Thirteen years ago, Congress enacted an attempted solution to a long-running pharma problem. Although infectious diseases that afflicted the developing world or could trigger pandemics presented one of the world’s most lethal disease threats, they didn’t present any sizeable market for drug developers.
So, following a proposal laid out by academics, legislators started a program that gave companies that successfully developed products for these diseases “priority review vouchers,” which they could use to get an FDA decision on one of their other drugs early or, more likely, sell to a large pharma for tens of millions of dollars. It created a backdoor market, whereby Big Pharmas developing lucrative products for cancer or autoimmune conditions would subsidize unprofitable but globally needed drugs and vaccines — all without the government spending a penny.
Over the next 13 years, the FDA quietly and uncontroversially awarded 10 different vouchers for tropical diseases and two for what’s known as a “material threat,” most of them for little known products that treated or prevented malaria, leishmaniasis (a parasite), onchocerciasis (river blindness), fascioliasis (a grisly infection involving liver fluke), and drug-resistant tuberculosis.
Then, late last month, the FDA controversially approved remdesivir, and Gilead received a priority review voucher for a product that had rapidly become one of the most famous drugs on the planet. Remdesivir has already earned Gilead $872 million this year and could continue as a blockbuster into 2021.
That didn’t sit well with Gilead’s critics, including Public Citizen. The Washington-based NGO publicly called this week for the California drugmaker to relinquish its voucher, calling it “entirely unnecessary and inappropriate incentive” given Gilead’s projected revenues.
“Gilead is already being handsomely compensated through remdesivir sales and is slated to recoup any investment it made in its development many times over, which, again, was heavily subsidized by taxpayers,” Public Citizen’s Peter Maybarduk wrote in an open letter. “Provision of the PRV was clearly an unnecessary windfall to Gilead in addition to these already excessive revenues.”
The public call is the latest in a series of skirmishes between a drugmaker that has spent years at the center of drug pricing debates, first for its HIV antivirals and now over remdesivir, and activists who have called for tighter controls, lower prices, and greater access.
During the pandemic, Public Citizen, has called out Gilead for the price of remdesivir, for failing to develop a similar antiviral, and for not allowing more companies around the world to produce the drug generically. At times, they’ve been joined by state attorney generals desperate for a product in persistent short supply.
Gilead could sell their priority review status for tens or potentially hundreds of millions of dollars, but told STAT that they wouldn’t.
“Gilead does not intend to sell the voucher, given the many investigational compounds in our pipeline that we believe have the potential to transform the treatment of serious diseases for individual patients and to advance global health,” they said.
The debate comes amid a larger, quieter one over the effectiveness of the priority review program in the first place. Based on a recent government accountability report, critics have argued a robust market for the vouchers never developed and cite “scant evidence” that they’ve encouraged drug development for rare diseases.
This is not the first time Gilead has come under fire for applying for FDA honors meant to accelerate development of rare or neglected diseases. The company was also called out after they applied for orphan drug designation due to the extended exclusivity the status brings. They applied for and received the designation shortly before US case counts broke 200,000, the ceiling for the rare disease honor, only to ask the FDA to rescind it amid public outcry.
Still, Gilead would not be the first company to receive a voucher for a widely used product. Sanofi received one for Dengvaxia, the dengue vaccine they positioned for years as a significant commercial opportunity.
However, the only two companies to receive such a voucher under the “material threat” provision that Gilead used developed a treatment and vaccine for smallpox — a virus that has bioterror potential but has no active market, having been eradicated off the face of the earth.