Drugmakers failed to report quality issues to FDA
Half of the drugmakers required to report information about significant quality problems with products they shipped failed to do so between 2018 and 2021, Axios' Adriel Bettelheim writes about a new FDA report on pharmaceutical quality.
Why it matters: The so-called field alert reports (FARs) are a key barometer of drug plant quality and are used to assess the risk to the public and the adequacy of a company's response.
What they found: 49.1% of the 1,143 sites eligible to submit a FAR didn't over the four years the FDA reviewed.
- More than six in 10 were foreign plants, and the plants reviewed had a median of three new drug applications.
- 97% of sites that did submit a FAR submitted at least one follow-up report on the quality problem and corrective actions.
Go deeper: FARs have to be submitted within three days of when a manufacturer receives information that a drug or its labeling may be mistaken for another product.
- Reporting is also required when manufacturers learn about bacterial contamination, significant chemical or physical deterioration or any failure of a batch to meet specifications laid out in a drug application, per Regulatory Focus.
Flashback: The FDA during the Trump administration imposed tougher safety and testing requirements, with a focus on raw ingredients.
- Reasons generally cited for problems range from poor quality controls to weak management oversight.