Pharma CEOs see risk-averse climate in U.S.

By Lisa Richwine and Kim Dixon

NEW YORK (Reuters) - Pharmaceutical companies see U.S. regulators applying a tougher standard to some new medicines by looking for evidence they are better than drugs already on the market, officials told Reuters this week.

The Food and Drug Administration is demanding more safety data amid a heightened spotlight on risks, after the recall of Merck & Co's (MRK.N) pain drug Vioxx in 2004, executives said.

Some said FDA reviewers have shifted their mindset and now look at how an experimental drug compares with what is already on the market. The law says medicines must be proven safe and effective. Usually they are compared to a placebo in pre-market trials.

"I strongly believe that regulators increasingly look not only at the element of safety and efficacy, (but also) does it bring more to what is out there already," Roche Holding AG (ROG.VX) CEO Franz Humer said at the Reuters Health Summit in New York.

Humer said that scenario was good for Roche, which has focused on products that are clearly different than others.

AstraZeneca Plc (AZN.L) Chief Executive David Brennan said the FDA was seeking more data than in the past and asking questions about alternative therapies. "Products that are not first in class ... are looked at differently" than the pioneer drugs, he said.

Deputy FDA Commissioner Janet Woodcock said the agency has placed more emphasis on safety amid broader scrutiny of FDA decisions by the public, lawmakers and interest groups.

But she said the agency has always looked at comparable drugs' safety records when reviewing new medicines.

"We have always turned down drugs that have major liabilities compared to standard of care," said Woodcock, who has worked for the agency since 1986.

The FDA has "no standard you have to prove yourself better than existing therapy on efficacy," Woodcock said. "The standard has not changed."

For example, if a drugmaker brought the agency a drug in a class full of alternatives, and it caused bloody diarrhea when others did not, the FDA is likely going to pass, she said.

"Maybe (the idea) is being articulated more clearly" in the current environment, she said.

Through October, the FDA approved 15 novel drugs this year. The total for 2006 was 22. Recent years have lagged far behind the 53 cleared in 1996 during a mid-1990s boom for drugmakers.

FDA data show manufacturers have submitted fewer new drug applications in recent years than in the past. About three-quarters of them eventually get approved, and that rate has remained steady, Woodcock said.

Even so, complaints about FDA caution have been lodged for years by various drugmakers, some of which may not like agency rejections or want their products cleared more quickly.