Ranbaxy Fakes Data But FDA Continues to Approve Its Drugs

The news that Scott S. Reuben of Baystate Medical Center in Springfield, Mass., has faked data for Celebrex, Vioxx, Effexor XR and Lyrica might make you think that the FDA will enact strict new guidelines on drug testing.

You’d be wrong. When the FDA discovers fake data it takes only limited actions, applying extra scrutiny only to the lab that developed the bogus studies, according to a recent letter from the FDA.

The FDA has continued to approve multiple new drugs for one major company that repeatedly submitted fake data in its new drug applications. That company is Ranbaxy, which has recently had applications for generic versions of heart drug ramipril and blood pressure drug Accuretic approved despite that fact that the FDA said on Feb. 25 that Ranbaxy “submitted untrue statements of material fact in abbreviated and new drug applications filed with the Agency.”

Reuben’s fake studies have nothing to do with Ranbaxy’s fake data. (None of the 21 Reuben studies that have been retracted by anesthesiology journals (published between 1996 and 2008) were used in new drug applications.)

But when companies like Ranbaxy do submit fake data, the consequences seem minor. In the Ranbaxy case, the company has been accused of:

• Storing drug samples in refrigerators when they were supposed to be undergoing room-temperature stability tests.
• Putting bogus dates on test material.
• Submitting signatures on test samples from staff who were not present at the test facility on the dates they signed.
• Incorrectly transcribing raw data from test results 122 times.

The drugs involved included simvastatin, fluconazole, and ciprofloxacin. The FDA concluded:

These and other findings indicate a pattern and practice of submitting untrue statements of material fact and other wrongful conduct, which raise significant questions regarding the reliability of the data and information contained in applications (pending and approved) that your firm has filed with the Agency…

But instead of crippling Ranbaxy with regulatory review and retrospective checks, the FDA is continuing to approve Ranbaxy medicines. Ramipril was approved March 9. Accuretic was approved March 5.

(And it’s not just the U.S. In Australia, the drug regulator there approved a generic version of Lamisil for Ranbaxy on March 7.)

Why? Because the FDA is restricting its review to the one lab in India from which the data emanated.

Here’s the history:

Of the 18 companies which went through the [FDA] audit, five of them shut down. And, three other companies, for whom data is available, it took about 26 long months to come clean.

Hat tip to Derek Lowe.

• See previous BNET stories on the Pfizer Trovan case:
• Pfizer Close to Settling Trovan Case? Perhaps Not
• Claim: LeCarre’s “The Constant Gardener” Was Based on Pfizer Trovan Case
• NEJM: Foreign Drug Trials Could Hurt U.S. Patients
• Pfizer Expands in China Faster Than the FDA
• India to Regulate Clinical Drug Trials by Foreign Companies
• Body Count Linked to GSK Vaccine Trial Rises
• Pfizer Trovan Case: Doctor Sues Over Link to Nigerian Attorney General Who Allegedly Wants Slice of Settlement