Feds Permit Malaria Drugs For Coronavirus Patients, State Has Not Rescinded Threat Of Sanctions
FDA’s chief scientist: ‘Based on the totality of scientific evidence … may be effective’
On March 24, the state of Michigan’s Department of Licensing and Regulatory Affairs threatened administrative action against physicians for prescribing certain anti-malaria drugs not specifically approved for the COVID-19 coronavirus, or for trying to stockpile the drugs.
But on March 28, the U.S. Food & Drug Administration approved the use of hydroxychloroquine or chloroquine in emergency situations to combat the coronavirus for certain hospitalized patients. The agency’s chief scientist wrote, “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19. ...” Those drugs have been widely used for decades to fight malaria.
The state of Michigan would not address whether it would still pursue punitive actions against physicians now that the FDA has commented.
Instead, the state licensing agency wrote an email on March 30 to Michigan Capitol Confidential that read: “Prescribers and dispensers have a responsibility to apply the best standards of care and use their clinical judgment when prescribing and dispensing these and any other drugs to treat patients with legitimate medical conditions.”
On March 30, LARA released a statement from Debra Gagliardi, the director of the Bureau of Professional Licensing, that acknowledged the FDA ruling's on the new drugs. But Gagliardi's statement didn't reference LARA's previous stance that threatened administrative action.
"LARA appreciates the essential role of our prescribers and dispensers and recognizes their ability to make proper clinical decisions including following responsible prescribing and dispensing practices," Gagliardi stated. "LARA thanks all of the dedicated licensed health professionals and others who continue to provide the best possible care for Michigan’s citizens during this state of emergency."
The FDA noted that because the drugs meet relevant safety and effectiveness criteria, it would let chloroquine phosphate and hydroxychloroquine sulfate be used to fight coronavirus in specified circumstances, even if they have not been formally approved for treating COVID-19.
The FDA stated that, based on limited trials and data, it was reasonable to think that the drugs could be effective treatments. The agency’s permission, given as an emergency authorization, allows physicians to prescribe the drugs to adults and adolescents hospitalized for the coronavirus.
Below is the March 24 statement of the Michigan Department of Licensing and Regulatory Affairs:
“Prescribing hydroxychloroquine or chloroquine without further proof of efficacy for treating COVID-19 or with the intent to stockpile the drug may create a shortage for patients with lupus, rheumatoid arthritis, or other ailments for which chloroquine and hydroxychloroquine are proven treatments. Reports of this conduct will be evaluated and may be further investigated for administrative action. Prescribing any kind of prescription must also be associated with medical documentation showing proof of the medical necessity and medical condition for which the patient is being treated. Again, these are drugs that have not been proven scientifically or medically to treat COVID-19.”