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# ‘Race to the Bottom’ Generic Model Threatens Quality/Supply: Expert
- URL: https://www.fdaweb.com/race-to-the-bottom-generic-model-threatens-quality-supply-expert/
- Published: 2026-03-24T12:00:00.000Z
- Updated: 2026-09-14T13:36:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160868

A leading health policy expert is warning that intense price competition in the U.S. generic drug market is undermining manufacturing quality and increasing the risk of shortages, calling for targeted reforms to stabilize the system. In a Brookings [commentary](https://www.brookings.edu/articles/when-cheap-becomes-fragile-how-the-race-to-the-bottom-in-generics-undermines-manufacturing-quality-and-what-to-do-about-it/?ref=fdaweb.com) that was adapted from recent remarks to the Senate Special Committee on Aging, **Marta E. Wosinska** argues that the structure of the generic drug market has created a “race to the bottom,” where relentless cost-cutting discourages investment in robust manufacturing and quality systems.

Generic drugs account for roughly 90% of prescriptions filled in the U.S., particularly among older adults who rely on them to manage chronic conditions. While these medicines are required to meet the same regulatory standards as brand-name drugs, their prices have been driven sharply downward by market dynamics.

Wosinska points to powerful purchasing groups — formed by major pharmacy chains and hospital systems — that negotiate aggressively for the lowest prices. Because reimbursement systems often reward providers for selecting the cheapest equivalent drug, manufacturers face continuous pressure to reduce costs.

According to the commentary, shrinking margins and unpredictable demand are contributing to weakened quality assurance and a growing risk of manufacturing defects. These pressures also make supply chains more fragile, increasing the likelihood of drug shortages.

Wosinska cautions that several widely discussed solutions — such as broad onshoring of drug manufacturing or increased consumer-facing transparency — may not address the root causes of the problem and could even introduce new risks or costs. Instead, she urged policymakers to focus on “fit-for-purpose” interventions that directly target weaknesses in manufacturing oversight and market incentives.

Among the key recommendations is the adoption of a “Qualified Person” (QP) system, modeled on European regulations. Under such a framework, a designated U.S.-based expert would be required to certify that each batch of imported drugs meets Current Good Manufacturing Practice standards before entering the market. The proposal also calls for mandatory testing of imported drug batches in U.S.-based laboratories, particularly for products originating from countries without mutual regulatory recognition agreements.

Wosinska says this approach would increase both the likelihood of detecting quality issues and the accountability of manufacturers, as individuals — not just companies — would bear responsibility for certifying compliance.

The commentary emphasizes that any reforms must carefully balance affordability with reliability. While generics play a critical role in keeping healthcare costs down, policies that focus solely on price may inadvertently weaken the system that ensures drug safety and availability.

“Patients deserve safe, high-quality medicines,” Wosinska says, adding that policy solutions must align with the specific failures they are designed to fix.