldwater Institute, the group behind much of the state and federal lobbying efforts on the right-to-try legislation.

The New Jersey lawmaker also pointed out that there was nothing in the House bill that compelled drugmakers to provide their experimental products to patients. Plus, there was also no guarantee that the drugs would work, he added.

An experimental medicine could, in the end, hasten a patient's death, rather than extend the person's life, Pallone said.

Drugmakers and healthcare providers involved in administering those drugs, however, would gain protections under the legislation from liability if the patient was harmed, he noted.