Dova Pharmaceuticals

[anonymous]

Why won’t they give us our rank reports? I know I didn’t finish top 10%. I know I probably finished top 20% but I can’t show it! Do they think we won’t interview without it? No merit increase. No rank reports. What are they hiding?

 

[anonymous]

So our ipad’s Track us now? Anyone else get that message on their iPad?

 

[anonymous]

Why won’t they give us our rank reports? I know I didn’t finish top 10%. I know I probably finished top 20% but I can’t show it! Do they think we won’t interview without it? No merit increase. No rank reports. What are they hiding?

For fifty bucks, I can “generate” you a ranking report. For an additional 50, I’ll rank you in the top 5%. No problem.

 

[anonymous]

Why won’t they give us our rank reports? I know I didn’t finish top 10%. I know I probably finished top 20% but I can’t show it! Do they think we won’t interview without it? No merit increase. No rank reports. What are they hiding?

all of the above. And what they are hiding should be obvious

 

[anonymous]

So our ipad’s Track us now? Anyone else get that message on their iPad?

There was a message saying it’s tracking you? FR?

 

[anonymous]

There was a message saying it’s tracking you? FR?

Yes, this company has become so darn shady its unbelievable.

 

[anonymous]

I know some reps are selling off label but is it worth it? It seems to be working for them but it just doesn't seem very ethical to me.

 

[anonymous]

Some ya-hoo “regional sales director” Steve L tried to recruit me for a position in the east.

Once I heard his pitch and the comp numbers, I politely declined. Had a gut feeling from the
moment he called that Dova was bad news.

Now 18 months later it’s interesting to hear how that place has imploded. And now Jason H. is the head of commercial?

 

[anonymous]

Some ya-hoo “regional sales director” Steve L tried to recruit me for a position in the east.

Once I heard his pitch and the comp numbers, I politely declined. Had a gut feeling from the
moment he called that Dova was bad news.

Now 18 months later it’s interesting to hear how that place has imploded. And now Jason H. is the head of commercial?

FR? Steve L only starts DOVA in early 2018 and he tried to recruit you 18 months ago (Sep 2017? - 3 months after IPO). Wow..?

 

[anonymous]

I know some reps are selling off label but is it worth it? It seems to be working for them but it just doesn't seem very ethical to me.

The company operates off label by trying to force doctors to write prescriptions for people that don't need a procedure and also for people with ITP. They are going to get BUSTED big time one of these days!

 

[anonymous]

I know some reps are selling off label but is it worth it? It seems to be working for them but it just doesn't seem very ethical to me.

The company operates off label by trying to force doctors to write prescriptions for people that don't need a procedure and also for people with ITP. They are going to get BUSTED big time one of these days!

As a sales, you need to understand and research the law:

"The practice, called "off-label" prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies."

Please refer to FDA website for guidance:
https://www.fda.gov/forpatients/other/offlabel/default.htm

So, no, they wont get BUSTED or anything as it is completely legal. The decision is on doctors/healthcare providers who have expertise and would need to access benefit/risk - you as sales only introduce the medicine for them to consider benefit/risk for their patients.

 

[anonymous]

I know some reps are selling off label but is it worth it? It seems to be working for them but it just doesn't seem very ethical to me.

The company operates off label by trying to force doctors to write prescriptions for people that don't need a procedure and also for people with ITP. They are going to get BUSTED big time one of these days!

Again, following my earlier reply, it seems that many of the "top performers" in pharmaceutical sales do not understand off-label prescribing??? How could you not have any idea of such common knowledge? OMG..

“Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing, and ... doctors are free to prescribe a drug for any [reason they think is medically appropriate],” says G. Caleb Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center. "Off-label use is so common, that virtually every drug is used off-label in some circumstances."

 

[anonymous]

You are correct that a physician can prescribe a drug for an off label use. However, IT IS ILLEGAL FOR A REP TO PROMOTE OFF LABEL!!!
Asking a doctor to prescribe Doptelet for a patient that does not need a procedure is OFF LABEL at this time. That is called insurance FRAUD! You may consider reading the PI to refresh youself on our current indication.

 

[anonymous]

You are correct that a physician can prescribe a drug for an off label use. However, IT IS ILLEGAL FOR A REP TO PROMOTE OFF LABEL!!!
Asking a doctor to prescribe Doptelet for a patient that does not need a procedure is OFF LABEL at this time. That is called insurance FRAUD! You may consider reading the PI to refresh youself on our current indication.

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?

 

[anonymous]

You are correct that a physician can prescribe a drug for an off label use. However, IT IS ILLEGAL FOR A REP TO PROMOTE OFF LABEL!!!
Asking a doctor to prescribe Doptelet for a patient that does not need a procedure is OFF LABEL at this time. That is called insurance FRAUD! You may consider reading the PI to refresh youself on our current indication.

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?

 

[anonymous]

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?

Actually it is illegal for a sales representative or anyone compensated based on sales of a product to share information (factual or not) that is not on label or currently approved. This includes sharing or discussing information regarding potential upcoming indications. It is also illegal to provide guidance to a physician that is not included in the indication / PI - for example how to dose. patient with a count above 50k.

 

[anonymous]

Actually it is illegal for a sales representative or anyone compensated based on sales of a product to share information (factual or not) that is not on label or currently approved. This includes sharing or discussing information regarding potential upcoming indications. It is also illegal to provide guidance to a physician that is not included in the indication / PI - for example how to dose. patient with a count above 50k.

Before May/18, there is only Draft Guidance "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices", published in 2011. It only allows firms to reply unsolicited requests.

However, FDA published new final guidance in June/2018, part C: "Communications by Firms to Payors Regarding Unapproved Products and Unapproved Uses of Approved/Cleared Products" - page 18

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537347.pdf

Who is payors, formulary committees, and similar entities:
"Section 502(a) specifies that HCEI can be provided to “a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.” This audience includes public and private sector payors, formulary committees (e.g., pharmacy and therapeutics committees), drug information centers, technology assessment committees, pharmacy benefit managers, third party administrators, and other multidisciplinary entities that, on behalf of health care organizations, review scientific and/or technology assessments to make drug or device selection or acquisition, formulary management, and/or coverage and reimbursement decisions on a population basis"

Another thing is mindset you could not / do not force doctor to prescribe for sale (doc is not your employee, especially of a startup like DOVA), you could only provide factual information as per allowed in guidance of FDA to those payors, KOLs..

 

[anonymous]

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?

Wow...if this is the guidance you’re receiving you guys are in worse shape than even your stock price reflects.

 

[anonymous]

You are correct that a physician can prescribe a drug for an off label use. However, IT IS ILLEGAL FOR A REP TO PROMOTE OFF LABEL!!!
Asking a doctor to prescribe Doptelet for a patient that does not need a procedure is OFF LABEL at this time. That is called insurance FRAUD! You may consider reading the PI to refresh youself on our current indication.

Pretty sure the guy in Northern California is doing this.

 

[anonymous]

lets face it. Dova is desperate. Everyone knows exactly why