Egalet is a COMPLIANCE NIGHTMARE.

Discussion in 'Egalet' started by anonymous, Jul 14, 2017 at 9:41 PM.

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  1. anonymous

    anonymous Guest

    Investors and Leadership - we know you're reading this so pay attention. Junior reps, where this is your first pharma job, think before you speak.

    Desperation makes teams and individuals do desperate things. There should be no surprise there. Google the average dollar amount fine from the FDA when a company inappropriately promoted their drugs or breaks compliance expectations. It is more than the entire market cap of Egalet AS of today with a $1.48 share price.

    For those of you not previously in pharma, taking meals to a doctor weekly (and if possible 2-3 times per week if you follow management direction) is NOT standard. The meal is supposed to be for access in conjunction with a meal. Management, including senior leadership, stress the importance of these "extended selling sessions" because Arymo ER and Oxaydo are "relationship drugs." Words from the horses mouth (an executive leader), "The people who drive the most miles and spend the most money on a core and select few physicians generate the most scripts. We see it in the data that rolls into home office." For a company whose stock price is in the tank, you would wonder why the reps in this company DO NOT have a spend budget. Audit Concur. Audit Emails. I beg you, FDA. Every district has a spreadsheet updated monthly with the names of physicians, dollars spent on those physicans, and correlation to how many scripts of products they have written. That's not selling. That's attempted bribery.

    Second, again audit emails PLEASE - who did Egalet select as speakers in the new speaker roster? You'll find emails from management asking for names of doctors from reps. Specifically the names of doctors who are writing Egalet products, and also have high volume and potential to be a large volume writer. There's nothing educational about that. That a bribery in the form of speaker fees and strokes egos.

    Since coverage of all products is limited to commercial, the copay cards over ride prior auth and will continue to buy it down even with a denial. Obviously, the company doesn't make money that way. Emails and direction from sales leaders include instruction on how to supplement prior auths in offices so they'll get approved. "Do you know what goes into the prior auth?" - Mark T. in an email in June. Last time I checked, you can't coach or assist staff with specific patient information to increase the odds that prior auths are approved. It's A) non-compliant and B) a gigantic HIPPA violation.

    And last but not least, the marketing and brand message that is focused on the opioid epidemic. "Tell the story about how addiction begins and ends." What FDA approved information does Egalet have that allows us to even address that generic non-ADF opioids are addictive, and that Arymo and Oxaydo comparatively are less addictive? Or have a less likelihood of death from overdose? Nothing. We habe nothing.

    It's shocking that in such a high-focus pharmaceutical category given today's climate...that Egalet has flown under the radar with all of the massive compliance violations that occur from a daily basis. Even more concerning, it flows from the top down. And since 90% reps have little to zero pharma experience...they don't know differently or have the context to recognize that the conduct being asked of them is inappropriate.

    A toxic stain on the pharma industry and a prime example of why public perception of pharma is negative.
     
  2. The FDA

    The FDA Guest

    Thanks, we're on it

     
  3. anonymous

    anonymous Guest

    You rookies should read up on what Insys pharma did.
    Might prevent you from going to jail!
     
  4. anonymous

    anonymous Guest

    Legit say this same thing all the time. I am shocked we haven't gotten in major trouble yet. They've got all the reps scared to death that they'll lose their jobs if we speak up. They do not even have reps reporting side effects. If a patient reports that it does not work...in my managers words "talk to the doctor about the fact that it's an abuse deterrent and of course the patient is going to say the drug doesn't work as soon as they fill it and realize they can not inject it. So it's a patient problem not a product problem." Seriously? I thought it was a requirement to report that. Isn't that how drugs go years and cause harm because companies fail to report a known issue to the FDA in a timely manner? It is a brand new drug, how does Egalet know it's a product problem when it could very well be a manufacturing problem or a bad batch? It would be a shame to see a veteran or another human being that is living with their pain continue to be prescribed a bad batch of product because the management and reps have persuaded them that the product is perfectly fine their patient is just a drug addict. Something here is not right. I plan on looking for a new job. Eventually the FRA is going to find out or someone is going to blow the whistle and when that happens the company will not survive the 20 million dollar fine for violating FDA regulations on top of the 25 million dollars that the comlpany is already losing every quarter.

    ....oh and I wonder why the Activity Tracker changed right before our regional OPS meeting. I guess someone read your post and realized maybe they don't have some reps as afraid as they originally thought. Thanks for speaking out someone needed to do it
     
  5. anonymous

    anonymous Guest

    Stock will be under a dollar tomorrow. An FDA fine will be the final blow and eventually someone's gotta whistleblow and the government will find out
     
  6. anonymous

    anonymous Guest

    Thanks dude for your sound advice. Time has proven you right. Egalet and especially our management is in the shitter. We all hate Bob, Mark and Pat.