How FDA’s Emergency Powers Speed Drugs, Other Supplies to Fight Coronavirus

From The Daily Signal.com (April 9):

The shortage of tests for diagnosing COVID-19, like other aspects of the public health crisis, has drawn attention to the U.S. government’s emergency powers.

In recent weeks, the Food and Drug Administration in particular has taken a series of actions to address COVID-19, the disease caused by the new coronavirus.

The Trump administration’s declaration of a public health emergency Jan. 31 triggered provisions in law that permit the FDA to exercise greater discretionary authority in meeting its responsibilities to approve and regulate medical products.

The purpose of those emergency provisions is to ensure that the statutory standards and requirements that the Food and Drug Administration is tasked with administering do not become impediments to quickly getting patients and health care providers the medical products they need in an emergency.

When it comes to regulating medical products such as drugs, devices, and tests, the FDA’s congressionally mandated responsibilities can be summarized as ensuring that the product works as intended and that the product information provided by the manufacturer to doctors and patients is complete, accurate, and based on sound science.

Congress has given the Food and Drug Administration authority to determine whether medical products may be sold in the U.S. That authority extends to every new product, even if it is just a copy of one already on the market (such as a new version of a generic drug), or is a modification to an existing product (such as adding remote monitoring functionality to a ventilator).

The FDA also regulates the content and wording of the information that manufacturers provide, both to consumers (such as medication guides or advertisements) and to physicians and other medical professionals.

The latter is called the product’s “label,” though it actually is a lengthy document containing extensive, scientific information about the product, including how it works, the conditions it has been proven to treat, recommended dosing, and any safety issues such as side effects, interactions with other medicines, or considerations when prescribing it for patients with other medical conditions. [read more]