Stained eye drops highlight problem: U.S. drugs are less tested than clothing

Concerns about the safety of over-the-counter eye drops surfaced again last month when the FDA issued a warning to consumers to avoid using more than two dozen eye care products due to bacterial contamination at the factory. manufacture But this is not a newly discovered risk.

The first news of a serious outbreak of eye infections caused by highly resistant strains of bacteria was reported by CDCs Health Alert Network on February 1, 2023. Laboratory tests indicate the source is artificial tears. The contaminated product was quickly pulled from the market, though. But the outbreak ultimately infected 81 people in 18 states, fourteen lost their vision and four died.

The FDA responded by promoting inspections of overseas manufacturing facilities. This has dropped significantly during the pandemic. But it didn’t issue a widespread warning about additional products until late October. Nine months after CDC notification

Contamination of OTC products is uncommon. But it’s never happened before.

This isn’t the first time that contaminated over-the-counter products have reached consumers. For example, in 2021, Valisure, an independent lab in Connecticut, Benzene, a carcinogen, has been found in several brands of hand sanitizer, sunscreen spray and other aerosol skin care products. Valisher has also found cancer-causing substances, such as NDMA, in some generic medicines. For example, ranitidine (Zantac) has been followed in each case by a recall.

Are American generic drugs safe?

On its public website, the FDA states that generics are drugs that are created to be identical to brand name drugs that are already on the market. in dosage form, safety, potency, route of administration, quality, performance characteristics and purpose of use This is because generic drugs are cheaper than brand name drugs. Sales thus increased to the point where they accounted for approximately 90% of prescriptions dispensed in the United States.

This is because each manufacturer’s generic version of a drug must be approved by the FDA before it can be legally sold in the United States. Doctors and patients therefore assume that generic drugs are just as safe and effective. With the brand name drugs they imitate, the FDA reinforces this view by publicly asserting that generic drugs work in the same way and provide the same clinical benefits as brand name drugs. In other words You can equally substitute generic medicines for brand name medicines.

The good news is that this statement is often true. The bad news is that it is. not always True. Problems with the quality and safety of generic drugs can occur and patients are harmed. In fact About two-thirds of drug shortages in the United States are due to quality or safety concerns. Unfortunately, without access to product testing data Consumers and health care providers also have no way to distinguish generic drugs produced by reliable companies from drugs produced by less discreet companies.

Three overlapping factors cause this situation:

1. Competition

The Hatch-Waxman Act of 1984 created a streamlined path to FDA approval for generic drugs. In the beginning, it worked well, but as competition became fiercer, Drug wholesalers also scour the world to find the lowest cost generic drug manufacturers. This is because many buyers believe that the FDA guarantees quality. The only criterion they consider is price. The race to the bottom results in razor-thin margins for manufacturers.

2. Globalization

Domestic manufacturers find it nearly impossible to compete with domestic companies with low labor costs. There is less strict supervision. And in some cases, there may be illegal trade practices. As time passes Most generic drug production has moved overseas. Today, the United States is largely reliant on other countries. Especially India and China For generic drugs as well as raw materials and active pharmaceutical ingredients required for production.

3. Limited supervision

The globalization of generic drug production is limiting the FDA’s ability to protect the public. When a manufacturer is approved to sell a generic drug in the United States, the FDA relies on document reviews and periodic factory inspections to ensure that the company follows good manufacturing processes. FDA does. no Test the medicines these plants produce regularly.

On the contrary The National Highway Traffic Safety Administration will conduct crash tests on cars. and use these findings to compile an easy-to-understand safety score. which the agency will share with the public on its website. It will also enhance the work of watchdog agencies such as the Insurance Institute for Highway Safety and consumer reports.

Private Sector Solutions

Instead of waiting for Congress or the FDA to act, health systems, drugstore chains and the three major pharmaceutical distributors that dominate the U.S. market. Independent testing can be done to identify high-quality products. Kaiser Permanente and University of Kentucky Health System are already testing some products. either internally or through external laboratories. Recently, the U.S. Department of Defense It has initiated a pilot project with Valisure to assess the quality and safety of essential generic medicines.

President Ronald Reagan once said: “Trust but you must prove.” Generic drugs are negotiable. But not verifying quality and safety through independent testing puts patients at risk. This risk can be reduced if products are tested regularly and problems are promptly reported to the FDA and shared with the public. Quality is emphasized. and Prices should keep consumer costs low and ensure a safer and more reliable supply of medicines.

America regularly tests cars, toys, clothing, and other consumer products. Generic drugs and OTC products can be tested as well.