April 30, 2020, New York City. The Center for Medicine in the Public Interest (www.cmpi.org) urges the Food and Drug Administration to grant Gilead’s remdesivr an emergency use authorization. Under an EUA, the FDA does not grant formal market approval to a product. Instead, as it has done with several diagnostics and drugs such as hydroxycholoroquine, EUA allows doctors to provide access to products with early data showing clinical benefit for whom a clinical trial is not available, or participation (in a trial) is not feasible.
Further, the FDA, NIH and integrated health systems should be collecting real world data on how patients are doing on remdesivr through a parallel-track system.
As noted in a recent CMPI article: “AIDS activists wanted to expand the evaluation of other potential HIV drugs beyond people who were enrolled in clinical trials. In 1990, they "collaborated with Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID) to come up with a plan called "parallel track." Under the parallel-track system, patients could receive drugs if they were unwilling or unable to participate in the typical clinical trial.
Formal clinical trials for remdesivir as well as hydroxychloroquine can be conducted while the community studies are taking place.
To facilitate the establishment of parallel track studies, CMPI recommends the following:
Paying physicians, accountable care organizations, Medicare advantage plans, urgent care centers an additional $50 per patient per month to provide care and enter data related to the use of remdesivir, hydroxychloroquine and other modalities, separately or in combination.
The Patient-Centered Outcomes Research Institute, NIH, FDA, DARPA, BARDA, along with biopharmaceutical companies, insurers, health information companies should fund the establishment of an open source data repository that can be accessed by researchers, patient organizations, clinicians, etc. The federal government, along with the funders of an open source data repository, should grants to community-based researchers that establish a parallel track study program. Additionally, any data collected must be stored consistent with recent HHS regulations that allow patients access to their medical information.
Further, consistent with FDA guidance, the collection and analysis of real-world data, should demonstrate that a treatment effect is present and predictable. As Janet Woodcock has noted: The question FDA must answer is ‘can you make a causal inference’ from the data?
As an incentive to support the parallel track process, the FDA should provide approval for use based on the evidence of treatment effect. Health plans should pledge not to use step therapy, prior authorization or cost sharing to delay access to those products approved under a parallel track pathway. Pharmaceutical companies should pass any discounts or rebates directly to patients or price products to ensure patients have no out of pocket cost for their products.
Remdsivir studies show no new safety signals and positive impact on those hospitalized with serious manifestations of COVID-19. An emergency use authorization is the right and sound decision for the FDA.
