This Week in Washington: Countdown to Election Day- Focus on polls, campaigns and who will be in control of the House and Senate
The House is in recess until Nov. 14
The Senate is in recess until Nov. 14
Senators Write USTR to Urge Protection of American Innovation in Therapeutics and Diagnostics
U.S. Senators Tom Carper (D-Del.) and Pat Toomey (R-Pa.) led a bipartisan group of senators in writing U.S. Trade Representative Katherine Tai to urge the Biden Administration to safeguard American innovation in the World Trade Organization’s (WTO) negotiations on whether to expand its waiver of IP rights enforcement for COVID-19 vaccines to also include therapeutics and diagnostics. Senators Bill Cassidy (R-La.), Chris Coons (D-Del.), John Barrasso (R-Wyo.), Kyrsten Sinema (D-Ariz.), Thom Tillis (R-N.C.), Robert Menendez (D-N.J.), Richard Burr (R-N.C.), and Jon Tester (D-Mont.) also signed onto the letter.
In June 2022, WTO members agreed to waive obligations under the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for COVID-19 vaccine patent subject matter for a five-year period. This requires the United States to not enforce certain IP rights on behalf of U.S.-based companies at the WTO. The expansion under consideration would enable eligible WTO member countries to ignore otherwise enforceable intellectual property (IP) protections for therapeutics and diagnostics that treat COVID-19.
GOP Senators Ask FDA to Increase Focus Non-Opioid Pain Medication
On Oct. 19, Sens. James Lankford (R-OK), Roger Marshall (R-KS), Shelley Moore Capito (R-WV) and Marsha Blackburn (R-TN) wrote the Food and Drug Administration Commissioner Robert Califf asking that the FDA increase focus on development of non-opioid pain medication. They note that no non-opioid alternative for pain management was approved in 2021. In 2018, the SUPPORT for Patients and Communities Act required FDA issue guidance addressing challenges in non-addictive pain therapies and to assist drug developers in creating non-opioid alternatives for acute and chronic pain management. The FDA did publish draft guidance in February, but the senators state the FDA has not met the requirements of the legislation fully. The senators asked that they be responded to by Nov. 9.
CBO Looks At Doctors’ Reimbursement and Access
The Congressional Budget Office (CBO) included “analyzing how the amount physicians are paid for services affects access to care for dual-eligible beneficiaries (people dually enrolled in Medicare and Medicaid) compared with Medicare-only beneficiaries” on a recently released list of its ongoing projects.
This comes as MedPAC, the congressional advisory panel on Medicare reimbursement, is also looking at how to raise reimbursement for safety net doctors. At its most recent meeting, MedPAC discussed four ways to target funds for providers caring for patients with low-income subsidies.
Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.