Last week the FDA reported another recall of sterile products, specifically the drug Avastin, a cancer drug that is being used for the treatment of severe macular degeneration. The pharmacy under scrutiny in this case is the Clinical Specialties Compounding Pharmacy near Augusta Georgia. The CDC and the FDA reported that 5 patients developed eye infections after using so-called sterile injections—eye infections that could lead to blindness. The recall was expanded to include dozens of drugs, including the antibiotic, vancomycin, and the preterm labor drug, hydroxyprogesterone. (Washington Post 3/21)
This is the second compounding pharmacy to be investigated in less than two weeks for unsafe conditions. And only a matter of months since over 700 people were made sick and 50 patients died after receiving injections of medications produced at the New England Compounding Center.
There is no federal regulation of pharmacies; states have the power to enforce industry standards but only 17 states are requiring compounding pharmacies to comply. As a general rule compounding pharmacies don’t have to register with the FDA, they don’t even have to disclose what they’re making. So we have unregulated pharmacies, run by unscrupulous people, producing off-label medications, repackaging and mixing drugs in dirty labs in non-sterile environments.
The LA Times reports, “The absence of strong FDA enforcement powers over compounding pharmacies, and the discovery of filthy conditions at the New England Compounding Center, has spurred more aggressive FDA efforts to monitor conditions at compounding pharmacies, which repackage existing prescription into made-to-order medications.” LA Times, 3/21)
As drug costs continue to rise, doctors’ offices are looking for less expensive drugs, often prescribing off-label medications (meaning the drug has not been tested by the FDA for treatment of a particular disease) to treat patients. Compounding pharmacies are able to ‘manufacture’ these medications at significantly less cost than the more highly regulated drug manufacturers. These pharmacies take pre-existing medications and mix or repackage them for sale to doctors or medical facilities.
Dr. Michael Carome, the deputy director of Public Citizen's Health Research Groups, is concerned over the recent growth of compounding pharmacies. “These pharmacies have expanded beyond their traditional role of mixing prescriptions for individual patients to become, in many cases, large-scale manufacturers. In some cases, compounders can sell products more cheaply than larger manufacturers that are regulated more closely”. Carome says the recall at the Georgia compounding pharmacy stem from, "at least a decade of inadequate enforcement by the FDA." USA Today
The FDA is currently in reactive mode—trying to police these pharmacies after people have been made ill or killed as a result of the production of drugs. As noted by the Washington Post, FDA Commissioner Margaret A. Hamburg for greater involvement in protecting citizens from substandard, unethical compounding pharmacies like the Clinical Specialties Compounding Pharmacy. Hamburg says, “We’ve reached a critical point on this issue,” she said. “New, stronger and clearer legislation is necessary to help FDA effectively oversee firms engaged in large-scale distribution of complex compounded products…” (Washington Post 3/21)
There are people who say we have excessive regulations in this country. I believe we have a crisis when people are allowed to die because some faction (better word?) opposes industry standards for the production of medications. Health care is no longer a about taking care of the sick—it’s an out of control machine focused on profit. Where is the concern for the health and well-being of Americans? Are we willing to let our neighbors or loved ones risk possible illness or death due to the greed of unregulated drug manufacturers in the name of a profit?
Is your doctor or hospital using compounding pharmacies for your medications?
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