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Friday, June 8, 2018

To Promote Lower Cost Drugs Including High Cost Specialty Meds, FDA Publishes Two New Draft Guidances


On June 1st, the FDA published two new "draft guidance" documents, which are recommendations for review and comments to address one of the many complex obstacles to timely generic and biologic drug launches.   Some of these obstacles are related to the current Risk Evaluation and Mitigation Strategies (REMS) program developed by the Brand manufacturer.   After 60 days, the "draft guidance" comments will be evaluated and new policies will be voted on and become effective with the goal to bring lower cost generics and biologics to the market sooner.

Currently the FDA requires certain Brand medications to have a REMS program provided prior to the approval of the drug.   The REMS document outlines serious safety concerns and employs tools beyond prescribing information to ensure that the benefits of a medication outweigh its risks. 

The FDA may also require certain "Elements To Assure Safe Use" (ETASU) such as requiring the provider to have specific training or experience, that patients using the drug be monitored, or that the drug is dispensed to patients with evidence of other documentation of safe-use conditions.  The ETASU may also include a system for the applicant to monitor, evaluate and improve a subscribed drug implementation.   Lastly, a REMS document must have a timetable for submission of assessments of the strategy. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609045.pdf 

Once the period of Brand patent protection or exclusivity has lapsed, it seems that generic and biosimilar drug competition is not materializing judiciously.   Sometimes this is due to Brand drug manufacturers' tactics before and after the generic or biologic drug manufacturer seeks approval for market entry.  One example is restricting the sale of the Brand drug to the generic or biologic manufacturer, which typically requires an estimated 5,000 doses in order to run bioequivalence and bioavailability studies to prove that the generic is the same as the Brand.  

Mylan, one of the largest generic manufacturers, recently sued Celgene over their refusal to share samples of Revlimed, which costs approximately $180,000 per year.   In 2016, its third year on the market, Revlimed had $6.97B in sales, and given the initial $800M on research and development, Celgene continues to reap a significant ROI. The expiration date for the patent will be 2019, but Celgene’s delay strategies could allow the company to put off unrestricted competition from generics until 2026, which could cost an extra $45B to patients who need this cancer drug.     https://www.bloomberg.com/news/features/2017-12-20/the-loopholes-drug-companies-use-to-keep-prices-high    


After bioequivalency has been determined, Brand manufacturers make the negotiation time between the Brand and generic or biologic drug applicant a lengthy process often resulting in litigation.  This causes delays in the approval of the generic or biologic.   Brand manufacturers have used this litigation to their advantage delaying market entry.

The FDA's new "draft guidances" are an effort to address these issues currently delaying generic and biologic drug competition.   The two new FDA "draft guidances" are:   1) "Development of a Shared System REMS Guidance for Industry" and 2) "Waivers of the Single, Shared System REMS Requirement Guidance for Industry".  The objective is to shorten the time that a generic or biologic can launch.  In the first "draft guidance" Brand and generic/biologic applicants are encouraged to use an industry working group (IWG) or third party to expedite negotiations and develop a shared REMS Guidance and ETASU.    The second "draft guidance" allows the generic manufacturer an option to seek a waiver to obtain a separate and comparable REMS policy with ETASU in certain situations where the Brand manufacturer is not cooperating.   https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609048.pdf 


These guidance reports are expected to translate to new policies and will be a major opportunity for client and member savings as they will allow lower cost generics and biosimilars to come to market earlier.  High cost biologics continue to represent not only 40%-50% of total pharmacy benefit dollars, but also a large percentage of medical costs i.e. infused drugs and drugs bought and billed by physicians.  However, physicians will have to agree that biologics are safe and that patients equally feel comfortable being prescribed a biologic versus the Brand reference or originator drug.

 At the same time Pharmacy Benefit Managers have a tremendous amount of control given that they develop formularies with preferred drugs from manufacturers who provide the highest rebate including some of the currently few biosimilars approved in the United States.  As biosimilars come to market sooner, losers will be the clients who are not using an independent pharmacy benefit consulting firm, thus leaving thousands of dollars as PBM profits for shareholders because they signed a three year PBM agreement, which has language excluding biosimilars from rebates.


PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.


15 comments:

  1. Dr Itua cure my HIV, I have been a ARV Consumption for 10 years. i have been in pains until i came across Dr Itua on blogs site.I emailed him about my details of my HIV and my location i explained every thing to him and he told me that there is nothing to be scared of that he will cured me, he gave me guarantee,He ask me to pay for items fees so when i'm cured I will show gratitude I did and giving testimony of his healing herbs is what I'm going to do for the rest of you out there having HIV and other disease can see the good work of Dr Itua.I received his herbal medicine through EMS Courier service who delivered to my post office within 5 working days.Dr Itua is an honest man and I appreciate him for his good work.My GrandMa called him to appreciate him and rest of my friends did too,Is a joy to me that I'm free of taking Pills and having that fat belle is a nightmare.you will understand what i'm talking about if you have same problem I was having then not now though.I'm free and healthy Big Thanks To Dr Itua Herbal Center.I have his calendar too that he recently sent me,He Cure all kind disease Like,Cancer,Herpes,Hiv,Hepatitis B,Fibroid,Diabetes,Dercum,Copd ,and also Bring back Ex Lover Back..Here his Contact .drituaherbalcenter@gmail.com Or Whats_app Number +2348149277967

    ReplyDelete
    Replies
    1. It's indeed a miracle I can't believe am finally free from herpes virus, am grateful to this powerful herbalist called Dr Perfect.
      I'm Chris Anderson from UK I was sick of herpes for 3 years it affected my relationship with my girlfriend when she find out I was having herpes she left me, I missed her so much because I loved her with all my heart and she always makes me happy she was the source of my happiness I wanted her to come back to me, so I took every treatment and drugs but none could cure my sickness I never lose hope because I believe I will surely get cured and be reunited with my girlfriend again so I went online to search for herpes cure and I came across a comment of a man on how this powerful herbalist cured him of herpes, I didn't hesitate I emailed him and explained my problem to him on how this herpes has affected my relationship he replied my mail and he asked for some information which I gave him and he prepared a herbal cure when he finished preparing the cure he sent it to me and instructed me on how to use it and I did it as I was instructed, five days later I couldn't find any sign of herpes that's was how I was free from herpes virus and he also did a love spell that brought back my ex girlfriend, this was the best thing that have ever happened to me am indeed grateful to Dr Perfect for the help he has rendered to me if you need help to cure your diseases or bring back your ex contact him and get your problems solved at solutiontoallproblems1@gmail.com
      You can also add him up on WhatsApp +12562513614

      He can also cure the following diseases
      1. Herpes virus
      2. Chronic venous disease
      3. Gonorrhoea
      4. Hiv/aids
      5. Alzheimers disease
      6. Asepsis
      7. Cancer
      8. Cerebrospinal meingtitis
      9. Infertility problems
      10. Als/ebv
      11. Hpv
      12. Enlargement of any type
      13. Getting back ex lover/divorce
      14. Hepatitis a,b,c
      15. Syphilis
      16. Arthritis
      17. Severe atopic dermatitis
      18. Leukaemia/lupus virus and many more....

      Delete
    2. It's indeed a miracle I can't believe am finally free from herpes virus, am grateful to this powerful herbalist called Dr Perfect.
      I'm Chris Anderson from UK I was sick of herpes for 3 years it affected my relationship with my girlfriend when she find out I was having herpes she left me, I missed her so much because I loved her with all my heart and she always makes me happy she was the source of my happiness I wanted her to come back to me, so I took every treatment and drugs but none could cure my sickness I never lose hope because I believe I will surely get cured and be reunited with my girlfriend again so I went online to search for herpes cure and I came across a comment of a man on how this powerful herbalist cured him of herpes, I didn't hesitate I emailed him and explained my problem to him on how this herpes has affected my relationship he replied my mail and he asked for some information which I gave him and he prepared a herbal cure when he finished preparing the cure he sent it to me and instructed me on how to use it and I did it as I was instructed, five days later I couldn't find any sign of herpes that's was how I was free from herpes virus and he also did a love spell that brought back my ex girlfriend, this was the best thing that have ever happened to me am indeed grateful to Dr Perfect for the help he has rendered to me if you need help to cure your diseases or bring back your ex contact him and get your problems solved at solutiontoallproblems1@gmail.com
      You can also add him up on WhatsApp +12562513614

      He can also cure the following diseases
      1. Herpes virus
      2. Chronic venous disease
      3. Gonorrhoea
      4. Hiv/aids
      5. Alzheimers disease
      6. Asepsis
      7. Cancer
      8. Cerebrospinal meingtitis
      9. Infertility problems
      10. Als/ebv
      11. Hpv
      12. Enlargement of any type
      13. Getting back ex lover/divorce
      14. Hepatitis a,b,c
      15. Syphilis
      16. Arthritis
      17. Severe atopic dermatitis
      18. Leukaemia/lupus virus and many more....

      Delete
    3. My herpes is cured and it's miracle healing. Thanks to Dr. Sam who cure my Genital Herpes

      I was in trouble when doctor told me that I have been diagnosed with Genital Herpes. I thought about my Family, how they will feel if they knew, i was also felling pains in my Anus and vagina. I lost hope and I wept all day, but one day I was surfing the internet I found about Dr. Sam on how he cured a lady with natural herbs, I decided to contact him through his mobile number, i also wrote him letter through his email address. he guided me. I asked him for solutions and he prepared a herbal remedy and send to me,when i received it, i started taking it as directed. Thank God, now everything is fine, I’m cured by Dr. Sam herbal medicine, I’m very thankful to God and very happy with my hubby and family. You can contact him through his email address on
      Email: supremecurehome@gmail.com Or supremecurehome@yahoo.com
      His website: http://www.supremecurehome.blogspot.com
      Whatsapp/Call: +2347087462033






      My herpes is cured and it's miracle healing. Thanks to Dr. Sam who cure my Genital Herpes

      I was in trouble when doctor told me that I have been diagnosed with Genital Herpes. I thought about my Family, how they will feel if they knew, i was also felling pains in my Anus and vagina. I lost hope and I wept all day, but one day I was surfing the internet I found about Dr. Sam on how he cured a lady with natural herbs, I decided to contact him through his mobile number, i also wrote him letter through his email address. he guided me. I asked him for solutions and he prepared a herbal remedy and send to me,when i received it, i started taking it as directed. Thank God, now everything is fine, I’m cured by Dr. Sam herbal medicine, I’m very thankful to God and very happy with my hubby and family. You can contact him through his email address on
      Email: supremecurehome@gmail.com Or supremecurehome@yahoo.com
      His website: http://www.supremecurehome.blogspot.com
      Whatsapp/Call: +2347087462033

      Delete
    4. HOW I GOT CURE TO MY HERPES WITH THE HELP OF DR EBAKO NATURAL HERBS CURE WHATSAPP HIM ON +1 (213) 861-9461


      I can’t believe this. A great testimony that i must share to all HERPES patient in the world i never believed that their could be any complete cure for HERPES or any cure for HERPES,i saw people’s testimony on sites of how DR EBAKO prepare herbal cure and brought them back to life again. i had to try it too and you can,t believe that in just few weeks i started using it all my pains stop gradually and i had to leave without the HERPES DRUGS the doctor gave to me. Right now i can tell you that few months now i have not had any pain,delay in treatment leads to death. Here is his email: doctorebakospellhome@gmail.com his WHATSAPP number is +1 (213) 861-9461
      https://drebakocurehome.blogspot.com/
      http://drebakocurehome.over-blog.com
      he can also cure you from
      HPV
      HIV
      HIV2
      Hepatitis B
      Diabetes
      etc

      Delete
  2. My herpes is cured and it's miracle healing. Thanks to Dr. Sam who cure my Genital Herpes

    I was in trouble when doctor told me that I have been diagnosed with Genital Herpes. I thought about my Family, how they will feel if they knew, i was also felling pains in my Anus and vagina. I lost hope and I wept all day, but one day I was surfing the internet I found about Dr. Sam on how he cured a lady with natural herbs, I decided to contact him through his mobile number, i also wrote him letter through his email address. he guided me. I asked him for solutions and he prepared a herbal remedy and send to me,when i received it, i started taking it as directed. Thank God, now everything is fine, I’m cured by Dr. Sam herbal medicine, I’m very thankful to God and very happy with my hubby and family. You can contact him through his email address on
    Email: supremecurehome@gmail.com Or supremecurehome@yahoo.com
    His website: http://www.supremecurehome.blogspot.com
    Whatsapp/Call: +2347087462033

    ReplyDelete
  3. My life is beautiful thanks to you, Mein Helfer. Lord Jesus in my life as a candle light in the darkness. You showed me the meaning of faith with your words. I know that even when I cried all day thinking about how to recover, you were not sleeping, you were dear to me. I contacted the herbal center Dr Itua, who lived in West Africa. A friend of mine here in Hamburg is also from Africa. She told me about African herbs but I was nervous. I am very afraid when it comes to Africa because I heard many terrible things about them because of my Christianity. god for direction, take a bold step and get in touch with him in the email and then move to WhatsApp, he asked me if I can come for treatment or I want a delivery, I told him I wanted to know him I buy ticket in 2 ways to Africa To meet Dr. Itua, I went there and I was speechless from the people I saw there. Patent, sick people. Itua is a god sent to the world, I told my pastor about what I am doing, Pastor Bill Scheer. We have a real battle beautifully with Spirit and Flesh. Adoration that same night. He prayed for me and asked me to lead. I spent 2 weeks and 2 days in Africa at Dr Itua Herbal Home. After the treatment, he asked me to meet his nurse for the HIV test when I did it. It was negative, I asked my friend to take me to another nearby hospital when I arrived, it was negative. I was overwhite with the result, but happy inside of me. We went with Dr. Itua, I thank him but I explain that I do not have enough to show him my appreciation, that he understands my situation, but I promise that he will testify about his good work. Thank God for my dear friend, Emma, I know I could be reading this now, I want to thank you. And many thanks to Dr. Itua Herbal Center. He gave me his calendar that I put on my wall in my house. Dr. Itua can also cure the following diseases ... Cancer, HIV, Herpes, Hepatitis B, Inflammatory Liver, Diabetis, Bladder Cancer,Colorectal Cancer,Breast Cancer,Kidney Cancer,Leukemia,Lun,Fribroid,Parkinson's disease,Inflammatory bowel disease ,Fibromyalgia, recover your ex. You can contact him by email or whatsapp, @ .. drituaherbalcenter@gmail.com, phone number .. + 2348149277967 .. He is a good doctor, talk to him kindly. I'm sure he will also listen to you.

    ReplyDelete
  4. My name is Promise Dickson am from Texas USA. I want to share a testimony of how Dr. OLU herbal mixture cream saves me from shame and disgrace, my penis was a big problem to me as the size was really so embarrassing,and i was also having weak erection problem. I can make love to my wife and my penis was just too small my name is Promise dickson Finch am from Texas USA. I want to share a testimony of how Dr. OLU herbal mixture cream saves me from shame and disgrace, my penis was a big problem to me as the size was really so embarrassing,and i was also having weak erection problem. I can make love to my wife and my penis was just too small a full grown man like me having 4 inches penis and to worsen it i don't last in sex i cant even last two minutes it was really a thing of shame to me. My wife was really tired of me because my sex life was very poor,she never enjoyed sex,i was always thinking and searching for solutions everywhere until when i saw a testimony of how Dr. OLU. herbal mixture cream have been helping people regarding their sex life, so i decided to give him a try and to my greatest surprise in less than two weeks of taking the herbs my penis grow to 8 inches i couldn't believe my eyes and as i speak now my penis is now 8 inches and i do not have weak erection again. I can make love to my wife longer in bed. And my marriage is now stable,my wife now enjoy me very well in bed. You can contact him via (drolusolutionhome@gmail.com) You can contact him today and get your problem solved.Call +2348140654426 .." or you can also contact him through his what-app +238140654426

    ReplyDelete
  5. I was depressed when doctor told me that I have been diagnosed with Herpes disease… I thought about my Family, I know my Family will face a serious problem when I'm gone, I lost hope and I wept all day, but one day I was searching the internet I found Dr.ezomo contact number. +2349069171173 I called him and he guided me. I asked him for solutions and he started the remedies for my health. Thank God, now everything is fine, I'm cured by Dr.ezomo herbal medicine, I'm very thankful to Dr.ezomo and very happy with my hubby and family. email him on dr.ezomorootandherbals@gmail.com or you can also reach him through WhatsApp number+2349069171173 He can also cure so many sickness {1}HIV And AIDS {2}Diabetes {3}Epilepsy {4}Blood Cancer {5}HPV {7}ALS {8}Hepatitis

    ReplyDelete
  6. I am bold enough among many others to state that there is now a potent cure to this sickness but many are unaware of it. I discovered that I was infected with the virus 3 months ago, after a medical check-up. My doctor told me and I was shocked, confused and felt like my world has crumbled. I was dying slowly due to the announcement of my medical practitioner but he assured me that I could leave a normal life if I took my medications (as there was no medically known cure to Herpes). I went from churches to churches but soon found that my case needed urgent attention as I was growing lean due to fear of dying anytime soon. In a bid to look for a lasting solution to my predicament, I sought for solutions from the herbal world. I went online and searched for every powerful trado-medical practitioner that I could severe, cos I heard that the African Herbs had a cure to the Herpes syndrome. It was after a little time searching the web that I came across one Dr Itua(A powerful African Herbal Doctor), who offered to help me at a monetary fee. I had to comply as this was my final bus-stop to receiving a perfect healing. My last resolve was to take my life by myself, should this plan fail. At last it worked out well. He gave me some steps to follow and I meticulously carried out all his instructions. Last month, to be precise, I went back to the hospital to conduct another test and to my amazement, the results showed that negative,Dr Itua Can As Well Cure The Following Desease…Cancer,Hiv,Herpes, Hepatitis B,Liver Inflammatory,Diabetis,Fribroid,,Non Hodgkin Lymphoma,Skin Cancer,Uterine Cancer,Prostate Cancer Dercum,Infertility,fibromyalgia,Get Your Ex Back,Als,SYPHILLIS,Genetic disease,Epilepsy, Parkinson's disease..You can free yourself of this Herpes virus by consulting this great African Herbal Doctor via this e-mail: drituaherbalcenter@gmail.com or call and whatsapp him on +2348149277967 He will help you and his herb medication is sure. he has the cure on all disease .You can talk to me on INSTAGRAM..tashamoore219....

    ReplyDelete
  7. Natural herbs can cure epilepsy, I had epilepsy for over 14 years, i have spent a lot money getting drugs from the hospital to keep me healthy, I went to many hospitals for cure but there was no solution, One day I was in the office going through the internet when I saw a post about Dr Itua herbal medicine on how he cure a Lady from Kansas who was suffering from HIV and she listed Epilepsy as list of illness Dr Itua can as well cured I contacted him with epilepsy Cure solution, I email him. He told me the things I need to do and also give me instructions to take, which I followed properly. Before I knew what is happening after two weeks To my greatest surprise after patiently going according to instruction given to me by Dr Itua, my epilepsy was cure, I want to say a big thanks to Dr Itua who God have sent to heal his people with his natural medicine I pray that God will bless you for the good work you are doing.for all who are still suffering from this illness, you can also contact him through his email on :;;drituaherbalcenter@gmail.com Or Whatsapp Number...+248149277976 like they say his herbal remedy is the only permanent solution to Seizure. He Can as well cure the following... Herpes Virus, HIV/Aids, Hepatitis A/B, Shingles, Cold Sore, Epilepsy, Wart, Lupus, Diabetes, Men/Woman Infertility, Seizure, Cancer all types.

    ReplyDelete
    Replies
    1. My Herpes virus that was cured by a great herbal medicine man. Since last 7 months i was having these virus and some time i experience the herpes outbreak. last three weeks I was in a great pain so I told one of my friends about it she told me that there is a great herbal medicine man that can cure Herpes and so many diseases and he also help people in getting pregnant and bringing back EX. I asked her if she had the man contact so i could give it a try, she gave me the contact, I contacted him he talked to me, and he send me the herbal medicine and herbal soap via DHL service to my country, told me how i will be using the herbal soap and drinking the herbs and after two weeks I should go for a test. Which I did, when the doctor told me that am now Herpes negative I couldn't believe myself I went to see another doctor the result was still the same i couldn't keep this to myself when i know that a lot of people are having issues with their health due to ignorant so i decided to let it out on this page that if anyone here need help in curing his/her Herpes virus or trying to conceive should also contact him he also have herbal medicine for HIV, Herpes, Cancer, Hepatitis etc and deal with spiritual problems too once again you can email him on: drinibokuspelltemple@gmail.com or WHATSAPP him via his mobile number +2347059186346

      Delete
  8. I was diagnosed with herpes since I was a child. My mother has them too, and does nothing to stop the spread. it was hard to not kiss my children all the time, but they grow up knowing that “when mommy has a lip owie, she can’t kiss.” They give me kisses on my forehead instead and we have extra hugs. It was also very painful to not kiss my partner. However, I was 100% determined to not pass this on to anyone, especially those I love.I mostly want to thank those who feel the way I do.
    dr saibu health herbs home helped me and my family to find happiness and peace ,their herbal remedies for herpes works like miracle,i was totally cured of herpes virus within 5 weeks of usage . for your herpes cure contact them today
    order online via call or whatsapp +2348064438762 address...
    you can also email them via drsaibu2@gmail.com

    ReplyDelete
  9. God bless Dr Lobo for his marvelous work in my life, I was diagnosed of HERPES since 2017 and I was taking my medications, I wasn't satisfied i needed to get the HERPES Cured out of my system, I searched about some possible cure for HERPES i saw a comment about Dr Lobo, how he cured HERPES with his herbal medicine, I contacted him and he guided me. I asked for solutions, he started the remedy for my health, he sent me the medicine through UPS SPEED POST. I took the medicine as prescribed by him and 2weeks later i was cured from HERPES, Dr Lobo truly you are so great and powerful in spiritual works, do you need his help also? Why don't you contact him through his VIA EMAIL: (Loboherbalcure@gmail.com) whatsapp him on +2349078118695

    ReplyDelete
  10. God bless Dr Lobo for his marvelous work in my life, I was diagnosed of HERPES since 2017 and I was taking my medications, I wasn't satisfied i needed to get the HERPES Cured out of my system, I searched about some possible cure for HERPES i saw a comment about Dr Lobo, how he cured HERPES with his herbal medicine, I contacted him and he guided me. I asked for solutions, he started the remedy for my health, he sent me the medicine through UPS SPEED POST. I took the medicine as prescribed by him and 2weeks later i was cured from HERPES, Dr Lobo truly you are so great and powerful in spiritual works, do you need his help also? Why don't you contact him through his VIA EMAIL: (Loboherbalcure@gmail.com) whatsapp him on +2349078118695

    ReplyDelete