Ranbaxy: Test Data Without Test Samples

In the Ranbaxy manufacturing settlement, the company agreed to pay $350 million to resolve civil allegations that it caused government health care programs to pay for drugs that fell short of their specifications or approved formulation. The Food and Drug Administration’s separate civil enforcement action described backdated tests and test data submitted without test samples. The government received test results for samples that did not exist.

The Department of Justice announced the settlement on May 13, 2013. A former Ranbaxy executive brought the whistleblower case against Ranbaxy Laboratories Limited. The manufacturing allegations concerned drugs from Paonta Sahib and Dewas, two facilities in India. The case connects manufacturing decisions to government payments, a recurring issue in pharmaceutical fraud cases.

What Happened at Paonta Sahib and Dewas?

The government alleged that Ranbaxy manufactured, distributed and sold drugs from Paonta Sahib and Dewas whose strength, purity or quality differed from their specifications, or that were made outside the FDA-approved formulation. The civil case followed the drugs from those facilities into claims for government payment.

A drug manufacturer sells a particular approved product: its strength, dosage form, route and presentation matter. The name of the active ingredient is only part of that description. This is why the Ranbaxy allegation reached both what the drugs contained and whether the company had made them according to the formulation FDA approved.

In its civil injunction announcement, the Justice Department described manufacturing and testing problems in India and at facilities owned by Ranbaxy’s U.S. subsidiary. The government said Ranbaxy lacked written records showing that drugs had been made properly and failed to investigate evidence that drugs did not meet their specifications.

The same announcement described inadequate separation of penicillin and non-penicillin manufacturing, inadequate procedures to prevent contamination of sterile drugs, and insufficient testing to establish that drugs would keep their strength and effectiveness until expiration.

A test result outside a product’s specifications calls for an investigation into the drug. Missing production records make that investigation harder. The government described failures in both, alongside the false information sent to the Food and Drug Administration.

Stability Testing and False FDA Statements

Stability testing backs the expiration date: it supports what the company says the medicine will be like after it has spent time on a shelf.

The civil enforcement account made the data problem unusually plain:

A backdated test changes the history presented to the regulator. Test data with no sample behind it removes the physical basis for checking that history. Both leave the regulator reading an account of testing that the manufacturer cannot substantiate as reported.

The document supporting the shelf life and the work actually done in the laboratory have to describe the same product over the same period. Putting a date on a report does not supply the missing work.

A 2021 review in Proceedings, Risks of Corruption in the Healthcare and Pharmaceutical Sector and the Impact of a Pandemic, places batch testing, laboratory controls and analysis certificates among the manufacturing controls that protect medicine quality. It also follows the medicine through manufacturing, registration, procurement and distribution. False laboratory data can follow that same path, from a plant’s records into an application and then into the market where public programs buy the drug.

For a testing or regulatory employee, the useful connection is between the underlying sample and test, the company’s account of that work, and the application the Food and Drug Administration received. Ranbaxy’s civil injunction addressed that connection directly by requiring a review of applications containing data from affected facilities.

How the Drugs Reached Government Claims

The civil settlement covered alleged false claims for drugs from the two facilities between April 1, 2003, and September 16, 2010. The United States alleged that Ranbaxy knowingly caused claims for those drugs to reach Medicaid, Medicare, TRICARE, the Federal Employees Health Benefits Program, the Department of Veterans Affairs and the U.S. Agency for International Development, which administers the President’s Emergency Plan for AIDS Relief.

The government alleged that public healthcare programs paid for drugs that fell short of their specifications or approved formulation. Patients relied on that quality, and taxpayers paid the bill.

The drug and the payment travel through different hands. A manufacturer can cause a false claim even when a pharmacy or physician submits it. The government alleged that Ranbaxy’s manufacturing and sales caused the claims.

An insider may see the laboratory result, the production decision or the regulatory submission without seeing the eventual claim. Our work is to connect that knowledge to the product the government paid for and the decisions behind its sale.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. In Ranbaxy’s case, the Justice Department announced approximately $48.6 million for the former executive who brought the case, from the federal share of the civil settlement.

The Food and Drug Administration’s Response Reached Back Into the Applications

The Food and Drug Administration placed drugs from Paonta Sahib and Dewas on Import Alert on September 16, 2008. The Justice Department’s later settlement announcement said Ranbaxy had not imported drugs from those facilities into the United States since that alert.

A court order blocked drugs from Paonta Sahib and Dewas from entering the U.S. market until the facilities complied with federal drug requirements. It also required Ranbaxy to review and verify the data in its past applications to the Food and Drug Administration.

The requirements described in the civil filing announcement explain the scale of that review. Ranbaxy had to hire an outside expert to review affected facilities and audit applications containing data from them. Applications found to contain false data had to be withdrawn. The company also had to establish a separate office of data reliability and hire an outside auditor for future facility audits.

Fixing the plant did not remove the old information from the Food and Drug Administration’s files. A facility review concerns how the data was produced. An application audit concerns where it went. Ranbaxy had to address both.

The Same Gap Between the Factory and FDA

GlaxoSmithKline’s Cidra manufacturing case also connected drug quality to government payment. Its civil settlement announced in October 2010 was $600 million and resolved allegations of causing claims for adulterated drugs made at that facility. The quality of drugs leaving a plant became the subject of a civil case over the government’s money.

A whistleblower complaint against Gilead alleged another gap between manufacturing knowledge and what the Food and Drug Administration heard. The complaint described known contaminants in Cayston and alleged that the company withheld them from the agency:

Ranbaxy’s civil enforcement account described false testing data sent to the Food and Drug Administration. The Gilead complaint alleged that information about contaminants stayed inside the company. Employees working with the product can know something the regulator’s file does not reveal.

You Know What the Laboratory Actually Did

If you know the testing record differs from what your company sent to FDA, bring that account to our whistleblower experts. We connect the manufacturing evidence to the government payments and bring in pharmaceutical manufacturing whistleblower lawyers who understand laboratory records, FDA applications and False Claims Act cases. We work beside you from that first conversation to build your strongest pharmaceutical whistleblower case.