Managing Editor

Jim Greenwood, president and CEO of the Biotechnology Industrial Organization (BIO), is taking issue with comments made during a BIO 2008 session Tuesday that the debate over follow-on biologics legislation has included the use of "fears" and "accusations."

The comments were made by Craig Wheeler, president and CEO of Momenta Pharmaceuticals Inc., of Cambridge, Mass., who was advocating what he believed is the least-obstructive pathway for adoption of biosimilars. "We have got to find a way to foster constructive dialogue in Washington," he said during a Super Session on biosimilars. "I have been in many of those discussions over the past year and a half, and it has not been a shining moment for the biotechnology industry. Our positions have not been clear, we have used fear and we have used accusations to make our case."

While Wheeler did not specifically name BIO, Greenwood took umbrage. In a Wednesday interview with BioWorld Today he commented - smiling but not joking - "I wish I had been there to defend my honor.

"That statement demonstrates a lack of familiarity with what BIO has actually done," he continued. While "many pundits and many in the media" assumed BIO would oppose follow-on biologics, that has not been the case, he said.

The organization did oppose parts of the original Senate legislation proposed by Sen. Henry Waxman (D-Calif.), but "we also adopted our own set of principals," he added. "We are advocating passage of follow-on biologics legislation harder than anyone else is, harder even than the generics [companies] are."

Washington-related issues likely will stir many emotions leading up to election of a new president, and Greenwood was far from enthusiastic about either of the major party candidates.

"Neither of the two has identified themselves as a great friend of the industry," said the former six-term U.S. representative from Pennsylvania.

He noted that Republican nominee Sen. John McCain, during a debate, referred to the drug industry as "the bad guys." Sen. Barack Obama, the locked-in Democratic nominee, has identified special interest lobbyists - of which the biotech and drug industry has more than a few - as the problem, he said.

"That's an easy sound bite, but it doesn't get to the real structural issue with health care," Greenwood added, and that is to make health care more affordable without destroying the incentives that fuel innovation.

"The big issue is that the baby boomer generation is rumbling toward Medicare, and Congress and the next president will be under pressure to keep Medicare from going completely in the red," he said. "The temptation is to ratchet down the reimbursements for doctors and nurses. The danger is that if you do that excessively, you stifle innovation."

Instead, Greenwood is pushing the idea of cutting costs by getting chronic diseases under control. In a bylined commentary in Wednesday's daily conference newspaper, he argued that cutting chronic disease costs by 10 percent will lop $150 billion a year off the nation's health care tab. That, he said, is more than double the savings from dropping U.S. prescription drug costs closer to the levels in Canada and Europe, a popular rallying cry in Congress.

Also, biotech, if allowed to innovate, can play a role in that by developing the medicines needed to control chronic diseases, he said.

That is a long-term view, he acknowledged. "But policy-makers need a long-term view. A shortsighted view results in an underfunded biotech industry."

Another election-related priority for BIO is to convince the campaigns of both candidates to make the selection of the next FDA commissioner a high priority. That position can get lost in the shuffle of filling other cabinet posts, Greenwood said. And "when the FDA doesn't have strong leadership, it tends to drift and be overly conservative."