The recent drug recall surge from the FDA has been somewhat staggering. According to RAPS, “2014 is already shaping up to be the biggest year for serious drug recalls in the last decade.” The total number of drug recalls so far almost surpasses that of 2013, which in itself was extremely high. With the year not over yet, 2013 and 2014 could see more recalls than the previous nine years combined.
But what is driving the drug recall surge? Knowing and understanding fluctuations like these can be half the battle for drug manufacturers. Your company should be aware of the causes that may be the driving forces behind the drug recall surge.
According to RAPS, compounding pharmacies have much to do with the surge in drug recalls in the last two years. “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.” Because compounding pharmacies make specialized medicine meant for specific individuals, they were up until recently regulated by the states.
After the outbreak, the FDA has decided to oversee these compounding pharmacies, which may be why many more drugs are being recalled through their channels. The FDA now promises to inspect all compounding pharmacies making sure that products and the facilities themselves are up to code.
Compounding pharmacies also add to the surge because the FDA will count two recalls as equal when after inspection they can seem to be very different. One recall notice may be for a singular item or drug while another could be for an entire line of them or several thousand products. However, both recalls count as one. “Because many compounding pharmacy recalls are for just a small handful of products,” there can potentially be a larger number of recalls by the FDA while the actual number of products being recalled are consistent with those of former years.
As stated by USA Today, “Experts say the increase is a result of a combination of greater oversight by the regulators, better testing procedures and the use of social media where consumers can quickly point out and discuss problems with other people.” Because nearly everything is discussed on social media sites, issues with drugs can often be noticed more quickly or in a way that grabs the attention. When these problems are investigated, there is often a chance for recall.
For your company, the use of social media can be extremely beneficial. Those who use websites like Twitter, Facebook, Tumblr, YouTube, and LinkedIn could be alerted to issues more quickly and have a way to reach out to their customers as well. Since social media may be a component in the drug recall surge, having an online presence on these sites could allow for more understanding for where and why many current drug recalls begin.
Current Good Manufacturing Practice Deficiencies
RAPS states that Class II recalls are the most common with 77% of 2014’s drug recalls being of this type at the time of publication. While these were the most common type of recalls in the past two years and before, the cause for many of them were current good manufacturing practice deficiencies. These issues can affect many different products at one time, but they are each counted individually as separate recalls. If one manufacturing plant experiences these issues, then “dozens, if not hundreds of recalls” can be the result.
Protecting your company from these issues is very important and can help you avoid these high levels of drug recalls. After all, one deficiency can affect the whole company which can cause many of the products it manufactures to be recalled.
There are numerous causes which could potentially have had an effect on the drug recall surge of the past two years. Without the ability to be sure, you will want to be aware of all of them and how they can potentially affect you and your company. Being more informed about what may be driving the surge in drug recalls will help you and your drug manufacturing company stay ahead of the curve.