BIO SmartBrief editor Ashley McMaster corresponded with BIO's Jim Greenwood to get his thoughts on what direction the biotechnology industry is headed in 2009.What were some of the top challenges and opportunities for the biotechnology industry in 2008?
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Last January, the FDA finalized its risk assessment on the safety of foods from cloned animals, concluding that these foods are just as safe, because they are just the same, as foods from non-cloned animals.
On patent reform we have made it clear that we will support reforms that improve the patent system, but we will not accept changes that weaken intellectual property rights or threaten the ability of our companies to innovate.
We're working on a sound regulatory pathway for follow-on biologics. We took the lead on the legislation, and we will make sure that Congress gets it right.
The House and the Senate Small Business Committee passed a bill to restore SBIR grants for our venture-backed companies and we continue that fight. Through our work with the Alliance for a Stronger FDA, we ensured increased funding for the FDA and that effort continues.
With a new presidential administration and Congress, what do you believe will be the opportunities and challenges for 2009?
One of the most pressing issues facing the industry is the need for a qualified leader for the FDA. This is critical for both health and agricultural biotechnology companies regulated by this agency.
I expect the new Congress will quickly take up bills to expand the State Children's Health Insurance Program (S-CHIP) and to allow NIH funding of embryonic stem cell research. Broader health care reform measures will require a debate on how best to achieve more affordable access to quality health care in this country.
BIO's position is that maintaining innovation needs to be at the center of that discussion. Health care costs are so high because the incidence of chronic disease is so high -- heart disease, cancer, diabetes, stroke and many other persistent conditions that can be reduced or prevented.
If we imposed price controls that brought drug prices down by 25 percent, it would save about $60 billion dollars. If we focus instead on reducing the incidence of chronic disease by 10 percent, that would save about $150 billion in health care costs.
What is the effect of the current financial crisis on the industry and will it continue to affect the industry through the coming year?
The fundamentals of the biotechnology sector are sound. We can safely predict that both the demand for biotech health care products and the ability of the biotech industry to innovate new products will continue to expand. Health care is not an item of discretionary spending. People may spend less at restaurants and on vacation, but they won't be cutting back on treatments for cancer, diabetes and cardiovascular disease.
No one knows how long it will take for the credit crunch to ease, but one thing we do know is that the top pharmaceutical companies have large amounts of cash on hand. Biotech companies that are unable to attract capital from wary investors may find money from pharmaceutical companies, who will be buying and investing in biotech companies for the foreseeable future.
What is sometimes more difficult to foresee is how federal policy will impact innovation. What happens in the next Congress with legislation on follow-on biologics, patent reform, health care reform, FDA reform and reimbursement will have much to do with the value of future biotech investment.
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