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The FDA Is An Entrenched Bureaucracy: Can The Drug Approval Process Be Streamlined and Drug Prices Reduced?

March, 14, 2017, Armchairpoliticianfda, By Brad Peery, ArmchairPolitician.US

President Trump has vowed to bring down drug prices. That could be a very big challenge, especially for newer drugs.

The FDA has a fiscal 2016 budget of $4.9 billion, which is a $424.8 million (9%) increase above FY 2015. It includes a $147.7 million (6%) increase in budget authority and $277.2 million (15%) increase in user fees.

Pharmaceutical manufacturers and some consumer groups praised President Donald Trump’s nomination of Scott Gottlieb, MD, as the new FDA commissioner. If confirmed by the Senate, Gottlieb is expected to significantly cut regulations on drugs and devices, and speed approval for new medicines. He will likely increase flexibility in the clinical trial development process.

The US Food and Drug Administration (FDA) drug approval process is very expensive and lengthy. The number of drugs approved declined in 2016. In 2016, the FDA cleared just 22 new medicines for sale, the lowest number since 2010 and sharply down from 45 in 2015.

In streamlining the approval process, below are some statistics as of December 14, 2016.

  • About Two – thirds (68%) of the novel drugs approved to date in CY16 were approved under Priority Review
  • Almost a third (32%) of the novel drugs approved to date in CY16 received Breakthrough Therapy designation
  • About four out of ten (37%) of the novel drugs approved to date in CY16 received Fast Track designation

According to a Reuters article by Ben Hirschler, the following are some of the issues facing the Drug Industry and the FDA.

The slowdown in 2016 was due to a number of factors. Five drugs won early approval in 2015. There was a decline in drugs being filed for approval.

Factors affecting the drug industry include: There are advances being made in fighting cancer; There is an improved understanding of the genetic basis of diseases; However, the lengthy FDA approval process, and the niche nature of many of the drugs, is making it difficult for drug companies to make a return on their R&D investments; Also, there is increasing opposition to higher drug prices from healthcare insurers, and governments. According to Deloitte, returns on research and development investment at the top 12 pharmaceutical companies fell to just 3.7 percent in 2016 from a high of 10.1 percent in 2010.

ArmchairPolitician.US Opinion. The FDA has its own rigid process for drug approvals, so it will be interesting to see how that process might be improved. The drug industry is heavily regulated, so reduced regulation could lower the cost of getting new drugs to market. A streamlined new drug approval process could also significantly reduce drug approval costs.

39 comments to The FDA Is An Entrenched Bureaucracy: Can The Drug Approval Process Be Streamlined and Drug Prices Reduced?

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    • acp

      Hi,
      Thanks for your interest in ArmchairPolitician.US, and our present and future posts. We intend to continue to post a new blog 3-4 days per week.
      We are in the early stages of establishing our subscriber list and Web presence. We are now available on Twitter, please follow us @ArmchairpolUS. We will tweet all of our upcoming blog titles, and other important information. Soon you will be able to follow and Like us on Facebook, so stay tuned. We can be found on Facebook at ArmchairPolitician.US.
      If you are interested in contacting me, please send an email to: armchairpolitician.us@gmail.com.
      Looking forward to hearing from you about your thoughts,

      Brad

    • acp

      Hi,

      I spent last year working with a healthcare focused investment banking firm, raising capital for an early stage healthcare payments company, and have a continuing healthcare industry interest.

      Thanks for your interest in ArmchairPolitician.US, and our present and future posts. We intend to continue to post a new blog 3-4 days per week.

      We are in the early stages of establishing our subscriber list and Web presence. We are now available on Twitter, please follow us @ArmchairpolUS. We will tweet all of our upcoming blog titles, and other important information. Soon you will be able to follow and Like us on Facebook, so stay tuned. We can be found on Facebook at ArmchairPolitician.US.

      If you are interested in contacting me, please send an email to: armchairpolitician.us@gmail.com.

      Looking forward to hearing from you about your thoughts, particularly regarding healthcare.

      My best,

      Brad

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

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      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

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      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

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      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

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      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

      Hi,

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

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      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

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      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

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      Brad Peery & ArmchairPolitician.US

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      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

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      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

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      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

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      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

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      Brad Peery & ArmchairPolitician.US

      Book: WWW. Amazon.com, Trump’s Political Agenda and Achievements
      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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    • acp

      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

      Hi,

      Thanks for your comments and interest in the ArmchairPolitician.US blog.

      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: http://WWW.Amazon.com, Trump’s Political Agenda and Achievements

      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

  • very good post, i definitely love this website, keep on it

    • acp

      ArmchairPolitician.US book on Amazon and Kindle, Title: Trump’s Political Agenda and Achievements

      Hi,

      Thanks for your comments and interest in the ArmchairPolitician.US blog.

      We at ArmchairPolitician.US have published our first book on Amazon. We have also published it on Kindle. Its title is: Trump’s Political Agenda and Achievements, By ArmchairPolitician.US and Brad Peery.

      I thought you might have an interest in getting an update on our website that is organized by subject, making it easier for you to get an overall picture of each of the subjects, countries, and events that are going on and affect U.S political issues and possible solutions.

      I look at this as the first edition of what will be our first of publication. I plan to update the book about every 3-4 months as an update to our blog site http://WWW.ArmchairPolitician.US. I plan to continue posting political blogs on http://WWW.ArmchairPolitician.U.S.

      If what I am doing is of interest, please buy the book and let me know you have done so. I will then put you on a preferred list that can stay in touch with me personally, and with whom I can communicate directly.

      Thanks for your interest in our blog, and hopefully our book, and staying in touch with us.

      Brad Peery & ArmchairPolitician.US

      Book: http://WWW.Amazon.com, Trump’s Political Agenda and Achievements

      Blog Site: http://WWW.ArmchairPolitician.US
      Email: ArmchairPolitician.US@gmail.com

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