Utah lawmakers OK bill on experimental, off-label treatments for COVID-19

(John Locher | AP Photo) FILE - This Monday, April 6, 2020 file photo shows an arrangement of hydroxychloroquine pills in Las Vegas.

Utah lawmakers gave final passage Friday to a measure meant to give health care workers more flexibility during the coronavirus pandemic and establish their legal immunity when prescribing experimental and off-label medication.

But first, they stripped out a provision designed to shelter companies that are contracting with the state to manufacture, distribute or dispense drugs for off-label use.

Rep. Val Peterson, R-Orem, who presented the bill to fellow House members, agreed to this amendment, saying it keeps the legislation tightly focused on the current pandemic. Later in the day, Senate Majority Leader Evan Vickers, R-Cedar City, said the provision for these companies was unnecessary, since other parts of the bill grant legal immunity to health care workers, including pharmacists.

Two physicians who serve in the Legislature — Reps. Ray Ward and Suzanne Harrison — said the measure, SB3002, contains important protections for health care workers forced to work outside their specialties during the COVID-19 outbreak.

Harrison later tweeted about her support for the amendment removing legal immunity for pharmacy companies contracting with the state.

“We need to be guided by good medicine & science,” the Draper Democrat wrote on Twitter. “I am grateful for the ongoing clinical trials in Utah to determine the effectiveness of possible treatments.”

Vickers’ proposal states that physicians would be protected from lawsuits when prescribing investigational or off-label drugs to patients suffering from COVID-19. These provisions would not shield health care providers who are grossly negligent or malicious, and these protections would only apply during a public health emergency.

However, House Minority Leader Brian King said he believes issues of legal responsibility should be reviewed on a case-by-case basis within the judicial system rather than decided by the Legislature.

“I think it’s almost always a bad idea to step in with a one-size-fits-all approach,” King, D-Salt Lake City, said.

The House passed the bill by a vote of 65 to 7, and the Senate later gave it final approval by agreeing to amendments made in the other chamber. The measure heads now to the desk of Gov. Gary Herbert and will take effect immediately if he signs it.

Sen. Kathleen Riebe voted in favor of the legislation but said she had reservations about aspects of it, especially since health experts don’t fully understand the risks of treating COVID-19 patients with unproven medications.

“I believe this is a person’s right to try this medicine,” the Cottonwood Heights Democrat said. “But I think there are still some concerns that are not being addressed.”

While the bill doesn’t mention specific medications, it would apply to the off-label use of anti-malaria drugs that have been touted by President Donald Trump as a potential treatment for COVID-19. However, experts have cautioned that there’s no clear evidence showing the drugs are beneficial for coronavirus patients, and one small chloroquine study in Brazil was even shut down because patients were developing potentially life-threatening heart irregularities.

Physicians at the University of Utah Health and Intermountain Healthcare earlier this month launched a pair of clinical trials on hydroxychloroquine — an appropriate setting for prescribing the unproven medicine, they said, since researchers can carefully monitor patients for side effects and screen out people who might be at heightened risk.

One of the investigators in these clinical trials. Dr. Brandon Webb, said he doesn’t believe SB3002 would increase Utahns’ access to investigational or off-label drugs. In his written analysis of the legislation, the Intermountain Healthcare infectious disease specialist said physicians already prescribe medications for off-label use without fear of legal repercussions, so long as they’re acting responsibly and exercising “good clinical judgment."