Biotech Industry Lobbyists Seek Support For Tough Generic Prescription Drug Standards
- Thursday, December 21, 2006, 10:12
- Pharma Industry, Public Health
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In an effort to slow the market arrival of generic competitors, lobbyists for the biotechnology industry have been raising questions about the safety of generic biotech drugs “in an effort to win support among the new Democratic leaders of Congress,” the Boston Globe reports. James Greenwood, a former member of Congress who now is president of the Biotechnology Industry Organization, has encouraged federal regulators to require that generic biotech drug manufacturers be required to meet the same standards of research and testing as brand-name manufacturers. Greenwood said, “Unlike a pharmaceutical product, where you can simply demonstrate that you have the same chemical formula and you don’t need the clinical data, a follow-on biologic is a very, very different process.” Sen. Edward Kennedy (D-Mass.) who is expected to become chair of the Senate Health, Education, Labor and Pensions Committee in January 2007, has promised to quickly hold hearings on legislation to speed the approval of generic biotech drugs when the next session of Congress begins. Kennedy said, “We must … act so that patients can afford the health care and breakthrough new medicines they need.” Sen. Hillary Rodham Clinton (D. N.Y.) has said that generic biotech drug legislation will be a major focus for Democrats in 2007. Sen. Barack Obama (D-Ill.), who will join Kennedy and Clinton on the Senate HELP Committee, said, “The barriers presented to generics entering the market have more to do with companies wanting to maintain the high profits they make on brand names than it does on safety issues.” Bruce Downey, Generic Pharmaceutical Association board chair, said, “I don’t want unsafe products on the market, either. It is something we need to account for in how the regulatory process gets established. But it’s not something that should delay the legislation” (Henderson, Boston Globe, 12/18).
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