Utah Senate passes bill on using off-label, experimental drugs during COVID-19

(Leah Hogsten | Tribune file photo) In this April 16, 2020, file photo, Senate President Stuart Adams, R-Layton, and Senate workers conduct business during the Utah Legislature first-ever digital special session at the Capitol. Adams has been an advocate of the state stockpiling malaria drugs as a potential treatment for COVID-19, although medical professionals have warned against this.

A bill giving legal immunity to physicians who prescribe off-label or experimental medications to coronavirus patients sailed through the state Senate on Thursday.

Supporters of the “right to try” measure have said it will increase the confidence of doctors who might otherwise worry about trying unproven therapies against COVID-19. A patient could still sue a physician for gross negligence or intentional or malicious misconduct. But in other cases, the provider would be protected, said the bill’s sponsor, Senate Majority Leader Evan Vickers.

“We need to have all hands on decks, all tools available for us because it’s a new horizon for us,” said Senate Minority Leader Karen Mayne, D-West Valley City, who worked with Vickers on SB3002. “We need to give those people that are dealing with this horrible disease the structure that they need and the pathway that they need.”

The bill’s protections would only apply during a public health crisis, Vickers said, and would not be available to health care workers in normal circumstances.

Only one lawmaker, Sen. Todd Weiler, R-Woods Cross, voted against passing the bill over to the House. He said he’d heard from disability advocates concerned that the measure’s provisions would shield nursing homes that give substandard care during the pandemic.

Vickers, R-Cedar City, responded that the bill’s legal immunity shields would only apply if a patient is suffering from COVID-19 and wouldn’t protect poor care in other scenarios.

The bill is expected to be voted on by the House on Friday, the second day of the Legislature’s emergency special session.

While the bill doesn’t mention specific medications, it would apply to the off-label use of hydroxochloroquine, an anti-malaria drug that has been touted by President Donald Trump as a potential treatment for COVID-19. The medicine has been approved by the Food and Drug Administration (FDA), but not for coronavirus, and the nation’s top health experts have cautioned that the drugs have not been proven effective for the new disease.

Vickers’ proposal would also pertain to the use of investigational drugs such as remdesivir, which was previously studied as a treatment for the Ebola virus and has not been approved by the FDA. A small study by the drug’s maker, Gilead Sciences, found that a majority of severely ill COVID-19 patients improved after taking remdesivir, according to a Forbes report.

Under Vickers’ bill, a physician who wants to use an experimental drug would have to inform the person of the potential risks and disclose that an insurer could deny coverage for the medication, potentially leaving the patient on the hook. On Thursday, senators amended the bill to mandate a similar informed consent process for patients who are interested in using off-label drugs.

In addition, Vickers said, the bill would extend immunity to anyone helping the state to manufacture, distribute or dispense off-label drugs, “if the assistance is provided under contract with and under the direction of the stage agency.” It would also protect health workers who are providing treatment outside their education, training or experience when there are staffing shortages during a pandemic or other crisis situation.

“In these kinds of situations, where you have a major public health emergency, oftentimes you’ll have practitioners — physicians in particular — that are asked to act out of their normal realm of practice,” said Vickers, a pharmacist by profession.

Dr. Brandon Webb, an Intermountain Healthcare infectious disease specialist, said he supports this part of the bill but believes the rest would do little to improve Utahns’ access to coronavirus treatments.

Physicians currently prescribe off-label medication without fear of legal liability if they’re acting responsibly and with “good clinical judgment,” he wrote, adding that doesn’t think the bill would enhance patients’ access to investigational drugs, either.

“Rather, it appears that one of the purposes of this bill may be to pave the way for the Utah Department of Health to purchase medications from private sector sources, and to shield the source of medications from civil liability should they result in harm,” Webb wrote, in analysis he shared with Rep. Suzanne Harrison, D-Draper.

State leaders are in talks with a Utah pharmacist who has stockpiled ingredients for the anti-malaria drugs being promoted — without proof — as a potential treatment for COVID-19. Health officials have confirmed that they are thinking of procuring some of these drugs from the business, Meds in Motion, for distribution to pharmacies across the state.

Webb, who is helping lead an Intermountain clinical trial on hydroxychloroquine, wrote that he doesn’t see how the bill would “change anything for patients” in terms of access to investigative drugs.

“[P]atients already have the right to participate in Expanded Use Access (compassionate) use programs for investigational drugs and devices, with appropriate informed consent, when these programs are made available, at the discretion of the manufacturer,” he wrote.

Utah hospitals have reached out to the makers of remdesivir, but there is widespread demand for the medication, and the manufacturer is allowing select hospitals in hard-hit areas to participate in the compassionate use program, he added.