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We’ve got lots to cover this week—including what to expect on Mexico’s corn ban, what Sen. Bill Cassidy MD said about FDA’s Orange Book, and more news on price controls and bird flu. (871 words, 4 minutes, 21 seconds) |
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As Mexico changes presidents, House members urge action on corn ban |
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As Claudia Sheinbaum became Mexico’s president on Oct. 1, a bipartisan letter from 21 American Congress members called on U.S. officials to address Mexico’s planned biotech corn ban.
The message: “With this change in leadership, we strongly urge you to engage with the incoming administration” to resolve the dispute, said the letter, addressed to U.S. Trade Representative Katherine Thai and Agriculture Secretary Tom Vilsack.
Why it matters: Mexico would ban imports of all biotech corn under a decree by outgoing President Andrés Manuel López Obrador. The U.S. exported $5 billion in corn in 2023, and 90% of it is biotech corn.
The U.S. has challenged Mexico’s ban as unscientific, calling a dispute panel to rule whether it is a violation of the U.S.-Mexico-Canada Agreement (USMCA). That panel should rule in the coming months.
What’s happening now: Mexican President Sheinbaum was López Obrador’s hand-picked successor, and her incoming agriculture minister has promised to maintain the biotech corn ban. However, drought in Mexico means the country has been importing U.S. corn at record levels instead of starting the ban as scheduled.
Lawmakers would keep trade open: “It is our hope that you will work with President Sheinbaum and her administration to resolve this dispute and ensure continued access to Mexico’s market for U.S. corn and biotechnology, which has long been proven safe for human consumption,” the letter said.
BIO agrees. “At a time when Mexico faces a historic drought and relies on a record number of imports of U.S. agricultural commodities to meet its population’s growing demand, the role of biotechnology in agriculture has never been more critical,” BIO said in a statement coinciding with the congressional letter.
Read more in Bio.News. |
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BIO is announcing a new series produced for us by BBC StoryWorks and launching in 2025. In this new iteration, the series will build on the storytelling expertise developed in the previous series to explore biotechnology in greater depth, combined with a campaign poised to reach an even bigger audience and further generate evidence-based understanding of the tangible impact of cutting-edge science.
Click to learn more and submit your story. |
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Senator tells FDA to act, not abdicate, on drug device patents |
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Food and Drug Administration (FDA) inaction on patents for drug delivery devices has been troubling drug manufacturers for 20 years, and the situation is getting worse, a lawmaker says.
The FDA is committing “an extraordinary abdication of authority” by allowing Federal Trade Commission (FTC) intervention that burdens drug makers, says a Sept. 30 letter to FDA Commissioner Robert Califf, M.D. written by Sen. Bill Cassidy, MD (R-La), the Ranking Member of the Senate Health, Education, Labor, and Pensions Committee.
FDA’s Orange Book identifies FDA-approved drugs and related patents, including for devices to deliver a drug, such as asthma inhalers and injection pens for insulin.
The old problem: BIO and drugmakers have been asking since 2005 for clarity on the right way to register drug delivery device patents in the Orange Book, but the FDA has delayed any decision on the issue.
The new problem: For lack of FDA guidance, the FTC has begun threatening lawsuits against patent holders. “FTC’s actions have sown confusion amongst manufacturers about how they should list patents,” Sen. Cassidy writes, calling on FDA to reassert its authority.
BIO’s view: When FTC started challenging Orange Book patents a year ago, BIO wrote to them: “What is needed at this point is not the threat of enforcement or legal liability, but rather, increased regulatory clarity and a forum for stakeholders and regulators to jointly and proactively address new patent listing questions.”
Read more on Bio.News. |
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What Else to Know This Week |
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Centers for Medicare & Medicaid Services (CMS) releases guidance for next year’s price control process, planning to announce up to 15 drugs for price setting in February. The guidance includes changes like “multiple opportunities for engagement and the potential for additional written offers and counteroffers between CMS and participating drug companies during the negotiation process,” CMS says. The process is also supposed to increase patient involvement, with “up to 15 patient-focused roundtable events, as well as one town hall meeting, to solicit feedback.”
U.S. policy changes could jeopardize groundbreaking research,writes Erika Smith, CEO of ReNetX Bio (and BIO Board member), in the Hartford Courant. She explains how amendments to the tax code and potential “march-in rights” on patents could undermine investor confidence and details legislative action needed to reverse the tax changes. Read the whole thing.
CSL Seqirus, Sanofi, and GSK receive BARDA funds to prepare bird flu vaccines for humans. The BIO member companies received a total of $72 million from the Biomedical Advanced Research and Development Authority (BARDA), a Center within the Administration for Strategic Preparedness and Response (ASPR). CSL Seqirus, Sanofi, and GSK are contracted to fill and finish additional doses of their influenza A(H5) vaccines from bulk storage into ready-to-use vials or pre-filled syringes. The companies will also manufacture additional bulk influenza antigen “from seed stocks that are well matched to circulating strains,” (ASPR) said. BARDA is separately providing $121.4 million to CSL Seqirus for general pandemic influenza preparedness and keeping an inventory of additional adjuvant used in the company’s H5 influenza vaccine. “Although the risk to Americans from influenza A(H5) virus infection remains low, we’re leaning forward with our preparedness efforts,” said BARDA Director Gary Disbrow.
LanzaTech made Fortune’s Change the World list, highlighting 52 businesses that harness “the creative impulses of capitalism to address social problems,” with LanzaTech CEO Jennifer Holmgren one of just seven women leaders on the list. Read more in Fortune. |
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Beltway Report: What's Ahead in Washington
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