[Ip-health] FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status Application is ‘Confidential’

Claire Cassedy claire.cassedy at keionline.org
Wed Mar 25 08:12:52 PDT 2020


FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status
Application is ‘Confidential’

Posted on March 25, 2020 by Claire Cassedy

On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan
designation[1] from the US Food and Drug Administration (FDA) for the
treatment of COVID-19. Remdesivir has been reported to be one of the
candidates to potentially treat COVID-19, which the World Health
Organization (WHO) has officially declared to be a pandemic and the US
Centers for Disease Control and Prevention (CDC) has declared a public
health emergency.

When considering a company’s application for orphan designation, the FDA
considers a disease to be rare and eligible for orphan status if it:

-“Affects less than 200,000 persons in the United States, or
-Affects more than 200,000 in the United States and for which there is no
reasonable expectation that the cost of developing and making available in
the United States a drug for such disease or condition will be recovered
from sales in the United States of such drug.”
Critically, the statute notes that “Determinations under the preceding
sentence with respect to any drug shall be made on the basis of the facts
and circumstances as of the date the request for designation of the drug
under this subsection is made.” 21 U.S.C. § 360bb(a)(2).

KEI reached out to the FDA to ask under which criteria Gilead had sought
orphan status, and at what date did Gilead submit the application for the
orphan designation. As the determination of orphan status is “made on the
basis of the facts and circumstances of the date of the request for
designation[,]” this information is critical for the public to assess the
circumstances under which the FDA has allowed this potential pandemic
treatment to be considered a treatment for a rare disease.

The FDA’s response:

“Orphan drug designation was granted for Remdesivir because the disease or
condition for which the drug is intended (COVID-19) had been diagnosed in
fewer than 200,000 people in the United States at the time of submission of
the orphan drug designation request was submitted, which is the standard
criteria for prevalence for designations.”

Regarding when the orphan drug designation request was submitted, the FDA
stated that it was, “*unable to share that information as it’s considered
commercial confidential*.”

With the date of submission such an absolutely critical piece of data in
this case, it is incredible that the FDA would state that this is
commercial confidential data.

The orphan designation is intended to give a seven year regulatory monopoly
to “rare” diseases in the US. Under the designation announced today, the
FDA would not be allowed to register an generic version for use for
COVID-19 for 7 years, allowing Gilead an incredible monopoly on a potential
treatment for a global pandemic, and giving them the power to charge
incredibly high , national-budget breaking prices for remdesivir. It is
appalling that the FDA would hand over such a powerful monopoly in such an
unprecedented time, and insist that the date of submission is confidential
information when a corporation is seemingly manipulating statutes in order
to ensure market superiority that was intended to help stimulate innovation
in the treatment of truly rare diseases.

We do note that there are patents filed for the compound in remdesivir.
While the US government can override patent rights under 28 U.S.C. § 1498,
there is no similar exception for orphan exclusivity.

This action by the FDA also sets a dangerous precedent. There are several
other candidates in the pipeline that have been reported to potentially
treat COVID-19, some of which are off patent, and if other companies were
to follow suit in seeking orphan designation (at the time of publication
there are 54,000 diagnosed cases in the US, and 430,000 globally) it would
severely impact broad, affordable access to whichever treatment proves most
effective against this global pandemic.

For more on KEI’s work on COVID-19, see:

[1] https://www.keionline.org/32546

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