New Bill Forces FDA to Approve Foreign Drugs and Devices in 30 Days—or Congress Steps In

If you’ve ever waited for a new treatment or medical device to hit the market, you know the FDA approval process can feel like watching paint dry. Enter the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025, which aims to put the pedal to the metal by creating a new, lightning-fast approval lane for certain medical products already available overseas.

Here’s the deal: This bill establishes "reciprocal marketing approval" for drugs, biological products, and devices that are already legally authorized in the United Kingdom or any country listed in section 802(b)(1) of the Federal Food, Drug, and Cosmetic Act. If a sponsor (the company) requests this status and can show the product is approved in one of those jurisdictions, the FDA Secretary must grant the approval within a stunningly short 30 days. This reciprocal approval effectively treats the product as if it went through the standard, years-long FDA process, instantly opening the U.S. market. The catch? The Secretary can only deny the request if they make an explicit, affirmative finding that the product is unsafe or ineffective here in the U.S., or if the foreign authorization was pulled for safety reasons. It’s a major shift in how foreign-approved treatments enter the U.S. marketplace, designed to prioritize speed and access, especially when there’s an “unmet medical need” in the U.S.

The 30-Day Clock: Cutting the Line

For most of us, quicker access to new treatments sounds great. If a drug has been safely used in the UK for two years, why should U.S. patients wait another two years for the FDA to re-review every detail? This bill addresses that by treating the foreign approval as sufficient evidence. For drug and device makers, this is a massive win, allowing them to skip the bulk of the domestic regulatory gauntlet and get their products—and revenue—flowing much faster. The bill even requires the FDA to conduct an outreach campaign to encourage companies to use this new fast track, showing a clear intent to maximize its use.

However, the 30-day requirement is where the rubber meets the road—and where the potential for friction is highest. The FDA’s job is to ensure safety and effectiveness for the specific U.S. population and context. Compressing that review to 30 days means the agency has minimal time to scrutinize the foreign dossier, check for potential differences in manufacturing quality, or ensure labeling is appropriate for U.S. doctors and patients. For the FDA, this creates an enormous administrative burden and significant pressure to greenlight products quickly, potentially leading to less rigorous domestic oversight than the public expects.

The Congressional Override: Politics Over Science?

Perhaps the most eyebrow-raising provision is the Congressional Disapproval Process. If the FDA Secretary reviews the product and decides, based on safety data, to deny reciprocal approval, that denial isn't final. Congress can step in and pass a joint resolution of disapproval against the Secretary’s denial. If Congress does this, the reciprocal marketing approval takes effect anyway.

Think about that: Congress, a political body, could effectively overrule the FDA’s scientific determination that a drug or device is unsafe or ineffective and force its approval. This provision raises serious questions about maintaining the independence of the FDA’s safety determinations. It means that even if career scientists find a deal-breaker safety issue, political pressure could still force the product onto the market. For the average person, this means the safety net you rely on—the FDA’s scientific review—could be bypassed by a legislative vote, creating a risk that the public bears if the expedited product proves to be less safe than expected.

Who Pays the Price?

While the goal is clearly to boost patient access, the bill creates a two-tiered system. Companies using the reciprocal pathway get a massive time advantage, while domestic manufacturers who develop new products from scratch must still go through the full, standard FDA review process. This could incentivize companies to prioritize developing products for foreign markets first to take advantage of the fast track here. Furthermore, while the bill streamlines the approval process, it doesn't waive the fees; a request for reciprocal approval is treated like a standard application for fee purposes, ensuring the FDA still collects the necessary operating funds, even if they only have 30 days to do the work.