In a warning letter, the FDA criticized Bayer Healthcare with unusual severity. At issue: two new painkillers that Bayer is selling over the counter, but which the agency says must go through the new drug application (NDA) process. “The marketing of these unapproved drugs is troubling,” said Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research (CDER). “Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations.” Here’s the text of one warning letter.

Research and Markets announced a “Contract Research Organizations in Asia 2008” report. It covers Japan, Taiwan, Korea, Singapore, Hong Kong, India, China, Malaysia, Philippines, Indonesia and Thailand. Included for each CRO is the contact information and description of services and comments about the CRO.

Over the past 15 years, CRO services expanded to encompass all aspects of the drug development process. Outsourcing now affects almost 50 percent of trials, compared to 5 percent in the early 1990s. “Contract Research Outsourcing: A Global Strategic Business Report” published by Global Industry Analysts, analyzes the global market. Service segments independently analyzed include drug discovery and clinical research. Here’s the release.

Lab Research’s Hungarian site has successfully completed its biennial Good Laboratory Practices (GLP) inspection by Hungarian authorities. The site was also subject to a favorable audit of the chronic inhalation studies performed for one of its sponsors last August by the FDA. “We take great pride in the fact that our Hungarian GLP certificate remains in full force following the recent inspection while several larger CROs have been recently subject to less favorable reviews. We invite all our clients to visit each of our sites to assess for themselves the quality and regulatory compliance of our operations,” stated Luc Mainville, president and CEO, Lab Research. Here’s the release.

Alberto Grignolo, corporate VP of Parexel Consulting, received a lifetime achievement award from the Good Clinical Practice Journal (GCPj). According to Helena Jensen, publisher of GCPj, “GCPj’s lifetime achievement award is presented to an exceptional individual with a distinguished career in the field of clinical development. We are pleased to honor Grignolo, who exemplifies dedication to advancing critical aspects of our industry, and whose achievements are especially notable for being consistently forward-looking and visionary, from the championing of personalized medicine to his current role on the executive committee of the Clinical Trials Transformation Initiative.”

Phase Forward reported yet another quarter of strong financial results. Revenues jumped 24 percent, to $43 million. Net income under the GAAP accounting rules dropped 22 percent, to $5.4 million. During the quarter, the company acquired Clarix, an interactive voice response system (IVRS), as we reported here. Said Phase Forward president and CEO: Robert Weiler: “The company’s broad range of offerings, combined with our strong, debt-free balance sheet, makes Phase Forward a financially secure business partner that is able to consistently meet the diverse needs of customers.” Here’s the release.

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