categoryMenu_new
 
  Home
  EXTRAORDINARY AH Teaching from Spiritual Hierarchy
  AbundantHope
  NEW READERS! Read Here First
  Supporting AH
  Leadership of AbundantHope
  Announcements
  Regional AH Sites
  Other Sites with AH material
  Contact Us
  Becoming A Messiah
  OUR PUBLIC FORUM IS OPEN TOO ALL
  Mission Ideas
  System Busting
  Cleric Letter/English
  Translations of Cleric Letter
  AH Member Writings
  Candace
  Ron
  Rosie
  Jess
  Brian's Poetry
  James
  Giuseppe
  Esteban
  Telepathic Messages
  Candace
  Jess Anthony
  Vince
  Leonette
  John
  Adam
  Bela
  Joyce
  Hazel
  Kibo
  Peter
  Rosie
  Johan
  Lucia
  Lucia G
  Rubens
  Shellee-Kim
  Ben
  Dorothea
  Solon
  Others
  Targeted Messages
  Hano
  Light Flower
  Changing The Face Of Religion
  - Phoenix Journals - PDF in German
  Candace on Religion
  Other Spiritual Pieces
  Gems from God Like Productions
  Spiritual Nuggets by the Masters
  Phoenix Journals
  Phoenix Journals - PDF
  Telepathic Messages PDF books
  Selections from the Urantia Book
  Illustrations For The Urantia Book
  CMGSN Pieces
  THE WAVE
  Environment/Science
  David Crayford and the ITC
  Health and Nutrition
  Podcasts, Radio Shows, Video by AH
 
  Political Information
  True US History
  Human/Animal Rights
  The Miracle That Is Me
  Education
  Resources
  911 Material
  Books - eBooks
  government email/phone #'s
  Self Reliance
  Video
  Websites
  Alternative News Sources
  Art and Music
  Foreign Sites
  Health and Healing
  Human/Animal Rights
  Scientific
  Spiritual
  Vegan Recipes
  Translated Material
  Dutch
  Gekanaliseerde berichten Jess
  Gekanaliseerde berichten Candace
  Gekanaliseerde berichten Anderen
  Artikelen/berichten
  French
  Canal Jess
  Par Candace
  Other Channels
  Articles
  German
  Telepathische Nachrichten (Candace)
  Telepathische Nachrichten (Jess)
  Telepathische Nachrichten (div.)
  AH Mitgliederbeiträge (Candace)
  AH Mitgliederbeiträge (Jess)
  Spirituelle Schätze
  Italian
  Translations - Candace
  Translations - Jess
  Translations - Others
  Portuguese
  by Candace
  By Jess
  By Others
  Spanish
  Anfitriones Divinos
  Bitácoras Fénix
  Creadores-de-Alas (WingMakers/Lyricus)
  Escritos de Candace
  Escritos de Otros
  Monjoronsón
  Telemensajes de Candace
  Telemensajes de Jess Anthony
  Telemensajes de Otros
  Chinese
  By Candace
  By Jess
  By Others
  Korean Translations
  Hungarian Translations
  Swedish Translations

Search
[an error occurred while processing this directive]
Political Information Last Updated: May 16, 2021 - 12:18:46 AM


Why Does the FDA Get Nearly Half Its Funding From the Companies It Regulates?
By C Michael White
May 16, 2021 - 12:15:42 AM

Email this article
 Printer friendly page Share/Bookmark

https://childrenshealthdefense.org/defender/fda-nearly-half-funding-companies-it-regulates/

There are some signs that the pendulum may be swinging too far in the direction of the manufacturers.

The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the dayIt's free.

The Food and Drug Administration (FDA) has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.

As a pharmacist and medication and dietary supplement safety researcher, I understand the vital role that the FDA plays in ensuring the safety of medications and medical devices.

But I, along with many others, now wonder: Was this move a clever win-win for the manufacturers and the public, or did it place patient safety second to corporate profitability?

It is critical that the U.S. public understand the positive and negative ramifications so the nation can strike the right balance.

The FDA blocks Thalidomide

Americans in the early 20th century were outraged when they found out that manufacturers used poor-quality methods for producing food and medication, and used unsafe, ineffective and undisclosed addictive ingredients in medications. The resulting Food, Drug and Cosmetic Act of 1938 gave the taxpayer-funded FDA new authority to protect the U.S. consumer.

One of the FDA's most shining successes occurred in the late 1950s when the agency refused to approve thalidomide. By 1960, 46 countries allowed pregnant women to use thalidomide to treat morning sickness, but the FDA refused on the grounds that the studies were insufficient to demonstrate safety. Debilitating birth defects resulting from thalidomide arose in Europe and elsewhere in 1961. President John F. Kennedy heralded the FDA in 1962 for its stance. An FDA driven by the data - and not corporate pressure - prevented a major tragedy.

How AIDS changed how the FDA is funded

The FDA continued its work fully funded by U.S. taxpayers for many years until this model was upended by a new infectious disease. The first U.S. case of HIV-induced AIDS occurred in 1981. It was rapidly spreading, with devastating complications like blindness, dementia, severe respiratory diseases and rare cancers. Well-known sports stars and celebrities died of AIDS-related complications. AIDS activists were incensed about long delays in getting experimental HIV drugs studied and approved by the FDA.

In 1992, in response to intense pressure, Congress passed the Prescription Drug User Fee Act. It was signed into law by President George H.W. Bush.

With the act, the FDA moved from a fully taxpayer-funded entity to one funded through tax dollars and new prescription drug user feesManufacturers pay these fees when submitting applications to the FDA for drug review and annual user fees based on the number of approved drugs they have on the market. However, it is a complex formula with waivers, refunds and exemptions based on the category of drugs being approved and the total number of drugs in the manufacturers portfolio.

CHD and The Defender Now in 5 Languages - Watch Now

Over time, other user fees for generic, over-the-counter, biosimilar, animal and animal generic drugs, as well as for medical devices, were created. As time passed, the FDA's funding has increasingly come from the industries that it regulates. Of the FDA's total U.S. $5.9 billion budget, 45% comes from user fees, but 65% of the funding for human drug regulatory activities are derived from user fees. These user fee programs must be reauthorized every five years by Congress, and the current agreement remains in effect through September 2022.

We've missed an opportunity to debate FDA funding and user fees #BMJOpinion by @joel_lexchin https://t.co/cBsbyPMfNE pic.twitter.com/JOmq5DVOj7

- The BMJ (@bmj_latest) September 6, 2017


Have user fees worked?

The FDA and the drug or device manufacturers negotiate the user fees. They also negotiate performance measures that the FDA has to meet to collect them, and proposed changes in FDA processes. Performance measures include things such as how quickly the FDA responds to meeting requests, how quickly it generates correspondence, and how long it takes from submission of a new drug application until the FDA approves or refuses to approve a drug or product.

Because of the additional funding generated by user fees and performance measures that the FDA has to meet, the FDA is quicker and more willing to discuss what it wants to see in an application with manufacturers. It also offers clearer guidance for manufacturers. In 1987, it took 29 months from the time a new drug application was filed by the manufacturer for the FDA to decide whether to approve a medication in the U.S. In 2014, it only took 13 months and by 2018, it was down to 10 months.

Changes in more recent years have also increased the number of standard new drug applications approved the first time around by the FDA from 38% in 2005 to 61% in 2018. In diseases where there are not many medication options for patients, the FDA has a priority review process, where 89% of new drug applications were approved the first time around and the approvals were completed in eight months in 2018. All this occurred while the number of new drug applications have been increasing over time.

Most recently, the COVID-19 pandemic has seen the FDA provide emergency use authorization for potential treatments in a matter of weeks, not months. The infrastructure and capacity to review the available information so rapidly is due in large part to the funding from user fees.

While the number and speed of drug approvals have been increasing over time, so have the number of drugs that end up having serious safety issues coming to light after FDA approval. In one assessment, investigators looked at the number of newly approved medications that were subsequently removed from the market or had to include a new black box warning over 16 years from the year of approval. These black box warnings are the highest level of safety alert that the FDA can employ, warning users that a very serious adverse event could occur.

Before the user fee act was approved, 21% of medications were removed or had new black box warnings as compared to 27% afterwards.

Some potential reasons that more adverse effects are coming to light after drug approval include senior FDA officials overturning scientist recommendations,lower burden of proof for medication approval, and more clinical data in new drug applications coming from foreign clinical trial sites that require additional time to assess in an environment where regulators are rushing to meet tight deadlines.

Lack of money limits FDA

User fees are a viable way to shift some of the financial burden to manufacturers who stand to make money from the approval and sale of drugs in the lucrative U.S. market. Successes have occurred and provided U.S. citizens with medication more quickly than before.

However, without careful consideration of what is being negotiated, the FDA can become weak and ineffective, unable to protect its citizens from the next thalidomide. There are some signs that the pendulum may be swinging too far in the direction of the manufacturers. Additionally, while drug approval functions at the FDA are well funded, the FDA is insufficiently funded to protect consumers from other issues such as counterfeit drugs and dietary supplements because they cannot collect user fees to do so. In my view, these functions need to be identified and require additional taxpayer funding.

Originally published by The Conversation.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.

Subscribe to The Defender - It's Free!

SUGGEST A CORRECTION

C. Michael White's avatar


C. Michael White, Pharm.D., FCP, FCCP is a board of trustees distinguished professor and chair of the Department of Pharmacy Practice at the University of Connecticut School of Pharmacy.



 




All writings by members of AbundantHope are copyrighted by
©2005-2021 AbundantHope - All rights reserved

Detailed explanation of AbundantHope's Copyrights are found here


Top of Page

Political Information
Latest Headlines
The Curious Case Of The United States
COVID-19 Vaccine Passports Officially Launch In Australia
DOCUMENTS: U.S. Gov’t Sent “mRNA Coronavirus Vaccine Candidates” to University Researchers WEEKS BEFORE “COVID” Outbreak in China!
Political Satirist Takes Up the Fight Against Tyranny
As a GP In The NHS I Witnessed first-hand The Catastrophic Way Matt Hancock Failed The Old And Vulnerable in Care Homes
"Four more weeks to, er..." - The UK Government's Weakest Excuse For A Lockdown Yet
Canadian Pastor Tracked Down by Police Helicopter, Arrested for Violating COVID Rules
NOW WE HAVE PROOF: FBI and DHS Attempted to Recruit Green Beret to Infiltrate Oath Keepers Before Jan. 6 Riot — AND HE RECORDED IT
Israel Strikes Gaza, 1st Time Under New Government & After Ceasefire That Ended 11-day War
Refugee Week! UK Celebrates Taking in More Refugees as Migrant Crisis Rages
HUGE! Revolver News Breaks Report on Likely Deep State Plants Inside Jan. 6 Uprising — WAS IT ALL PLANNED?
"GodHelpUsAll"
Debate Has Become Yet Another Casualty of Covid-19, We Must Relearn The Ability to Argue, But Then Smile And Shake Hands
Empire of Clowns vs Yellow Peril
The Wages Of Socialized Medicine is Death...for babies
Deep State DOJ Won’t Touch Obvious 2020 Election Fraud But Instead Appear to be Creating a Narrative to Shut Down the Election Audits
This Isn't Your Father's Left-Wing Revolution
Secretary General: NATO Won’t “mirror” Russia
The Media’s Amnesia Over Smearing The Pentagon Papers Leaker As A Russian Spy Exposes Their Refusal to Admit They’ve Been Duped
Chevron Imprisons Lawyer Who Exposed Their Crimes Against Humanity