Drugmaker GlaxoSmithKline settled for $750 million in federal court yesterday over charges this that it knowingly sold unsafe drugs that didn’t meet quality standards set by the company and the FDA. The drugs include Paxil CR, an antidepressant, Bactroban, an ointment, Tagamet, an acid-reflux medication, and Kytril, an anti-nausea drug.
The quality problems at the center of the case occurred at its flagship Puerto Rico plant in Cidra, which made $5.5 billion worth of drugs each year but closed in 2009 after contamination problems could not be resolved. In 2002, Cheryl Eckard, GSK’s quality assurance manager, found major contamination problems at the facility after she was sent to address an FDA warning letter. She complained to executives but the problems went unresolved. Her requests to recall drugs for quality problems were not authorized (more evidence of the problem of leaving companies to conduct voluntary recalls), and in 2003 Eckard was let go.
The company allegedly failed to guarantee that some of the drugs were free from bacterial contamination, and in the case of Paxil, a chemical separation meant some patients may have been getting the wrong amount of the drug, causing it to be less effective. According to news reports, there were no reported illnesses linked to the drugs in the case.
According to the New York Times, “the case may lead to a collective industry shiver because it opens a new frontier for whistle-blower suits. Nearly all previous cases against the industry involved illegal marketing. This is the first successful case ever to assert that a drug maker knowingly sold contaminated products.”
Though Eckard’s findings came during a follow-up to an FDA warning letter, the Times report suggests that FDA inspectors also missed some of the quality problems identified in the suit.
Ensuring companies adhere to manufacturing quality standards is a critical oversight role of the FDA, and one that has been made more difficult as manufacturing increasingly occurs outside of the U.S. The announcement of GSK’s settlement comes as a new GAO report on the FDA’s foreign inspection program shows better resourcing for overseas inspection — the agency devoted four times as much money to foreign inspection in 2009 as it did in 2007 — but still suggests that the number of plants making raw materials and drugs for the U.S. far exceeds the FDA’s resources to inspect them. This leaves thousands of uninspected plants each year — plants that potentially manufacture raw materials for prescription and over-the-counter drugs on American pharmacy shelves. Often, as with the Lipitor recall announced earlier this month, companies are wary to name the source supplier of suspect or contaminated materials.
Several bills before Congress would increase FDA's authority to guarantee the safety and efficacy of drugs, and establish more stringent supply chain management requirements for drug makers that regulators could use to better enforce drug quality and safety, both in the drug application and post-market phase. They would also create important new whistleblower protections for industry employees bringing information on violations of the FDCA and the Public Health Service Act. Currently, whistleblowers not employed by the government are covered by federal protections under the False Claims Act, when they can show that a false claim has been made against the government (in GSK's case this was sub-standard medications sold to Medicare/Medicaid). But employees that want to alert regulators to a public health threat where evidence of a false claim against the government is not available or easily demonstrated are not specifically covered by those protections.
--Kate Petersen, PostScript blogger.