Valeant Shortcomings Caught By FDA

 

Pharma Manufacturing  reports that the FDA has

posted a warning letter stating that management at

Valeant Pharmaceuticals failed to properly oversee a

contract manufacturer that supplied it with Sculptra

Aesthetic (injectable poly-L-lactic acid). In particular, the

FDA found no evidence that anyone at Valeant had

reviewed and approved the vendor’s deviation report

after the manufacturer stopped production to fix

problems affecting drug quality. The article says that the

FDA “wants to see evidence Valeant has taken steps to

improve its monitoring of CAPAs and review of supplier

deviation reports.” However, Valeant is confident it can

resolve the issues raised and has already divested

Sculptra Aesthetic as part of a deal with Nestle’s

Galderma unit.

Sculptra Aesthetic, a facial injectable that is marketed to smooth wrinkles. The product competes with Juviderm, which is sold by Allergan. Valeant is trying to buy Allergan, which also sells Botox, for $53 billion in conjunction with Pershing Square Capital Management.

 

Nonetheless, the letter raises the possibility that Allergan and its supporters may use the agency warning to support their argument that Valeant cutbacks focus too heavily on areas other than marketing, which may jeopardize R&D or patient safety. Earlier this week, the Allergan board reiterated that the Valeant offer is “grossly inadequate and substantially undervalues” Allergan.

We asked Valeant for comment and will update you accordingly. [UPDATE: Shortly after we posted, Valeant released a statement that says, in part, the warning letter "pertains to the management of Valeant's contract manufacturers, rather than Valeant's own internal manufacturing."  A Valeant spokeswoman adds that Sculptra Aesthetic was sold shortly after the inspection.]