Peters, Murray Call on Administration to Take Aggressive Actions to Address Coming Critical Drug Shortages during Coronavirus Pandemic

Health Care Providers Could Face Shortages of Paralytics, Sedatives and other Critical Drugs for Coronavirus Patients, Putting Lives at Risk

WASHINGTON, DC – U.S. Senators Gary Peters (D-MI), Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, and Patty Murray (D-WA), Ranking Member of the Health, Education, Labor & Pensions (HELP) Committee, are calling for the Federal Emergency Management Agency (FEMA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Food and Drug Administration (FDA), and the White House Coronavirus Task Force to take immediate action to prepare for and prevent anticipated critical drug shortages during the pandemic. Currently, medical professionals are suffering from a shortage of personal protective equipment and ventilators because of a lack of preparedness – and the federal government must take aggressive action to prevent shortages of critical drugs needed to treat Coronavirus (COVID-19) patients from similarly wreaking havoc on our nation’s health care system during this public health emergency. Drugs including antibiotics, antivirals, sedatives and pain management medication are all at risk of shortages due to the Coronavirus pandemic, and without action to address these supply chain issues, patients could be left without access to the medicine they need to survive.

“Given missed opportunities to prepare for and head off shortages of critical medical supplies and protective equipment, it is imperative that the federal government learn from its failures and act now to procure, supply, and sustain our nation’s current stock of lifesaving and life-sustaining drugs essential to treat patients battling COVID-19,” the Senators wrote. “Our medical professionals are doing everything they can to save lives but we must ensure they have the medication necessary to properly treat patients.”

Michigan has the third highest number of COVID-19 cases in the country, and hospitals in Michigan are currently experiencing a shortage of critical drugs used for placing patients on ventilators. Washington, another early hotspot of the Coronavirus pandemic, faces similar problems and pharmacists in the state have warned of critical drug shortages. Senator Peters raised concerns about vulnerabilities in the medical supply chain in a December report, outlining steps that needed to be taken to address critical drug shortages impacting hospitals across the country. Even before the Coronavirus pandemic arose, active drug shortages in the U.S. were at their highest levels in almost five years. As Peters’ report found, these shortages are, in part, due to U.S. overdependence on foreign pharmaceutical supply chains. The U.S. is the largest consumer of pharmaceutical products in the world, but over 80% of the active ingredients in prescription drugs sold in the U.S. now come from foreign countries, primarily China and India.

The Senators requested detailed information on the Administration’s plan to address forthcoming drug shortages including the current status of critical drugs held in the Strategic National Stockpile, the drug requests made by states struggling with the Coronavirus pandemic, and a list of the Administration’s contracts and procurement proposals to obtain the critical drugs needed to combat COVID-19, among other critical information.

Text of the letter is copied below and available here

 

April 8, 2020

 

The Honorable Mike Pence                                        The Honorable Robert Kadlec, M.D.
Vice President of the United States                            Assistant Secretary for Preparedness
The White House                                                        and Response
Office of the Vice President                                       U.S. Department of Health & Human
1600 Pennsylvania Avenue N.W.                               Services
Washington, DC 20500                                              200 Independence Avenue, S.W.
                                                                               Washington, D.C. 20201

The Honorable Stephen M. Hahn, M.D.                    The Honorable Peter Gaynor
Commissioner of Food and Drugs                              Administrator
U.S. Food and Drug Administration                          Federal Emergency Management Agency
10903 New Hampshire Ave                                       500 C Street, S.W.
Silver Spring, MD 20993                                           Washington, D.C. 20024

 

Dear Vice President Pence, Assistant Secretary Kadlec, Commissioner Hahn, and Administrator Gaynor:

We write to urge you to take immediate and necessary steps to mitigate and prepare for critical drug shortages as our country’s health care providers fight the growing number of Novel Coronavirus 2019 (COVID-19) cases throughout the United States. Given missed opportunities to prepare for and head off shortages of critical medical supplies and protective equipment, it is imperative that the federal government learn from its failures and act now to procure, supply, and sustain our nation’s current stock of lifesaving and life-sustaining drugs essential to treat patients battling COVID-19.

Our medical professionals are doing everything they can to save lives but we must ensure they have the medication necessary to properly treat patients. Placing a patient on a ventilator so that they can keep breathing requires administering certain paralytic drugs. Keeping a patient alive on a ventilator requires additional sedatives and other drugs. Ensuring a patient does not suffer from a secondary infection or septic shock requires other critical drugs, including antibiotics, antivirals, IV fluids, and antihypotensives. As states across the country face growing numbers of cases, hospital needs are especially critical, and as one doctor in New York put it, “[w]e’re running out of all the drugs.” Senator Peters raised such concerns in a December report regarding the need to take steps to address critical drug shortages faced by hospitals across the United States, before this pandemic even arose.

Reports indicate that in the past month, orders for sedatives like morphine, propofol, and midazolam have increased between 60 and 100 percent. Similarly, during that same time frame, orders for antibiotics and antivirals nearly tripled.

While there is a spike in demand, orders are not being filled at the same rate. We were disturbed by reports that the Department of Health and Human Services waited until March 4 to procure essential N95 respirators despite evidence in early February about the lack of critical personal protective equipment in the U.S. and throughout the world. The Administration cannot make the same mistake in delaying its response for critical drugs given an already fragile supply chain.

To ensure our nation’s health care providers are able to meet the needs of patients as we continue to fight this pandemic, we request that you take immediate steps to ensure critical medications do not go into shortage. Please provide the following information no later than April 14, 2020, with respect to the Administration’s efforts to prevent critical drug shortages:

  1. The number of drug products currently held in the Strategic National Stockpile. This number should be broken down by category (e.g. sedatives, paralytics, antibiotics, antivirals, IV fluids, and antihypotensives, etc.) and further broken down by medication and corresponding expiration date.

  2. The number of requests by states for drug products from the Strategic National Stockpile during COVID-19. For each request, include the following: state that made the request; date of request; specific drugs requested; date(s) request filled; and percentage of request filled.

  3. The Agency responsible for procuring and distributing critical drugs that will likely experience a significant increase in demand during this pandemic.

    • A list of the federal government’s contracts/procurements, including but not limited to requests for proposals, for critical drugs necessary to combat COVID-19.

  4. The Administration’s plan for allocating needed resources from the Strategic National Stockpile, including lines of authority between and among officials at the Department of Health and Human Services (HHS), the Department of Homeland Security (DHS), and the White House Coronavirus Task Force; the responsible agency and official for ensuring critical drugs reach pharmacies, hospitals, and other health care facilities; and “last-mile” delivery plans to ensure needed medications reach intended recipients.

  5. The Administration’s plan to address and prevent continued drug shortages, including, without limitation, steps taken to (1) coordinate with manufacturers and distributors, including Food and Drug Administration coordination with manufacturers to assess and address impacts to supply chains, and (2) assess whether additional modifications are necessary to address production limitations under current Drug Enforcement Administration quotas.

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