The number of FDA drug recalls is swelling year after year, but 2014 is on track to having the all-time record for medications removed from the market. The why’s of this are still conjecture – perhaps it’s linked to the fungal meningitis outbreak of 2012 – but the trend is pretty glaring…
…Or so says Alexander Gaffney at the Regulatory Affairs Professionals Society, who deserves a hat tip for writing this one up nice. He found:
As FDA data show, the last two years have seen almost as many recalls (2,061) as the previous nine years combined (2,217) — and that’s only counting the first seven months of 2014.
Pharma companies often have to recall drugs, medical devices and food products for a variety of reasons – improper labeling, packaging defects, contamination, improper testing or the inherent safety of a product that could harm a user. And more products are being found to have these issues.
The data comes from a pretty fantastic open-sourced FDA database, called OpenFDA, that was launched in beta testing a few months back to provide more transparency in the drug, medical device and food product approval process. Gaffney, again, does a nice job of describing the API’s goals. The FDA just launched the drug recall and adverse events APIs; it plans many more soon, FDA Chief Health Informatics Officer Taha Kass Hout said in a blog.
FDA recalls aren’t necessarily indicative of some egregious error on a manufacturers’ part. In June, for instance, a soba noodle salad was recalled at Whole Foods for not disclosing it contained soy.
These recalls are broken down into three categories:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Class I – The worst! Where a product will cause serious ill effect in a user, or even death.
Class II – Kinda bad. The product causes – or could cause – a reversible but still adverse health effect.
Class III – Eh, whatever. Not likely to cause adverse health consequences, but worth a recall – just to be on the safe side.
Most drug recalls – about 70 percent – are Class II “kinda bad” meds. About 21 percent are Class I danger-filled and 9 percent are Class III. (Soba noodlegate was a Class I offense, by the way – soy can, after all, cause anaphylaxis on occasion.)
Here’s Gaffney’s chart of the drug recalls over the past decade:
Next up – postulating why. Let’s just let Gaffney take this one home:
It’s difficult to blame any one factor for the rise in recalls, but one trend may be to blame for a sizeable portion of it. Beginning in 2012, FDA initiated a crackdown on compounding pharmacies after a massive and deadly outbreak of fungal meningitis which killed more than 60 people.
An inspection of recall reports by Regulatory Focus indicates that a sizeable number of Class II recall reports were related to compounding pharmacies. Many of those pharmacies had products which had possible—but unconfirmed—microbial contamination.
Other Class II recalls seen by Focus were for current good manufacturing practice (cGMP) deficiencies, which can often affect dozens of products at one time, with each generating its own recall notice. A single manufacturing plant experiencing cGMP deficiencies can result in dozens, if not hundreds of recalls.
It’s also worth noting that not all recalls are created equal. Under FDA’s recall classification scheme, a recall of 100,000 drug products is treated the same as a recall notice for just one dialysis bag. And because many compounding pharmacy recalls are for just a small handful of products, it’s possible that even with a large surge in the number of recalls, the total amount of product recalled could be relatively consistent.
But with 2014 already on pace for a record-breaking year for recalls, perhaps it’s worth asking if this is an anomalous, one-time surge in recalls, or if the rise is the new normal for the foreseeable future.
