According to several news reports, last month, the drugmaker Warner Chilcott, disclosed that the feds issued a subpoena for information on a wide array of sales and marketing activities. 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 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 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.
The warning letter reads, “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,” said the FDA. In other words, some tablets may not have been up to speed, and therefore the shelf life of the product could be compromised.
Apparently, 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.”
Warner now has 15 days to provide the agency with the steps it will take to resolve the matter. Failure to do so could result in legal actions by the FDA that could include seizure of products and injunctions.