In the United States, generic drugs make up 90% of all prescriptions filled. However, recent concerns have been raised about the safety of over-the-counter eyedrops. The FDA issued a warning last month, advising consumers to avoid using certain eye care products due to bacterial contamination at their manufacturing plants. This warning came after a serious outbreak of eye infections caused by a drug-resistant strain of bacteria. The contaminated product was quickly removed from the market, but the outbreak infected 81 people, with 14 losing their vision and four dying.
This is not the first time contaminated over-the-counter products have reached consumers. In 2021, a laboratory found benzene, a known carcinogen, in several brands of hand sanitizer and aerosol skin care products. Cancer-causing substances have also been found in some generic drugs. Recalls followed each of these incidents.
The FDA states that generic drugs are created to be the same as brand-name drugs in terms of dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. They are approved by the FDA before being sold in the U.S., leading physicians and patients to believe that they are as safe and effective as brand-name drugs. However, problems with generic drug quality and safety have occurred in the past, leading to patient harm. Two-thirds of drug shortages in the U.S. are triggered by quality or safety concerns.
Three factors contribute to this state of affairs. First, intense competition has led to drug wholesalers prioritizing price over quality. Second, globalization has shifted most generic drug production overseas, where oversight may be less stringent. Third, the FDA's limited oversight relies on paperwork reviews and occasional inspections, without routine testing of the medications produced.
To address these concerns, health systems, pharmacy chains, and major drug distributors could conduct independent testing to identify high-quality products. Some institutions are already doing this, and the U.S. Department of Defense has initiated a pilot program with a laboratory to assess the quality and safety of essential generic medicines.
It is important to prioritize quality and safety in the production of generic drugs and over-the-counter products. Regular testing and prompt reporting of problems to the FDA and the public can minimize risks to patients. By focusing on both quality and price, consumers can benefit from lower costs and a more reliable drug supply. Just as America tests cars, toys, and clothing, it should also test generic drugs and over-the-counter products.