Dova Pharmaceuticals

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anonymous said:
Not really, this is very much of a gray area and currently is on debate.

Yes, there definitely is restriction on off label promotion and in serious case could be considered as an act of criminal and civil fraud perpetrated by unscrupulous manufacturers (under the False Claims Act, and misbranding actions by the FDA). There are some famous cases (Eli Lilly in 2009, Pfizer in 2009, Abbott Labs in 2012, JNJ in 2013).

However, in recent years, "the trend toward heightened constitutional protection of commercial speech in the health care arena has opened up opportunities for off-label promotion without threat of liability. Proponents of both off-label drug promotion and expanded protection of commercial speech argue that, in an era of increasing transparency in health information, citizens have a right to know about any evidence that a drug might be effective for a particular off-label use."

Such argue bases on First Amendment right to free speech. Besides the 2012 case, US v. Caronia leading to some changes in off-label promotion, the recent famous case is AMRN v U.S. FDA, settled in March 2016. In this case, the agency has seemingly agreed to refrain from bringing misbranding actions against truthful, non-misleading off-label promotion, and has shifted the burden onto the company to ensure the communications meet the standard. Two bills: Medical Product Communications Act of 2017 (H.R. 1703) and the Pharmaceutical Information Exchange Act (H.R. 2026) are currently under debate through Houses

In June 2018, the FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. "Additionally, it’s our belief that giving companies clear guidelines for providing payors with truthful and non-misleading information about unapproved products and unapproved uses of approved or cleared products will help facilitate communications that can allow payors to provide coverage for these new products and new uses more quickly after FDA approval or clearance"
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610415.htm

So, yes, it is still illegal to promote off-label usage (especial to direct consumers) but it is not illegal to share truthful, non-misleading certain types of information about unapproved products or off-label uses of approved products with healthcare providers (e.g: Information about the indication(s) sought, Factual presentations of results from studies...). In this specific case, sharing factual information regarding studies of cITP indication, anticipated timeline for possible FDA approval..., factual information about its safety and efficacy profile to elevate platelet production in low platelet count condition from actual studies (it might benefit patients suffering from such condition...).

It is a thin line between off-label promotion and sharing factual information but you should be trained what information is allowed to share and discuss?
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I love it when people think they are so smart and “research” the facts and then manipulate the information to fit their own illegal activities! I’m sure the DOJ just LOVES reading all of this ridiculousness! You’re throwing your own company under the bus because they LOVE keeping a very very close eye on new companies with new products especially the ones that are struggling and most likely doing the wrong thing.

Maybe you should talk to your head of compliance so you correctly interpret the information your reading or being fed. The info you’re quoting is in regards to payors aka insurance companies! It allows for clinical/scientific conversations with payors in order to get the ball rolling prior to new product approval. You are obviously not a seasoned rep by your misinterpretation!

To set the record straight...Sure providers can prescribe off- label but It is absolutely NOT legal for a commercial team to discuss ANYTHING that is not covered in the PI. That is the limitation of YOUR position within sales and the FDA makes it very clear. As a sales rep it is ILLEGAL to share “information about unapproved products or off-label uses of approved products with healthcare providers.” However, you’re correct, if you work on the non-commercial/medical side (aka MSL) then you can respond to unsolicited requests for medical information, which are often times off-label. It’s pretty black and white with a clear line my friend. If you leadership is telling you otherwise then I’d run as fast as you can from this company. If you think I’m wrong then I can connect you with some reps who are in jail for off-label promotion which equates to insurance fraud. Seems pretty clear to me!
 








With Scott Gottlieb being appointed as FDA commissioner last year, it is a score for bios/ pharms. He has long argued for loosening clinical standards and promoting a framework for companies to distribute "valuable and truthful" off-label information to physicians for decade. The whole industry is shaddy and corrupted.
 








Oh yeah.. we all love making money from distressed miserable bios. They are in fantasy land with all that crazy spending money for sales, marketing... I earned ton shorting these dogs when they finally face cruel facts after approval. This industry is full of shitty management, useless sales who live in wonderland
 












anonymous said:
dog shit product, terrible sales, terrible leadership, zero value. Leave the mess, short it to ground and earn ourselves lots of $
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That is not true. It is actually a good product, the doctors I talked to seem really like it. Rx starts slow but it is progressing. And there is no such guidance nor does my manager push me to force my docs to prescribe off label uses.
 




anonymous said:
That is not true. It is actually a good product, the doctors I talked to seem really like it. Rx starts slow but it is progressing. And there is no such guidance nor does my manager push me to force my docs to prescribe off label uses.
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Idiot! Jumping off that sinking ship before too late. BK coming and short is winner here. None needs another dog shit product/bio
 
























anonymous said:
Allow me to ask a supid question? Arizona and Tennessee state laws permit Off Label Promotion so what is the situation here really?
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You are kidding me right ?
First - Your wrong.
Second - Your company doesnt care about state level laws - Recreational maryjane may be legal in your state - doesnt matter.
 




anonymous said:
You are kidding me right ?
First - Your wrong.
Second - Your company doesnt care about state level laws - Recreational maryjane may be legal in your state - doesnt matter.
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Jeez, what is wrong with people here? Does my question offend you? I totally agree with you off label promotion is not permitted, just ask to know if state laws permit then what happens in those states. I admit I am stupid from upfront and you seem to be knowledgeable in this subject.

But never mind, just passing by, love to all.
 








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