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

On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan designation 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 keionline.org/coronavirus.