Report Sees More FDA Regulation This Year
Stericycle’s first annual State of the Nation 2020: Product Recall report projects increased regulation by FDA and other government agencies this year. The report combines a look at recall activity in 2019 with projections for the future.
The 2019 recall story for drugs, Stericycle says, centered on supply chain challenges, punctuated by concerns about the active pharmaceutical ingredient industry. Facing challenges involving vaping, cannabis, CBD, asbestos in talc, and impurities in drugs, the report says, FDA inspectors struggled to keep up with their workload, even as the agency has been focused on faster approvals of new drugs.
Drug recalls came at a rate of more than six per week in 2019, but the recalls were smaller in size on average compared to previous years. The total number of units recalled in 2019 dropped below 100 million units for the first time since 2016.
Stericycle says the average size of a fourth-quarter recall remained steady compared to previous quarters, about 310,000 for the third quarter in a row.
Current Good Manufacturing Practice deviations remained the top reason for drug recalls, accounting for 23.7% of all fourth-quarter recalls, while sterility issues were the top reason for recalled units, affecting 68.8% of units.
Some 66 companies announced fourth-quarter recalls, with 17 having more than one recall. Pharmaceutical recalls increased 29.2% to 93, including a dozen recalls linked to NDMA impurities. Recalled units increased to 29 million, with about four million of them attributed to NDMA impurities.
Looking ahead, Stericycle says companies should expect FDA to act quickly, decisively, and with consumers front of mind in 2020. As long as drug makers rely on global suppliers and production facilities, it says, product quality will be a challenge. Specific challenges seen by Stericycle include: (1) concerns about NDMA impurities will remain a focus; (2) NDMA will lead the industry to more impurities that are cause for concern; (3) drug makers should be prepared for FDA to turn up the heat on API manufacturers; (4) the fate of e-cigarettes has not been decided; (5) marijuana and CBD will face a regulatory crackdown; and (6) cosmetics will experience a rush of recalls.
In 2019, the report says, alarms were raised about security and data privacy linked to connected devices in homes in the U.S. “What manufacturers and healthcare organizations need to worry about in 2020 is that patients largely don’t understand the safety and hacking risks associated with connected devices…. This limited understanding of how data-driven medical devices work and how they can compromise personal data or malfunction under the direction of online hackers is something manufacturers need to keep in mind when designing and marketing their products to hospitals, doctors, and patients. Recalls are important in this space, but litigation is the real threat.”
Medical device recalls increased another 14% to 277 in the fourth quarter of 2019, but recalled units dropped 74.3% to 56.3 million. Stericycle says this is again evidence of how medical device recalls have been getting smaller in recent years.
Software issues remained the top cause for recalls for the 15th consecutive quarter, but leakage concerns were the top cause for units recalled at 28.3% or nearly 16 million units.
For 2020, the report says the risk profile for medical device companies will continue to evolve. It says: (1) when a patient’s long-term health is adversely affected because a medical device is hacked, a firestorm will erupt that will affect the entire industry; (2) more regulatory guidance on cybersecurity is on the way; (3) recalls will continue and more often than not will remain small; and (4) the recall process will become quicker and more strict.