By Kevin E. Noonan --
Earlier today, Patent Docs participated in a conference call with Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO) and Joshua Boger, Ph.D., Chairman of BIO's Board and President and CEO of Vertex Pharmaceuticals Inc. Mr. Greenwood, who represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005 prior to his BIO appointment, had invited the press as well as biotech and pharma bloggers to participate, where he and Dr. Boger provided a briefing on BIO's accomplishments during the 110th Congress and its expectations and hopes for the new Congress and the next administration.
Mr. Greenwood (at left) started the briefing by recounting BIO's legislative successes. He mentioned the challenges BIO faced with the change in the majority party in Congress, mentioning that the new Congress had new perspectives and priorities. Despite these challenges, he declared 2008 "a good year" for BIO and its member companies. Among the victories, some were ones of avoidance, such as there being no "bad" follow-on biologics legislation passed. There were several bills introduced in this session of Congress that BIO opposed; the latest bill, which Mr. Greenwood reported now has 40 co-sponsors in the House, is one that BIO supports, and Mr. Greenwood predicted that it would be introduced early in the next Congress. Mr. Greenwood was also gratified by the recent report from the Government Accounting Office (GAO) that confirmed BIO estimates that the amount to be saved under Senator Kennedy's follow-on biologics bill would be less than its advocates predicted.
Mr. Greenwood also counted among BIO's successes failure to pass patent "reform" legislation; during the question and answer session he expanded on this point, saying that the conventional wisdom that the fight over the patent bill was between the biotech/pharma industry and the IT industry was not entirely accurate. He credited BIO's efforts to engage universities, sole inventors, and small, entrepreneurial start-ups as important in convincing the Senate that the bill did not represent the kind of reform the patent system may need.
BIO is also supporting increased funding for the Food and Drug Administration, and Mr. Greenwood called this one of BIO's top priorities for the new Congress. He mentioned various funding and budgetary efforts to increase appropriations for FDA, as well as mentioning the importance for the new administration and Congress to make naming an FDA head one of its top priorities. Other successes mentioned by Mr. Greenwood include tax credits for cellulosic and renewable fuels research and development, preventing passage of new Medicaid rebate increases, passage of the Genetic Information Nondisclosure Act (GINA), and he gave new efforts to increase funding of the Small Business Innovation Research program "a 50:50 chance" of being approved.
Turning to the future, Mr. Greenwood said that, no matter which candidate won the Presidency there would be some form of health care reform enacted, and said that BIO was committed to supporting reform that would be comprehensive and support innovation. BIO is also using its contacts with the presidential campaigns to impress upon the candidates the urgency in having a new FDA administrator appointed and approved by the Senate as early in the new administration as possible.
Both men expanded on this theme during the question and answer period; Dr. Boger (at right) raising the paradox that the monies spent on the human genome project had resulted in an unprecedented amount of new information leading to new therapies over the past 10 years, but that the American public was not seeing the benefit of many of these breakthroughs due to flat funding of FDA. He said that it was time for the FDA to cease being a political punching bag in this regard. Mr. Greenwood mentioned that while the PFUDA system had increased drug company ("user fee") funding of FDA from 7% to >60% of the agency's budget, user fees also created the false impression that industry was too influential in the drug approval process. He said it would be better if user fees accounted for about 50% of agency funding, which would require an additional $200 million in taxpayer funding over 5 years, an initiative BIO supports. He also mentioned that FDA needed more funds to support inspections of API and generic drug suppliers overseas, in view of the heparin incident earlier this year, and that BIO supports passage of a drug import safety bill (although in view of the different industry sectors involved, he acknowledged that this will need thorough vetting by Congress).
Turning to the election, Mr. Greenwood said that both candidates have "said good things" about biotechnology, and both support expanded Federal government support for embryonic stem cell research; in this regard, Mr. Greenwood predicted that we would return to science-based, rather than ideologically-based, policymaking on stem cell research. He noted that the candidates differed in the details, mentioning that Senator Obama was supportive of increasing investment in biotech research and the FDA, as well as expansion of the H-1 visa program. He noted, however, that both candidates have also been critical of the biotech/pharma industry, and have supported policies (such as drug re-importation and government involvement in Medicare Part D price negotiations) that BIO opposes.
Dr. Boger said that the election represented an "enormous opportunity" for BIO and its member companies to participate in a new dialog on these issues, one that is focused on problem-solving rather than partisan finger-pointing. He said that decreasing health care costs was easy: cure more disease, something that is BIO's companies' business. Mr. Greenwood said BIO was engaging the campaigns in this dialog, meeting with campaign staffers, and initiating studies to provide the data that supports BIO's positions. This is part of a broad-based communication plan to educate policymakers as well as the public about the importance of biotechnology in health care reform and the availability of better health care in this country.
During the question-and answer period, Mr. Greenwood commented generally on the patent reform bill authored by Senator Kyl of Arizona; while admitting that he hasn't studied the bill (his staff has), he said the BIO supports many of the provisions in the bill and that BIO will participate in the debate in the next Congressional session. The goal, he said, is not to have one industry disadvantaged at the expense of others, and that BIO's alliances with universities, small inventors, and start-up biotech companies will help make the case in the next Congress.
Despite believing that both candidates have supported expanded Federal funding research for embryonic stem cell research, in response to a question, Mr. Greenwood did concede that Senator McCain may be refining his position on the subject (presumably due to pressure from the conservative Republican base). Mr. Greenwood mentioned that the embryonic stem cell bill vetoed in the last session by President Bush was H.R. 3, and predicted that a similar bill would have the same priority of being one of the first bills introduced in the next Congressional session. BIO will support passage of an embryonic stem cell bill and believes that it would be "surprising" if Mr. McCain vetoes it should he be elected President. He also said that the new President could change Federal policy as President Bush had done, by executive fiat, but that BIO preferred that Congress set policy, because that would permit the political process to work.
Mr. Greenwood addressed a question regarding the candidates' criticism of biotech drugs as being a source of rising health care costs. He said he expected that a follow-on biologics bill would change the present "non-competitive" environment for these drugs, and that BIO is committed to getting a "good bill" passed that addressed questions of access and indemnification for high drug costs. He also said that there was not sufficient time in this session to have a realistic chance of passing a bill before next year. Dr. Boger maintained that breakthrough biotechnology drugs were actually a bargain, when development costs and the morbidity and mortality costs of not having these drugs were factored into the analysis.
On other policy matters, Mr. Greenwood affirmed that BIO would be filing an amicus brief with the Federal Circuit in the Tafas v. Dudas case, and that BIO would not be endorsing either presidential candidate, saying that there were not sufficient differences between the candidates on issues important to BIO's member companies. He did acknowledge that BIO's campaign contributions are more evenly distributed between Democratic and Republican candidates than they have been in the recent past (with Senator Obama receiving slightly more campaign contributions than Senator McCain).
One area where Mr. Greenwood and Dr. Boger expanded on the prepared remarks during the question and answer period was the issue of comparative effectiveness of drugs. Dr. Boger said Congress should "let doctors be doctors" and make the individual medical decisions in each patient's best interest, and that the fact that a particular formulation or species of API is effective in 80% of the population should not impair a doctor's ability to prescribe (or a patient's ability to obtain reimbursement) for a different drug that works for them. Comparative effectiveness cannot be used for producing drug formularies, he said. Mr. Greenwood added that the diversity of patient reactions as having a big effect, and said that legislation and/or regulations were needed that prevented payors from reimbursing alternative drugs.
A podcast of the briefing can be obtained here.
For additional information on this and other related topics, please see
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part II," February 14, 2008
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part I," February 14, 2008
• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
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