There has been a lot of talk recently regarding the Meningitis outbrake linked to a compounding Pharmacy around the PharmaSys office lately (as one can imagine). As experts in FDA regulations and compliance, it has been a hot topic internally.
Hal Sanborn, Vice President at PharmaSys, presented the following quote: "You're the grand poobah of the FDA and I'm asking you, 'could you have prevented this tragedy?' and you're saying you couldn't have because you don't have jurisdiction." Rep. Cliff Stearns, R-Fla. on the meningitis tragedy and FDA's oversight of compounding companies.
Naturally, this presented the following questions and thoughts: Any thoughts on the regulations related to this? Did the FDA in fact have a duty to act? In your opinion, what is the first step compounding pharmacies need to make to comply with current or forthcoming regulations?
Charles Lankford (@CLLankford), CEO of PharmaSys, had this to say:
"My Opinion:
The FDA does not have jurisdiction over compounding pharmacies. It’s a loop-hole in federal laws intended to allow pharmacies to customize compounds for an individual. The problem is that it’s open for abuse by greedy corporations who are willing to circumvent patient safety for the sake of profit and may be outdated.
I believe that the FDA does have a duty to act on illegal compounding pharmacies but it’s a complex problem. The FDA is under-funded and with their current resources, it’s near impossible for them to investigate whether or not every compounding pharmacy meets the intent of regulations or are in-fact drug manufacturers operating illegally.
Additionally, the only reason that the FDA had authority to inspect the compounding pharmacy in question was the fact that drugs were killing people and shipped across state lines. Without that prerequisite the FDA could not act.
We need more stringent federal laws that allows the FDA to regulate compounding pharmacies and more funding to enable them to provide the proper oversight."
Hal provided some additional background from Fox News background and comments by Hamburg
""The challenge we have today is that there is a patchwork of legal authorities that oversee the regulatory actions we can take," said Hamburg, who was nominated to head the FDA by President Obama in 2009.
Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They are typically overseen by state pharmacy boards.
In the last two decades some compounders, like the NECC, have grown into large businesses that ship thousands of doses of drugs to multiple states. Hamburg said that when her agency tries to intervene in those cases they face a "crazy quilt," of court rulings, which are split on whether the federal government has authority over pharmacies.""
Hal then commented:
"So essentially – Yes, I agree with Charles, it may not be as much they are underfunded and under resourced as much as tied up in the courts by those seeking to extract a profit at the cost to those they profit from (Much higher than the original dollars exchanged)."
What are your thoughts?
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