Claudia Lewis, partner with Venable LLP, describes how the U.S. Food and Drug Administration is revising its policies, practices and regulations in response to the coronavirus pandemic.
The pandemic has motivated FDA to undertake some dramatic, if temporary, changes in its procedures. Some relaxation of rules and regulations have been allowed in order to meet heavy demand for personal protective equipment (PPE), drugs and the ingredients of a still-developing vaccine. In response, the agency has quickly issued a number of guidance documents — around 40 in a matter of weeks. That’s in sharp contrast to the 18 months FDA usually takes to review rules under normal conditions. But even the accelerated procedures are designed “to make sure we have the healthcare supply we need, but are still safe and effective,” Lewis says.
Some of the changes involve a suspension of registration and listing requirements, and allowing drug and healthcare companies to partner with jurisdictions from other countries, such as Japan.
It all adds up to less red tape, but keeping up with the changes can be challenging. FDA’s recent communications “are almost like water from a firehouse,” Lewis says. Attorneys have been working overtime to digest the information and relay it to clients in a timely matter. “It has been a team effort between FDA and the legal community,” she says.
Looser rules open up the possibility that counterfeit and gray-market goods will enter the marketplace. It’s still important to keep tabs on such items, and conduct the necessary due diligence to keep the medical supply chain safe. And producers still must follow strict rules on the types of materials they use to make masks and gowns. “It doesn’t matter if we’re meeting supply needs if the PPE isn’t effective,” Lewis says.
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