Three drug manufacturing companies have been issued cease and desist letters as part of Massachusetts’ investigation into manufacturers of sterile drugs. Although it was stated that there is currently no reason for a recall, the fact that so many questionable practices were found raises the question of whether there may be dangerous or contaminated drugs on the market that may soon be recalled when they are discovered.
The investigation is a direct response to the spinal meningitis outbreak—new cases of which are ongoing, although the newest ones are being deemed “non-life threatening”. The sterile, preservative free spinal injections were contaminated due to poor manufacturing practices and a dirty (mold-inducing environment) manufacturing site.
In the short term, the increased oversight will probably mean a safer drug market for consumers, but long term? It’s not possible to regulate and oversee everything at a level you can rely on. What’s more, FDA regulations regarding manufacturing schedules have caused shortages which this situation could exacerbate if those schedules—which take months to get approved—are interrupted.
Other recent problems have included a recall of the generic form of Lipitor that was manufactured by an Indian company, and which contained tiny glass shards (unable to account for how the glass got in, the company has been temporarily banned from selling in the US).
There’s no clear path for the average patient. Try to avoid prescription drugs, etc., if possible, but that’s not an easy answer. Follow drug recalls, watch for unexpected side-effects, and maintain a good relationship with your prescribing doctor.
What do you think of the messy state of drug manufacturing?
