Aug. 16, 2013 at 6:24 PM ET
The Food and Drug Administration took an unusual step on Friday, warning patients and health care providers to stay away from sterile products made by a Dallas-based compounding pharmacy called NuVision.
It’s a new twist in an ongoing fight the FDA has had with compounding pharmacies, which are supposed to make individual products to order on a prescription-by-prescription basis. The FDA says these companies often act as large-scale manufacturers, but evade FDA oversight because of glitches in the law.
The FDA says its inspections show the sterility of products made by NuVision cannot be guaranteed, but the pharmacy says it doesn’t have to meet FDA standards.
The FDA forced a showdown in a battle that almost perfectly illustrates the agency’s complaints that it doesn’t have the powers it needs to regulate such pharmacies.
“This alert follows the FDA’s notice on May 18, 2013 recommending that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for NuVision Pharmacy sterile products, quarantine those products, and not administer them to patients. NuVision Pharmacy has repeatedly declined to recall its sterile products.”
NuVision, for its part, has a notice posted on its website saying it doesn’t have to recall its products.
“NuVision Pharmacy is not recalling all sterile injectables. All of our sterile injectables are tested by a third party lab for sterility prior to dispensing. For anyone with questions or concerns about the sterility of our products, NuVision Pharmacy will send you the results proving that our products are sterile,” it says.
“NuVision pharmacy is a compounding pharmacy committed to patient safety. We are not a manufacturer,” it adds. “The FDA has been inspecting compounding pharmacies based on a different set of standards for manufacturers,” it adds. “The current state laws do not require compounding pharmacies to follow the standards for manufacturing.”
The FDA has been asking Congress to give it specific powers to regulate pharmacies like NuVision. “Under its authority, the FDA cannot require NuVision to undertake such a recall. Therefore the agency reminds health care providers not to use any sterile products from NuVision,” the FDA says.
It says NuVision has had possible problems with some of its products.
“In April 2013 NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA’s April 2013 inspection. The FDA received adverse event reports of fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product that was previously recalled. The agency is not aware of any adverse event reports associated with other sterile products from NuVision.”
The FDA has redoubled efforts to check on compounding pharmacies after an outbreak of fungal infections linked to a single Massachusetts pharmacy last year killed 63 people. So far, 749 people in 20 states have been sickened in that outbreak, the worst cases with meningitis or stroke, with some local abscesses and similar infections as well.
Inspection of the New England Compounding Center showed products made there were contaminated with bacteria and fungi. The pharmacy, which shipped dozens of different products in large batches all over the country, has closed down.
Currently, states are supposed to regulate compounders while the FDA sticks to drug manufacturers.
But FDA argues there are many pharmacies like NECC and NuVision that make products in large batches and behave more like manufacturers than pharmacies.
A Senate bill would give FDA authority over compounding pharmacies that produce sterile drugs without a prescription and ship those drugs across state lines. Some consumer groups, as well as some Republicans in Congress, say the FDA already has enough power and simply hasn’t been exercising it.
Public Citizen says the FDA could do more. “Since the fall of 2012, the FDA has identified significant objectionable conditions at 50 compounding pharmacy facilities, but only 16 of those have initiated a product recall or have been the subject of an FDA enforcement action beyond issuance of an inspection report,” the group says in a statement.
The FDA announced a recall of products earlier this month from Texas-based Specialty Compounding after 15 people given its products developed infections.
“The FDA knew there was a serious problem here but didn’t use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “What’s the purpose of inspecting a facility if you’re not going to take appropriate action when you find conditions that pose a safety threat to patients?”
Nuvision was preparing a response to FDA’s Friday announcement.