The Centre for Drug Evaluation and Research (CDER), which as a US FDA agency

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monitors most drugs, has told Hyderabadbased Dr Reddy's that it needs more time to resolve the generic drug maker's request that the agency enforce the Federal Food, Drug and Cosmetic Act to prevent some companies from using rules to block or delay generic competition.

In June, Dr Reddy's was forced to knock on US FDA doors for redressal after US-based Celegene Corporation rejected multiple requests from Dr Reddy's to obtain a bio-study sample of Revlimid, a blood cancer drug with sales of over $1.3 billion in 2008.

As an oral medication, Revlimid can stop or slow the growth of cancerous myeloma cells in the bone marrow. Each Revlimid course for therapy costs an estimated $50,000.

Since the drug ­ known to cause human birth defects if taken during pregnancy ­ falls under the ambit of FDA's Risk Evaluation and Mitigation Strategy (REMS), Dr Reddy's cannot legally procure the drug from anyone except Celegene. Sensing Dr Reddy's intentions to study a potential generic version, the US-based firm stopped all attempts at studying the drug. In an interim response to Dr Reddy's June request, Jane A Axelrad, associate director for policy, CDER said: "FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials. We will respond to your petition as soon as we have reached a decision on your request."

Dr Reddy's petition had specifically asked the FDA establish certain procedures to facilitate the availability of generic versions of drug products subject to a Risk Evaluation and Mitigation Strategy (REMS). The generic drug maker also requested that FDA work with the Federal Trade Commission to prevent anti-competitive REMS abuses. After Dr Reddy's filed the petition, Celegene Corporation had asked FDA to turn down Dr Reddy's request. Celegene had pointed out that there is simply no statutory authority for FDA to require the sale of product between two competitors.