Gilead Sciences Statement on State Attorneys General Letter on Remdesivir
Gilead is deeply disappointed that a group of state Attorneys General have chosen to misrepresent facts on access to our investigational antiviral remdesivir, which has been authorized for emergency use by the FDA for the treatment of COVID-19. Their recent letter to HHS Secretary Azar, NIH Director Collins and FDA Commissioner Hahn is premised on multiple factual inaccuracies and a fundamental lack of understanding of how remdesivir is being used to treat patients.
One significant factual error is the assertion that all 3.5 million current COVID-19 patients should be treated with remdesivir. This assertion ignores the fact that not all COVID-19 patients are eligible to be treated with remdesivir and, thankfully, many will recover prior to hospitalization and never need the drug. Under the Emergency Use Authorization (EUA), remdesivir is only indicated for use by hospitalized patients with severe COVID-19. Remdesivir additionally must be administered by intravenous infusion. Current NIH guidelines recommend that remdesivir be prioritized for hospitalized patients requiring supplemental oxygen. This represents a very small percentage of patients diagnosed with COVID-19 and, as of today, most eligible patients hospitalized in the U.S. are able to get remdesivir.
Gilead is investing more than $1 billion this year to expand its manufacturing capacity for remdesivir, including bringing on board numerous manufacturing partners around the world, and plans to invest significantly more in 2021, if needed. This will enable Gilead to manufacture two million courses of therapy this year, and we expect to meet and exceed actual projected patient demand for remdesivir globally in October. Through our proactive efforts, we have increased supply more than 50-fold since January of this year.
The AGs' letter also fails to account for the value remdesivir provides to patients and the U.S. healthcare system. It erroneously asserts that remdesivir will increase patient out-of-pocket costs, when the reality is patients will not be billed separately for remdesivir when treated in an inpatient hospital setting. The AGs’ letter ignores the significant savings hospitals will see from shortening COVID-19 patients’ average time to recovery by four days, resulting in earlier discharge for many patients.
Further, the regulatory actions proposed by the AGs’ request are not only unauthorized under these circumstances, they will do nothing to speed access to remdesivir. Proposals to allow generic manufacturers to make remdesivir ignore the fact that it takes six to 12 months to manufacture remdesivir. The use of “march-in” rights under the Bayh-Dole Act will do nothing to produce additional doses of remdesivir this year and will discourage other manufacturers from investing in the development of new therapies and vaccines that hold the potential to better treat and one day eliminate COVID-19, as well as meet the challenges of future pandemics.
Gilead will encourage the Administration to remain focused on ensuring that U.S. patients continue to receive access to remdesivir and maintaining incentives for Gilead and others to continue to invest in developing much needed treatments and vaccines.
Remdesivir is an antiviral product that is being studied in multiple ongoing international clinical trials. In recognition of the current public health emergency and based on available clinical data, the approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir have not been established.
Remdesivir has not been approved by the U.S. Food and Drug Administration (FDA) for any use. In the U.S., the FDA granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. This authorization is temporary and may be revoked, and it does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.shenx60.icu/remdesivir.