Nearly 40 patient advocacy groups told House leaders they opposed the "right to try" bill on experimental drugs, arguing the measure would “likely do more harm than good.”
In a letter sent to the House leaders of both parties, the groups wrote that they believe the right to try legislation wouldn’t actually lead to greater patient access to unapproved drugs and that the current regulatory framework exists so patient protections aren’t undermined.
“As you consider bringing this troubling legislation to the House floor for a vote we ask that you remain mindful of our concerns, and take into consideration the negative impact the policies could have on patients living with life threatening disease,” the group of organizations — which includes the American Cancer Society Cancer Action Network, National Organization for Rare Disorders and Susan G. Komen — wrote in the letter sent Tuesday.
“We welcome the opportunity to work with all members of the House of Representatives to develop alternative legislative proposals that would improve the ability of patients to genuinely and safely access both approved and unapproved innovative, lifesaving therapies.”
The right to try legislation would let patients with serious illnesses request access to experimental medicines that the Food and Drug Administration (FDA) hasn’t approved.
Its supporters believe terminally ill patients should have every tool at their disposal to access a drug that could help save their life, and argue the drug approval process is too lengthy. They also believe the bill received a major endorsement when President TrumpDonald TrumpJulian Castro knocks Biden administration over refugee policy Overnight Energy & Environment — League of Conservation Voters — Climate summit chief says US needs to 'show progress' on environment Five takeaways from Arizona's audit results MORE urged Congress to pass it during his State of the Union address last week.
In Tuesday’s letter, the patient advocacy groups pointed to the FDA’s compassionate use program, which lets physicians ask the FDA to let a terminally ill patient access an unapproved drug.
“Removing FDA from this process is not likely to facilitate increased access to investigational therapies because FDA currently approves 99.7 percent of all expanded access requests submitted by physicians and companies for patients with immediately life-threatening illnesses who cannot participate in clinical trials,” the groups wrote.
They noted that, when access is denied, that denial generally comes from the company.
Opponents argue that the agency program’s process is cumbersome, and that the government shouldn’t have a hand in making this decision, even if drug companies do decide not to give out the medication to a terminally ill patient.
The legislation passed the Senate by unanimous consent in August, but the House hasn’t taken up the measure. Some right to try advocates want the House to take up the Senate’s version to speed up the process of sending the legislation to President Trump's desk.
“My concern is if they change it in any way, shape or form in the House, we’re going to have to bring it back up in the Senate,” Sen. Ron JohnsonRonald (Ron) Harold JohnsonThe Hill's Morning Report - Presented by Alibaba - Democrats argue price before policy amid scramble Liberal group launches campaign urging Republicans to support Biden's agenda Domestic extremists return to the Capitol MORE (R-Wis.), who championed the measure in the upper chamber, said after meeting with GOP leadership on the bill Monday afternoon. “It’s a relatively heavy lift to get anything passed in the Senate, even something that previously passed by unanimous consent — 100 to 0.”
But the bill will most likely change, House Energy and Commerce Committee Chairman Greg WaldenGregory (Greg) Paul WaldenEx-Sen. Cory Gardner joins lobbying firm Ex-Rep. John Shimkus joins lobbying firm Lobbying world MORE (R-Ore.) told reporters Monday night. He met with FDA Commissioner Scott Gottlieb and Vice President Pence roughly two weeks ago on the measure, and noted, “We’ve been socializing language, and we’re very, very close.”
Walden said, “We’re working to make sure that the program will work for the patients who need access to these medicines. We want to make sure it’s safe, we want to make sure it works and they can take advantage of it.”