Ovcon Birth Control Pill Quality Problems Earn FDA Warning letter

Warner Chilcott has failed to meet industry standards in production of their Ovcon birth control pill, federal drug officials say. 

The drug maker received a warning letter from the FDA on March 8, for “significant violations of Current Good Manufacturing Practice (CGMP) regulations” at its Puerto Rico drug manufacturing plant involving production of Ovcon.

FDA inspectors say that the company has failed to maintain good quality control measures at the plant and made changes to the manufacturing process that put the quality of some Ovcon pills in question.

Specifically, the FDA says that Warner Chilcott failed to investigate why some batches of Ovcon failed to meet stability goals, meaning that the pills may go bad before their expiration date. This should have sparked an investigation into stability to ensure the problem did not repeat, but there appears to have been no such effort on behalf of Warner Chilcott, according to regulators.

The problem has plagued the company’s pills since 2006. As recently as November 10, 2011, Warner Chilcott had to send out a Field Alert Report warning that one lot of Ovcon 50, lot 02260T, failed to meet specifications.

The company has pledged to make packaging changes that it thinks will address the problem, but the FDA says that the company has not explained how the new packaging design will prevent degradation.

The FDA investigators said that the company is failing to make sure its quality control department does its job, as required by federal regulations. The FDA letter chastised the company for using test methods that would give them the best results, as opposed to the most thorough or accurate results. The department should have looked at the drying process for the pills when batches began to fail in 2006, the FDA stated.

“Instead, you continued to manufacture and release batches to the market place for five years,” the letter notes. “Your quality unit failed to ensure that the drug product quality issues were adequately evaluated.”

The company has 15 days to respond with a list of steps it intends to take to address the problems outlined in the letter. Failure to do so could result in legal actions by the FDA that could include seizure of products and injunctions.