Rx Import Alert: CVS Branded Generic Drugs Singled Out In Bloomberg Report For Most Recalls

Rx Import Alert: CVS Branded Generic Drugs Singled Out In Bloomberg Report For Most Recalls

The foreign labs in China and India that make the branded drugs for CVS pharmacies nationwide are coming under increased scrutiny for unsafe manufacturing practices. No pharmacy chain has dealt with more recalls of its imported generic over-the-counter medication like CVS has, a Bloomberg report showed on June 10.

Other chains have seen their share of recalls for their own store-branded medications. But over the past decade CVS’s have been recalled about two times more than those from Walgreens and three times more than those from Walmart Inc.

One of the examples used in the report was CVS Health branded eye drops. The report did not say who made these eye drops, but considering the incident they referred to – of a New York consumer who purchased the eye drops in November 2023 – had occurred during a nationwide recall of imported eye drops, they were likely made in India.

Last year, at least four deaths and several cases of vision loss from tainted eye drops were linked to imports from India.

CVS, Walmart, Walgreens, Rite-Aid, and every other pharmacy across the country, are not in the business of making drugs. They are purchasers of drugs made in contracted labs and they simply slap their logo on the packaging. Retailers will argue that they are not responsible for the quality of the drugs sold in stores. They rely on their contract manufacturer for quality, and the Food and Drug Administration’s inspectors who are supposed to make sure those labs are following the Current Good Manufacturing Practices set forth by the FDA for labs selling medicine into the U.S. market. 

The manufacturers themselves are responsible for the quality of the drugs, according to FDA guidance, and are the ones who voluntarily recall products when they find something wrong with them, or receive complaints from doctors or patients.

Some 80% of generic drugs sold in the U.S. are imported.

Since 2014, CVS hired at least 15 contract manufacturers – including some in the U.S. – that received lackluster results from FDA inspections. Bloomberg reported that CVS partner labs were twice as likely to receive requests for improvements to their lab practices as Walgreens. There have been some 133 recalls of CVS store-brand drugs — an average of more than one a month — in the last 10 years. Walgreens had 70 recalls over the same period and Walmart had 51, according to Bloomberg. 

In February 2023, a lab in Xiamen, China that made burn cream for the CVS Health brand was given an FDA Import Alert notice, banning the company’s Benzalkonium Chloride cream due to microbiological contamination. 

Sun Pharmaceutical Industries of India recalled their CVS Health generic version of Allegra this January after FDA investigators found stagnant liquid inside an air purification unit during a December inspection. Poor air quality can lead to spores that contaminate the lab, and taint the drugs.

The FDA generally does not ban imports from foreign labs that have received lackluster inspection results.  This is mostly due to concerns about supply back home. The FDA is constantly weighing supply concerns with safety concerns and unless the drug is a known hazard, supply concerns win out.

Over 320 drugs are currently considered to be in short supply or unavailable in the U.S., based on industry data.

With companies under pressure to keep generic drug prices low so hospitals and large pharmacies like CVS will keep buying from them, there’s little incentive to manufacture domestically, where the FDA has a much stronger footprint than they do abroad. 

“This sole emphasis on cost pushes the price down to the point where high-quality manufacturers don’t want to stay in the market,” Kevin Schulman, professor of medicine at Stanford University, told Bloomberg.

Foreign Lab Recalls Up, But Imports Surging Anyway

Pharmaceutical imports rose in 2023, and continue to be a leading source of the U.S. goods deficit each month. At $208 billion worth of imports last year, pharmaceuticals are gaining quickly on car imports, and are likely to surpass them in a year or two.

At the same time, pharma imports from China and India increased their share of total pharma imports, reaching 58% by weight. While imports from those two countries dominate the $208 billion in total imports, their dominance is much greater in specific drugs and medicines, sometimes reaching 100%.

“Doctors regularly write angry letters to newspapers complaining that they cannot find the drugs their patients need. It’s widely acknowledged that our generic drug supply system is broken. The heart of the problem is that we have driven prices too low, moved supply of generic medicines to a small number of the cheapest-of-the-cheap offshore suppliers, and sacrificed resiliency, manufacturing quality, and backup supply to chase the false god of low prices.”

According to a Morning Consult poll, 84% of Americans want the FDA to ban imports of generic medicines from foreign manufacturers that have received a Warning Letter following an inspection. Another 86% of survey respondents said they support the FDA testing generic medicines imported into the U.S. from foreign manufacturers that have received a Warning Letter. Labs that have received Warning Letters have a period to correct the problems the FDA identified or have their product put on an Import Alert, which is a ban.

CPA supports the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines Act, known as the PILLS Act, which would provide corporate tax credits for pharmaceutical companies investing in U.S.-based manufacturing facilities. The bill was introduced last October by Rep. Claudia Tenney (R-NY).


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