MANHATTAN – U.S. Senator Jerry Moran (R-Kan.) sent a letter to Food and Drug Administration (FDA) Commissioner Stephen Hahn requesting answers regarding the steps and resources necessary for American manufacturers to start making Personal Protective Equipment (PPE) such as masks, medical gowns and gloves.

Kansas’ inventory of PPE is dangerously low, and manufacturers have expressed interest in shifting production to help bolster the state’s supply of PPE.

“The resolve of American manufacturers remains strong,” wrote Sen. Moran. “I am encouraged by the many manufacturers who have contacted my office wanting to help contribute to the production of needed health care equipment. It is time the federal government leverage the resources and innovation of our manufacturing base while working to remove any unnecessary barriers that could slow production.”

Sen. Moran’s questions to FDA:

1. To date, what steps has the agency taken to expedite the review and approval process for manufacturers seeking to produce PPE? 
2. When can manufacturers expect clear and detailed guidance to navigate this process?
3. Will specific manufacturing standards to assist industry production be included in published guidance?   
4. Will manufacturers be provided a direct and open means of communicating with your agency to ensure their questions are answered as expeditiously as possible?
5. Will manufacturers be compelled to sell equipment directly to FEMA or will they have the ability to contract with states and local governments?
6. Does the FDA require any additional resources or authorities from Congress in order to help expedite the private sector production of PPE?

The full letter is below and here.

The Honorable Stephen M. Hahn, M.D.
Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Dr. Hahn,

As the COVID-19 pandemic continues to spread throughout our nation and around the world, the global shortage of personal protective equipment (PPE) threatens to undermine our ability to combat the virus and save lives. We must explore new avenues to produce this equipment to make certain that doctors, nurses, first responders, and all individuals working on the frontlines are able to protect themselves and others from contracting COVID-19.

In Kansas, our state inventory of PPE is dangerously low. On Thursday, April 2^nd, Kansas received its latest shipment from the strategic national stockpile, the supply of which falls well short of our state’s anticipated needs in the weeks ahead. Several requests from the state of Kansas for additional gloves, masks, face shields, ventilators, and testing supplies remain unfulfilled^[1], and given the intense nationwide competition for PPE it is possible these supplies will never arrive.

Thankfully, the resolve of American manufacturers remains strong. I am encouraged by the many manufacturers who have contacted my office wanting to help contribute to the production of needed health care equipment. It is time the federal government leverage the resources and innovation of our manufacturing base while working to remove any unnecessary barriers that could slow production. As such, I respectfully request your timely response to the following questions:

1. To date, what steps has the agency taken to expedite the review and approval process for manufacturers seeking to produce PPE? 

2. When can manufacturers expect clear and detailed guidance to navigate this process?
3. Will specific manufacturing standards to assist industry production be included in published guidance?   
4. Will manufacturers be provided a direct and open means of communicating with your agency to ensure their questions are answered as expeditiously as possible?
5. Will manufacturers be compelled to sell equipment directly to FEMA or will they have the ability to contract with states and local governments?
6. Does the FDA require any additional resources or authorities from Congress in order to help expedite the private sector production of PPE?

Thank you in advance for your attention to these questions. I am grateful for your leadership and efforts during this challenging time to help keep Americans safe from the effects of COVID-19. I believe that all of us must do our part to make certain that the heroes working hard to protect us have the equipment they need to stay healthy and safe. If I can be of any service, please do not hesitate to contact me or my office.

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