I have an important update to last Thursday’s post The DEA Nabs Another Wholesaler.Incredible as it may sound, Harvard Drug Group immediately sued the Drug Enforcement Administration (DEA) after its license suspension…and won an impressive victory.
Here’s the lead from the company’s press release Harvard Drug Group Gains Injunctive Relief From DEA:
“Today, the Drug Enforcement Administration and U.S. Attorney’s Office, and Harvard Drug Group announced their agreement to immediately modify the suspension, upon certain conditions, of Harvard’s registration to distribute schedule III through V controlled substances out of its Livonia Distribution Center, and a mutual commitment to commence discussions, towards resolution of the issues raised in the DEA’s suspension order. The suspension remains as to schedule II controlled substances.”You can also read this letter from Chairman and CEO Randy Friedman. No press release or retraction from the DEA, naturally.
I wonder if the executives at Cardinal Health (NYSE:CAH) are kicking themselves for not being more aggressive back in 2007. Lawyer’s remorse?
Randy won't be breaking rocks in the hot sun, but we can still celebrate the first day of summer 2010 with The Clash!
Adam,
ReplyDeleteLifting the Class III-V ban is a help to Harvard, I guess, but this is by no means a reversal of the DEA action. Most of the opioid derivatives are Class II; morphine and opium themselves are Class I. Anabolic steroids--of MLB infamy--are Class III. I don't have market data at my fingertips, but i venture that 80% or more of the DEA controlled substances from the pharma industry are Class I-II.
You can see a complete list at http://www.deadiversion.usdoj.gov/schedules/orangebook/d_cs_drugcode.pdf
Your comments regarding the latest news on Harvard Drug’s modified license suspension deal with the DEA included “No press release or retraction from the DEA, naturally”. As you state – I cannot find mention of this deal on the DEA website or the DOJ website. But as a manufacturer, I don’t feel comfortable accepting a company’s press release and / or trade letter from the CEO as undisputed fact – without corroboration from the agency.
ReplyDeleteIs there a reason why the DEA won’t update their original press release? Do you know of a different way to confirm / verify that they are in agreement with what’s been put out by Harvard?
Many thanks,
Randy will fight anyone and very aggressively.
ReplyDeleteI enjoyed the Clash video too. Thanks.
Adam,
ReplyDeletein my opinion, the crux of their argument is nestled in Mr. Friedman's letter to customers:
"...alleging insufficient control of the identification of orders emanating from customers licensed by the DEA and State Boards of Pharmacy, who are nevertheless engaged in or likely to be engaged in suspicious, potentially illegal activity."
I speculate that counsel was quick to advise .... "wait a minute .... Harvard Drug is not responsible for licensing these potential/alleged criminals .... shouldn't DEA have a better process?"
With any regulation, it is fair to ask who bears the burden of oversight and enforcement. Harvard clearly felt that (in many aspects) they were operating within the legislative boundaries. I applaud them for taking on the DEA.
Do you know what the issue was with C-IIs? I suspect it had to do with order/inventory reconciliation and accountability.
Great stuff as always.
P.S. good call with the Clash version .... Bobby Fuller was the oldest (original?) performer I remember. grateful dead used to cover it at concerts as well, typically with someone dumb enough to run on stage during the song so they could get hauled off to crowd applause ... ahhh the simple times!
Adam, my company is a small distributor that has been "invited" back to DC for their "chat" about the new game in town, which essentially says all responsibility is on the distributor that sells controlled drugs to the end user. We are to "know" our customer.
ReplyDeleteThis may sound reasonable, but it's not that simple, and the DEA refuses to provide any information that will help us make an informed decision as to whether or not to sell to a customer.
For example, we cannot conceivably visit doctors or pharmacies half way across the country. We instead rely on them filling out a lengthy questionnaire, providing photos of their facility, phone conversations, etc., and then put them on a limit of so many units of a given drug family per month, depending on the type of clinic/pharmacy they are.
That's not good enough, says the DEA. They may be buying the same amount or more from other distributors, which is one of the questions on our questionnaire. We asked DEA if we could call the local DEA where the customer was located, and they said "no, that they could not divulge any info". The net effect of this interpretation is for us to guess if the customer is telling the truth on the form, when the DEA has that information readily available.
The DEA says they want to work together with distributors to solve the diversion problem, but their actions speak louder than words. In my opinion, they are equally to blame for this mess, and the sooner they actually start working with us, the sooner this rampant problem can be controlled.
A crazy system, typical of a government body, that says if you make a mistake, your busted, and we have the information that can keep you from being busted, but we won't give it to you. Absolutely insane.
to nick, morphine is a class 2, class one means no medical purpose for the drug as classified by the DEA. class 2 is only for extreme pain. 80% covers class 3-5, vicodin is class 3 and is on the top 5 list of most prescribed drugs with lipitor being number 1. look up diludid its stronger than morphine and heroin. people take 3-9 different pain meds multiple times a day, its not uncommon at all. all supplies and buyers go through a very tough prosses to buy and sell c2s. the DEA gets a paper or e form of every transaction. the state medical board and Pharm board gives these docs permission to dispense meds. there are nurses watching this go on and office staff. the DEA should become alert much sooner and not wait until it becomes an issue. the drug suppier should also monitor much closer and not let it become an issue. and some are paid for by inssuranc who has docs and pharmasist on staff who let this slip by also. its mostly about profit for the docs and the suppliers and the manufacurers.a hard working doc does not need to over dispense meds. not even close. sleazy docs who are lazy or using themselves may sell too much oxy. every single company involeved in drugs in the last few decades has been involed in court cases. makers, sellers, distributors, buyers, insurance all of them. AWP is a made up number. the bottom line is patient care! people are getting over medicated and mismedicaded every single day. the docs start the process and every one who dont work as hard as the docs wants to make money. if a place makes millions then you can bet they will do what they can and what they want to make billions. in 45 years i have not seen very many big companies or corps not get caught for lieing cheating or stealing. posting about does not change it. I use Harvard and i like them, i do not think it is acceptable for them to miss this florida thing. there are hundreds of trades that dont allow mistakes and over sites like the medical field does and the banking industry. nice place, booze and oxy are legal and a toxic combo, pot is not legal or toxic. hmmm.crook is a crook even if he wears a white coat.!
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