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In Era of 'Dismal' FDA Performance, It Helps to Be a Companion Dx/Rx Product, Lawyer Says

SAN FRANCISCO (GenomeWeb News) — Financial cutbacks, under-trained and overworked reviewers, widespread risk aversion, and eroding morale at the US Food and Drug Administration are hurting the agency’s ability to effectively review new drugs, according to a prominent regulatory lawyer.
However, pharmacogenomic-based companion drug-diagnostic products can typically overcome this environment because they receive special treatment from senior agency officials, said the lawyer, Bruce Mackler, founder of the Life Sciences Management Group in Rockville, Md.
The FDA “is performing dismally,” Mackler said at Biotechnology 2007, a two-day conference sponsored by Law Seminars International held here this week. “What the FDA is facing is low appropriations, loss of revenue, and more mandates,” he said. “What are they doing? More work for reviewers. They don’t have the time. That’s the problem.”
“Training is not good, [there are] cutbacks in labor,” and concern “in the trenches” that superiors will not always stand behind regulatory decisions has led reviewers to become more “cautious” in their decision making.
According to Mackler, 32 percent of all drugs that the FDA approved in 2006 were “innovative” — that is, new entities — whereas 68 percent were “approvals to changes in older drugs,” which can be updates such as new formulations or delivery systems. “This is because it is safer for the reviewer to make this kind of approval,” he said.
In addition, sponsors won’t necessarily solve these challenges by crossing the Atlantic — a common strategy for drug and diagnostic companies, which view the European Union as a relatively safe and swift launching pad for new products. The reality, said Mackler, is that “no matter how much we complain about the FDA, EMEA [the European Agency for the Evaluation of Medicinal Products] is doing worse.”
For example, 52 drugs approved by the European regulatory body were on average approved by the FDA 11 months earlier, he said. “Everybody for a long time has been saying, ‘Go to Europe and get an early approval,” said Mackler. “The real issue is that the FDA is approving them faster than Europe.”
How will this environment affect pharmacogenomic-based drug discovery? “Drug-device combinations are the thing to do,” Mackler said.
Although approvals of innovative products represented a minority of FDA green lights last year, Mackler said that when it comes to reviewing companion products, officials from the office of FDA Commissioner Andrew von Eschenbach participate in meetings for all stages of the drug-approval process.
“When you have someone from the commissioner’s office sitting in … you get much better input from the division,” said Mackler. “That oversight helps” reviewers become more confident and make better decisions, he added.
Otherwise, he said, “innovatives are great, but no one is going to take the risk of telling you what to do until you do it, and then they’ll tell you what you didn’t do right.”
Officials from the FDA did not immediately return an e-mail request seeking comment.

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