FDA relaxes some DSCSA provisions during COVID-19 crisis

The FDA has exempted some products from the Drug Supply Chain Security Act (DSCSA) requirements during the coronavirus pandemic to avoid delaying access to drugs that may treat COVID-19.

In guidance released yesterday, the US regulator said it has been monitoring requests related to the DSCSA and is taking action “to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19.”

The new stance also extends to enforcement of supply chain trading requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act, according to the agency.

First signed into law in 2013, the DSCSA sets out steps to build and implement an electronic system for the identification and tracing of prescription drugs as they are pass through the hands of manufacturers, wholesale distributors, dispensers, and repackagers in the US medicines supply chain, using standards that allow data to be shared between them.

The product identification and tracing exemptions extend to COVID-19 products that are approved under emergency use authorisation (EUA), a temporary green light that stops short of full regulatory approval but which will allow early access to drugs and vaccines that show promise for COVID-19.

It also applies to any products that are approved to “diagnose, cure, mitigate, treat or prevent COVID-19,” according to the FDA, and may also apply to drugs that treat complications of the infection – such as acute respiratory distress syndrome – or provide supportive care to coronavirus patients.

Under the new guidance, distribution of these products won’t be considered a “transaction” and therefore subject to the DSCSA wholesale distribution provisions until the crisis is over. Wholesalers will also not have to adhere to licensing and reporting requirements for them.

Just this week, Gilead Sciences’ antiviral candidate remdesivir became the first therapeutic candidate to show in a controlled clinical trial that it can hasten recovery in severely-ill COVID-19 patients, and now looks like it could be the first drug to get EUA.

The EU’s medicines regulator, the EMA, has already started a rolling review of the drug to make sure it can get it to patients quickly if that initial promise is backed up in ongoing studies, and there are reports the FDA is already considering emergency approval.

The FDA guidance also has some specific warnings about fraudulent activities during the pandemic, specifically “people and companies…trying to profit from the COVID-19 pandemic by selling unproven and illegally marketed products with false claims.”

“Wherever possible, trading partners should engage in transactions of product with trusted sources,” advises the regulator.

“Trading partners should ensure that their trading partners are appropriately licensed or registered by checking with FDA and state authorities for confirmation or assurance that the trading partner being considered is actively working with the relevant authorities to operate during the COVID-19 public health emergency.”