Christopher thank you. I'm grateful for the time you put into collecting your thoughts and presenting this information in such an interesting and informative way. It shows a lot of respect for your channel viewers, our time, and the importance of this information.
Compounding pharmacies have reaped a windfall of profit from a law that allows them to override a patent on a new drug that’s in short supply. Could there be any greed with these companies? And most of these pharmacies do not have to follow FDA guidelines for quality control.
Of course you are correct but be careful. People don’t want to hear it and someone will accuse you of being paid by Eli Lilly just because you were trying to get the truth out there. The compounding companies are just as craven as the drug companies. They have been making hay while the sun shone knowing that like every other drug in shortage that they produce, when these drugs went off shortage, they would need to stop making them There are hundreds of drugs on the shortage list that the compounders make every year for a little while and every year they have to stop making them when supplies can be met by a brand name drug. The runaway success of these drugs has meant they have made squillions while doing none of the research to create the drug and not having to meet the exacting safety and efficacy standards that the pharmaceutical companies have to meet. If Bernie Sanders is correct and it only costs five dollars per shot to actually make the drug then the compounders are ripping everyone off as well. Everyone needs to realise that the compounders are not your friends. They are doing this for one reason only, to make money.
@jc10907Sealy Pharmacies are HEAVILY regulated They can't just dispense whatever. Of course they have to follow National and State Pharmaceutical regulations
@@autchicabFrom the FDA website "Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. In addition, licensed pharmacists and licensed physicians who compound drug products in accordance with section 503A are not required to comply with CGMP requirements. Furthermore, FDA does not interact with the vast majority of licensed pharmacists and licensed physicians who compound drug products and seek to qualify for the exemptions under section 503A of the FD&C Act for the drug products that they compound because these compounders are not licensed by FDA and generally do not register their compounding facilities with FDA. Therefore, FDA is often not aware of potential problems with their compounded drug products or compounding practices unless it receives a complaint, such as a report of a serious adverse event or visible contamination. "
@@autchicab This is from the FDA website "Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. In addition, licensed pharmacists and licensed physicians who compound drug products in accordance with section 503A are not required to comply with CGMP requirements. Furthermore, FDA does not interact with the vast majority of licensed pharmacists and licensed physicians who compound drug products and seek to qualify for the exemptions under section 503A of the FD&C Act for the drug products that they compound because these compounders are not licensed by FDA and generally do not register their compounding facilities with FDA. Therefore, FDA is often not aware of potential problems with their compounded drug products or compounding practices unless it receives a complaint such as a report of a serious adverse event or visible contamination. "
The FDA should have more authority on drug shortages. The US House needs to pass H.R.3008 and the US Senate needs to pass S.2362 which is the "Drug Shortage Prevention Act." I recommend that you contact your two senators and representative letting them know that you support this legislation.
I am on JoinFridays and on a maintenance dosage of tirzepetide but now I have to switch to semaglutide. I used to be on name brand Zepbound but the cost was exorbitant since my insurance does not cover it. I hope that I can go back to tirzepetide; I have three weeks before I have to switch. At least I am blessed to be on maintenance.
Here’s my take on the legal bit (I’m not a lawyer). This suit could have been brought anywhere, but it was brought in Ft. Worth because the plaintiffs were blatantly venue-shopping, that is, finding the most favorable judge in the country. I believe they were assigned Judge Pittman, a Republican who has a history of slapping down the agencies for overreach. He gets appealed a lot, and he also gets affirmed a lot because the courts above him lean the same way he does. One issue is this case involves aligning the interests of an agency and big pharma. Normally, a judge of his leaning would be pro-big-pharma and anti-agency, so there is a conflict. However, my gut is he would still try to find the law and facts to justify shrinking the power of the agency. All that means… I think this will take years to solve, but hopefully for us, it will mean that not only can tirzepatide be legally compounded, but maybe it will open the way for other drugs to be compounded and to help with the access issues we have in our country. Oh, and I only bring up politics as an explanation of why I think things will turn out a certain way, not as an endorsement of any political party. For more information, anyone can google Judge Pittman, Judge Reed O’Connor, and forum or venue shopping. There are lots of articles about it. Also, if there are any lawyers on here, correct me if I’ve put out any misinformation! This is my best understanding.
@dalithecat In the end this is about a patent that Lilly holds..Yes I know the whole shortage issue of a way of scapegoating the patent so that compound pharms can keep making big money off of a patent ..but that will come to and end .. A patent would be meaningless if they did not have the right to uphold said patent ...
In the end it’s about a company charging exorbitant prices to desperate americas. The patent simply protects their investment. This is just another battle in the war to reinvent the American healthcare system, create transparency and encourage business to be good corporate citizens
I recently switched to Tirzepetide from Semaglutide and found it much more effective and the side effects much less intense. Have loved the progress and have been feeling rejuvenated in my weight loss journey. This is such a blow! I do not want to go back on Semaglutide because it was not working for me anymore and the side effects were becoming unbearable. My insurance does not cover these drugs and Tirzepetide was an answered prayer. Feeling so worried about this now. Thank you for the info! Any idea when a judge might rule on a temporary decision to allow compounded tirzepetide to continue to be produced?
Thank you for all the information!! You’d asked how we were doing on our compound orders. I’ve been getting mine from Remedy meds since July and they just shipped my next months order (fingers crossed)
Thank you for sharing this information. The situation is still unfolding, and I believe the FDA may have acted prematurely in this case. It seems their decision was heavily influenced by Eli Lilly’s position, without fully considering the thousands of patients relying on compound. I truly hope the judge carefully weighs all these factors and rules in favor of the OFA.
CD: so do we. Lilly could make this a non story by releasing the vials at all doses at $299 approximately the price from compounders. And so it through Lilly direct cutting out the PBMs and maintaining or increasing their profit while decreasing the cost to customers
The judge should only be evaluating if the FDA was following the law. Judges job is not social activism. If you want to change the law, this is the legislatures job. Senator Bernie Sanders is particularly active in this area.
If you cannot afford/access the name brand medication, should a patient even start? Are these telehealth and compounding pharmacies actually helping patients or just stealing money from desperate people?
CD: Clark - those are great questions. That lead to bigger questions about our entire healthcare system, innovation, access and equity. Are they stealing money from desperate people? That is dramatic but no there is no stealing involved they are legally selling a good for a price. Are they completely blameless and the good guys in the complicated and convoluted American healthcare system? No they are just another cog in the continuum of big businesses who are profiting off of obesity.The entire system needs revamped.
Mochi dr today told me not to worry because it is a compounded formula. my local compounding pharmacy told me not to worry because he makes the formula himself
Like why is Lilly offering single doses? Why not a monthly vial at $300-$400. With more and more people getting on Tirz. There’s still billions to be made at a decent price🫠 isn’t it super inexpensive to make?
@@lillyr1786 Zero chance of messing up the dose amount if there is only a single dose. There have been 6,053 GLP-1 calls to the poison control center for overdoses of GLP-1 medications.
CD: Vials at all doses will come. Lilly sells vials in other countries. Anff id they did it through Lilly Direct they would cut out the pbms and make more money
Thanks for keeping us informed. I hope the judge allows compounding to continue at least until a ruling is made. 🤞🏻
Let’s just hope the judge doesn’t pull a plot twist on us! Stay tuned for more updates!
Follow the money, this has the smell of corruption all over it.
That is unfortunately true of much of our system
Still remaining calm.🙏 This medication is a blessing, I'm staying informed and hopeful. Thanks Christopher
CD: I love that approach
Red Rock shipped my script yesterday. So I'm good for 9 weeks. I'll order again in 2 weeks if they allow me to.
I just heard that the FDA needs to respond to the allegations by Friday.
Thanks
Christopher thank you. I'm grateful for the time you put into collecting your thoughts and presenting this information in such an interesting and informative way. It shows a lot of respect for your channel viewers, our time, and the importance of this information.
CD: thank you for the kind words
I appreciate your prompt reporting on this issue. You and Laraine have been a beacon of light during this entire ordeal.
Hoping for the best.
Thank you so much for your kind words! We're doing our best to keep everyone informed during this situation.
Compounding pharmacies have reaped a windfall of profit from a law that allows them to override a patent on a new drug that’s in short supply. Could there be any greed with these companies? And most of these pharmacies do not have to follow FDA guidelines for quality control.
Of course there is greed - it exists across all these companies. None are blameless.
compounding pharmacies are state regulated
Of course you are correct but be careful. People don’t want to hear it and someone will accuse you of being paid by Eli Lilly just because you were trying to get the truth out there.
The compounding companies are just as craven as the drug companies. They have been making hay while the sun shone knowing that like every other drug in shortage that they produce, when these drugs went off shortage, they would need to stop making them
There are hundreds of drugs on the shortage list that the compounders make every year for a little while and every year they have to stop making them when supplies can be met by a brand name drug.
The runaway success of these drugs has meant they have made squillions while doing none of the research to create the drug and not having to meet the exacting safety and efficacy standards that the pharmaceutical companies have to meet.
If Bernie Sanders is correct and it only costs five dollars per shot to actually make the drug then the compounders are ripping everyone off as well.
Everyone needs to realise that the compounders are not your friends. They are doing this for one reason only, to make money.
@jc10907Sealy Pharmacies are HEAVILY regulated They can't just dispense whatever. Of course they have to follow National and State Pharmaceutical regulations
@@autchicabFrom the FDA website "Compounded drug products are not FDA-approved, which
means they have not undergone FDA premarket review for safety, effectiveness, and quality. In
addition, licensed pharmacists and licensed physicians who compound drug products in
accordance with section 503A are not required to comply with CGMP requirements.
Furthermore, FDA does not interact with the vast majority of licensed pharmacists and licensed
physicians who compound drug products and seek to qualify for the exemptions under section
503A of the FD&C Act for the drug products that they compound because these compounders
are not licensed by FDA and generally do not register their compounding facilities with FDA.
Therefore, FDA is often not aware of potential problems with their compounded drug products
or compounding practices unless it receives a complaint, such as a report of a serious adverse
event or visible contamination. "
@@autchicab This is from the FDA website
"Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality.
In addition, licensed pharmacists and licensed physicians who compound drug products in accordance with section 503A are not required to comply with CGMP requirements.
Furthermore, FDA does not interact with the vast majority of licensed pharmacists and licensed physicians who compound drug products and seek to qualify for the exemptions under section 503A of the FD&C Act for the drug products that they compound because these compounders are not licensed by FDA and generally do not register their compounding facilities with FDA.
Therefore, FDA is often not aware of potential problems with their compounded drug products or compounding practices unless it receives a complaint such as a report of a serious adverse event or visible contamination. "
The FDA should have more authority on drug shortages. The US House needs to pass H.R.3008 and the US Senate needs to pass S.2362 which is the "Drug Shortage Prevention Act." I recommend that you contact your two senators and representative letting them know that you support this legislation.
Thanks Clark that's a great recomendation
Thnx for the timely updates. They are appreciated and informative.
Glad you like them!
Thank you again for the update and information. Greed vs. Health ? So sad 😢
Thanks for watching
Thank you for this great information. I appreciate your work.
My pleasure!
I am on JoinFridays and on a maintenance dosage of tirzepetide but now I have to switch to semaglutide. I used to be on name brand Zepbound but the cost was exorbitant since my insurance does not cover it. I hope that I can go back to tirzepetide; I have three weeks before I have to switch. At least I am blessed to be on maintenance.
Congrats on the maintenance!
Thx
Here’s my take on the legal bit (I’m not a lawyer). This suit could have been brought anywhere, but it was brought in Ft. Worth because the plaintiffs were blatantly venue-shopping, that is, finding the most favorable judge in the country. I believe they were assigned Judge Pittman, a Republican who has a history of slapping down the agencies for overreach. He gets appealed a lot, and he also gets affirmed a lot because the courts above him lean the same way he does.
One issue is this case involves aligning the interests of an agency and big pharma. Normally, a judge of his leaning would be pro-big-pharma and anti-agency, so there is a conflict. However, my gut is he would still try to find the law and facts to justify shrinking the power of the agency.
All that means… I think this will take years to solve, but hopefully for us, it will mean that not only can tirzepatide be legally compounded, but maybe it will open the way for other drugs to be compounded and to help with the access issues we have in our country.
Oh, and I only bring up politics as an explanation of why I think things will turn out a certain way, not as an endorsement of any political party. For more information, anyone can google Judge Pittman, Judge Reed O’Connor, and forum or venue shopping. There are lots of articles about it.
Also, if there are any lawyers on here, correct me if I’ve put out any misinformation! This is my best understanding.
CD: I assume they looked for a favorable judge.
So the scenario seems reasonable
Great comment, I appreciate the insight and will look up these judges.
Chevron
@dalithecat In the end this is about a patent that Lilly holds..Yes I know the whole shortage issue of a way of scapegoating the patent so that compound pharms can keep making big money off of a patent ..but that will come to and end .. A patent would be meaningless if they did not have the right to uphold said patent ...
In the end it’s about a company charging exorbitant prices to desperate americas. The patent simply protects their investment. This is just another battle in the war to reinvent the American healthcare system, create transparency and encourage business to be good corporate citizens
I recently switched to Tirzepetide from Semaglutide and found it much more effective and the side effects much less intense. Have loved the progress and have been feeling rejuvenated in my weight loss journey. This is such a blow! I do not want to go back on Semaglutide because it was not working for me anymore and the side effects were becoming unbearable. My insurance does not cover these drugs and Tirzepetide was an answered prayer. Feeling so worried about this now. Thank you for the info! Any idea when a judge might rule on a temporary decision to allow compounded tirzepetide to continue to be produced?
It should be in the next few days
Thank you for all the information!! You’d asked how we were doing on our compound orders. I’ve been getting mine from Remedy meds since July and they just shipped my next months order (fingers crossed)
CD: thanks for the info
Thank you for sharing this information. The situation is still unfolding, and I believe the FDA may have acted prematurely in this case. It seems their decision was heavily influenced by Eli Lilly’s position, without fully considering the thousands of patients relying on compound. I truly hope the judge carefully weighs all these factors and rules in favor of the OFA.
CD: so do we. Lilly could make this a non story by releasing the vials at all doses at $299 approximately the price from compounders. And so it through Lilly direct cutting out the PBMs and maintaining or increasing their profit while decreasing the cost to customers
The judge should only be evaluating if the FDA was following the law. Judges job is not social activism. If you want to change the law, this is the legislatures job. Senator Bernie Sanders is particularly active in this area.
@@clarkkent7973 CD: I think it is unlikely the judge will do any social activism - that's not really his history
If you cannot afford/access the name brand medication, should a patient even start? Are these telehealth and compounding pharmacies actually helping patients or just stealing money from desperate people?
CD: Clark - those are great questions. That lead to bigger questions about our entire healthcare system, innovation, access and equity.
Are they stealing money from desperate people? That is dramatic but no there is no stealing involved they are legally selling a good for a price. Are they completely blameless and the good guys in the complicated and convoluted American healthcare system? No they are just another cog in the continuum of big businesses who are profiting off of obesity.The entire system needs revamped.
❤❤❤❤❤Yes!!!
thanks
Someone needs to ask Eli Lilly why they don't think a value of $868 billion is enough for them.
If Corporate greed had a nick name, it would be Eli.
!!
Mochi dr today told me not to worry because it is a compounded formula.
my local compounding pharmacy told me not to worry because he makes the formula himself
I think that’s wishful thinking.
Like why is Lilly offering single doses? Why not a monthly vial at $300-$400. With more and more people getting on Tirz. There’s still billions to be made at a decent price🫠 isn’t it super inexpensive to make?
@@lillyr1786 Zero chance of messing up the dose amount if there is only a single dose. There have been 6,053 GLP-1 calls to the poison control center for overdoses of GLP-1 medications.
CD: Vials at all doses will come. Lilly sells vials in other countries. Anff id they did it through Lilly Direct they would cut out the pbms and make more money