News - 2021
|Today’s lesson is on a Big Pharma term that may be new to my readers. “Overfill” is the extra drug quantity, over and above the labeled dose, in FDA-approved containers. This is a standard manufacturer’s practice to ensure that clinicians who administer the drug will always be assured the full labeled dose can be extracted. It’s a patient quality assurance control, and overfill is NOT included in the vial price.
A recent article by Jonathan Stempel from Reuters explained how a unit of AmerisourceBergen Corp, a large drug wholesaler, agreed to pay a Department of Justice settlement fine of $625 million relating in part to overfill fraud.
The scheme worked when the drug product was removed from the original FDA-approved glass vials. Then the medication was pooled into untested and unapproved plastic containers. Finally, the drug (which included the overfill) was extracted and repackaged into syringes. Over a million unapproved syringes per year were manufactured, and Big Pharma’s profit was overfilled by $100 million.
The FDA did not take kindly to this process, which they believed risked the safety and efficacy of these medications, and placed greed over the protection of vulnerable patients.
Big Pharma never ceases to amaze.
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“Consistency is the hobgoblin of little minds.”
~ Ralph Waldo Emerson, Self-Reliance
There was a recent publication from NPR concerning a study of physicians who treat with Seroquel (an antipsychotic drug). These physicians received letters from Medicare that gave a general warning that they were being “flagged/warned” as above-average prescribers of this medication. Guess what, two years later and without follow-up, the physicians’ usage of this drug dropped dramatically.
We have found that scientific peer-to-peer intervention with treating physicians is one of the most cost-effective techniques to improve outcomes. This is best handled by a professional, highly credentialed panel of providers who will engage treating physicians with data on the latest science and industry guidelines. Nothing is more rewarding and cost-effective than providers who are willing to listen and then voluntarily modify their protocols.
No attorneys. No regulators. No disputes. No appeals.
Just doctors who decide to do better and change their minds. Sometimes you need a hobgoblin to correct a wrong.
Call us. We can do better.
“Fasten your seatbelts, it’s going to be a bumpy ride.”
~ Bette Davis in All About Eve
I’m linking to a press release from the Food and Drug Administration, as well as a recent article by Jeffrey Singer in Cato At Liberty. The headline below tells me we might be in for a scientific royal rumble:
“New FDA Initiative Implies CDC
Opioid Guidelines Are Not Evidence-Based”
The Centers for Disease Control and Prevention (CDC) promulgated opioid prescribing guidelines in 2016. Some patient advocacy groups, as well as addiction/pain medicine specialists, have criticized these guidelines as not being evidence-based.
In light of these criticisms, the FDA has awarded a contract to the National Academies of Sciences, Engineering, and Medicine to more specifically develop guidelines relative to opioid prescribing. The FDA intends this study to be indication-specific and based on evidence drawn from clinical practice.
Buried in the press release is this nugget: “Our work could potentially inform drug labeling.”
Let the science and evidence speak. We’re fastened up and ready to do better.
A common saying for a distasteful process is that “it’s like watching sausage being made.” We can appreciate the end result, but we don’t necessarily want to see the inner workings.
I’ve had occasion recently to see the sausage being made as regulations are drafted for new Kentucky legislation:
Limiting medical benefits to 754 weeks in most cases;
Selecting and installing new treatment guidelines for medical providers to use in workers’ comp cases;
Installing a pharmaceutical formulary.
If this sounds like a lot to do in a short period of time, you would be correct.
All of these are mandated by statute and have different effective dates. Nevertheless, Commissioner Robert Swisher and Chief Administrative Law Judge Douglas Gott must act fast to get this accomplished. To assist them, they have formed two committees — one which will draft regulations, and the other which will advise on selection of treatment guidelines and drug formulary — and I was fortunate to sit in on their meetings yesterday. The committees include plaintiff and defense attorneys, various physicians, physical therapists, and claims and carrier representatives. All are well qualified to offer guidance germane to their areas of expertise, and Swisher and Gott are genuinely receptive to what they are hearing.
So, I have to tell you that watching this sausage being made isn’t so bad. With well intentioned, intelligent folks on all sides, this may work out after all.