Execs at troubled Valeant Pharmaceuticals ($VRX) had their hopes crushed for a quick approval, and pumped-up revenues, when the FDA issued a complete response letter (CRL) in July for a new eye drug, citing conditions at the plant where it was to be made. A newly released FDA document on the Bausch & Lomb facility shows what caused FDA investigators to turn up their noses during a visit earlier this year.
When Valeant reported the CRL, it said the FDA didn't identify any efficacy issues or safety concerns about the drug candidate and didn't provide any insight into what the FDA found troubling at the Bausch plant. But the Form 483, posted recently by the FDA, shows that investigators were in the Tampa, FL, facility for nearly three weeks in February. While the report is highly redacted, it makes it appear the FDA was in the plant as part of the approval process for Valeant’s latanoprostene bunod ophthalmic solution.
Investigators came away with just four observations, but the problems they documented were enough to convince them that procedures there could not ensure quality production of the new drug.
Top of the list was a hard look at the lines where ophthalmic solutions are filled. Investigators found 20 cases where the plant reported and investigated nonconformance readings on the solutions, and in all 20 cases, the FDA said Valeant came up short in getting to the root of the problem and figuring out how to prevent further incidences.
In one case, they found metal particles in a sample that were not even mentioned in investigation reports. There was no source cited and no corrective action plan put into place. In some cases where root causes were listed, the investigators said there was no real scientific evidence that adequately explained them as the cause of the problem.
There were problems with leaking HEPA filters and questions about equipment maintenance. Finally, it says that the plant’s in-process controls established after the compounding of an unnamed drug were inadequate “to assure that during routine production the process remains in a state of control.”
When it tallied it all up, the FDA decided against approving Valeant’s candidate therapy for open-angle glaucoma or ocular hypertension, a drug that former CEO J. Michael Pearson had touted as a potential blockbuster before his exit in April.
The FDA denial came as Valeant has been challenged on multiple fronts. It is being probed for channel-stuffing to lift its financial picture. There has been pricing pushback and debt-default concerns and loads of litigation, all of which new CEO Joseph Papa is trying to face down simultaneously.
- here’s the Form 483
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