Letter to Vice President Mike Pence, Robert Kadlec, Assistant Secretary for Preparedness and Response, Stephen Hahn, Commissioner for the FDA, and Peter Gaynor, Admin. of FEMA - Peters, Murray Call on Administration to Take Aggressive Actions to Address Coming Critical Drug Shortages during Coronavirus Pandemic

Letter

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:

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.

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.

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.

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.

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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