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.

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.

Many in the industry, however, have heard top FDA officials talk the tech talk while lower level regulators walk the same old walk. Can they do better in 2011?

By the end of 2010, the FDA had also begun the lengthy work of establishing a regulatory pathway for biosimilars. Currently, there are no rules, but this new development category comes in a clearly outlined package. Biosimilars will be required to go through significant testing. And that will limit the business to key players with very deep pockets.

Looking ahead, 2011 will see these regulations take a clear shape. That's something everyone in the industry will be paying close attention to.