“The FDA is keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruption to supplier shortages of critical medical products in the U.S.,” FDA Commissioner Stephen Hahn said Tuesday, Feb. 25, during a Department of Health and Human Services (HHS) briefing on the COVID-19 outbreak.

While the FDA is proactively reaching out to manufacturers that may experience supply disruptions, Hahn said the agency is not aware of any shortages at this time. It will continue to monitor products that may be at risk, particularly personal protective equipment.

Hahn’s remarks came a day after Sen. Josh Hawley (R-Mo.) wrote to him demanding answers for how the agency will mitigate potential shortages. The senator’s letter cited reports that the outbreak of the novel coronavirus is threatening the domestic supply of about 150 prescription drugs, including antibiotics, generics and brands, many of which have no alternatives on the market.

“The FDA plays a key role in ensuring that Americans have safe and uninterrupted access to life-saving medications, and I urge that you take swift action to mitigate these shortages,” Hawley wrote in the letter, as he expressed “increasing alarm” about the security of the nation’s medical product supply chain.

While the concern about shortages has homed in on drugs, the threat could hit devices especially hard. In a Monday update on what the FDA is doing in lieu of onsite inspections of Chinese manufacturing facilities to ensure the quality of medical products intended for the U.S. market, the agency noted that more than 60% of the products it regulates that are imported from China are medical devices. Hawley recognized that threat in the questions he posed to Hahn, demanding answers within the week:

  • What actions has the FDA taken to ensure Americans don’t face shortages of life-saving drugs and devices?
  • What actions will the agency take in the coming weeks and months to ensure that safe alternatives to scarce medical products are available for public use?
  • What additional resources has the FDA devoted to identifying vulnerabilities in the U.S. medical product supply chain?
  • What additional statutory authority, if any, does the FDA need to require information from manufacturers about the sourcing of component parts, active pharmaceutical ingredients or scarce raw materials in the medical products they produce?

Hawley also asked Hahn to commit to testifying in congressional hearings about the “severe, longstanding and unresolved vulnerabilities” in the U.S. supply chain that have been highlighted by the emergence and spread of COVID-19.

“The degree to which some of our own manufacturers rely on China to produce life-saving and life-sustaining medications is inexcusable,” the senator said. “It is becoming clear to me that both oversight hearings and additional legislation are necessary to determine the extent of our reliance on Chinese production and protect our medical product supply chain.”

No windfalls

Meanwhile, other lawmakers are worried that companies will reap a windfall from government-funded research and development of coronavirus diagnostics, vaccines and therapies. Such fears are spurred by NIH-funded trials like the randomized, controlled study that started Tuesday at the University of Nebraska Medical Center to test remdesivir against COVID-19.

Developed by Foster City, Calif.-based Gilead Sciences Inc., remdesivir is an investigational broad-spectrum antiviral treatment that has been previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome, which are caused by other coronaviruses.

The first trial to test a potential COVID-19 drug in the U.S., the NIH-funded study was designed based on ongoing trials of remdesivir in China and in accordance with World Health Organization consultations. The study can be adapted to evaluate additional investigative treatments and to enroll participants at other sites in the U.S. and worldwide, according to the NIH.

A few days before the remdesivir trial started, 46 members of Congress, led by Reps. Jan Schakowsky (D-Ill.) and Lloyd Doggett (D-Texas), signed on to a letter to President Donald Trump urging that HHS not grant private manufacturers an exclusive license to coronavirus vaccines and treatments in any government grant, contract or licensing agreement.

Instead, HHS and other federal agencies should issue limited licenses that require the products to be priced affordably, according to the letter. Also, HHS should be allowed to intervene if a manufacturer prices a vaccine or treatment at an excessive level.

“Providing exclusive monopoly rights could result in an expensive medicine that is inaccessible, wasting public resources and putting public health at risk in the United States and around the globe,” the lawmakers said in the letter.

Referencing a recent Public Citizen report critical of the current U.S. drug development model, the lawmakers claimed that while the NIH has spent nearly $700 million on coronavirus R&D, “pharmaceutical companies have devoted startingly little resources in research and development relating to coronaviruses.”

Acknowledging that much of the NIH funding is focused on early stage research, the House members reminded the president that all six active coronavirus clinical trials that started prior to the COVID-19 outbreak received taxpayer support.

The letter also called out the Biomedical Advanced Research and Development Authority’s (BARDA) recently announced expanded partnership with Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., to develop multiple monoclonal antibodies that, individually or in combination, could be used to treat COVID-19. The collaboration, which began in 2017, uses Regeneron’s Velocisuite technologies to quickly identify promising antibody candidates targeting specific pathogens, validating preclinical results and then developing the antibodies.

“There must be guardrails in place to prevent Regeneron from monopolizing the medicine and maximizing profits,” the lawmakers said, noting that, under the agreement, BARDA will pay for 80% of the R&D and manufacturing costs for promising treatments. They added that BARDA already has paid up to $8.9 million to Regeneron to support the development of a MERS treatment, including the costs of an investigational new drug application, clinical trials, and packaging and labeling.

While the letter pointedly claims that Regeneron has the two highest paid executives in the pharmaceutical industry, it ignores the total cost of developing a new product, which can be upwards of $2 billion, and the limited demand for a coronavirus treatment after an outbreak has been resolved.

Funding the response

Another concern that’s fueling political rhetoric on Capitol Hill is the Trump administration’s funding request for responding to COVID-19. In the early days of the outbreak, which were just a few weeks ago, HHS requested the authority to shift up to $136 million from other departmental funds to respond to the developing health emergency. But many in Congress wanted the administration to replenish and use the Public Health Emergency Fund, which was depleted eight years ago after two decades of Congress refusing to put any more money into it.

To date, several federal agencies have contributed significant resources and personnel to support the domestic and international response to the outbreak, using their existing funding. But given the spread of the coronavirus and how much is still unknown about it and the disease it causes, the administration officially asked Congress Monday to appropriate $1.25 billion to the Public Health and Social Services Emergency Fund at HHS to continue supporting critical response and preparedness activities.

“Federal resources are necessary to take steps to prepare for a potential worsening of the situation in the United States,” the White House Office of Management and Budget (OMB) said in the request. Altogether, the administration expects to allocate at least $2.5 billion in response to COVID-19. The additional funding would come from transferring existing funds, including $535 million in emergency supplemental funding set aside for Ebola.

The administration said the funding would support all aspects of the U.S. response, including public health preparedness and response efforts; public health surveillance, epidemiology, laboratory testing and quarantining costs; advanced R&D of new vaccines, therapeutics and diagnostics; advanced manufacturing enhancements; and the Strategic National Stockpile. Funds also would be made available, as necessary, to states that are part of the current national response, OMB said in its request.

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