Regulatory Risk Remains a Key Theme for Biopharma CEOs in 2011

The Pharmaceutical Research & Manufacturers of America annual meeting kicked off today in Jersey City with the address by Chairman Christopher Viehbacher, whose day job is CEO of Sanofi-Aventis.

Viehbacher cited a number of challenges facing the drug industry, but made it a point to emphasize up top that "regulatory risk" isamong the steepest hurdles biopharmaceutical companies are encountering in the US.

He specifically mentioned FDA and the importance of the fifth reauthorization of the prescription drug user fee act (PDUFA), which is currently being negotiated. Viehbacher said the science behind pharmaceutical and biologic medicines is advancing rapidly. "We need to have a regulatory process that can keep pace with that," Viehbacher remarked. "We need some predictability."

To bring home the point, Viehbacher recounted a meeting between Eli Lilly CEO John Lechleiter and President Barack Obama, where Lechleiter made clear to the President that one of the primary issues holding research and development and innovation is heightened regulatory risk in the US.

Viehbacher's address carried a more sobering tone than some of the more recent chairman's remarks to the trade group annual meeting, when healthcare reform was gaining momentum at different phases in the life, death, and resurrection of the legislation. For example, he highlighted the impact on state budgets of implementing the reform law, global economic uncertainty (noting half jokingly that the credit rating agency Moody's may have more sway over the success of biopharma than any other single factor), and using pharma as a target with deep pockets to cut the deficit.

"Are they going to go after an industry that they see as fat and rich?" Viehbacher asked rhetorically.

He noted Obama's signature speech on deficit reduction and said it contained a number of initiatives that will be "detrimental" to research and development.

Viehbacher said PhRMA will focus on Three Ts going forward: transparency, truth, and trust. "We have allies. We don't have them everywhere and we don't have a lot of them but we have them. They're not going to be interested in earnings per share." --By Ramsey Baghdadi