Baxter - Naughty advertisements say FDA

Federal regulators are warning Baxter Healthcare that it is overstating the benefits of Aralast, an emphysema drug, and say they have noticed that the company has a disturbing trend of overstating the effectiveness of its drugs and medical products. On August 3, the FDA sent a warning letter to Baxter CEO

Robert Parkinson, Jr., accusing the company of deceptive advertising in a physician brochure for Aralast NP. The FDA has determined that the brochure misbrands Aralast NP illegally, making overstated claims of efficacy. The FDA warning letter states that the Aralast brochure makes the drug appear to be more effective than has been demonstrated by implying that its alpha1 – antitrypsin levels have a protective effect and clinical benefits that have not actually been clinically proven. In an unusual move, the agency also admonishes the company for its trend toward misleading advertising. “[W]e are very concerned by your continued violative promotion of your products,” the letter states, and then points out that the FDA has cited Baxter for similar violations of overstated efficacy and “unsubstantiated claims of superiority” in letters on April 14, 2009 and July 7, 2008. The April 2009 warning letter cited the company for false and misleading advertising for TISSEEL, a hemostatic surgical tissue glue. Baxter claimed that TISSEEL was 97.5% effective in achieving hemostasis in patients undergoing a cardiopulmonary bypass while on Baxter’s blood thinner, Heparin. The FDA said that claim was unsubstantiated. The July 2008 warning letter chastised the company for also overstating the efficacy of FEIBA VH, a freeze-dried, sterile form of human plasma used to control bleeding in patients with hemophilia in an e-mail. The company claimed that the substance controlled bleeding in 60% of cases within 12 hours of the first infusion. The FDA said that was inconsistent with the prescribing information, which only noted a success rate of 36% with one infusion. The FDA also said the company understated the risk of serious thrombotic events. In its latest warning letter, the FDA has demanded that Baxter not only fix the misleading Aralast information, but is also requiring the company to come up with a plan in writing that will put policies and procedures in place in the company to prevent future misleading advertising problems. If the company fails to comply it could be subject to FDA regulatory action, including seizures and injunctions.

What is Recombinant - Molecular Engineering?

FDA Accepts Novozymes Master File

Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, announced that the US Food and Drug Administration Center for Biologics Evaluation and Research (FDA/CBER) has accepted a Type IV Master File for its recombinant albumin, albucult. The dossier which contains proprietary information on the manufacture and safety of albucult, can help support the company's customers in applications such as drug formulation and medical devices. By providing customers with access to a single source of information filed with the FDA as part of their product applications, Novozymes can help to accelerate the regulatory process for products that use albucult.
Derived from Novozymes' proprietary yeast expression technology, albucult delivers unprecedented performance and quality benefits to a range of applications including drug and vaccine manufacture, device coating, sealants, IVF media and cell therapy applications. albucult complies with the excipient monograph standard for recombinant human albumin, published in the United States Pharmacopoeia - National Formulary (USP-NF) and confers a range of unique advantages including sustainability of supply and improved biocompatibility. In addition, albucult ensures batch-to-batch consistency which can significantly reduce lot testing burden for clients.
Wayne Prestwood, principal regulatory associate at Novozymes Biopharma, comments: "The company is always looking for the most effective ways of supporting our customers' applications through regulatory processes and we are delighted to have a master file for albucult accepted by CBER. By ensuring that the information required by the FDA as part of our customers'review processes is readily available, we can help speed up their regulatory approvals, enabling their products to be delivered to market faster."