The FDA is Being Kept Very Busy - And That's Good | Citizens Against Government Waste

The FDA is Being Kept Very Busy - And That's Good

The WasteWatcher

On March 31, the Food and Drug Administration (FDA) announced the “Coronavirus Treatment Acceleration Program.”  This new program is “part of the Trump Administration’s all-hands-on-deck approach across public, academic, and private sectors to combat the COVID-19 pandemic.”

The goal is to provide a rapid review of potentially safe and effective life-saving treatments that are being developed by pharmaceutical companies and get the therapies to patients with COVID-19 as quickly as possible.  Many of the products being considered have not been through the FDA approval process and are investigational.

To make this work, the agency is having their staff review requests day and night from companies, scientists, and doctors that are working on a variety of therapies.  Those that are developing their COVID-19 related therapies often need regulatory advice, guidance, and technical assistance from the FDA so they can get their products considered as quickly as possible.  Many are looking to get their products into a clinical trial or request an emergency use authorization to use an investigational product on a patient.

The agency has created review teams made up of medical and regulatory staff specifically dedicated to COVID-19 therapies to make the advisory and review processes quick and efficient.

Some of the therapies that are being developed and evaluated at the FDA are antivirals drugs that may already be approved for other diseases or under investigation for another virus but may be also effective against the coronavirus that causes COVID-19.  Other products may not be a specific therapy to attack the virus but help patients to breath easier.  The FDA has also approved the emergency use of convalescent plasma, which is antibody-rich plasma taken from the blood of people who had and recovered from the virus.  That plasma is being used in patients currently suffering with COVID-19.

There are several companies that are researching and developing or providing COVID-19-related products at lightning speed.  Some examples of products that are keeping the FDA very busy are:

AbbVie – The company is collaborating with the FDA and other health agencies in the U.S. and around the world to determine the effectiveness of Kaletra in treating patients with COVID-19.  Kaletra is a combination of antiviral drugs lopinavir and ritonavir, which prevent HIV from multiplying in the body.

Eli Lilly – The company announced it has entered into an agreement with AbCellera, which specializes in antibody therapies, to create products to treat and prevent COVID-19.  AbCellera received blood from one of the first patients that recovered from the disease, screened over 5 million immune cells looking for the ones that produced the antibodies that helped the patient recover. 

Gilead - The company is working with government and non-government organizations to provide its investigational compound remdesivir in clinical trials for COVID-19.  Remdesivir has demonstrated promise in pre-clinical data against similar coronaviruses MERS and SARS.

GlaxoSmithKline – The company had made its vaccine adjuvant technology available to scientists working on COVID-19 vaccines.  An adjuvant is important, particularly in a pandemic, because it can reduce the amount of a vaccine protein needed in each dose, thus help more people.  An adjuvant enhances the immune response and produce more antibodies and can create a longer lasting immunity.

Johnson & Johnson – The company has been working on a vaccine since January 2020 and expects to initiate human clinical trials by September 2020. The company anticipates the first batch will be available for use under emergency use authorization by early next year.

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