Warner Chilcott And Subpotent Birth Control Pills?

Yet another problem for Warner Chilcott. Last month, the drugmaker disclosed that the feds issued a subpoena for information on a wide array of sales and marketing activities (see here). Now, the FDA has issued a warning letter suggesting quality problems have existed for the past five years with the Ovcon birth control pill.

The letter was prompted by an inspection last June of a Warner Chilcott plant in Puerto Rico. And the FDA notes the drugmaker did not thoroughly investigate identify the reason that certain lots of Ovcon failed stability testing going back to 2006. This can cause a problem with expiration dates. Meanwhile, Warner Chilcott continued to make Ovcon 50 tablets, even though these may have been subpotent.

In its defense, the drugmaker maintained that updated packaging should mitigate any degradation issues, but the FDA responded that a recent lot failed to comply with assay specifications and there was no documentation to support the assertion that the packaging change would make a difference. Moreover, the agency wrote there was no comprehensive effort to understand the problems.

Things get worse. The FDA then writes that "the stability history of your drug product (Ovcon 50) suggests that since your acquisition of the product in 2005... your quality control unit has failed to exercise its responsibility to assure that your product meets its predetermined specifications throughout its shelf life." In other words, some tablets may not have been up to speed.

Then, the FDA points out that Warner Chilcott changed one aspect of the manufacturing process, but did so without any "scientific justification." Given the subsequent problem, the agency chides the drugmaker for not recognizing this could have caused the subsequent stability failures. But no review took place until last June, when a lot of Ovcon tablets was recalled.

Moreover, the FDA notes that Warner Chilcott did not take any "market action" prior to the June recall. This disclosure, by the way, came in response to an FDA 483 inspection report that was issued last August. And so, the agency is now telling Warner Chilcott to conduct a "comprehensive retrospective review of your stability program for all approved products."

"...We remain concerned regarding the quality problems that have gone unresolved for the last five years without you fully understanding the reason for the failures and without assurance that the product will meet its quality attributes throughout the product's shelf life. We would recommend that you place all lots of Ovcon 50 on stability until you verify that your corrective actions are effective.

"In addition, please provide your plan for how you intend to ensure that other products that you manufacture will meet the required specifications through their expiration dates." Here is the warning letter. We have asked Warner Chilcott for a reply and will update you accordingly.