How Good Are Your Drugs? (Part 4)

As we dig deeper into the issue of prescription drug safety and the multitude of issues surrounding the manufacture, distribution and profit from pharmaceuticals in the United States, it is becoming increasingly evident that Congressional members are under pressure to make the approval process easier.

Part One of this series looks at the gaps in the worldwide distribution systems of pharmaceuticals. Part Two examines the breakdown in oversight of the manufacturing process by the federal government. Part Three gives a glaring example of how state governments are dropping the ball. Now, we expand the scope even further.

While Michael Moore's new movie Sicko looks at the U.S. health care industry, this series takes this issue to the next level.Ranbaxy IndustriesRanbaxy has a plant in Paonta Sahib, India, that produces drug components as well as finished drugs. According to documents forwarded to me by Prevent Medical Error (PME), a non-profit that seeks to promote best practices, Ranbaxy has been in the center of a few issues:

In fall 2004, the World Health Organization (WHO) cited Ranbaxy’s failure to prove bioequivalence. This apparently triggered Ranbaxy to remove their remaining AIDS drugs from the WHO approval list.

It appears to have taken the Food and Drug Administration (FDA) until February of 2006 to inspect the Ranbaxy plant, and an additional three months or more to warn the company.

Similar to the WHO, in an FDA warning letter dated June 15, 2006, the agency cited the Ranbaxy manufacturing plant at the Paonta Sahib facility for stability issues:

Those deviations observed by the investigators were presented to you on an Inspectional Observations (FDA 483) form at the close of the inspection. These CGMP (Current Good Manufacturing Practice) deviations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351(a)(2)(B)].

It is currently unknown when and if the FDA has inspected and/or cited additional Ranbaxy plants, and at this time, there have been no reported product seizures of drug components and/or finished product associated with Ranbaxy’s Paonta Sahib plant. Although one branch of the FDA has put Ranbaxy under both civil and criminal investigation, another department within the FDA continues to approve Ranbaxy’s Abbreviated New Drug Applications (ANDA) for new generic drugs. The FDA also continues to allow Ranbaxy to manufacture and sell new generic drugs such as zolpidem, the generic form of Ambien. In some cases, Ranbaxy holds the exclusive rights to a generic drug for the first six months after the brand name drug goes off patent. Because they are often less expensive than competing generic versions, the big three drug wholesalers and many pharmacies and mail order pharmacy benefits managers (PBMs) continue to distribute, purchase, authorize, bill, and sometimes dispense Ranbaxy generic drugs. Despite reports of generic drug discrepancies, other Indian generic drug companies such as Indian subcontractor Lupin appear to remain largely under the radar screens of state and federal entities. WockhardtIn the case of Indian generic drug manufacturer Wockhardt, review of the FDA’s February 2006 warning letter to the company indicate that Wockhardt has a history of record keeping and documentation issues:

Complete, true and accurate records are the foundation for good manufacturing practices (GMP). Reliable documentation is a control which raises assurance of the quality of the product manufactured. Violations concerning inadequate documentation are serious and should be handled as such.

Continued on the next page Page 1 — Page 2 — Page 3

Article Author: Rick Vassar

Rick Vassar CPCU, ARM, AIS, ARM-P is a career commercial risk manager and the author of Hide! Here Comes the Insurance Guy, where he uses humor to explain insurance strategies in language everyone can understand.
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