Rx Drugs

Opponents of the COVID-19-related waiver of World Trade Organization intellectual property protections, surprised by the U.S. announcement Wednesday that it would back the effort, are being pushed to follow Washington's lead, which has decisively changed the conversation in Geneva.

The USC Schaeffer Center and the Aspen Institute published a paper with recommendations for how the government should achieve the president’s plan for an organization that appraises the value of drugs.

The U.S. will support a proposed waiver of World Trade Organization intellectual property obligations for COVID-19 vaccines and “actively participate” in text-based negotiations in Geneva, U.S. Trade Representative Katherine Tai announced on Wednesday, arguing the global emergency “calls for extraordinary measures.”

The House Energy & Commerce health subcommittee will hold a hearing next Wednesday (May 12) with HHS Secretary Xavier Becerra to discuss HHS’ 2022 discretionary budget request, and lawmakers will use the opportunity to quiz Becerra on the administration’s vague plans to cut prescription drug costs and expand health coverage.

Policy experts applauded the release of a bipartisan Senate bill that focuses on ramping up the antibiotic supply chain, but the experts say lawmakers also should focus on crafting and passing legislation that creates incentives for antibiotic developers.

Co-sponsors at the World Trade Organization of a proposed waiver of certain intellectual property commitments said on Friday they would review, and potentially revise, the language with an eye to finding common ground, even as the U.S. remains skeptical of the waiver’s likelihood of delivering more vaccine production.

FDA’s oncology advisory committee on Thursday (April 29) narrowly voted against letting Bristol-Myers Squibb’s Opdivo (nivolumab) maintain its accelerated approval as a second-line treatment for patients with a type of liver cancer known as hepatocellular carcinoma.

FDA’s oncology advisory committee on Wednesday (April 28) voted in favor of allowing Merck Sharpe & Dohme’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolizumab) maintain their accelerated approvals for treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

President Biden has not decided whether to support a proposed waiver of some World Trade Organization intellectual property rights rules as a part of a global pandemic response, nor has U.S. Trade Representative Katherine Tai made a recommendation to him, White House Press Secretary Jen Psaki said on Tuesday.