DeGette Presses FDA to Avert Hydroxychloroquine Hoarding
Rep. Diana DeGette (D-Colo.) has called on the FDA to ensure that supplies of hydroxychloroquine and chloroquine are saved for approved indications, citing reports of hoarding.
DeGette, who chairs the House Energy and Commerce subcommittee on oversight and investigations, called — in a letter to FDA Commissioner Stephen Hahn — for the agency to warn healthcare providers against unnecessarily prescribing the anti-malaria drugs. She also asked how the agency plans to ensure that stocks of the drugs are reserved for patients who need them for approved indications.
The congresswoman lashed out at the agency’s March 28 emergency use authorizations for the drugs, noting a lack of evidence for their efficacy in treating the novel coronavirus.
Since the agency’s authorization, lupus, malaria and rheumatoid arthritis patients have reported difficulties in getting the medicines, DeGette said, adding that hydroxychloroquine and chloroquine were added to the FDA’s drug shortages list just days after the emergency use clearance.
President Trump has repeatedly touted the drugs as potential COVID-19 treatments, adding to the spike in demand, although they are still being evaluated in clinical trials and serious adverse reactions have been reported in several countries.
India imposed strict export restrictions on exports of hydroxychloroquine in March but later agreed to loosen them (DID, April 8).
Indian manufacturers Zydus Cadila and Ipca Laboratories have said that they will massively ramp up production of hydroxychloroquine now that it can be exported, and Mylan has resumed production of generic hydroxychloroquine sulfate at its West Virginia plant to keep up with the soaring demand.
Read DeGette’s letter here: www.fdanews.com/04-09-20-Letter.pdf. — James Miessler