House probe urged on ‘detrimental’ DOH, FDA rules for COVID drug registration

A health worker shows a box containing a bottle of Ivermectin, a medicine authorized by the National Institute for Food and Drug Surveillance (INVIMA) to treat patients with mild, asymptomatic, or suspicious COVID-19, as part of a study of the Center for Paediatric Infectious Diseases Studies, in Cali, Colombia, on July 21, 2020. (Photo by Luis ROBAYO / AFP)

MANILA, Philippines — Two leaders of the House of Representatives are pushing for an inquiry into the Department of Health and the Food and Drug Administration’s policies and guidelines for the registration, utilization, manufacture, distribution, and sale of drug products for COVID-19.

Under House Resolution No. 1711, filed by House Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera-Dy, the House committee on good government and public accountability is urged to conduct the said inquiry, particularly on the “policies and guidelines which appear to be detrimental to the public interest.”

Specifically, the lawmakers want to look at FDA Circular No. 2020-12 or the “Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease.”

“Said FDA circular and other related guidelines have been questioned for being arbitrary, bureaucratic, and inhumane for causing unnecessary delays in the approval and clearance of drugs and therapeutics for emergency use authorization or for use of drugs under compassionate special permit against the dreaded COVID-19 disease,” the lawmakers said in the resolution.

The resolution was filed amid debates on allowing certain drugs for COVID-19 treatment, particularly the anti-parasitic drug ivermectin.

Herrera, an advocate of ivermectin in the House, earlier said that the FDA, as a regulatory agency, should keep “an open mind” on ivermectin because it is much cheaper than other drugs currently being used to treat COVID-19.

Velasco, meanwhile, earlier urged the DOH and the FDA to be more proactive and study the safety and efficacy of ivermectin for COVID-19 prevention and treatment.

Both the DOH and the FDA had repeatedly said that there is no registered ivermectin drug in the country for human consumption, while no less than the World Health Organization (WHO) said that there is not enough data to say that the drug can be used for COVID-19.

Nonetheless, the FDA later granted a hospital a compassionate special permit for the use of the anti-parasitic drug ivermectin to counter COVID-19, but stressed that it can only be prescribed by doctors in that hospital.

/MUF