FDA TAKEN TO TASK BY LAWMAKERS OVER DELAY ON DRUG APPROVALS
Members of the House of Representatives have put to task the Food and Drug Administration (FDA) over the perceived delay in the approval of new drug applications, including potential medicines for the deadly COVID-19.
In Thursday’s hearing of the House Committee on Good Government and Public Accountability, lawmakers took turns grilling FDA General Manager Eric Domingo on the guidelines and policies of the FDA and the Department of Health (DOH) that may hamper public health service delivery, especially amid the pandemic.
Committee chair DIWA Party-list Rep. Michael Edgar Aglipay said the FDA and DOH issuances “must be up to speed so the government may immediately contain the spread of the coronavirus and its variants.”
“It is the mandate of this committee to identity malfeasance, misfeasance and nonfeasance committed by public officials and to make appropriate recommendation in aid of legislation,” Aglipay said.
The House panel took a cue from Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera who have jointly filed House Resolution 1711 calling for a congressional inquiry into the policies and guidelines for the registration, utilization, manufacture, distribution or sale of COVID-19 treatment drugs, which “appear to be detrimental to public interest.”
During the hearing, representatives from the Philippine Chamber of Pharmaceutical Industry Inc. and the Philippine Pharmaceutical Manufacturers Association revealed that as of March 29, a total of 1,025 applications for certificate of product registration, 50 for license to operate,
and 381 for automatic renewal have been pending with the FDA since 2015.
They even claimed that the difficulty in registering drug products in the Philippines has prompted some multinational pharmaceutical firms to leave the country and transfer their manufacturing plants to Thailand and Vietnam.
Meanwhile, some lawmakers lamented the unnecessary delay in the approval of Ivermectin and Leronlimab for use in treating COVID-19, as well as the lack of supply of Midazolam, Tocilizumab and other repurposed drugs for the treatment of the coronavirus disease.
Pending the results of local clinical trials on Ivermectin, Domingo pointed out that the FDA has granted some hospitals compassionate special permit for its use to treat COVID-19 patients.
At this juncture, Deputy Speaker Lito Atienza accused the FDA of “dribbling” the issue on Ivermectin. He even went further by commenting that the current FDA chief is not fit for the job.
In her interpellation, Herrera said it is high time the FDA expand the list of drug products under emergency use to give doctors and patients more choices of COVID-19 medicines.
To address the lack of supply of repurposed COVID-19 drugs, Herrera called on the FDA and DOH to strengthen the capacity of local drug manufacturers to address the pharmaceutical needs of the public amid the COVID-19 crisis.
“We should actively push for self-sufficiency of our own pharmas to ensure accessibility and affordability of life-saving drugs,” she pointed out.
The party-list lawmaker also asked the DOH to consider suspending Department Order 2013-0021 that require local pharmaceuticals to register with the 33-step ASEAN guidelines before they can manufacture and market prescription drugs, and go back for the meantime to the 12-step national guidelines.
The inquiry focused on FDA Circular No. 2020-12, entitled “Guidelines for the Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019,” and DOH’s Department Memorandum No. 2020-0138 adopting clinical practice guidelines on COVID-19.
The 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 COVID-19.
One year into the pandemic, doctors and scientists are still scrambling to find treatments and drugs that can save lives of those infected with COVID-19 and perhaps even prevent people from getting sick.
Several doctors, politicians and business leaders have been pushing for the use of the human-grade Ivermectin as a treatment and prevention drug for COVID-19 in the wake of clinical trials abroad showing that the anti-parasitic drug is effective against coronavirus.
In the resolution that they filed, Velasco and Herrera lamented how COVID-19 has continued practically uncontrolled and unabated, “severely affecting the efficiency and capacity of our public and private health system, negatively impacting our economy, and compromising the health and safety of the Filipino people.”
“While there is no actual cure for COVID-19, health, drug and medical experts have come up with a treatment protocol including the administration of certain drugs and therapeutics currently allowed for use and treatment of COVID-19,” the House leaders said.
“In our efforts to examine and help propose possible solutions to help alleviate the effects of this public health crisis, the House of Representatives has followed the developments on the registration, utilization, manufacture, distribution or sale of drugs for emergency use authorization or for use of drugs under compassionate special permit against COVID-19,” they added. [#18thCongress]