PDT Selling Question

I considered the same, but Foundation Care sells single boxes for ASP + 1% and gives discounts for autoship.
Where is their margin?
With regular price increases they might have had one, but now it looks like they got the bad end of the deal (if this deal exists).

 

How can you know this? As far as I am informed only two reps switched away from BF since they recieved better offers.

Still i cant see BF looking for replacements anywhere. Not like SUN where position were open for up to three months and could not be filled. Feel free to show us a link for a open sales rep at bf.

 

Anyone else get a call from an attorney about a potential off-label suit? Someone is digging for hard copy evidence. This shit is real folks!

 

You need to report that to home office

 

Yeah I will get right on that skippy. I don't work there anymore. I used to work for DUSA. Even if I did work for Sun why would I tell them that I want to join a whistleblower case? Nice try management...

 

Ex-DUSA rep here too. Yes I was contacted as well. Seems like the lawyers are int he early stages of building a case. I gave them other ex-DUSA rep names but that is all I had. At least that's what you think Sun...hahahahaha

 

I would love to get in on this. The sales tactics here are pure criminal. Its all smoke and mirrors and ways to get around off label selling. Cant wait to leave.

 

so ... can you be more specific when you say 'sales tactics ... '

 

You obviously haven't read the entire thread. Go read the entire thread and then comment.

 

If you don't know what they are then you obviously don't work for Sun. The product is used 100% off label and the managers help the reps find ways around selling off label. If you work here you know what I mean.

 

Who is asking?

 

Probably the oompa loompa sales manager for Boston

 

One more question:

As far as i am informed Compounding pharmacies are not allowed to mix or sell anything as long as there is an approved Drug on the market. This is the law. How can they sell around that?

 

Post your proof source where that is the law? Not true. The only thing that can stop a compounding pharmacy is patent life. Once the patent is up on Levulan in 2018 compounding pharmacies can go to town. They will not be able to make Ameluz but who cares, the 20% compound will be what doctors want anyway and they will use it with the Blu-U light. Doctors will stick it right back at Sun for their price increases and use their light. They will laugh all the way tot he bank. Now the one problem is they can't bill for a compounded product but they won't care. The price will be so cheap that they will just bill the patient and make them pay cash. Good night PDT and Sun in 2018.

 

First we must understand that under the Drug Quality and Security Act (DQSA) of 2013 (H.R. 3204) there are two typs of compounding:

You have the "traditional compounding (i.e., patient-specific) = those fall under 503A
503A essentially establishes that pharmacies compounding only "patient-specific" drug products made in response to each prescription (among certain other related situations)

At the same time, Section 503B creates a new category of facilities called "outsourcing facilities" - by which non-traditional compounding facilities (i.e., those whose products include "non-patient-specific" batches) can be explicitly authorized by the Food and Drug Administration under specified circumstances. Notably, in both cases the compounding cannot encompass a drug product that is "essentially a copy" of a mass-produced drug product, but in 503B the definition of "essentially a copy" is broader than in 503A

"outsourcing facilities" in subsection (d)(2)(B) of 503B, by deeming a compounded drug a "copy" even if it just has an active ingredient that is also present in any mass-produced product.)

Oh and by the way BF will also soon have the BCC PDT approval for USA.
http://www.press-report.net/clanek-132726986-biofrontera-agrees-with-us-fda-on-ameluz-development-plan-to-treat-basal-cell-carcinoma

I think that 2018 will be a great year for PDT and Ameluz, Biofrontera.
But please feel free to prove me wrong!

 

First we must understand that under the Drug Quality and Security Act (DQSA) of 2013 (H.R. 3204) there are two typs of Compounders:

https://www.govtrack.us/congress/bills/113/hr3204/text

You have the "traditional compounding (i.e., patient-specific) = those fall under the cat. 503A
503A essentially establishes that pharmacies compounding only "patient-specific" drug products made in response to each prescription (among certain other related situations)

At the same time, Section 503B creates a new category of facilities called "outsourcing facilities" - by which non-traditional compounding facilities (i.e., those whose products include "non-patient-specific" batches) can be explicitly authorized by the Food and Drug Administration under specified circumstances. Notably, in both cases the compounding cannot encompass a drug product that is "essentially a copy" of a mass-produced drug product, but in 503B the definition of "essentially a copy" is broader than in 503A

"outsourcing facilities" in subsection (d)(2)(B) of 503B, by deeming a compounded drug a "copy" even if it just has an active ingredient that is also present in any mass-produced product.)

Also soon Ameluz will have the approval for BCC PDT.
http://www.press-report.net/clanek-132726986-biofrontera-agrees-with-us-fda-on-ameluz-development-plan-to-treat-basal-cell-carcinoma

I think 2018 will be a great year for PDT and Biofrontera.

SUN on the other hand will get in trouble selling PDT, with such competition.

Please feel free to prove me wrong!

 

Mass produced products are compounded all the time. The problem is enforcement. Once Levulan loses patent there wont be any enforcement ability. FDA doesnt have police. The only recourse a manufacturer like Sun has right now is their patent. Consider something like Lidocaine. It was a mass produced product for years. Once it lost patent protection pharmacies compounded the hell out of it. Its legal once the patent life ends. Thats what I dont think you understand.

 

Nobody to enforce this law that is the problem. There will be hundreds of pharmacies compounding levulan once patent expires and it will cost Sun more in court than they can make on Levulan. Wont be worth the fight.

 

Well I do not think that this is a good example, Lidocaine was discovered in 1946 and went on sale in 1948.
Lot of things happend during that time and also changed, and at one point there were national intresst in a constant supply.

Can you please give me a more recent one? So far I could not find a drug that had this problem with compounding on a larger scale.

Once more i would like to point out:

There are limits of FDA jurisdiction over traditional (i.e., patient-specific) compounding, So now, Section 503A essentially establishes that pharmacies compounding only "patient-specific" drug products made in response to each prescription (among certain other related situations) cannot be required to obtain FDA approval for such products as they will remain exclusively under state-level pharmacy regulation

At the same time, Section 503B creates a new category of facilities called "outsourcing facilities" - by which non-traditional compounding facilities (i.e., those whose products include "non-patient-specific" batches) can be explicitly authorized by the Food and Drug Administration under specified circumstances,

So i do not see an enforcement problem ... they even need to be authorised by the FDA.

Also Ameluzs superiority and better indication is a very important, thats why compounding wont be a real problem for Biofrontera. And regarding SUN, well i dont care about them.

Should i be wrong in my findings, please take your time to correct me.
Sincerly

 

No it's not legal.

A generica would be legal. But this must also be approved by the FDA.
But genericas wont be a problem.

Notably, in both cases the compounding cannot encompass a drug product that is "essentially a copy" of a mass-produced drug product!

(d)(2)(B) of 503B, by deeming a compounded drug a "copy" even if it just has an active ingredient that is also present in any mass-produced product.