The FDA Tuesday announced the Coronavirus Treatment Acceleration Program, a comprehensive public-private approach to swiftly bring coronavirus treatments to market. "As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies,” U.S. Health and Human Services (HHS) Secretary Alex Azar said. Under the accelerator program, FDA staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will provide regulatory advice, guidance and technical assistance to sponsors as fast as possible. The FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, connecting them with relevant FDA staff and providing rapid, interactive input to get studies underway quickly. For instance, the agency has reviewed some study protocols within 24 hours and reviews single-patient expanded access requests generally within three hours. The FDA also is collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to further streamline efforts. "Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA's highest priorities,” FDA Commissioner Stephen Hahn said. “We want to help patients by expediting promising treatments and are committed to maximizing our regulatory flexibility and proactively bringing the best innovators together to ensure we are getting the right treatments to the right patients at the right time."
Citing the COVID-19 public health emergency in the U.S., HHS formally issued a notice of emergency use authorization (EUA) declaration that enables the FDA to grant EUAs authorizing the emergency use of an unapproved drug or biologic and an unapproved use of an approved drug or biologic. The notice is scheduled for publication in the April 1, 2020, Federal Register, but it became effective March 27 when Azar signed it.
To expedite the development of COVID-19 diagnostics and therapies, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is shortening the clinical trial notification (CTN) timeline for starting first-in-human trials. Normally, a sponsor must submit a notification at least 30 days before the planned start date of a trial. The PMDA said it is waiving that 30-day period for COVID-19 products, so long as it has completed its review of the trial plan. “Currently, several CTNs for clinical trials for COVID-19 are being submitted and processed expeditiously,” the agency said. “All these efforts, among others, not only expedite development of products for COVID-19, but also provide the people affected with a variety of investigational medical products.”
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) reported Tuesday that it has written to its phase I accredited units that are conducting early stage clinical trials to confirm that those trials have undergone a COVID-19 risk assessment. “All ongoing clinical trials should have already undergone a risk assessment in relation to COVID-19, including analysis of any potential risk to trial participants, in line with current government advice on social distancing and measures to reduce the spread of COVID-19,” the MHRA said. As a result of the new communication, which doesn’t apply to ongoing or proposed trials of COVID-19 therapies, “some trials may be temporarily halted or terminated, while some will continue if clearly justified, in order to protect or promote public and patient safety,” according to the MHRA.
The Biotechnology Innovation Organization joined a host of other industry trade groups in sending a letter last week to federal, state and local officials asking them to adopt the Department of Homeland Security’s definition of “critical infrastructure” and commit to keeping critical manufacturing facilities open across the nation. The letter warned that well-intentioned actions – such as curfews, quarantines and shelter-in-place orders – being taken at the state and local levels “may fundamentally impede or otherwise threaten the supply of critical products.” Curfews that fail to consider transportation and workforce needs “could quickly become significant barriers to not only supply chains, but also actual supplies,” the groups said, adding that state and local governments must understand the need to transport products and have the workforce available to keep operations running. The letter calls for the president, governors and mayors to commit to not creating artificial barriers to the transportation of necessary products and to work in a coordinated fashion to ensure the safe shipment of goods from manufacturing facilities to retailers.
The FDA followed up on its inspection of a Pfizer Healthcare India Pvt. Ltd. facility in Visakhapatnam, India, nearly six months ago with a warning letter citing failed sterility testing of injectable products, deficiencies in the facility’s environmental monitoring program, and data accuracy and integrity issues. For instance, the letter, posted Tuesday, said the company didn’t “adequately investigate serious deficiencies in microbiology laboratory conditions and practices.” Those deficiencies included an inadequate investigation of numerous instances over a one-year period of microbial growth on negative control plates and the invalidation of microbial results without sufficient scientific justification.