That a batch of tainted vials from a single company could put thousands of
people across the country at risk for a deadly form of meningitis
is a sign the system for regulating pharmacies that mix drug compounds and ship
them nationwide needs to be overhauled. Roughly 14,000 people may have received
contaminated shots of a steroid used to treat back pain from the
New England Compounding Center in Framingham, Mass. So far, 304 people in 17
states have become ill — including 13 in Maryland — and 24 have died, with those
numbers expected to rise. The risks to public health exposed by the outbreak
clearly demand prompt action by Congress to strengthen the Food and
Drug Administration's power to protect Americans from tainted medicines.
Traditionally, compounding pharmacies were small-scale enterprises that mixed ingredients in limited quantities for patients who needed specialized medications that were either unavailable from large pharmaceutical manufacturers or too expensive when purchased that way. They typically served local doctors and clinics that needed customized drug mixtures tailored to the requirements of individual patients.
But New England Compounding Center represents a new kind of compounding pharmacy that mixes enormous batches of drugs, some identical to those produced by large drug manufacturers, and sends them around the country. It's closer to the mass-production operations of the pharmaceutical giants than to the mom-and-pop shops of yore, or even to the local compounding pharmacies found in many hospitals. Because the company is still classified as a pharmacy rather than a drug manufacturer, however, the FDA has far less oversight and regulatory authority over it than over other large-scale commercial manufacturers.
Instead, that task falls to state health departments, which often have neither the personnel nor the resources to adequately regulate such businesses. That has left companies like New England Compounding in a virtual legal no man's land where they're free to operate pretty much as they please, with minimal oversight from either federal or state authorities.
Massachusetts officials investigating the company's practices after the fact found that it failed to keep its facility clean or maintain a sterile environment, which allowed its drugs to become infected with a deadly fungus that can cause meningitis in people injected with contaminated drugs. In at least one case, the contamination was so obvious that the foreign particles were visible to the eye inside vials containing the medication.
Continue Reading here
Traditionally, compounding pharmacies were small-scale enterprises that mixed ingredients in limited quantities for patients who needed specialized medications that were either unavailable from large pharmaceutical manufacturers or too expensive when purchased that way. They typically served local doctors and clinics that needed customized drug mixtures tailored to the requirements of individual patients.
But New England Compounding Center represents a new kind of compounding pharmacy that mixes enormous batches of drugs, some identical to those produced by large drug manufacturers, and sends them around the country. It's closer to the mass-production operations of the pharmaceutical giants than to the mom-and-pop shops of yore, or even to the local compounding pharmacies found in many hospitals. Because the company is still classified as a pharmacy rather than a drug manufacturer, however, the FDA has far less oversight and regulatory authority over it than over other large-scale commercial manufacturers.
Instead, that task falls to state health departments, which often have neither the personnel nor the resources to adequately regulate such businesses. That has left companies like New England Compounding in a virtual legal no man's land where they're free to operate pretty much as they please, with minimal oversight from either federal or state authorities.
Massachusetts officials investigating the company's practices after the fact found that it failed to keep its facility clean or maintain a sterile environment, which allowed its drugs to become infected with a deadly fungus that can cause meningitis in people injected with contaminated drugs. In at least one case, the contamination was so obvious that the foreign particles were visible to the eye inside vials containing the medication.
Continue Reading here
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