Dear Dr. Woodcock,

We, the undersigned, respectfully request the U.S. Food and Drug Administration (FDA) reconsider its limitation of the recently released Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency (Docket FDA-2020-D-1106).

The policy waives certain Risk Evaluation and Mitigation Strategies (REMS) requirements – namely laboratory tests and imaging – but not others. The requirements that certain drugs must be dispensed in-person by certain medical professionals provides similar burdens and risks to patients and providers as the waived requirements. Therefore, we request that in-person dispensation requirements, specifically for mifepristone, be included in this policy as temporarily waived.

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Excerpt of CNN articles that features GJC President Akila Radhakrishnan.

Akila Radhakrishnan, president of the Global Justice Center, said the call "recognizes how violence and crisis situations exacerbate existing inequalities in society and emphasize the need to center those most impacted in responses."

"However, to date, we have consistently seen that Covid-19 responses have inadequately taken women’s rights and human rights into account. And there’s been a lack of inclusivity in the groups responsible for crisis response and decision-making," she said.

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NEW YORK – United Nations Secretary-General António Guterres gave an address today on violence against women living under quarantine measures issued to stop the spread of COVID-19.

Akila Radhakrishnan, president of the Global Justice Center, had the following response:

“We applaud the Secretary-General for his important call today to end violence against women, which recognizes one of the key gendered impacts of crises situations such as COVID-19. 

“Like his call for a global ceasefire, today’s call recognizes how violence and crisis situations exacerbate existing inequalities in society and emphasize the need to center those most impacted in responses. However, to date, we have consistently seen that COVID-19 responses have inadequately taken women’s rights and human rights into account. And there’s been a lack of inclusivity in the groups responsible for crisis response and decision-making. 

“As the Secretary-General recognized, violence against women requires a multi-faceted response, including access to support services and shelters and judicial systems. We hope that states heed this important call and take immediate measures to ensure that measures are taken to prevent and respond to domestic violence, and ensure that all measures are grounded in human rights and involve an inclusive group of women in its design and decision-making.”

(BANGKOK, April 2, 2020)—The Government of Bangladesh should immediately take all necessary steps to protect Rohingya refugees and nearby host communities in Cox’s Bazar District from COVID-19 infection, said Fortify Rights and 49 human rights organizations in an open letter today. The authorities should immediately lift all restrictions that prevent Rohingya refugees from freely accessing mobile communications and the internet and also halt the construction of fencing aimed to confine Rohingya refugees in camps.

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