Why an Indian company is under US FDA lens for Viagra data

Generic versions of popular erectile dysfunction drugs such as Viagra and Cialis, along with various other medications, have entered the US market using potentially flawed data that calls into question their safety and efficacy.

A Bloomberg analysis has brought this issue to light. The US Food and Drug Administration (FDA) was alerted on June 18 about Synapse Labs Pvt. Ltd., a research company based in Pune, India which had allegedly falsified data in critical studies that were essential for the approval of these medications.

Data from Synapse Labs may have influenced the approval of hundreds of drugs that are currently available on pharmacy shelves and in American households, reported Bloomberg.

How was this issue flagged by the FDA?

European regulators had flagged Synapse Labs to the FDA last year. Subsequently, the FDA informed US companies that had relied on Synapse for key studies to redo their research with another facility.

The FDA has granted these companies a year to submit new data. Without this new data, the true safety and efficacy of these drugs remain uncertain, posing a risk to patients. Furthermore, insurers may retrospectively decide not to cover these medications.

Signage is seen outside of the US Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, August 29, 2020. File Image/Reuters

“I think it raises a lot of questions about the implications for the drugs on the market,” commented Massoud Motamed, a former FDA inspector with a doctorate in biochemistry, told Bloomberg.

Motamed’s primary concern is that drugs associated with Synapse may contain incorrect amounts of active ingredients, leading to either dangerous toxicity or ineffective treatment.

But full data is being kept from the public…

Despite the gravity of the situation, the FDA has not disclosed to patients, doctors, or pharmacists which specific drugs might be affected. The agency has cited “confidential information” as the reason for this lack of transparency.

“This is kind of shocking to me,” said Michael Santoro, a business ethics professor at Santa Clara University and co-author of Ethics and the Pharmaceutical Industry, while speaking to Bloomberg.

“There’s no question in my mind that this data needs to be in front of the public.”

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Cherie Duvall-Jones, an FDA spokesperson, assured that “the FDA remains vigilant and will act should we identify safety issues.” So far, the FDA has not observed any significant safety concerns in its side effect data.

However, the agency has not suspended the sale of these drugs, unlike European Union regulators who recommended member states do so. Additionally, the FDA has not disclosed the number of drugs approved based on Synapse’s research.

So which are the affected drugs?

The US FDA has done little public outreach regarding this issue, making it challenging for patients to determine which brand-name drugs used Synapse research, reported Bloomberg.

For generics, the FDA has directed consumers to a less-known database with codes indicating the equivalence of generics to brand-name drugs. If a drug’s code has recently changed from equivalent to not equivalent, it might indicate Synapse’s involvement in its approval.

“It’s like a riddle,” Erin Fox, director of the University of Utah’s drug information service, which tracks drug shortages, told Bloomberg.

Data from the researcher, Synapse Labs Pvt. Ltd., may have been used in hundreds of drugs, which remain available for sale on pharmacy shelves and in Americans’ medicine cabinets, said the report. Representational Image/Pixabay

In addition to safety concerns, Fox mentioned that insurers might not cover non-therapeutically equivalent drugs and could potentially reclaim payments. Instances of such code changes are rare, and the FDA usually notifies the public.

For example, last year, the FDA reclassified a generic organ transplant drug from Accord Healthcare Inc. because it released too much medicine at once, potentially causing severe health issues, reported Bloomberg.

The market is filled with these drugs…

Bloomberg’s analysis revealed several generic drugs, including Viagra and Cialis generics produced by India’s Umedica Laboratories Pvt., which are no longer considered equivalent to their brand-name counterparts.

Umedica, a contract manufacturer, sells these drugs to companies like Nivagen Pharmaceuticals Inc. in Sacramento, California, and supplies to various healthcare facilities.

Other affected drugs include generics of the cholesterol-lowering drug Lipitor from India’s Lupin Ltd and risedronate sodium from Aurobindo Pharma Ltd.

Due to trade secret laws, the US FDA often protects information such as what factory a drug is made in. Representative Image/AFP

According to Symphony Health prescription data, Lupin sold 25 million generic Lipitor prescriptions in the US between 2020 and most of 2023. Umedica’s atorvastatin and carbamazepine, an epilepsy drug, are also under scrutiny.

The FDA frequently protects corporate information, including manufacturing details, due to trade secret laws.

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This is not the first time the FDA has encountered such issues. In 2011, the US FDA identified 1,900 instances of falsified data during an inspection of a Cetero Research facility, but did not disclose which drugs were approved using this data at the time.