Imported high risk defective drugs are a rising concern for the FDA. The agency wants to spend more resources to fight the “bad guys” and provide incentives to drug manufacturers who are adopting best practices for supply chain integrity by giving them expedited access for the importation of up to five of their drug products. The pilot will last two years and if effective, will be open to additional companies.
Companies that have qualified for the pilot are
• AbbVie Inc.
• Allergan, Inc.
• Astellas U.S. Technologies, Inc.
• Bristol-Myers Squibb Company • Celgene Corporation
• GE Healthcare Inc.
• GlaxoSmithKline LLC • Merck Sharp & Dohme Corporation
• Mylan Pharmaceuticals Inc.
• Novartis Pharmaceuticals Corporation
• Pfizer, Inc.
• Teva Pharmaceutcials USA, Inc.
• Watson Laboratories, Inc.
These companies have supply chain standards that have met all the conditions required by the FDA
For more info read the FDA Press Release