Rogers: FDA Failed To Act On Issues At Pharmacy Tied To OutbreakRogers: FDA Failed To Act On Issues At Pharmacy Tied To Outbreak

11/14/12 - Howell Congressman Mike Rogers says a committee’s bi-partisan investigation into the national meningitis outbreak has revealed serious missteps by the Food and Drug Administration. The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing Wednesday regarding its investigation into the deadly outbreak. Victims’ families, representatives from the facility in question, and an FDA Commissioner testified. Republican Representative Mike Rogers issued a statement saying he was disappointed to learn the FDA inspected the facility that produced the tainted steroids and identified contamination in its products more than 10 years ago yet the agency did not act to protect patients. Rogers says after observing multiple safety violations at the facility that led to a 2006 warning letter, the FDA never conducted a single follow-up inspection to ensure the safety issues were resolved. Rogers says because of the company’s egregious behavior and the FDA’s failure to address the contamination issues, the country is now faced with a tragedy that has impacted hundreds of families and he hopes the committee will take swift action to clarify and strengthen the FDA’s authority regarding compounding pharmacies. He called on the FDA to cooperate fully with congressional investigators so they can quickly determine why the mistakes were made and how they can be prevented in the future.” The contaminated steroids have been linked to a national wave of fungal meningitis cases, some of which have resulted in death including a Howell Township woman in September who received tainted steroids administered by a Brighton clinic. (JM)