Last week, Gilead came under new criticism because when remdesivir was approved, the company was awarded a priority review voucher, an incentive that allows it to get expedited review from the agency for a future product, or to sell that right to another company. The vouchers, which can sell for about $100 million on the open market, are awarded to companies that develop products — such as ones that address a public health threat like a pandemic — that might not otherwise be profitable.
But remdesivir is already proving to be a significant moneymaker for Gilead.
“The idea behind the priority review vouchers program is that there’s relatively little financial incentives for companies to make drugs for some of these conditions,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis who studies drug policy. “If we think that this drug will be a blockbuster, then the reasons why we created the program would seem to apply with much less force here.”
The F.D.A.’s approval was surprising to some because it came just days after the release of results from the Solidarity trial, a large, global study of more than 11,000 people that found that remdesivir did not reduce deaths.
Both the F.D.A. and Gilead have noted, however, that the Solidarity trial had shortcomings, including that it was not compared with a placebo, as the trial sponsored by the National Institutes of Health was.
Now that Veklury is F.D.A.-approved, Gilead can begin marketing it, including to doctors and hospitals that might be reluctant to use the treatment.
Gilead said it did not plan to run television advertising for Veklury, but would deploy a “field team of medical and sales professionals to educate health care professionals across the country.”
Article source: https://www.nytimes.com/2020/10/29/health/covid-remdesivir-gilead.html