U.S. District Judge Royce Lamberth’s February 5 order obligating the DEA to pay financial settlements to certain drugs defendants offers some protection for anyone selling drugs that contain some form of Nootropics. But it doesn’t do much to protect consumers.
The Judge is giving the DEA $25 million each to Bezabeh Pharmaceuticals and Mega Pharmaceuticals, for packaging each product with a label declaring “Use by two or more individuals at the same time is not appropriate.” Note that one of those products, Opana ER, is a Schedule II Schedule I narcotic, meaning it has a high potential for abuse.
Opana ER alone was reported to have caused roughly 200 deaths last year, and so, according to one of the drugmakers’ lawyers, defendants have been seeking settlements with the DEA for more than a year.
Beyond the numbers, what concerns me is the idea that anyone selling drugs on the shelves should be entitled to protections as that they may lie to their customers. There’s an old adage that you shouldn’t be able to eat French fries if you haven’t watched how they’re prepared, so what exactly are we to make of pharmaceutical makers selling a drug — then touting how it could give users the ultimate high — while claiming their products contain nothing that could give them a “high”?
Was the Drug Enforcement Administration made aware of the information being presented when it approved the drugs? It could certainly have had access to that information. That’s a given when dealing with controlled substances. Additionally, the fact that Bezabeh Pharmaceuticals can only sell its product for a single trip before it needs to repackage and re-label it raises some serious questions about its prescribing practices as well. What is their promotional message to prescribers? All I can say is, I wish I’d read it more carefully.
Is it just me or is this whole movement all a bit disturbing?
We already know there are people out there turning to harder drugs to feel better — heroin, OxyContin, Tramadol, etc. Which drugs are far less dangerous, but can easily be overdosed, are alternatives not well understood by patients, are not easily identified by doctor, or neither drug is correctly prescribed?
When opioids are used for chronic pain and counseling can be difficult or inaccessible, it may be tempting to substitute these drugs for non-opioid therapies, which doctors know are effective, can relieve pain, and provide certain mental, social and emotional benefits.
Fortunately, the FDA is proposing to tighten the rules. Several commenters on the FDA’s recently published proposal for new generic pain relievers use Nootropics to warn that they may not be adequately regulated. That’s not good for patients.
I hope Judge Lamberth has a better response.