U.S. sector spotlight

As the COVID-19 pandemic entered its second year, supply chain issues remained a challenge across the pharmaceutical industry. In June 2021, the White House released a report on its 100-day review of U.S. critical supply chains, which provided the new Administration’s view of the pharmaceutical industry.

One trend that may be a result of manufacturers having to change suppliers and ingredients, was a rise in benzene-related recalls. This has been an issue primarily for products that depend on an aerosol spray propellant where manufacturers have substituted butane for alcohol as an ingredient in the propellent.

One of the biggest changes for the FDA that was brought about by the pandemic was a dramatic rise in the use of Emergency Use Authorizations (EUAs). They have allowed the FDA access to a wealth of knowledge about why medication errors happen (because medication error reporting is mandatory with drugs under EUAs, not voluntary as it is with approved drugs). There has been some criticism, however, over how many products – both pharmaceutical and medical devices – were granted EUA status. The industry should already be planning for post-pandemic life and how to navigate the transition from EUAs to normal regulatory approvals.

While product recall numbers are important, they are only part of the story. Here's what you should take away from pharmaceutical product safety developments in 2022:

• Pharmaceutical products marketed under EUAs must comply with mandatory medication error reporting, which is voluntary for drugs that have gone through the normal FDA approval process. With more data available, companies have more exposure. Are you ready to act quickly if there is a product recall? How will you respond if there are a large number of medication errors for your product?
• The Pharmaceutical Research and Manufacturers of America’s (PhRMA’s) updated Code on Interactions with Health Care Professionals is in effect. While the new code is not legally binding, companies that adopt its rules are less likely to run afoul of federal fraud and abuse laws like the Anti-Kickback Statute. If you operate in a jurisdiction where these guidelines have become law, have you made any changes to events to comply with the new code? Have you considered voluntarily incorporating these guidelines as a way to help protect your reputation and mitigate risk?