Last week, Congress made a big leap forward in protecting patients from contaminated drugs when it passed legislation to give the FDA greater authority to monitor compounding pharmacies. Those are manufacturers of medicine that tailor drugs and doses for individual patients with specific prescriptions.
The legislation was prompted by last year’s outbreak of meningitis and a slew of infections these semi-rogue operations spawned because they weren’t subject to the same regulatory scrutiny as other manufacturers of pharmaceuticals.
But the news, although good, isn’t as good as it could be, as Congress failed to give the FDA total authority over compounding pharmacies.
As explained by the New York Times, the use of compounding pharmacies has grown recently, thanks largely to hospitals that now outsource a lot of their drug mixing. Some of those providers moved beyond the business of mixing medicines for individual patients to become mini-manufacturers.
They were subject to state law, but federal authorities had limited power over them. Unlike pharmaceutical manufacturers, they didn’t have to report problems to the FDA or allow federal inspectors to examine their records.
So when hundreds of people got sick with meningitis last fall because the steroids compounded by the New England Compounding Center were contaminated, the FDA said it couldn’t have done anything, even though some analysts said the agency hadn’t been as aggressive as it could have been.
The new bill, the Drug Quality and Security Act, is an effort to clarify who gets to do what. It would allow compounders that mass-produce drugs to register with the FDA as “outsourcing facilities” that would be subject to rules on quality control and oversight similar to pharmaceutical companies.
Companies that don’t want to register may continue compounding only for individual patients with a prescription, or making limited quantities ahead of a prescription. They wouldn’t be subject to the new federal oversight.
Not compelling companies to register with the FDA might seem like a loophole, but, as The Times points out, many people believe that market forces would prompt most of the larger compounders into registering – hospitals, 8 in 10 of which outsource some percentage of their sterile compounding, aren’t going to want to do business with compounders that aren’t registered.
Also of concern is product liability insurance, which FDA-approved manufacturers generally carry.
The Drug Quality and Security Act also establishes a system for tracking drugs to help ensure that counterfeit and stolen products are eliminated from the drug supply. The system includes serial numbers for drugs and an electronic drug-tracing mechanism.
FDA officials applauded the bill, but were disappointed that it failed to give them fuller regulatory power. They would like even unregistered compounding pharmacies to be required to open their records to federal inspectors. Now, officials said, they must get subpoenas to gain access to compounding facilities’ records, and the agency had sought additional powers to avoid that.
The compounding pharmacy industry opposed the bill, claiming that patients would be less able to get medication they need. But do you really want to put something in your body that could be contaminated because it was allowed to be manufactured without proper scrutiny?