FDA seeks new law for experimental drugs

The Food and Drug Administration (FDA) on Thursday reiterated that there is no law what would allow it to quickly approve the use of experimental drugs in times of emergencies like the COVID-19 pandemic.

Speaking before lawmakers during the hearing of the House committee on good government on Thursday, FDA director general Eric Domingo said the approval of pending measures in Congress would allow the agency to have more “flexibility” in its regulations during a public health emergency.

Domingo said Republic Act No. 9711, or the Food and Drug Administration Act of 2009, does not have provisions for emergency situations.

He made the remarks in answer to lawmakers who insisted on approving the veterinary drug, known as ivermectin, for experimental use although the drug has no proven benefits against the novel coronavirus.

Domingo stressed that the FDA is not anti-ivermectin but insisted that the agency must, by its legal mandate, oppose the use of unregulated and unregistered drugs.

“That’s why we really need a law to institutionalize it whenever we have an epidemic or emergency,” he told lawmakers.

At the House of Representatives, Quezon Rep. Angelina Helen Tan filed on Feb. 10 House Bill No. 8666, authorizing the FDA director general to issue emergency use authorization (EUA).

Sen. Francis Tolentino also filed Senate Bill No. 2024, institutionalizing the grant of EUA.