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A recent analysis in Health Affairs explains why we need to restore orphan drug incentives, and a new report highlights the toll of the record number of climate-related disasters in the U.S. (433 words, 2 minutes, 9 seconds) We’re off on Monday in recognition of Martin Luther King Jr. Day. We’ll resume publication on Tuesday, January 16. |
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2023 brought a record number of billion-dollar disasters, U.S. report shows
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The U.S. suffered an unprecedented 28 individual billion-dollar disasters in 2023, says a federal report published Tuesday—adding to data on a dismal year for climate change. 2023’s billion-dollar climate disasters included 17 severe weather/hail events, 4 flooding events, 2 cyclones, 2 tornado outbreaks, 1 winter storm, 1 wildfire, and 1 drought/heat wave, the National Oceanic and Atmospheric Administration (NOAA) reports.
The total bill: $92.9 billion in damage.
We’re in for more: The El Niño weather pattern will continue to drive up temperatures, NOAA predicts. Another global heat record is likely in 2024, reports Bloomberg—and trends are worsening, says the U.S. Fifth National Climate Change Assessment.
We’ll shout it from the rooftops: Let’s advance biotech solutions to reduce greenhouse gas emissions, like sustainable aviation fuels (SAFs), methane reduction measures, biomanufacturing to reduce reliance on fossil fuels, and plants that help with carbon sequestration.
The role for policymakers: Government efforts include climate provisions in the Inflation Reduction Act and initiatives to promote SAFs and biomanufacturing. Americans want more government support for biotech climate solutions, a poll shows. |
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Why we need orphan drug incentives |
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An analysis finds that allowing orphan drugs for rare diseases to maintain market protection for second indications (or more) has encouraged the development of new treatments. The Inflation Reduction Act (IRA) price controls could change that.
Why it matters: The Orphan Drug Act enabled 800 drug approvals to address 5% of rare diseases. The IRA exempts orphan drugs from price controls—but not if the drugs are approved for a second indication.
The study: Health Affairs reviewed more than 30 years of Food and Drug Administration (FDA) approvals to see if drug makers could use second indications to extend market exclusivity.
The key findings: FDA approval for follow-on indications in the orphan product space has not negatively impacted the market entry of competing generics—but it HAS enabled new treatments. The study highlights the importance of strong incentives to research and develop treatments for untreated orphan diseases.
By the numbers: 65% of orphan drugs were only approved for one disease, 15% were approved for multiple rare diseases, and 20% were approved for rare and common diseases.
A bipartisan solution: The ORPHAN Cures Act would amend the IRA to restore incentives for rare disease R&D. Bipartisan lawmakers, voters, and BIO support the bill.
BIO’s view: “It’s hard to believe the IRA’s architects actually intended to derail research into rare diseases,” says BIO Board Chair Dr. Ted Love. “Lawmakers can reverse course and correct the problem by passing the ORPHAN Cures Act.” |
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President Biden’s Friday: Making his second trip to Pennsylvania this week—to Allentown to discuss the economy, per CBS News.
What’s Happening on Capitol Hill: Enjoy the long weekend. |
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