Bipartisan Bill to Increase Access to Generics Reintroduced

A group of bipartisan lawmakers have reintroduced legislation aimed at preventing brand-name pharmaceutical manufacturers from blocking the entry of generics on to the market. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act creates a cause of action in federal court for generic manufacturers who are experiencing difficulties obtaining access to reference products subject to a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use (REMS with ETASU) or a restricted distribution system self-imposed by the reference product manufacturer. The Congressional Budget Office (CBO) estimates that the bill would decrease the federal deficit by $3.3 billion. S. 974 was sponsored by Sen. Patrick Leahy (D-Vt.), and is cosponsored by Sens. Chuck Grassley (R-Iowa), Dianne
Feinstein (D-Calif.), Mike Lee (R-Utah), and Amy Klobuchar (D-Minn.). Companion legislation (H.R. 2212) has been introduced in the House by Reps. Tom Marino (R-Pa.) and David Cicilline (D-R.I.).

Upcoming Congressional Hearings/Meetings

House Energy and Commerce Subcommittee on Health hearing on “Examining Improvements to the Regulation of Medical Technologies;” 10:00 a.m.; 2123 Rayburn Bldg.; May 2

House Energy and Commerce Subcommittee on Oversight and Investigations hearing on “Combating Waste, Fraud, and Abuse in Medicaid’s Personal Care Services Program;” 10:15 a.m., 2322 Rayburn Bldg.; May 2

Senate Armed Services Subcommittee on Emerging Threats and Capabilities hearing on “Department of Defense Laboratories and Their Contributions to Military Operations and Readiness;” 10:00 a.m., 222 Russell Bldg.; May 3

Senate Appropriations Subcommittee on Defense hearing on “A review of Defense Innovation and Research Funding;” 10:30 a.m., 192 Dirksen Bldg.; May 3

House Small Business Subcommittee on Contracting and Workforce and House Science, Space, and Technology Subcommittee on Research and Technology joint hearing on “Improving the Small Business Innovation Research and Small Business Technology Transfer Programs;” 9:00 a.m., 2318 Rayburn Bldg.; May 4

Senate Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies hearing on “Telemedicine in the VA: Leveraging Technology to Increase Access, Improve Health Outcomes, and Lower Costs;” 10:30 a.m., 124 Dirksen Bldg.; May 4

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