2010: The FDA gets tougher on safety

Every year brings a new discussion of whether the FDA is getting tougher. This year the question was just how much tougher regulators have become under the Obama administration.

Every year brings a new discussion of whether the FDA is getting tougher. This year the question was just how much tougher regulators have become under the Obama administration.

Even the GAO found earlier this year that the agency had been toughening its stance regarding non-inferiority trials. Analysts, meanwhile, have been buzzing about new rules on safety studies for diabetes drugs. New restrictions on Avandia drove the safety message home. And anyone watching the recent discussion on a trio of proposed weight drugs couldn't fail to notice that the experts are itching to see the safety and efficacy bar raised higher.

For developers, the regulatory environment is impossible to ignore. A bigger emphasis on safety may be overdue, but it will add to the cost--and lower the odds of success--for new drugs in key disease areas. In return, the agency has vowed to work smarter, recruiting experts familiar with new technology who can help expedite trial innovations.