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Analysis

FDA Takes 'Aggressive' Measures to Stimulate COVID-19 Pharmaceutical Solutions

By Mandy Roth  
   March 19, 2020

Trump and FDA Commissioner outline mechanisms being used to access drugs, cite specific therapies that could be approved within months. PhRMA says 80 trials are underway that could help.

In the battle to subdue COVID-19, the U.S. Food & Drug Administration (FDA) is engaged in "aggressive" measures to "break down barriers to innovation and to accelerate the development of lifesaving treatments," according FDA Commissioner Stephen Hahn, MD.

By accelerating initiatives, removing red tape, and promoting collaboration, new therapies to treat the virus could be available within weeks or months, said President Donald Trump. Although work on one vaccine is already in progress, and other studies are underway, those solutions will take longer to develop, he added.

Hahn and Trump spoke at the White House Coronavirus Task Force press conference on Thursday, outlining numerous initiatives designed to offer relief to providers who currently have few treatment options. Among the possibilities:

  1. Compassionate Use. Among the mechanisms being used to get drugs into the hands of providers and patients is compassionate use, also known as expanded access. This enables physicians to request use of an experimental drug outside of clinical trials for patients with an immediate life-threatening condition or serious disease.
     

"We have criteria and very speedy approval for that," said Hahn. In cases where drugs are employed for compassionate use, data collected from those experiences helps determine the safety and efficacy of these treatments, he explained.

  1. Drugs Approved for Other Uses. The FDA is reviewing drugs that have already been approved abroad or in the U.S. for other uses.
     
  2. Right to Try. Right to Try is another way to access drugs for patients in certain circumstances, said Trump. Typically, according to the FDA, patients have been diagnosed with life-threatening diseases or conditions, have tried all approved treatment options, and are unable to participate in a clinical trial to access certain unapproved treatments.
     

Promising Solutions Are Being Explored

Two drugs and one therapeutic solution under development were specifically mentioned during the press conference.

  • Trump and Hahn both mentioned hydroxychloroquine—commonly prescribed for malaria, as well as acute and chronic rheumatoid arthritis—is being explored for treatment of COVID-19.  

"The president has directed us to take a closer look at [hydroxychloroquine] as to whether an expanded use approach to that could be done to see if that benefits patients," said Hahn. "We want to do that in the setting of a large pragmatic clinical trial."

  • The president also mentioned remdesivir, manufactured by Gilead, based in Foster City, California. According to the company's website, "Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity—it is not approved anywhere globally for any use. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19."
     
  • In addition, a cross-agency effort to explore the use of convalescent plasma in the treatment of COVID-19, is underway, said Hahn. As the coronavirus issue began to unfold, Hahn said the FDA assisted other countries in exploring this methodology. The process involves collecting blood from recovered patients, concentrating it and treating ill patients with the pathogen-free serum, which contains immunoglobulins, or antibodies, to fight the disease. "This is not a proven treatment," said Hahn.

While Hahn said the FDA is accelerating development of vaccines and therapeutic solutions, ensuring safety was paramount. "We're trying to provide … regulatory flexibility, but at the same time, scientific oversight to make sure that it gets done in the best way possible for the American people."

80 Trials Underway That Could Help with COVID-19, Says PhRMA CEO

On Wednesday, the Pharmaceutical Research and Manufacturers of America, also known as PhRMA, which represents the country’s leading biopharmaceutical research and biotechnology companies, held a press briefing and outlined measure its members are taking to fight COVID-19.

"Our industry has invested billions in existing therapies that can potentially be used to treat infected patients," said PhRMA President and CEO Stephen J. Ubl. "There are now more than 80 such trials already underway and we could have approved treatments in a matter of months."

Companies involved in these endeavors "are taking substantial risks in this process, but we're doing it for the good of public health," Ubl said. Among the risks he cited were the complexity of the immune system which is why "large clinical trials are necessary to establish safety and efficacy," he said. Also, "not all potential vaccines will succeed, which is why it's really important to have as many shots on goal as possible and why it's encouraging that we will have several viable candidates." And finally, Ubl said that demand can change dramatically and unpredictably.

Ubl also addressed the issue of costs. "We're also working with government and insurers to ensure that when new treatments and vaccines are approved, it will be available and affordable for patients," he said. "Companies have a track record of pricing responsibly during pandemics, and we don't expect affordability will be a problem this time."

Representatives from GSK, Lilly, Pfizer, Sanofi, and Takeda also spoke during the PhRMA media briefing and presented COVID-19 initiatives underway at their companies, along with the biopharmaceutical industry’s efforts to prevent, diagnose, and treat coronavirus. Many of these leaders spoke of an unprecedented level of cooperation between competing companies to devise solutions to the pandemic.

“We're trying to provide … regulatory flexibility, but at the same time, scientific oversight to make sure that it gets done in the best way possible for the American people.”

Mandy Roth is the innovations editor at HealthLeaders.


KEY TAKEAWAYS

Compassionate use, Right to Try, and drugs approved for other uses are among the mechanisms being explored for rapid relief.

Hydroxychloroquine, remdesivir, and convalescent plasma are being explored as treatment options.

Pharmaceutical industry association PhRMA says 80 trials are underway with drugs that could help with COVID-19.


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