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Biotechs & VCs to US congress: Please Protect Innovation
Health care reform is in full swing in full swing in Washington D.C. Though the final fate of the bill and its final details are still unknown, there’s been one very important development for Silicon Valley VCs and biotech firms: Biological drugs have won crucial exclusivity from the FDA that guarantees that biotech R&D dollars will continue to flow into this new area of medicine.
Biological drugs, or “biologics” are a type of pharmaceutical that contain biological matter, such as proteins. Traditionally, most medicine, known as “small-molecule” drugs has simply come in the form of a chemical composition that is most often included in a pill.
Because biologics are so new, a federally-mandated exclusivity agreement after FDA approval had not yet been agreed upon. That’s where the current congressional health-care debate comes in. The final bill will, in all likelihood, carry the new agreed-upon terms for biologics’ exclusivity.
After a fierce battle, it appears that Silicon Valley will likely win this debate: two crucial senate and house committees approved provisions for 12 years of exclusivity for biologics. Although many, including the AARP, were arguing for five years, biotech companies, along with life science investors successfully convinced congress of the need to protect innovation for this new class of drugs.
After the house vote, Rep Anna Eshoo, D-Palo Alto, who fought the 12 year term, reflected Silicon Valley’s support for life science companies and investors alike. She reminded the media that the agreed provisions still “sets a straight-forward scientific process for approval [of generic biologics].”
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