What Does it Mean to “Fast-Track” a Drug?

Written By Robin Jabour

There is no lack of news about COVID-19.  Every day there are press conferences offered by federal and state officials which are designed to provide information to the public.

Recently, it was discussed in a press conference a new idea–the use of an already existing drug as a therapy for coronavirus.

Officials mentioned that the drug was being investigated for use with COVID-19 and would be “fast-tracked”.  But what does that mean?  Does it mean that the drug will be available anytime soon? And will it be safe?

Fast-tracking Cloroquine

In this instance, the drug proposed to be “fast-tracked” is chloroquine.  Chloroquine had been approved by the FDA for use in patients diagnosed with malaria decades ago. Chloroquine was deemed to be safe in patients with malaria for quite some time. Of course, as is the case with all drugs, there are potential side effects in patients with malaria and the risks of those side effects are considered by the prescribing physician prior to patient administration.

Recently, countries have tested chloroquine as a drug for use in patients diagnosed with coronavirus.  China, for example, has conducted studies involving patients affected by the virus and has found the drug to be effective.

FDA approval for Chloroquine

To market a drug for a particular illness in the United States, however, FDA approval must be obtained for that purpose. While the FDA found chloroquine to be safe and effective for patients afflicted with malaria, it has not studied the safety and efficacy of the drug for patients with coronavirus.

Typically, this process takes years and involves clinical studies conducted by experts in the field.  In cases of crisis or emergency, however, the FDA can “fast track” the approval process.  This means that the approval process may be “relaxed” and the manufacturer may forego some of the usual regulatory steps in order to put the drug on the market.  The marketing of the drug can then be earlier than expected. 

In the case of “fast-tracking” chloroquine, safety studies will still have to be conducted. It will be important to determine recommended dosage for patients with coronavirus, as well as what side effects might be expected when the drug is used for this purpose, and not malaria.

While it is critical to stream-line the approval of important drugs for serious illnesses, drugs should never be approved if the risks outweigh the benefits of the drug.

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