Mylan & FDA appear to disagree on QC inquiry
The issue arose following an article in the Pittsburgh Post-Gazette, which claimed that workers routinely ignored warnings about manufacturing problems. Mylan released a statement the same day denying the accusations.
This was followed by a fuller statement by Mylan that said it had contacted the US Food and Drug Administration (FDA) about the article out of courtesy.
Mylan stated that the FDA then visited the facility in Morgantown, West Virginia and “determined that the baseless accusations in the article were unfounded”.
The FDA agreed that there was a minor deviation in standard operating procedures but all corrective actions had been fully implemented by Mylan, according to the company’s statement.
However, Steven Solomon, the FDA's assistant commissioner for compliance policy at the office of regulatory affairs, has since issued a statement saying that the investigation is ongoing. He added that the agency is yet to form any conclusions and that “statements to the contrary are untrue”.
An explanation for this difference in opinion was put forward by Michael Laffin, a company spokesman. He told the Associated Press it could be because of timing issues relating to the local inspector returning to the FDA.
Laffin added: "Our CEO would have never gone out with a statement without being informed of a close-out on the FDA inspection."
The mixed messages have led to Mylan’s stock rising and falling over the past two days, with the gains made after the company statement cut back after Solomon contradicted them.
Source of the issue
The disagreement was sparked by an article in the Pittsburgh Post-Gazette that cited an internal Mylan report. In the report it said that workers routinely overrode computer-generated warnings about problems in the manufacturing process, according to the article.
Unfortunately for Mylan the article comes at a time when quality control issues at generics manufacturers have become increasingly prominent.
