Enforcement Requires the Right Information
Last week, I wrote about how FDA seems to have taken a more strict approach to enforcement. But now I’m wondering if the agency is making decisions too quickly in response to pressure from the public and Congress.
After issuing nine warning letters on Mar. 30 to companies manufacturing and distributing unapproved painkillers, FDA had to retract some of its language on Apr. 9. The agency received concerning reports from individuals in the palliative care community that there was going to be a shortage of one of the opioid products mentioned in the warning letters (specifically 20 mg/ml morphine sulfate oral solution). As a result, FDA had to reverse course and issue a new statement: “The agency has determined that this dosage form is medically necessary, and should remain on the market….” The companies who received warning letters asking them to immediately halt the manufacture and distribution of versions of this drug are now able to carry on their work, until the agency approves an alternative product.
I can’t imagine how much chaos ensured at these companies’ headquarters and manufacturing sites, not to mention among the hospitals and patents relying on this medication, while FDA changed its mind. I’m sure it wasn’t pretty.
There also has been much discourse on the Internet about whether FDA’s 14 untitled letters for online drug advertisements—issued just a few days after the above warning letters—were within the agency’s legal authority (see www.eyeonfda.com). Those ads did not contain allegedly required risk information about the drug products being promoted.
Clearly, enforcement is a positive thing when dealing with drug products because there are always risks involved. But as a parent, I also believe that follow-through is important. It’s difficult to earn respect (say, from the pharma industry, or in my case, a toddler) if you change your mind or give in too easily. For that reason, it’s necessary to have the right information up front so that you can take the best course of action (such as a justified warning letter or a time-out). In this case, FDA seems to have issued its initial warning letters too hastily and without all the necessary information, putting industry and patients in a muddy middle ground.
Thanks for highlighting this issue.
To put it more bluntly, this latest incompetent gaffe is just the tip of the FDA irresponsibility iceberg; whatever happened to management review and approval?
Regulatory Agencies hold pharmaceutical companies to high standards of accountability through GXPs and Regulatory oversight. Those that make the rules should also be seen to be living by them!
(I note that the EMEA has recently (Mar 2009) implemented their Integrated Agency Quality Management System; something FDA TALKED about several YEARS ago)
it is not only the leaders at FDA/CDER? that need to change. The politicized career-building (watching their rears) senior-middle management needs to be cleared out and replaced by regulatory-science-based savvy decision-makers who know their regulatory science ABCs (active ingredients, biosimilar comparabilities, and clinical efficacies?).
Let’s have a whole load of new guys, with attitude, who can really cut it, not just fudge it.
Hi,
You are missing one point. The FDA did not say that the companies are making a quality product. They said that no one else is making this product so that even the poor quality product currenlty on the market must continue to be sold. My Dad suffered a stroke when he was on heparin that most likely was spiked with oversulfated condroitin. My Dad survived the stroke and is in good health today but had he been give a quality product he probably would not have had the stroke. The FDA needs to oversee these products because some companies will sell the cheapest junk they can get away with selling.