The leadership of The New Democrat Coalition, 60 moderate Democratic members of the House of Representatives, on May 23rd announced they were supporting Rep. Jay Inslee's approach to creating a pathway for FDA approval for "follow-on biologics" rather than the bill sponsored by Rep. Henry Waxman.

The bill introduced by Inslee (D-WA), a member of The New Democrat Coalition, is more protective of innovator biologic drugs than Waxman's bill, and would make it more difficult for generic manufacturers to demonstrate that a similar biologic product is safe and effective.

"America's patients want new cures, and they deserve access to lower-cost
biological medicines. That's why the FDA needs the authority to approve follow-on biologics. Congressman Inslee's legislation will do just that while ensuring patient safety and the continued medical innovation for which America is world-renown," said coalition Chair Rep. Ellen Tauscher (D-CA).

"This bill would ensure we can move toward greater access to this care while
providing clear safety guidelines and adequate protections for the innovators," said coalition Vice-Chair Rep. Ron Kind (D-WI).

"The Inslee legislation is a commonsense proposal that will increase Americans' access to affordable, life-saving therapies," added coalition Vice-Chair Rep. Joe Crowley (D-NY).

"Unlike other proposals, this bill helps ensure the United States remains an
attractive place for innovators to develop new pharmaceutical treatments," said coalition Vice Chair Rep. Adam Smith (D-WA).

"We should encourage competition in biologics, but the approval pathway must
include rigorous standards in order to protect consumers and reward innovation. I see H.R. 1956 as a good starting point for negotiations," said
said coalition Vice-Chair Rep. Artur Davis (D-AL).