By Ed Silverman // January 13th, 2011
A whistleblower lawsuit filed in 2002 has been unsealed and reveals that nearly two dozen drugmakers have been accused of selling unapproved prescription meds for years. Of course, such charges must still be proven, but the US Department of Justice did get involved in pursuing three other companies - Forest Laboratories (read here), Schwarz Pharma and Eon Laboratories - originally named in the lawsuit and reached settlements.
What will happen from here is unclear. But for one other company, the DOJ has declined to intervene, or join, the lawsuit in pursuit of the rest of the drugmakers, including Abbott Laboratories, Actavis, Mylan Laboratories, Shire Pharmaceuticals, Watson Pharmaceuticals and Teva Laboratories. Nonetheless, the lawsuit offers some disturbing details in so far as that unapproved meds have apparently been available for years and, in some cases, the FDA failed to do anything to halt the practice.
As one example, the FDA declared in 1984 that any company selling oral nitroglycerin needed to submit supplemental information about their products, including bioavailability, in order to obtain approval based on safety and efficacy. The drugmakers were given a year to do so, although the deadline was pushed back to 1989. A decade later, the agency finally followed up after noticing none of the companies had complied with the 1984 requirement.
The lawsuit, by the way, was filed by Constance Conrad, who is described as having some 30 years experience in federal healthcare programs, although her attorney at Nolan & Auerbach declined to offer more specific information about her background (here is the lawsuit, which is partially redacted).