Introduction
The world has never faced a crisis like COVID-19 (SARS-CoV-2), a pandemic health emergency. As of May 7, 2020, there are over 3.6 million cases (70,581+ new) and over 251,446 deaths of COVID-19 worldwide. (1) In order to develop effective vaccine against COVID-19, the US Food and Drug Administration (FDA) has initiated new procedures to expedite the development of potentially safe and effective life-saving treatments, called the Coronavirus Treatment Acceleration Program (CTAP).
Department of Health and Human Services (DHHS) Secretary Azar indicated in an address that the FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to the market as fast as possible. 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.
Under the CTAP, staff from the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will provide regulatory advice for the development of novel vaccines against the COVID-19 pedantic, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly. (2)
Advantages of the FDA Fast Track Process
According to the FDA, speeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments.
Fast-tracking allows manufacturers early and quicker access to valuable time-saving resources to advance a drug product to market as quickly and safely as possible. Because of the resources required to do this, the FDA does not grant Fast Track status lightly.
The designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need. A Serious Condition label is based on whether the drug will affect such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. For a drug to address an unmet medical need, the drug may be developed as a treatment or preventative measure for a disease which lacks an existing therapy. The type of information necessary to demonstrate an unmet medical need classification varies with the stage of drug development. In early development stages, nonclinical data, mechanistic rationale, or pharmacologic data will suffice. Later in the development stages, clinical data is strongly suggested. If there are already existing therapies, a fast track eligible drug must show some advantage over available treatment. These could include:
Showing superior effectiveness
Avoiding serious side effects of an available treatment
Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
Decreasing a clinically significant toxicity of an available treatment
Addressing &...
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