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Drug approval moving slowly

– A decline in drug approvals, spurred by an “increased conservatism” on safety issues by the Food and Drug Administration, raises the stakes in 2011 for the nation’s largest drugmakers.

Regulators cleared 21 medicines, the fewest since 2007, for sale last year. It was the first time in a decade that Pfizer, the world’s largest drugmaker, as well as Merck, Eli Lilly and Bristol-Myers Squibb were shut out at the same time, according to agency records.

Pfizer, facing generic competition this year to the top-selling cholesterol pill Lipitor, and Bristol-Myers have said they are seeking approval of three drugs that may bring in $4 billion annually by 2016. Their applications follow a year in which analysts say that added safety reviews delayed approval of medicines with potential annual sales of more than $1 billion.

The FDA is “trying to cover their butts,” said Simos Simeonidis, a senior biotechnology analyst in New York. “Overall, you have seen an increased conservatism from the FDA and an increased emphasis toward safety.”

Congress passed legislation in 2007 authorizing the agency to require plans to minimize potential side effects of new drugs before approval. Confusion about how to apply the power has contributed to a rise in three-month extensions of reviews and “complete response letters” seeking more data, said Ira Loss, an analyst with Washington Analysis.

The FDA’s powers were expanded after the agency took years to identify heart risks with Merck’s painkiller Vioxx and GlaxoSmithKline’s diabetes pill Avandia. Vioxx was withdrawn from the market in 2004 and Avandia was restricted last year. New drugs now often require safety plans that can involve educating doctors and patients about known side effects or conducting additional studies to find rare complications.

The FDA’s 2010 tally is “disappointing” because it doesn’t include promising medicines that investors expected to be approved, including Glaxo and Human Genome Sciences’ Benlysta for lupus and Lilly and Amylin Pharmaceuticals’s Bydureon for diabetes, said Loss, who has covered the FDA for more than three decades.

Bristol-Myers’ ipilimumab for skin cancer, originally scheduled for a decision by the FDA by Dec. 25, was delayed until March. The medicine, which would be the first new melanoma drug in more than a decade if approved, may produce as much as $1 billion in annual sales within five years, according to Linda Bannister, a health-care analyst at Edward Jones & Co. in Des Peres, Mo.

The FDA twice canceled hearings on the drug and has most recently said issues the agency sought advice on have been resolved.

The Pharmaceutical Research and Manufacturers of America, a Washington-based trade group, estimates that it costs $1.3 billion on average to bring a new drug to market, and that only one in 10,000 medicines tested may reach commercialization.

“You get these complete response letters, which basically push things back at least a year,” Loss said in a telephone interview. “That has a tremendous effect on the planning and the expense outlay for these companies.”

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