Senator Ted Cruz (R-TX) dropped a legislative bombshell on Wednesday, introducing the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025.
The bill, aimed at slashing FDA red tape, would let drugs, biologics, and devices already approved in trusted countries zip into the U.S. market—potentially saving lives and shaking up the pharma game.
The proposal amends the Federal Food, Drug, and Cosmetic Act to greenlight “reciprocal marketing approval” for products legally sold in nations like those on the FDA’s trusted list (think Canada, Japan, or the EU) or the UK.
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If a sponsor proves a drug or device meets safety muster, hasn’t been yanked abroad for risks, and fills a U.S. health gap, the FDA has 30 days to say yes—or explain why not.
Here’s the kicker: if the FDA says no, Congress can override it with a joint resolution—a rare check on agency power.
The bill also mandates the FDA to hash out labeling pronto and, for devices, classify them on the fly. It’s not a free-for-all—the FDA can nix anything it deems unsafe or ineffective, and postmarket studies could be tacked on. But the default leans toward approval, a stark shift from the FDA’s usual grind.
Why now? Cruz points to “unmet medical needs” and a public fed up with delays.
Think cutting-edge cancer drugs or breakthrough devices stuck overseas while patients wait. The bill’s outreach clause even pushes the FDA to nudge foreign sponsors to jump in. Fees? Same as any FDA application—no budget hit there.
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Critics might cry foul—could this flood the market with risky stuff? Cruz’s camp says no, citing safeguards like the FDA’s veto power and reliance on rigorous peers like the UK’s MHRA.
Supporters see a lifeline: if it’s good enough for London or Tokyo, why not Houston? The bill’s landed in the Senate Committee on Health, Education, Labor, and Pensions, where it’ll face scrutiny—and likely a partisan slugfest.
For Cruz, it’s a signature play—deregulation with a populist twist. If it passes, expect a ripple effect: faster access to global meds, a leaner FDA, and a new frontier for U.S. healthcare. The clock’s ticking on that 30-day approval window—assuming the Senate doesn’t stall it first.
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