By Donald Zuhn --
In an interview with TechJournal South, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood discussed the state of the biotech industry and the biotech issues the new Administration will be facing in the coming year (see "BIO President Sees Biotech Industry Challenges for New Administration"). Mr. Greenwood told the technology business publication that while 2008 started out strong for the biotech industry, the year ended on a far different note as a result of the recession and financial crisis. According to Mr. Greenwood, this was particularly true for small biotech companies that have yet to market products, and are now finding it more difficult to secure financing.
Mr. Greenwood (at left) asserted that the Obama Administration would be facing two big issues in 2009: follow-on biologics and patent reform. With respect to follow-on biologics, Mr. Greenwood stated that BIO supported a 14-year exclusivity period, noting that while "[l]ots of folks in the generic industry think it should be less," BIO was concerned that "if the industry does not have enough time to recover its investments, those investments will never be made." He called the debate over the exclusivity period "a huge issue" for BIO's membership.
The other big biotech issue for the new President will be patent reform. On the IT industry's efforts to pass reforms that will make it easier to challenge patents, Mr. Greenwood argued that such reforms "could be a death knell for the [biotech] industry," adding that "[u]ndermining IP protection would be disastrous." Using stem cell research as an example, Mr. Greenwood argued that the bulk of such research would likely be conducted by the private sector using billions of dollars in private capital, rather than in academic institutions using public funds. Mr. Greenwood contended that "[t]he policy sector has to improve the environment for innovation or it won't get any of it."
As reported in the article, Mr. Greenwood also encouraged President Obama to pick a "competent, strong FDA commissioner" -- especially since "the FDA regulates something like a quarter of the U.S. economy." Mr. Greenwood said that BIO was also open to the proposal to divide the agency into separate food and drug divisions, each having their own commissioner. Such a division might help the FDA avoid future approval slowdowns. Whether the FDA has been experiencing a slowdown in approvals -- at least in 2008 -- is debatable. For example, Bloomberg.com reported earlier this month that the FDA approved 25 new drugs last year, the most since 2004 (when the FDA approved 36 new drugs), and that 2008 approvals increased by six over approvals in 2007 (see "Specialty Medicines Led Rebound in U.S. Drug Approvals in 2008").
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