[Ip-health] Axois: HHS Sec Azar and FDA Commissioner were blindsided by remdesivir Orphan designation

James Love james.love at keionline.org
Sun Mar 29 11:28:06 PDT 2020


Mar 26, 2020
Special status for coronavirus drug caught health officials off guard
Caitlin Owens
When an experimental coronavirus treatment received a special designation
from the Food and Drug Administration on Monday, it came as a surprise to
the government's top health care officials — including the FDA commissioner.

Why it matters: Top officials aren't normally involved in everyday
regulatory decisions. But this particular designation was particularly
controversial, as critics quickly questioned whether it was giving an
unfair financial advantage to one drugmaker in the midst of a pandemic.

Background: Pharmaceutical company Gilead Sciences is running clinical
trials to test whether one of its drugs, called remdesivir, is an effective
treatment against the novel coronavirus.

On Monday, the FDA granted remdesivir status as an "orphan" drug.

Orphan status is reserved for drugs that treat rare diseases. It gives
their developers lucrative perks, such as an extended monopoly and tax
credits, as an incentive to develop drugs that will only ever have a small
At the time of the designation, fewer than 200,000 people had been
diagnosed with the coronavirus in the U.S., which is the legal threshold
for an orphan drug. But the virus is obviously spreading fast, and experts
say it could eventually afflict a huge percentage of Americans.

The intrigue: Health and Human Services Secretary Alex Azar, FDA
Commissioner Stephen Hahn and Janet Woodcock, who leads the FDA office in
charge of new drugs, weren't aware ahead of time that remdesivir was
receiving orphan status, according to multiple sources familiar with the

"It's unfathomable that the secretary and commissioner would be blindsided
by their own agency on a major decision that was certain to be criticized.
We're not going to find cures for a global pandemic such as COVID-19 by
doling out exclusivity for one company and boxing out creative ideas," a
senior HHS official told me.

The other side: "The FDA's initial orphan drug designation for remdesivir
to treat COVID-19 was conducted in a similar manner as all determinations
for this designation within the Office of Orphan Products Development and
made based on standard legal and regulatory criteria," the FDA said in a

Gilead said yesterday that it was asking the FDA to rescind the orphan

James Love.  Knowledge Ecology International
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