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With appropriations negotiations underway on Capitol Hill, we look at what some members of Congress want the package to say about genome editing for food. Plus,the FDA cut back on use of Accelerated Approval in 2022—a very unwelcome holiday surprise for patients. (634 words, 3 minutes, 10 seconds) |
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Lawmakers say spending bill should require FDA to set policy on ag genome editing |
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Budget legislation currently under debate should require FDA to spell out its policy on genome editing in food, says a bipartisan letter sent last week from 11 members of Congress to their colleagues in the House and Senate.
Down to the wire: The House passed a one-week spending extension yesterday as lawmakers wrestle with year-end passage of a 2023 budget. The House and Senate must include the agriculture appropriation in final legislation; Democrats want to pass that legislation by year’s end, while Republicans are divided, says The Hill.
What they’re saying: The letter, organized by U.S. Reps. Jimmy Panetta (D-CA) and James Baird (R-IN), says the final agriculture appropriation should include provisions supporting biotech innovation that passed the House in July.
Modernized FDA regulations on genome editing would have to be submitted for public comment under the House plan. This would give biotech companies a clear path to market (and it’s something BIO has sought for years).
“FDA’s longstanding delay on issuing draft guidance for industry on novel genetic technologies and reviewing and modernizing the agency’s plant consultation has greatly increased regulatory uncertainty,” says the letter. Without change, “we will stifle American farmers from accessing these new, innovative technologies.” Why it matters: Ag biotech innovations are needed “to urgently address crop resiliency, sustainable cultivation, and the growing threat of food insecurity,” the letter says—and regulatory agencies need to deal with them.
BIO’s view: “The House-passed agricultural appropriations bill will help biotech developers and their farmer and rancher partners meet the 21st-century challenges we face through innovation. We urge the Senate also to support these provisions,” says BIO’s Chief Policy Officer, John Murphy. |
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NEW ADP R&D Tax Credit Offering
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After misguided criticism, FDA cut back on Accelerated Approvals in 2022 |
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The U.S. Food and Drug Administration (FDA) cut back on use of the Accelerated Approval pathway this year, a response to critics that would do more harm than good for patients.
Designed to speed treatments to patients, Accelerated Approval (AA) allows drugs for serious diseases that show effectiveness in the lab to enter the market before clinical trials are complete.
Why it matters: AA has enabled breakthroughs against diseases including cancer and HIV—but in 2022, the FDA granted AA for 10 drugs, fewer than in any of the previous five years, AP says.
Criticism is misguided: Critics have said drugmakers receiving AA take too long to complete trials, and the issue seems to have been politicized. But a report by Vital Transformation finds 75% of AA drugs get full FDA approval within four years.
“A higher bar could spell trouble for smaller drugmakers,” who use AA to raise more development funding, AP says. And it could chill development of new drugs, especially for cancers and rare diseases, said Vital Transformation CEO Duane Schulthess.
The bottom line: patients would lose treatments. Since 1992, AA has enabled market entry of approximately 300 drugs, mostly for cancer and rare diseases. About two-thirds would never reach the market if the program was dramatically altered, impacting as many as 3.6 million patients, according to Vital Transformation. More Health News: CNN: Gene editing technology for treatment-resistant cancer could be a ‘scientific layup’ to treat other diseases
“For the first time, a new gene editing technology called base editing was used to modify immune cells and successfully treat a teen with treatment-resistant leukemia. A month afterward, 13-year-old Alyssa was in remission, and she continues to do well several months later.” |
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