U.S. Drug Safety Agency Gets Tougher on Risks After Avandia

By | November 15, 2010

U.S. regulators appear to be increasing their scrutiny of product risks after cases like the bitter debate over the diabetes pill Avandia, industry executives and experts said this week.

The Food and Drug Administration imposed severe restrictions on GlaxoSmithKine Plc’s Avandia drug in September, aiming to end a three-year debate over the medicine once considered a top treatment choice and its link to heart risks.

“There’s no doubt in my mind that the FDA has become significantly more stringent in evaluating all drugs, especially diabetes drugs,” Novo Nordisk A/S Chief Executive Lars Sorensen said at the Reuters Health Summit this week.

Danish drugmaker Novo has benefited from recent FDA actions. The company won approval for diabetes drug Victoza in January after a lengthy review. And the agency recently dealt an unexpected setback to a potential competitor from Eli Lilly and Co and Amylin Pharmaceuticals.

Covidien Plc Chief Executive Richard Meelia said medical devices were under intense scrutiny in response to problems with orthopedic devices but that he hoped the FDA would respond appropriately.

“Let’s not overreact because of a handful of problems that could create a burden on the whole industry,” he said. Covidien makes devices used in hospitals.

Meelia said attention to risks tends to increase in response to publicity, but then reverts back.

Right now, “there is too much focus on safety, but I think it will eventually seek the proper level,” he said.

Kris Jenner, portfolio manager of the T. Rowe Price Healthcare Sciences Fund, said he felt the FDA was “reacting to multiple years of public concern about safety.”

“At some point, the pendulum will shift, but these shifts take years to develop,” Jenner said.

TOO FAST, AND TOO SLOW

Drugmaker complaints about an overly cautious FDA are nothing new. On the other hand, consumer groups and other critics typically argue the FDA is not stringent enough with its oversight of risks.

The current FDA commissioner, Margaret Hamburg, said people inside the agency joke that “there is sort of two modes of operation as people see us — too fast and too slow” when it comes to reviewing medications.

Hamburg is promoting investments in better scientific tools so the agency can improve its ability to quickly recognize and respond to safety problems.

“I have to believe that we don’t have to have it be either/or — innovation or safety — but that we can marry the two,” she said.

With the Glaxo diabetes drug, Avandia, the FDA came under pressure from outspoken critics including some lawmakers to seek the medicine’s withdrawal amid a debate over heart risks.

The case was seen as a test of how the FDA under Hamburg would handle safety clashes. In September, the agency settled on a plan that kept the drug available for some diabetics but sharply restricted its use.

Glaxo defended Avandia and fought to keep it widely available. But a company executive told Reuters that Glaxo has had largely positive dealings with the agency.

“Our relationship with the FDA is extremely strong and extremely positive. And Avandia did nothing to derail this. It was a very rational process,” said Glaxo Chief Strategy Officer David Redfern.

He noted the company had several medicines approved by the FDA in the past three years. He declined to say whether regulators were getting tougher in general.

“Our experience on a medicine-by-medicine basis has largely been positive and professional with them,” he said.

Some executives see other welcome signs. Trevor Mundel, global head of development at Novartis AG, said he sensed change toward a more positive direction for drugmakers.

The agency is “not always being hunkered down and dealing with the politics of the moment,” he said.

(Reporting by Lisa Richwine and Susan Heavey; Editing by Michele Gershberg and Matthew Lewis)

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