Acting Quickly to Safegaurd
Time is of the Essence!
Ranbaxy Laboratories, the India-based drugmaker that manufactures a generic version of the popular cholesterol medication Lipitor, has halted production of the drug amid concerns about product safety.
Ranbaxy Laboratories is the largest manufacturer of generic versions of Lipitor, and the company voluntarily recalled several dozen lots of the medication earlier this month when it was determined some of the product may have been contaminated with small, grain of sand-sized granules of glass.
Ranbaxy Laboratories is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo, and the generic Lipitor concerns are the latest of a few regarding product safety at some of the maker’s facilities, both in the US as well as India.
According to the New York Times, Ranbaxy Laboratories is currently “operating under a court-ordered consent decree,” that has been in effect since January. The paper quotes federal authorities as saying that the sanction is “unprecedented in scope” and due to some concerns about manufacturing standards as well as a conclusion that the company had “submitted false data in drug applications” to the Food Drug Administration before the decree was put in place.
FDA spokeswoman Sarah Clark-Lynn spoke to the Times about Ranbaxy’s recent issues with the generic Lipitor, and said that the affected product did not originate from “the same facilities whose conduct gave rise to the consent decree.” But in an email sent Monday, Clark-Lynn also stated that “the consent decree provides the FDA with additional tools to address violations for other Ranbaxy facilities.”
An investigation into how the glass particles came to be in the affected generic Lipitor is currently underway at the facilities from which the product originated. Ranbaxy has not disclosed which facilities may have produced the medication included in the generic Lipitor recall.
Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education, told the paper that Ranbaxy Laboratories’ ongoing FDA issues are part of a larger product safety concern when manufacture of medications is outsourced to other countries. Basu opined:
“I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job … But my confidence is not that high when we are getting products from outside the country.”
Basu explains that pending legislation will address issues of product standards in drug manufacturing regardless of whether medications are produced in the US or outside it, under the Generic Drug User Fee Amendments of 2012 – nicknamed Gdufa. But he admits that product safety is not an issue that Gdufa can fully guarantee:
“This is a very difficult and complex system, and how do we ensure the integrity of this supply chain? … I don’t know how much Gdufa will help.”
As an investigation into the generic Lipitor continues, the facilities from where it is believed to have originated remain closed. No injuries and no deaths have been linked to the affected batches of generic Lipitor (commonly known as atorvastatin) affected by the recall, and a shortage of the medication is not expected in the wake of the product recall.