Showing posts with label 04/09/2013 - 9:58am by Ed Silverman 2. Show all posts
Showing posts with label 04/09/2013 - 9:58am by Ed Silverman 2. Show all posts

Tuesday, April 9, 2013

MUST READ! During Pharmalot Interview FDA Acknowledges: We Could Have Done More To Pursue Compounders Posted Tue, 04/09/2013 - 9:58am by Ed Silverman 2


For the past several months, the FDA has been widely criticized by Congress and others for not doing more to crack down on the New England Compounding Center, the now-bankrupt pharmacy tied to a nationwide outbreak of fungal meningitis that has led to 53 deaths (see this).  Since the scandal broke, the FDA has argued various court rulings limited its authority, although critics maintain the agency has, in fact, been able to pursue violators, notably compounders that effectively mass produce medicines without individual patient prescriptions and ship out of state. Since early January, the FDA has responded to the pressure by inspecting 44 compounders (read here) and issued 31 reports (look here) detailing a host of violations, and follow-up actions are expected. Clearly, the agency is devoting more resources to a problem that has caused one of the worst public health crises in decades, and agency officials acknowledge that more could have been done sooner to thwart the NECCs around the country. We spoke with Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research, and Howard Sklamberg, who heads CDER's Office of Compliance, about the issues...
Pharmalot: What are you finding so far at the (44) pharmacies you’ve been inspecting?
Sklamberg – Those are in a couple of categories. A majority, about 30, are inspections we did that are based on a risk model. One of the issues with compounding is because firms don’t have to register with us we don’t know right now the universe of firms out there and what they produce. We have fragmentary information about firms, based on past interactions with firms, based on reports of illnesses and other events, recalls and things of that nature. So we identified about 30 firms to inspect.
Pharmalot: If you don’t know what they’re doing, how do you know which ones to inspect?
Sklamberg: We looked at the information we have.
Woodcock: The ones that rose to the top…
Sklamberg: We wanted to identify firms that are high risk, so that would include a few categories and combinations of factors. Their history – firms that have a history of problems that we observed, adverse events and products they produce. We looked at firms that produce riskier products, such as sterile injectables. And then as far as what firms are producing. We researched the Internet. The inspections are still ongoing. And then there are an additional set of firms that we found out problems during the course of these couple of months and we inspected those as well.
Pharmalot: There seems to be a lot of confusion and debate about the FDA’s authority. When I talk to people who say they know FDA law, what I continue to hear back is that FDA really does have –and has had the authority – to do more about compounding. And I know the FDA has said ‘No, we really don’t because of a couple of different court rulings and we need this straightened out.’ What is different today that stopped you from doing this two, three or five years ago? You’ve had the ability since January 1 to inspect however many pharmacies. Why hasn’t the agency done the same sort of thing in the past?
Continuing reading here