The Senate unanimously approved bills Thursday that would let dying patients try medicines that haven’t won full regulatory approval and inform doctors if a patient is a recovering drug addict, so they can prescribe safe treatment.
Both measures passed before the Senate voted overwhelmingly to extend the Food and Drug Administration’s ability to charge fees on companies that submit their products for pre-market review.
Taken together, the bills offered a bipartisan reset on health legislation after a bruising debate over Obamacare that stalled out last week when Republicans couldn’t muster enough troops to pass their bill through the Senate.
The FDA fee bill was considered must-pass legislation, with Congress facing an end-of-September deadline to renew four user agreements with industry players, who will pay fees totaling $8 billion to $9 billion over five years — more than a quarter of the agency’s funding.
Beyond user fees, the bill also direct companies developing cancer drugs for adults to look at whether their medicines could also help children, since there is little market incentive for drugmakers to focus on the comparatively small cohort of younger patients. It also will make certain kinds of hearing aids available over-the-counter to people with mild to moderate hearing loss.
The House acted earlier this year, clearing the way for Thursday’s 94-1 Senate vote to extend user agreements through fiscal 2022.
“It’s proof that we can make progress when we work together on areas where we can find agreement,” said Sen. Susan Collins, Maine Republican who faulted GOP leadership’s partisan push on Obamacare and rejected repeal efforts.
Sen. Bernard Sanders, Vermont independent, rejected the FDA reauthorization bill because “it does nothing to lower drug prices and is a giveaway to the pharmaceutical industry,” said spokesman Josh Miller-Lewis.
Earlier Thursday, the Senate by unanimous consent passed a bill that would let terminally ill patients who’ve exhausted other treatment options obtain drugs that made it through first-phase safety testing at the FDA — though not the full approval process — without fearing interference from the federal government.
The Trump administration and other supporters say it is a compassionate option, though opponents see it is an attempt to weaken the FDA, since the agency has an “expanded-access” program for similarly situated patients and approves almost all requests.
Drug companies wouldn’t be required to provide the experimental drugs to patients, though if they chose to, they would no longer need the FDA to sign off on it. Manufacturers and doctors would not face additional liability if the drug doesn’t work as hoped, and outcomes couldn’t be used to delay or adversely affect the normal review process.
The bill’s lead sponsors — Sens. Ron Johnson, Wisconsin Republican, and Joe Donnelly, Indiana Democrat — urged House lawmakers to take up the measure when they return to work in September.
“The Senate took a strong stand in support of the millions of Americans and their families suffering from terminal illnesses,” Mr. Johnson said. “Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives.”
Dozens of states have their own right-to-try laws. Vice President Mike Pence, a leading champion for the effort, signed a version of the law as governor of Indiana in 2015.
The Senate also approved a bill, known as “Jessie’s Law,” that would ensure that doctors have access to a consenting patient’s record of drug addiction, before prescribing treatment. It orders the Health and Human Services Department to come up with best practices for hospitals and physicians to share the information.
The bill was named for Jessie Grubb, a West Virginia native who died from opioid overdose following surgery in Michigan for a running-related injury.
Though her parents traveled to Michigan to tell doctors and hospital workers about her addiction history — she’d gotten clean and was building a new life — the discharging doctor wasn’t informed and prescribed her 50 oxycodone pills.
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