Bausch + Lomb recalled nearly 900,000 tubes of eye ointment last month, saying that freezing temperatures during delivery appeared to have caused the grit that some customers were complaining about. Now a Colorado biotech is also claiming to have fallen victim to that kind of supply chain issue, although its announcement raised eyebrows among observers.
Ampio Pharmaceuticals announced that the analysis of data from a study of one of its products under development would be delayed because both its inflammatory condition treatment Ampion and the placebo for the trial may have been frozen during delivery. It blamed its CRO for the problem and said it has asked the FDA to evaluate the situation.
"Although our entire trial drug supply was housed, packaged, and shipped in early January by a specialized drug shipment vendor contractually obligated to maintain predetermined temperature requirements under all conditions, our CRO discovered much of the drug product received at the clinical sites had been below the temperature requirement and may have been frozen for some period of time," the company said in a statement.
Some biotech observers, including Adam Feuerstein, senior columnist for TheStreet, and Scott Hensley, editor of NPR's health blog Shots, responded on Twitter with suspicion. "That kid whose dog ate his homework grew up and apparently works at Ampio," Hensley wrote. Notification about the delay came a couple of days after Ampio had announced some results of another study, which had pushed its share price up.
Still, some products require strict temperature control, and there can be issues when they go through extremes during delivery. Bausch & Lomb began recalling 850,000 lots of Muro 128 ointment plus 35,000 tubes of an unbranded sodium chloride product sold by Major Pharmaceuticals after it got complaints of a "gritty, sandlike feeling" in the eye from users. The company, now owned by Valeant Pharmaceuticals ($VRX), couldn't find an issue at its manufacturing plant and concluded that the extreme cold over the winter may have caused crystals to form in the product during shipping.
- here's the release