Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

FDA Contradicts Mylan's Position Regarding Investigation

Posted in Duragesic / Fentanyl

Yesterday, I blogged about the allegations that Mylan employees knowingly bypassed safety procedures to boost production.  Today, there's another story worth blogging about:

According to a press release issued by Mylan, the plant has been cleared of any problems by the Food & Drug Administration following a visit to the facility by agency officials on Monday. But in its statement the FDA’s assistant commissioner for compliance policy, Steven Solomon, said the investigation is not over.

“This investigation involves allegations of compliance violations that the FDA takes very seriously,” Solomon wrote. “The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue.”

Source: FDA, Mylan, at odds over status of probe at W.Va plant

I'm sure Mylan would like the investigation to be over, but I for one am relieved that the FDA is continuing to look into these allegations.  Many of the products made at this West Virginia plant, like Mylan's fentanyl patch, can be deadly if not manufactured according to specifications.

Considering how many lawsuits have already been filed against Mylan alleging their fentanyl patch is defective, I can't help but wonder if the safety procedures were skipped on the fentanyl line…