The curious case of molnupiravir

(Second of two parts)

Due to its standing as a leader in pharmaceutical manufacturing, this Filipino company has a technology transfer arrangement with a drug manufacturer in India who are seeking regulatory approval to produce a generic version of molnupiravir. Clinical trial results provided to the FDA showed a 77.5 percent PCR negativity following five days of usage, even better than MSD’s 50 percent result. This affirms that the composition of molnupiravir developed by the Indian company is effective and potentially life-saving for millions of our countrymen; it also should serve as assurance that every test subject received exactly 400mg of molnupiravir in each capsule, thus underscoring the quality of their Filipino counterpart’s manufacturing capabilities.

Some may say that the generic formulation that can (and hopefully, will) be manufactured in the Philippines is “pirated,” or something silly to that effect. This is absolutely untrue, since Merck itself stated that the licensing agreement for molnupiravir is voluntary, because there is no patent for the drug substance. Only a composition patent, or a patent on the varying amounts of the different ingredients used to make the drug, has been filed – and the Indian-Filipino partnership has formulated its own composition. This is exactly like how there are eight different brands of cetirizine, and none of them are “pirated.”

Were I a regulator, I would be fighting tooth and nail to speed things up, and expedite the manufacture and distribution of this life-saving medicine. Unfortunately, when the Filipino company applied for a Compassionate Special Permit (CSP) with the FDA, the government agency replied that “a CSP can only be issued to entities that are commissioned by MSD.”

Based on the FDA’s own charter, however, a CSP may be granted to an institution and/or physician, particularly for an unregistered or investigational drug product, through a licensed importer. Moreover, the charter states that “Patients, Doctors, Specialized Institutions, Specialized Society, Hospitals, Importers of Pharmaceutical Products” may avail of a CSP. To me, that sounds pretty straightforward, and I have not seen any reference that includes a “private-commission only” condition to the issuance of a CSP.

So this begs several questions – does the FDA itself not understand the urgency of the COVID-19 pandemic and of compassionate special permits? Has it been dragging its feet in getting life-saving medicines to the people, as Congress has repeatedly called out? Is it bending to the will of Big Pharma?

As Presidential Communications Operations Office (PCOO) Secretary Martin Andanar said recently, “Sa kabila ng krisis na hinaharap natin, pag-isipan natin: Can we be more self-reliant as a person, as a community, as a country? Siguro iyan na rin ang isang dapat maging legacy ng pandemya, na pagkatapos nito, ang Pilipino ay sana mas self-reliant. Dahil, kaya naman natin.”

True on all points, Sec. Martin, but our self reliance must also be assisted by enabling government agencies and regulators.