Washington Editor

WASHINGTON - Walking on the floor of the House chamber during the State of the Union Address at the end of January, Jim Greenwood felt a little nostalgic. He was, after all, a six-term congressman before he took the helm of the Biotechnology Industry Organization, which today began hosting its annual CEO & Investor Conference in New York.

But Greenwood plans to be back on Capitol Hill more and more this year, to work in an increasingly partisan congressional environment. But it’s manageable for Greenwood, long viewed as a moderate who can get things done on both sides of the aisle.

"I like the change," said Greenwood, the Washington-based trade association’s president and CEO. "I am extremely challenged, both in terms of the administrative responsibilities that I have, as well as the advocacy responsibilities."

Early in Greenwood’s tenure, BIO’s advocacy foundation underwent a rebuilding and has emerged with a new core that he said was "highly regarded by the industry and here inside the Beltway." The new hires had to be the public face in Washington, as Greenwood was precluded from lobbying Congress because of restrictions during his first year out of office. So he hit the road and toured 87 cities to visit BIO members, meet state affiliates and attend BIO meetings and conventions.

While Greenwood, who replaced BIO’s founding president, Carl Feldbaum, admitted that last year’s reorganization had some "bumps in the road," the results were satisfying and paid immediate dividends.

"We’ve been effective in terms of our advocacy," he said, noting success on a range of issues. Pandemic flu funding tops the list, with a bill passing just before Congress closed shop for the holidays. Importantly for the industry, the measure included provisions to shield drug and vaccine makers from legal liability while developing pandemic countermeasures. BIO’s messengers also were effective in convincing Congress to back off "draconian measures" related to drug safety concerns that ballooned last year, essentially shelving calls for a safety office outside the FDA. In addition, the organization has played a role in keeping a patent reform bill "from having seriously negative consequences for the ability of companies to protect their intellectual property," Greenwood said.

Moving forward, he said he plans to spend "a lot of time on the Hill," and issues remaining for this year include BIO’s ongoing efforts to lift restrictions to Small Business Innovation Research (SBIR) grants. The Small Business Administration, which manages the program, is disqualifying venture-owned companies from the grants, but a bill is floating in the House and Senate "and now we’ve got to get it passed," Greenwood said.

Additional efforts from BIO will push for federal funding of embryonic stem cell research. A bill has passed in the House and has received key support in the other chamber despite White House opposition. "We’d like to see the bill move in the Senate," Greenwood said, and noted that even if Bush stamps his veto, "it’s important to push the issue anyway."

Other BIO advocacy work will focus on Sarbanes-Oxley reform at the SEC - seeking to minimize small public companies’ financial burden for compliance - and pushing the president’s initiatives to increase the usage of biofuel. BIO also will center on negotiations for the reauthorization of the Prescription Drug User Fee Act (PDUFA). This year will be crucial for a fourth version of the bill, as the current PDUFA expires Sept. 30, 2007. Greenwood said BIO would work with the FDA to "protect and maintain" the law’s intent, as "it’s been effective in providing FDA the resources it needs to approve drugs in a timely fashion."

In conjunction with that work, he said BIO would work to build a bipartisan consensus around ways to improve the FDA, to make it more efficient and better able to handle drug safety questions. He said the agency should continue to move toward a "rich data environment" that relies less on "haphazard" adverse event reporting protocols and more on data collection based on systematic approaches that track usage and outcome trends.

In other FDA matters, it is not yet known whether the president will nominate Acting Commissioner Andrew von Eschenbach to head the agency on a permanent basis. But Greenwood said BIO would throw its full support behind him, whom he praised as "an advocate for patients" and "an ally of patient groups."

"2006 will be quite a different year than 2005 was for me," Greenwood said. He plans to put together a BIO bioethics committee as part of a wider vision for the organization to better anticipate policy issues in advance and use its internal resources as a proactive approach.

"An important component of that is to have a board level ethics committee," Greenwood said, to predict as far out as possible "what the ethical considerations should be for our industry, so that we anticipate them and avoid any ethical missteps or pitfalls."

He also said BIO, which is holding its annual international convention in Chicago two months from now, would "dramatically beef up" its communications efforts to ensure that the American public better values the drug industry, instead of the skeptical attitudes most consider fallout from recent drug safety issues. Greenwood also expects that increased insurance benefits for drugs would improve the image of drug companies, which he conceded have "suffered some body blows" over product safety.

The general public today has declining trust in big pharma. But biotech is different, and Greenwood plans to take that message to people who "don’t know much about biotechnology" and "tell them our story."

The conference ends Wednesday.

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