In 2010, the FDA uncovered violations it later called “egregious” and “pervasive” at a major pharmaceutical testing lab. But even though the agency no longer knew for sure that drugs tested at the lab were safe, it allowed them to remain on pharmacy shelves with no new testing — in some cases until now. And the FDA won’t name the drugs.

by ProPublica – April 15, 2013

Key Points

• In 2011, the FDA announced years’ worth of studies from a major drug research lab were potentially worthless.
• About 100 drugs were on the U.S. market based in part on these tests.
• The FDA let the drugs stay on pharmacy shelves with no new testing (in some cases until now).
• As the FDA investigated and ordered re-tests, its European equivalent pulled seven drugs from the market.
• The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed.

The FDA has never named the drugs, saying to do so would reveal trade secrets. On the morning of May 3, 2010, three agents of the Food and Drug Administration descended upon the Houston office of Cetero Research, a firm that conducted research for drug companies worldwide.

Lead agent Patrick Stone, now retired from the FDA, had visited the Houston lab many times over the previous decade for routine inspections. This time was different. His team was there to investigate a former employee’s allegation that the company had tampered with records and manipulated test data.

When Stone explained the gravity of the inquiry to Chinna Pamidi, the testing facility’s president, the Cetero executive made a brief phone call. Moments later, employees rolled in eight flatbed carts, each double-stacked with file boxes. The documents represented five years of data from some 1,400 drug trials.

Pamidi bluntly acknowledged that much of the lab’s work was fraudulent, Stone said. “You got us,” Stone recalled him saying.

Based partly on records in the file boxes, the FDA eventually concluded that the lab’s violations were so “egregious” and pervasive that studies conducted there between April 2005 and August 2009 might be worthless.

The health threat was potentially serious: About 100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston’s tainted tests. The vast majority, 81, were generic versions of brand-name drugs on which Cetero scientists had often run critical tests to determine whether the copies did, in fact, act the same in the body as the originals. For example, one of these generic drugs was ibuprofen, sold as gelatin capsules by one of the nation’s largest grocery-store chains for months before the FDA received assurance they were safe.

The rest were new medications that required so much research to win approval that the FDA says Cetero’s tests were rarely crucial.

Stone said he expected the FDA to move swiftly to compel new testing and to publicly warn patients and doctors.

Instead, the agency decided to handle the matter quietly, evaluating the medicines with virtually no public disclosure of what it had discovered. It pulled none of the drugs from the market, even temporarily, letting consumers take the ibuprofen and other medicines it no longer knew for sure were safe and effective. To this day, some drugs remain on the market despite the FDA having no additional scientific evidence to back up the safety and efficacy of these drugs.