clear
Monday June 25th, 2018 2:30AM

House vote nears on GOP bill easing use of unproven drugs

By The Associated Press
Related Articles
  Contact Editor

WASHINGTON (AP) — A Republican bill easing how experimental drugs are provided to people with terminal illnesses headed toward a House vote Tuesday, but opposition by top Democrats and scores of patients' groups left its fate uncertain.

The "Right to Try" legislation, backed by President Donald Trump and Vice President Mike Pence, gives fresh hope to patients with fatal diseases and erects safeguards to protect them, Republicans said.

Democrats said it would achieve little since the federal Food and Drug Administration already approves 99 percent of the 1,000 requests it receives annually for an existing program that lets patients use unproven treatments. They also said the proposal would create risks by rolling back the FDA's oversight role in the process.

The FDA would no longer need to sign off if a doctor and pharmaceutical maker agree that a patient with no other options should try an experimental treatment.

The agency would have to be notified after treatment begins, manufacturers would have to report if problems arose and drug makers and doctors would be broadly shielded from legal liability. Manufacturers would still not be required to provide their pharmaceuticals.

Drew Hammill, spokesman for House Minority Leader Nancy Pelosi, D-Calif., said Tuesday she will "follow the lead of numerous patient and disease groups in opposing this legislation."

Democratic support was crucial because Republicans were debating the measure under rules — usually reserved for uncontroversial bills — requiring a two-thirds majority for passage. That meant majority Republicans would likely need at least 50 Democrats, or nearly 1 in 4.

More than 70 patients and research groups sent a letter of opposition Monday to House leaders saying the bill "would not increase access to promising therapies" and "is still less safe" that the FDA's existing process.

Eliminating required FDA approval for use of the drugs erases "some really important protections for patients" because of the agency's knowledge, said Dr. Richard Schilsky, chief medical officer for the American Society of Clinical Oncology, which signed the letter.

House Speaker Paul Ryan, R-Wis., tweeted that the measure would "empower patients and their families," adding, "For those who are faced with terminal conditions, they deserve the #RightToTry."

The Senate passed a similar bill in August.

Critics said the measure misleadingly suggests that the FDA is the bottleneck to providing the experimental treatments. They say the more common hurdle is manufacturers, which often prefer to use their limited quantities of early-stage drugs for clinical trials needed to gain final FDA approval for wide-spread sales or worry that a setback could damage the product's marketability.

Scott Gottlieb, FDA commissioner and a Trump appointee, told Congress in October that 70 percent of the experimental drugs his agency currently lets seriously ill patients use are never approved.

"The vast majority of people" granted access to unproven treatments "are using a drug that doesn't work," he said.

  • Associated Categories: Associated Press (AP), AP Online Headlines - Washington, AP Online Congress News, AP Health, AP Business, AP Business - Corporate News, AP Business - Industries, AP Business - Health Care
© Copyright 2018 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Trump's CIA pick is career spymaster, oversaw secret prison
President Donald Trump's pick to be the next _ and first female _ director of the CIA has conflicting public reputations
3:26PM ( 12 minutes ago )
Western PA special: A Trump embarrassment or close call?
Western PA special election: A Trump embarrassment or just a close call?
3:25PM ( 13 minutes ago )
The Latest: Trump pays visit to prototypes for border wall
President Donald Trump is paying a visit to the prototypes that have been built on the outskirts of San Diego for his promised border wall
3:24PM ( 13 minutes ago )
Associated Press (AP)
Zinke defends hiking park fees amid travel spending flap
Interior Secretary Ryan Zinke bristles under questioning about his spending on travel as the Trump administration seeks deep cuts to conservation programs and fee increases at national parks.
3:10PM ( 27 minutes ago )
The Latest: Trump lands in San Diego to view wall prototypes
President Donald Trump has arrived in San Diego, where he'll be touring the prototypes for his stalled border wall
2:55PM ( 43 minutes ago )
AP: Pentagon often fails young sex assault victims on bases
AP Investigation: Pentagon doesn't know extent of sex assault among juveniles on military bases, has no specific personnel or protocols to help young victims or offenders
2:50PM ( 47 minutes ago )
AP Online Headlines - Washington
The Latest: Russia won't answer UK ultimatum without samples
The Russian Embassy in London says Moscow won't respond to a British ultimatum unless it gets samples of the nerve agent used in the attack on a former spy and his daughter
1:53PM ( 1 hour ago )
The Latest: Germany's Merkel taking UK assessment seriously
German Chancellor Angela Merkel says Russia must provide "quick answers to the legitimate questions posed by the British government" about the poisoning of an ex-spy and his daughter
1:21PM ( 2 hours ago )
The Latest: Key vacancies at the top at State Department
Now that Rex Tillerson and a key aide are out at the State Department, there are vacancies at the top of the department
1:08PM ( 2 hours ago )
AP Online Congress News
Stocks sink as technology rally fades; Qualcomm drops
U.S. stocks are falling as technology companies give up an early gain.
2:53PM ( 45 minutes ago )
Affleck, Damon's production company to adopt inclusion rider
Matt Damon, Ben Affleck and Paul Feig are jumping on the inclusion rider bandwagon following Frances McDormand's Oscar acceptance speech
2:31PM ( 1 hour ago )
For the tech industry, a red flag on megadeals?
Trump decision to scuttle a hostile takeover by Singapore's Broadcom of the U.S. chipmaker Qualcomm caught some on Wall Street off guard
1:45PM ( 1 hour ago )
AP Business
Trump's CIA pick is career spymaster, oversaw secret prison
President Donald Trump's pick to be the next _ and first female _ director of the CIA has conflicting public reputations
3:26PM ( 12 minutes ago )
Western PA special: A Trump embarrassment or close call?
Western PA special election: A Trump embarrassment or just a close call?
3:25PM ( 13 minutes ago )
The Latest: Trump pays visit to prototypes for border wall
President Donald Trump is paying a visit to the prototypes that have been built on the outskirts of San Diego for his promised border wall
3:24PM ( 14 minutes ago )
The Latest: Travelers hard to find at Boston's Logan Airport
The terminals are mostly empty at Boston's Logan International Airport at the height of the winter storm, with security workers and cleaning crews outnumbering passengers
3:22PM ( 16 minutes ago )
The Latest: Schumer says White House chaos hurts America
Secretary of State Rex Tillerson has been fired, and Democrats are pointing to the latest White House departure as proof that the Trump administration is mired in its own chaos.
3:18PM ( 19 minutes ago )