Pew Applauds U.S. House Passage of FDA User Fee Legislation
WASHINGTON—The U.S. House of Representatives Wednesday passed the Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the FDA’s drug and device reviews.
"We commend the House for passing the bipartisan Food and Drug Administration Safety and Innovation Act," said Allan Coukell, director of medical programs at the Pew Health Group. "This legislation will help deliver safe, effective and innovative medical products to patients. We also commend the Energy and Commerce Committee for its leadership throughout this process. We look forward to the bill’s passage through the U.S. Senate."
Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced legislation intended to bring antibiotics to patients with few other treatment options. In a letter, Pew called the bill, named the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, “a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them the most.” More info
On Nov. 18, 2013, Congress passed the landmark Drug Quality and Security Act, bipartisan legislation to safeguard the U.S. pharmaceutical supply from counterfeit and contaminated drugs. The act creates a national system to track and authenticate prescription medications as they progress from the manufacturer to the patient. It also addresses the risks posed by drugs made by large-scale compounding pharmacies. More info
The U.S. Senate on Monday approved a bill designed to prevent the type of quality control problems that led last year to a deadly outbreak of fungal meningitis traced to a tainted pharmaceutical mixed by a Massachusetts pharmacy. More info