Tuesday, July 22, 2014

FDA Spars With Recalcitrant Compounding Pharmacy, Again

For the third time in 15 months, the FDA is warning health care providers and consumers not to use drugs that were made by a Dallas compounder because the medicines may be contaminated. And the ongoing struggle between the agency and NuVision Pharmacy underscores the difficulties that beset the pharmaceutical supply chain despite a recently passed law designed to bolster safety.

In an alert issued late last week, the FDA took the unusual step of including a link to a 15-page inspection report that was completed July 16, showing numerous instances in which NuVision failed to investigate batches of various medicines after finding sterility problems. The FDA noted in its alert that these medicines had been marketed to the public as ‘sterile.’

The inspection follows two similar FDA alerts issued in April and May of last year about sterility problems with NuVision medicines. NuVision recalled one product. Last July, the FDA tried unsuccessfully to persuade NuVision to recall still more products. But NuVision defiantly posted a notice on its web site saying that it did not qualify as a drug manufacturer and was not required to follow FDA standards for manufacturing.

We left messages at NuVision seeking comment about the latest FDA alert and will update you with any reply that we receive.

The NuVision posture was cited last year by the agency as further need for Congress to pass legislation that would allow the FDA to bolster its regulatory oversight and legal options when encountering recalcitrant compounders. The FDA, at the time, was defending its actions in the wake of an outbreak of fungal meningitis in 2012 that was tied to a compounder and caused dozens of deaths.

The episode was called one of the worst public health crises in the U.S. in decades and cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority. Last fall, after months of recriminations, President Obama signed the Drug Quality and Security Act, which includes a section devoted to compounding oversight.

The law, effectively, creates two classes of compounders – one that voluntarily chooses to register with the FDA and another that may decline to do so. The first group is subject to certain conditions, such as meeting so-called good manufacturing standards, but the FDA hopes that the added requirements will give hospitals and physicians the confidence needed to purchase medicines from such compounders.

An FDA spokesman says that NuVision did not register with the FDA (here is the list). Even so, such compounders are still subject to warning letters, product seizures, injunctions and, possibly, criminal prosecution for violations of the Food, Drug & Cosmetic Act for distributing contaminated products, according to a recently issued FDA guidance on compounding.

And state boards of pharmacy are expected to continue to provide oversight. Gay Dodson, the executive director of the Texas Board of Pharmacy, tells us her agency has not taken any action against NuVision, but “we know what they’re finding.” She declined to comment when asked whether the board would investigate in light of the most recent FDA alert.

The flap is evidence that, while the law may give FDA added oversight, the voluntary nature of the registration process also means that cornering wayward compounders remains challenging.
“We’re still undergoing change says Gabrielle Cosel, manager of drug safety at Pew Charitable Trusts. Some compounding facilities will join that first category and others will change their business models and some other facilities will get into disagreements with FDA over what is allowed and what isn’t. This will have to shake out over time. A lot of work has to be done, but a lot of groundwork is in place.”


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