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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WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) today held a video conference meeting with Crawford County-area leaders to give an update on federal COVID-19 efforts and hear from local health providers, businesses, education leaders and city, county and state officials.

“Speaking with community and business leaders across Crawford County was important as I work to understand how relief efforts we’ve passed a the federal level are impacting our communities and what my office can do to better assist the Pittsburg area during the COVID-19 pandemic,” said Sen. Moran. “The meeting was also an opportunity for me to provide an update on my efforts to increase testing in Kansas and assist with PPE production. I also spoke on the SBA’s Paycheck Protection Program and the health care provider relief fund program, which deposited resources into local hospitals’ accounts yesterday.”

“I was pleased to hear the level of coordination happening in Crawford County between health care providers and local law enforcement, and that the relief from SBA’s Paycheck Protection Program has been afforded to some local businesses and their employees,” continued Sen. Moran. “Thank you to all the local leaders for joining the meeting this Easter weekend and for all of their hard work to help and protect Kansans. As President Scott reminded us during the meeting, it is important now more than ever to, ‘Tell the truth, give people hope, and tell people how they can help.’”

Sen. Moran’s Video Conference Meeting Included:

• Rebecca Adamson, County Health Department Director
• Blake Benson, Pittsburg Area Chamber of Commerce President
• Ken and Debbie Brock, Business leaders
• Ruth Duling, Girard Medical Center CEO
• Daron Hall, Pittsburg City Manager
• Richard Hilderbrand, State Senator
• Brian Jones, Business leader
• Kevin Mitchelson, Business leader
• Monica Murnan, Kansas State Representative
• Shawn L. Naccarato, Pittsburg State University
• Steve Scott, Pittsburg State University President
• Danny Smith, Sheriff
• Drew Talbott, Pittsburg Via Christ Vice President of Operations
• Jared Turnbull, Banker with SBA loans
• Bruce Blair, Chair, Crawford County Commission

# # #

WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) today announced $325 million in relief funding to Kansas health care providers and hospitals. This information was confirmed to Sen. Moran by Vice President Mike Pence this morning. The funding, which will support hospitals fighting COVID-19 on the frontlines, is part of the $100 billion provider relief fund established in the Phase III Coronavirus Aid, Relief, and Economic Security (CARES) Act and is being administered by the U.S. Department of Health and Human Services (HHS).

 “The CARES Act created a fund to help meet the needs of hospitals and health care providers, and today over $325 million is being distributed across Kansas,” said Sen. Moran. “As hospitals are seeing significant revenue losses and others see their costs go up because of COVID-19, these new resources will be a necessary benefit not just to our hospitals, but to the communities and patients they serve. In the fight against COVID-19, these new resources will put our health care providers in a better position to keep us healthy and meet the needs of Kansans.”

 

# # #

WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) today led a bipartisan group of eight other Senators urging Senate leadership to clarify eligibility for publicly owned hospitals and similar care providers within the Paycheck Protection Program (PPP) administered by the U.S. Small Business Association (SBA). Currently, both for-profit and non-profit hospitals are eligible for assistance, creating a disparity this clarification seeks to resolve. The PPP was provided an additional $350 billion in the Phase III Coronavirus Aid, Relief, and Economic Security (CARES) Act to support businesses impacted by COVID-19.

In response to cautionary guidance from the Centers for Disease Control (CDC), many hospitals are canceling routine procedures and appointments, resulting in revenue declines as high as 80 percent. Over the past decade, 128 hospitals have closed and an additional 450 hospitals are at-risk of closure. The COVID-19 pandemic puts public hospitals at increased risk of closure.

“Many of these hospitals are the sole provider for health needs in their community and their closure would leave wide areas of America with even greater access to care issues than ever before, which we simply cannot risk during this pandemic,” the Senators wrote. “As nearly one quarter of rural hospitals were financially struggling before the burden of COVID-19, Congress must provide immediate relief in the form of eligibility for the loans in the Paycheck Protection Program to allow them to continue operating until additional assistance can be made available.”

Sen. Moran was joined by U.S. Senators Cindy Hyde-Smith (R-Miss.), John Boozman (R-Ark.), Cory Gardner (R-Colo.), Shelley Moore Capito (R-W.Va.), James Lankford (R-Okla.), Kevin Cramer (R-N.D.), Joni Ernst (R-Iowa) and Joe Manchin (D-W.Va.).

The full letter is below and here.

April 9, 2020

The Honorable Mitch McConnell
Majority Leader, U.S. Senate
U.S. Capitol, S-230
Washington DC 20510

The Honorable Chuck Schumer
Minority Leader, U.S. Senate
U.S. Capitol, S-221
Washington DC 20510

Dear Leader McConnell and Leader Schumer,

Thank you for your efforts and collaboration on the substantial assistance packages passed through Congress to address the economic consequences of the COVID-19 crisis. As you know, the economic difficulties facing our hospitals during this crisis threaten significant, long-term consequences. As routine procedures and appointments are canceled due to cautionary guidance from the Centers for Disease Control and Prevention our hospitals in many areas are facing revenue declines as high as 80%. Our small rural hospitals regularly struggle with their razor-thin margins but are now facing difficult choices that range from significant staff furloughs to permanently closing the doors of their community’s lone hospital. Many of these hospitals are small, county-owned public hospitals who are currently denied access to funding included by Congress in the CARES Act. We ask that you clarify that publicly owned hospitals and similar care providers are eligible entities for the Paycheck Protection Program relief program administered by the Small Business Administration.

According to the National Rural Health Association and the Cecil G. Sheps Center for Health Services Research at the University of North Carolina, 128 hospitals have closed since 2010 and an additional 450 were considered at-risk of closure leading into this crisis. These hospitals are often not only an important care provider, but are also one of the largest employers in many small towns. The health and economic burdens of these institutions shutting down due to temporary cash-flow complications during this crisis is something that is entirely avoidable. This issue is particularly difficult for our public hospitals who are ineligible for this assistance since they operate similar their for-profit and non-profit colleagues who are already eligible for the SBA loan program during this crisis.

Many of these hospitals are the sole provider for health needs in their community and their closure would leave wide areas of America with even greater access to care issues than ever before, which we simply cannot risk during this pandemic. As nearly one quarter of rural hospitals were financially struggling before the burden of COVID-19, Congress must provide immediate relief in the form of eligibility for the loans in the Paycheck Protection Program to allow them to continue operating until additional assistance can be made available.

As a Congress, we must prevent an unnecessary loss of providers and health workforce during this pandemic. This can be avoided by ensuring these needed entities are able to access the assistance Congress has already deemed necessary in the CARES Act. We would like to work with you to address this oversight through appropriate legislative changes in the upcoming additional funding package for the Paycheck Protection Program.