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The Food and Drug Administration admits it has been slow to issue guidance on biosimilar drugs that are expected to hit the U.S. market next year.
But Sally Howard, the agency's deputy commissioner for policy planning and legislation, said the FDA is incredibly supportive of the new market, which experts say could lower prices of prescription drugs by 30 to 50 percent.
"Two companies have actually submitted applications and those are under review," she said. "There's no additional guidance needed before an application can be approved."
Washington, D.C. – Representative Gus Bilirakis (R-FL), member of the Energy and Commerce Health Subcommittee, is honored to host a conversation about Mental Health and Substance Abuse issues, featuring Representative Tim Murphy, clinical psychologist and author of the bipartisan H.R. 3717, Helping Families in Mental Health Crisis Act. The goal of this event is to facilitate dialogue among health care professionals, policymakers, and family members of those struggling with these problems.
Washington, D.C. – Congressman Gus Bilirakis (R-FL), member of the Energy and Commerce Subcommittee on Commerce, Manufacturing, and Trade, today questioned witnesses regarding the failure of Takata airbags and the recall of millions of vehicles in the United States.
Washington, D.C. – Congressman Gus Bilirakis (R-FL), member of the Energy and Commerce Subcommittee on Health, tomorrow will be delivering a keynote speech for The Hill's A Discussion on Biosimilars, Patient Access & Affordability.
Washington, D.C. – Representative Gus Bilirakis (R-FL), member of the Energy and Commerce Health Committee, was named to serve on the Subcommittee on Health, the Subcommittee on Communications & Technology, and the Subcommittee on Commerce, Manufacturing, & Trade.
Washington, D.C. – Representative Gus Bilirakis (R-FL) is honored to join State Senator Simpson, State Representative Corcoran, State Representative Burgess and the Kiwanis Foundation to host a Holiday Farm Share Food Giveaway for those in need on December 6, 2014.
Washington, D.C. – Representative Gus Bilirakis, member of the House Energy and Commerce Committee, today led a letter to Environmental Protection Agency (EPA) Administrator McCarthy, joined by other Florida Republicans, to oppose the ramifications the proposed carbon emissions rule for Existing Electric Utility Generating Units, also known as the Clean Power Plan (CPP), will have on Floridians across the state.
U.S. Rep. Gus Bilirakis has introduced H.R. 5750 to Congress, known as the Orphan Product Extensions Now Accelerating Cures & Treatment — or the OPEN ACT.
The bill would incentivize drug makers and innovators to repurpose major market drugs for life-threatening, rare diseases and pediatric cancers, the Palm Harbor Republican said, which would open the door to development of hundreds of treatments for rare disease patients.
Washington, D.C. – Representative Gus Bilirakis, member of the House Energy and Commerce Subcommittee on Health, today introduced H.R. 5750, the Orphan Product Extensions Now Accelerating Cures & Treatments (OPEN ACT). The OPEN ACT will incentivize drug makers and innovators to "repurpose" major market drugs for life-threatening rare diseases and pediatric cancers, which opens the door to the development of hundreds of safe, effective, and affordable treatments for rare disease patients.
U.S. Rep. Gus Bilirakis, R-Fla., the vice chairman of the House Committee on Veterans Affairs, testified in front of the House Veterans Affairs Subcommittee on Health on Wednesday about giving veterans more medical choices. Bilirakis showcased his "Creating Options for Veterans' Expedited Recovery (COVER) Act" in his testimony which includes alternative therapies in VA care.