Many people can recall the meningitis outbreak that plagued over 20 different states in the US killing hundreds of people who were exposed because of a contaminated steroid drug manufactured at a compounding pharmacy in Massachusetts. While that scare launched what was believed to be tighter regulations and enforcement by the FDA and other federal health regulators, according to recent reports the compounding pharmacies around are still a dangerous threat to all.
According to a report by Rep. Frank Pallone, Jr., a Ranking Member of the House Energy and Commerce Subcommittee on Health, a large number of these compounding pharmacies are “untracked, under regulated and under inspected” throughout the country.
This is a huge danger because as we saw not even a year ago, compounding pharmacies have a wide reach across the countries, and if there is a health risk thousands and thousands of people may be exposed and placed at risk.
Congressman Pallone states that this industry serves an important purpose, though they are required to hold a high standard, and anything less is entirely unacceptable. His investigation was stemmed from what took place at the New England Compounding Center over the summer, and Pallone describes that their findings were shocking.
The studies show that the FDA must be given the authority and tools to hold these companies accountable for their actions and to be able to enforce the safety and health standards that are necessary. Compounding centers all over the country are falling short with the health standards, and even if there are certain states with stricter regulations, this needs to be a federally controlled issue that gives the FDA the authority to effectively protect the health of the public.
Even if one state has strong standards they are upholding, there is no way they can enforce that within he other states, it is the governments responsibility to ensure that they are doing what is necessary to regulate these pharmacies.
Many representatives with the government are concerned that the countries current system for regulating compounded medications is extremely unorganized; therefore creating a great risk for Americans. According to the studies found regarding compounding centers through the country, this is what they have learned. Many pharmacy state boards are unaware of which pharmacies in their state use compounding centers at all, only two states were completely aware of all participating centers.
Not one state in the US is requires pharmacies to track the number of compounded drugs produced and what is being sold in other states. Just two thirds of the states in the US have historical data on which pharmacies are licensed in their state.
Another big concern is that most states do not perform routine inspections on the pharmacies and compounding centers, nor do they regularly check to find that their operations are done in a sterile environment (the cause of the meningitis outbreak last year.)
Lastly, this research showed that only five inspectors in each state are given the responsibility to examine every pharmacy in the state; only 19 of these states provide their inspectors with any sort of training for the inspections.
The negligence that is shown in the compounding pharmaceutical industry is uncanny, and quite frankly disturbing to think of. The fact that the states are doing so very little to improve and regulate this large industry just shows that the negligence is much more far reaching that that of those in charge of the pharmacies.
If you or someone you know has been recently made ill because of a drug that was contaminated or otherwise questionable from compounding center, contact the Whitley Law Firm today to discuss the details of your case.