Jay Inslee: Washington's 1st Congressional District
Issues
Health
Lawmakers call for safe, science-based regulation for follow-on biologics
19 April 2007
U.S. Reps. Jay Inslee (D-Wash.), Gene Green (D-Texas) and Tammy Baldwin (D-Wis.) today filed legislation in the House that would provide clear guidance on a pathway for production of follow-on biologic, also known as bio-similar or bio-generic medicines.
Their bill, the Patient Protection and Innovative Biologic Medicines Act, H.R. 1956, amends the Public Health Service Act to create an abbreviated process for the approval of potentially less expensive biotech drugs, while assuring patient safety and promoting innovation. These complex drugs, made from living cell lines, typically are injected and used in the treatment of serious conditions like cancer, diabetes and neurological disease.
"We can create a pathway to lower-cost copies of biotech drugs without sacrificing safety or eliminating incentives to create breakthrough medicines," said Inslee, who serves on the House Energy and Commerce Committee and represents a Seattle-area district with a strong biotech sector. "This is not an either-or situation. We can do both."
"An FDA pathway for the approval of bio-similar biologics is the critical next step to providing patients with increased access to lifesaving biologic therapies," added Green. "In creating that regulatory pathway, however, we must ensure that we strike the appropriate balance between bringing biosimilars to the market and ensuring that the market remains open to the development of the next generation biologics that offer so much hope to the millions of Americans suffering from incurable disease."
"As medical science develops new and better treatments for disease, we must ensure that they are safe and affordable. Emerging biologics companies need and deserve encouragement and incentives to succeed. In the pursuit of good health, patients and businesses should not and must not compete for our support," said Baldwin, who holds a seat on the House Energy and Commerce Subcommittee on Health.
The bill comes at a time when Congress is considering legislation to speed the approval of lower-cost versions of biologics by requiring fewer Food and Drug Administration (FDA) requirements. The unique qualities of biologics, however, pose a policy challenge. Biotech medicines can be determined to be the "same" as the original drug, but they never can be identical. And even small differences between a copy and an original biologic can cause differences in effectiveness, and, in some cases, serious side effects.
A wide range of patient groups support Inslee's legislation as a means of protecting patient safety through clinical trials and preserving an environment that encourages the development of innovative and life-saving therapies. They include Candlelighter Childhood Cancer Foundation, the Interamerican College of Physicians and Surgeons and the Lupus Research Institute National Foundation, among others.
"At the critical moment when targeted therapies are finally bearing the fruit of decades of research and providing new hope for cancer patients and their families, the Patient Protection and Innovative Biologic Medicines Act would speed and expand access to life-saving biologics, while encouraging the development of future treatments," Executive Director of Candelighter Childhood Cancer Foundation Ruth Hoffman said in a statement.
The bill also wins high marks from physician groups as well. "The EU experience shows that a science-based, patient-focused pathway works," added Dr. Rene F. Rodriguez, president of the Interamerican College of Physicians and Surgeons. "The Patient Protection and Innovative Biologic Medicines Act of 2007 follows the example of the EMEA - the European Medicines Evaluation Agency - by testing both the structural and functional features of the follow-on biologic medicine, with an emphasis on identifying difference from the innovator."