Eye drop recall shines light on lack of US drug testing

Concerns about the safety of over-the-counter eye drops emerged last month when the FDA issued a major warning to consumers not to buy or use more than two dozen brands of eye care products sold by such well-known retailers as CVS, Rite- Help and Target because of the potential risk of eye infection. The agency took this action after discovering bacterial contamination in the production facility. But this was not a newfound risk.

The first news of a serious outbreak of severe eye infections caused by a highly drug-resistant strain of bacteria was reported by the CDC’s Health Alert Network on February 1, 2023. Laboratory testing determined that artificial tears were the source. Although the manufacturer recalled the implicated products, the outbreak ultimately infected 81 people in 18 states. Fourteen lost their sight and four died.

In response to the CDC’s warning, the FDA stepped up inspections of overseas manufacturing facilities, which have declined sharply during the pandemic. But its warning about contamination in additional eye care products was not issued until late October, nine months after the CDC alert.

Two weeks after the October 27 FDA warning, Bloomberg reported that all the products were made by a single company in Navi Mumbai called KilitchHealthcare India Ltd. According to Bloomberg, the eye drops pulled from pharmacy shelves across the US last month were made in an unsanitary factory. in India where workers went barefoot and fabricated test results to make the products appear safe.

The FDA did not identify Kilich as the source of the contaminated products.

Contamination of OTC products is unusual, but not unprecedented

This is not the first time that contaminated over-the-counter products have reached consumers. For example, in 2021 Valisure, an independent laboratory based in Connecticut, found benzene, a known carcinogen, in several brands of hand sanitizers, spray sunscreens, and other aerosol skin care products. Valisure has also found cancer-causing substances such as NDMA in some generic drugs, including Ranitidine (Zantac). In any case, recalls followed.

Are American generic drugs safe?

On its public website, the FDA states that a generic drug is a drug that is created to be the same as a drug already on the market in terms of dosage, safety, strength, route of administration, quality, performance characteristics and intended use. Because generic drugs are less expensive than their brand-name counterparts, sales have grown to the point that they represent about 90% of prescriptions filled in the US

Because each manufacturer’s version of a generic drug must be approved by the FDA before it can be legally sold in the US, doctors and patients assume that generic drugs are just as safe and effective as the brand-name drugs they mimic. The FDA supports this view by asserting to the public that the generic drug works in the same way and provides the same clinical benefit as the brand name drug. In other words, you can take a generic drug as an equal substitute for its brand-name counterpart.

The good news is that this statement is usually true. The bad news is that it is not always the truth. Quality and safety problems with generic drugs could and did happen, and patients were harmed. In fact, about two-thirds of drug shortages in the US are caused by quality or safety concerns. Unfortunately, without access to product testing data, consumers and healthcare professionals have no way to distinguish generic drugs made by reliable companies from those made by less conscientious ones.

Three overlapping factors have led to this state of affairs:

1. Competition

The Hatch-Wakman Act of 1984 created a streamlined pathway for generic drug approval by the FDA. In the early days this worked well, but as competition intensified, drug wholesalers scoured the world to find generic drug manufacturers with the cheapest prices. Since bulk buyers believe that quality is guaranteed by the FDA, the only criteria they consider is price. The ensuing race to the bottom left manufacturers with slim margins.

2. Globalization

Domestic producers found it almost impossible to compete with companies in countries with low labor costs, less stringent controls and, in some cases, illegal trade practices. Over time, most of the production of generic drugs moved abroad. Today, the United States relies heavily on other countries, particularly India and China, for its generic drugs, as well as for the raw materials and active pharmaceutical ingredients needed to manufacture them.

3. Limited supervision

The globalization of generic drug production is straining the FDA’s ability to protect the public. Once a manufacturer is approved to sell its generic drug in the US, the FDA relies on paperwork reviews and periodic facility inspections to ensure that the company is complying with good manufacturing processes. The FDA is working not routinely test the drugs produced by these plants.

In contrast, the National Highway Traffic Safety Administration crash tests cars and uses the results to compile easy-to-understand safety ratings, which it shares with the public on the agency’s website. It also uses the work of watchdogs such as the Insurance Institute for Highway Safety and Consumer Reports.

A solution for the private sector

Instead of waiting for Congress or the FDA to act, health systems, chain pharmacies and the big three drug distributors that dominate the US market could conduct independent testing to identify high-quality products. Kaiser Permanente and the University of Kentucky Health System are already doing some product testing, either internally or through an outside lab. Recently, the US Department of Defense launched a pilot program with Valisure to evaluate the quality and safety of essential generic drugs.

President Ronald Reagan famously said: Trust, but verify. Generic drugs are cheap, but not trusting their quality and safety through independent testing puts patients at risk. This risk can be minimized if products are tested regularly and problems are promptly reported to the FDA and shared with the public. Focusing on quality and the price should keep consumer costs low and ensure a safer and more reliable supply of medicines.

America routinely tests cars, toys, clothing and many other consumer products. It can test both generic drugs and OTC products.

Update: This article was originally published on November 9. It was updated on November 10 with new details published by Bloomberg.