India's Synapse Labs falsified data to get USFDA approval for erectile dysfunction drugs

Generic versions of erectile dysfunction drugs Viagra and Cialis, among other medications, were allowed on the US market using potentially problematic data that call into question their safety and efficacy, a Bloomberg analysis found.

The US Food and Drug Administration alerted brand-name and generic companies on June 18 about a research company in India that had falsified the data used in key studies to gain approval of their medications. 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.

European regulators last year flagged Synapse to the FDA, which later told US companies that relied on Synapse for key studies to gain approval of their medications that they would have to redo the work somewhere else.

The FDA said companies that used Synapse will get a year to submit new data on the drugs. Without that information, it’s difficult to know the true outcomes of the studies and whether they’re safe. And insurers may have reason to retroactively decide not to cover the medications.

“I think it raises a lot of questions about the implications for the drugs on the market,” said Massoud Motamed, who was an FDA inspector until January 2023 and has a doctorate in biochemistry.

Motamed said his biggest concern is that the drugs Synapse was involved with may have too much or too little active ingredient. Too much can lead to dangerous toxicity issues. Drugs that don’t have enough active ingredient run the risk of not working.

‘Confidential Information’

The FDA isn’t telling patients, doctors or pharmacists which drugs among thousands might be impacted because the agency said whether a drugmaker used a particular research company for hire is “confidential information,” according to the FDA alert.

“This is kind of shocking to me,” Michael Santoro, a professor at Santa Clara University who specializes in business ethics and co-wrote a book called Ethics and the Pharmaceutical Industry, said about the FDA keeping the drugs secret. “There’s no question in my mind that this data needs to be in front of the public.”

Cherie Duvall-Jones, a spokesperson for the agency, said “the FDA remains vigilant and will act should we identify safety issues.”

She said so far the FDA hadn’t noticed any signs in its side effect data that the drugs had serious safety concerns. The FDA has not suspended sales of the drugs as European Union regulators recommended to member states and declined to say how many drugs were approved using research done by Synapse.

US regulators have done little public outreach about this issue. There’s no way for patients to know which brand-name drugs used Synapse research. But for generics, the FDA guided consumers to an obscure database with codes that indicate whether a generic is deemed to be equivalent to the brand-name drug. If a drug’s code recently changed from equivalent to not equivalent, this could indicate that Synapse was involved in its approval in the US.

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

In addition to safety concerns, Fox said insurers may not cover non-therapeutically equivalent drugs and could even claw back payments.

Generics Database

Such switches rarely occur and usually the FDA notifies the public. For example, last year, the FDA said it no longer considered a generic organ transplant drug from Accord Healthcare Inc. the same as the brand-name version it copied. Accord’s tacrolimus released too much of the medicine at once in the body, which could cause kidney failure or seizures, the agency determined after testing the drug following years of concern from doctors.

Bloomberg’s analysis identified a number of generic drugs that are no longer deemed the same as the brand though they were earlier this year. Among them are Viagra and Cialis generics made by India’s Umedica Laboratories Pvt. Umedica is a contract manufacturer that sells these drugs to other drugmakers to package and market, including Nivagen Pharmaceuticals Inc. in Sacramento, California and pharmacies that stock various health-care facilities such as doctors offices and hospitals. Bloomberg used databases from the FDA and the National Institutes of Health to identify the drugs and their sellers.

Other drugs on the list include generics of the cholesterol-lowering drug Lipitor from India’s Lupin Ltd and risendronate sodium from Aurobindo Pharma Ltd. Lupin sold 25 million generic Lipitor prescriptions in the US between 2020 and most of 2023, according to Symphony Health prescription data compiled by Bloomberg. Umedica’s atorvastatin and carbamazepine, an epilepsy drug, also made the list.

Umedica, Nivagen, Lupin and Aurobindo didn’t respond to requests for comment.

The FDA often protects corporate information, including what factory a drug is made in, for fear of running afoul of trade secret laws. In 2011, the FDA said it found 1,900 instances during an inspection of a Cetero Research facility where lab technicians that supposedly conducted certain tests weren’t in the office at that time. The agency didn’t share what drugs had been approved using Cetero data at the time.