FDA Slaps Valeant With A Warning Letter

Published: Oct 01, 2014

FDA Slaps Valeant With A Warning Letter

October 1, 2014

By Mark Terry, BioSpace.com Breaking News Staff

Valeant Pharmaceuticals International, Inc. , headquartered in Laval, Quebec, announced today that it had received a Warning Letter from the U.S. Food and Drug Administration about its Bridgewater, New Jersey facility. In June 2014 the FDA inspected Valeant’s records related to the company’s Sculptra Aesthetic Injectable, which in July 2014 was divested to Galderma S.A. The Warning Letter does not relate to Valeant’s internal manufacturing, but focuses on the company’s management of manufacturer contracts regarding specific Good Manufacturing Practice (GMP) activities. Those GMPs specifically relate to review and documentation of supplier’s deviation reports before batch release and the company’s processes for performing corrective and prevention action (CAPA) effectiveness checks.

The company can continue to manufacture and distribute Sculptra and all its other products. Sculptra Aesthetic is a “facial injectable” used to smooth wrinkles. It’s primary competitor in the marketplace is Juvederm, sold by Allergan. Allergan is best known for Botox.

Valeant has been tangled in a Security and Exchange Commission (SEC) investigation over a hostile takeover bid of Allergan Inc. with Bill Ackman’s New York hedge fund, Pershing Square Capital Management. Allergan has responded with a lawsuit, citing insider training. In related news announced today, investor shareholder advisory firm ISS advised Allergan to allow its shareholders the opportunity to vote on any large, buyout-blocking acquisitions. This refers specifically to Allergan’s $10 billion offer to acquire Salix Pharmaceuticals , which would make the company too large and expensive for Valeant to acquire.

In March 2014, Pershing Square started to purchase over-the-counter call options, resulting in becoming Allergan’s largest shareholder. In April, Valeant and Pershing Square announced their joint bid, which resulted in a 15 percent stock increase. Pershing saw $1 billion in gains. In September the three companies announced an agreement to settle pending litigation before the Delaware Court of Chancery.

Valeant has also been noted for the way it has gobbled up smaller companies. Since 2008 Valeant has acquired more than 100 smaller companies. It is a multinational specialty drug company that develops, manufactures and commercializes many pharmaceutical products in the areas of dermatology, eye health, neurology and branded generics.

In response to the FDA Warning Letter, Valeant stated in a press release that “Valeant takes all correspondence from the FDA seriously and will be responding to the agency with our improved system and procedure implementations to address the FDA’s concerns shortly. As the issues referenced by the FDA were never at any time regarding the manufacturing quality or safety of any product, we believe that we will be able to resolve this matter in a timely fashion.”

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