House Deputy Speaker and Bagong Henerasyon Rep. Bernadette Herrera on Friday, May 7, lauded as a “groundbreaking development” the reported decision of the Food and Drug Administration to issue a Certificate of Product Registration for Ivermectin which has been promoted by lawmakers as a drug that could treat and prevent human infection of the 2019 coronavirus disease (COVID 19).
Herrera is among the Lower House officials who have expressed support for the use of Ivermectin against the deadly COVID-19 disease. Deputy Speaker and 1Sagip Partylist Rep. Rodante Marcoleta and Anakalusugan Rep. Michael Defensor are also Ivermectin advocates and have even recently distributed free tablets in Quezon City..
The well-publicized debate on the safety and efficacy of Ivermectin as a prophylaxis and cure for COVID 19 has triggered a significant demand for the product notwithstanding the lack of medical findings to support the lawmakers’ claims.
In a press statement, Herrera disclosed that the CPR for the anti-parasitic drug was issued by FDA to Lloyd Laboratories.
She said CPR will enable the company to “manufacture, distribute and sell the drug under specified conditions.”
The deputy speaker aired hopes that the FDA decision will “pave the way for more thoughtful, responsive, and expedient regulatory procedures from the FDA, especially during this pandemic.”
She noted that while the drug was not originally intended to treat COVID-19, Ivermectin has made global headlines due to a number of doctors and medical groups who have gone on record to vouch for its efficacy as both a prophylaxis and a treatment for the SARS-CoV-2 virus.
Herrera said she acknowledges that there is currently no actual cure for COVID-19. However, she staunchly advocated the exploration of all all possible treatment protocols, and more importantly, making these options legally available for doctors to prescribe to their patients.
“I would like to personally thank FDA Director General Dr. Eric Domingo for being open to our suggestions, and for taking the necessary steps to ensure that this in-demand drug now has clear regulation and quality-control standards behind it,” the Party List solon said.
“It is common knowledge that the unmonitored distribution and use of Ivermectin created an entire gray-market, which subsequently led to questionable and dangerous products. With a reputable company now holding an official CPR, the public is now assured of the quality and legality of their doctor-prescribed Ivermectin dosages,” she added.
The Department of Science and Technology has agreed to conduct clinical trials on the use of Ivermectin, just like other countries are currently doing.
“As of now, we already have a number of foreign clinical trials that can be used as a basis. Now that the FDA has allowed a local pharmaceutical company to make Ivermectin available in the market, however, the proper documentation, observation, and follow-ups can already be used for statistical inference,” Herrera said.
Based on the CPR issued to Lloyd Laboratories, Ivermectin will be made available as a prescription-only drug in 3mg, 6mg., 9mg., 12 mg., and 15 mg. doses.