New Act Creates 60-Day Fast Lane for Importing Drugs During Shortages and for Old, Off-Patent Medicines

The “Short on Competition Act” is essentially a new emergency toolkit for the Secretary of Health and Human Services (HHS) to deal with drug supply problems. When the Secretary sees a drug shortage—or even the likelihood of one—they can authorize the temporary importation of that drug from certain foreign countries for up to three years. The imported drug must have the exact same active ingredient as the one in shortage here, and the manufacturer has to promise they’ll work toward full U.S. approval eventually. The big takeaway for anyone relying on a specific medication is that once the importer files the right paperwork, the Secretary must authorize the import within 60 days, unless there’s a safety issue. This is a clear attempt to speed up the supply chain and avoid the panic that happens when pharmacy shelves go bare.

The 'Marginally Competitive' Backdoor

This bill doesn't just address sudden crises; it also targets specific long-term market failures. It introduces a new category called a "marginally competitive drug market." This is where the bill gets interesting because it forces the Secretary to treat this situation as if it were a drug shortage, triggering the fast-track importation rules. A drug falls into this category if three conditions are met: it’s been commercially available for at least two months with fewer than five versions on the market; the original drug was approved over 10 years ago; and crucially, all patents covering the active ingredient have expired. Think of those older, essential medications—like certain antibiotics or blood pressure drugs—where the patents are long gone, but the market never developed robust generic competition, leaving consumers vulnerable to price hikes or supply disruptions. This provision is designed to use importation as a competition lever, potentially lowering prices for these specific, older drugs by flooding the market with alternatives.

What This Means for Your Wallet and Safety

For consumers, especially those reliant on older, essential medications, this bill could mean greater supply stability and potentially lower costs. If you work at a pharmacy or in healthcare, this provides a clear, 60-day deadline for the FDA to act when a shortage hits, which is a massive improvement over open-ended regulatory processes. However, there’s a trade-off. This process temporarily bypasses the full, rigorous FDA approval system. While the Secretary can still veto an import based on safety concerns—for example, if the foreign country pulled the drug's approval—the bill relies heavily on the Secretary’s judgment to ensure the imported drugs meet U.S. safety and efficacy standards. This increased reliance on foreign regulatory systems, even if temporary, represents a shift in how the U.S. handles its drug supply security. The FDA and HHS will suddenly be tasked with rapidly vetting foreign supply chains, which is a significant administrative lift that could strain their resources. Meanwhile, U.S. drug manufacturers will face immediate competition from imported versions in these specified markets, potentially reducing their revenue from older, off-patent drugs.