All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Navigating Uncharted Waters

July 2, 2020
By Rita C. Peters
News
Article
Pharmaceutical TechnologyPharmaceutical Technology-07-02-2020
Volume 44
Issue 7
Pages: 10

FDA Commissioner Hahn commits to a science-based review and approval process.

For researchers involved in the development of new treatments and vaccines to combat COVID-19, the past five months have been a scramble to research potential therapies, collect and analyze data, accelerate clinical trials, and plan manufacturing processes. While the biopharma industry knows these development efforts are moving at record pace, for some patient groups, policymakers, and the public, the efforts are not moving fast enough.

When someone is seriously ill, family members and healthcare providers are desperate for an effective treatment. History has shown that many “promising” therapies initially raised the hopes of patients, only to disappoint when the therapy did not work as predicted. During this global pandemic, public and policymaker pressure can make the R&D task more difficult.

For example, earlier this year, hydroxychloroquine was touted as a possible treatment for COVID-19; FDA faced criticism when it issued emergency use authorization (EUA)-based on limited data-on March 28, 2020. When subsequent clinical trials showed the drug was unlikely to be effective as a treatment for COVID-19, and the cardiac side effects outweighed the benefits, FDA withdrew the EUA on June 14, 2020.

Keeping pace with the rapidly emerging research about the SARS-CoV2 virus and vaccine and therapy development is a monumental task. Thousands of scientific papers have been released, and drug companies and research organizations have been collaborating and sharing information on levels described as unprecedented. These findings need to be reviewed to ensure decisions about therapies are based on data rather than political motives, or undue influence.

Missteps and misinformation related to diagnostic testing, distribution of personal protective equipment, and the wearing of face masks have eroded public trust in the abilities of FDA and other government authorities to manage the pandemic. While anecdotal evidence points to the availability of a vaccine before the end of 2020, public confidence in FDA, the government, and drug companies needs to be established.

Following the “North Star”

During a BIO 2020 digital event on June 10, 2020 (1), FDA Commissioner Stephen M. Hahn emphasized the importance of science-based decision making, as well as regulatory authority independence to make approval decisions, key factors to assuring the public that the vaccines and therapies are approved with public safety and health at the forefront.

As applications for emergency use and investigational new drug applications poured into FDA in the initial days of the pandemic, Hahn says the agency reviewed all applications, and prioritized those with the highest level of science behind them and the greatest chance of making it to clinical trials.

Some bio/pharma companies are participating in and receiving funding from the federal government’s Operation Warp Speed and Accelerating COVID-19 Therapeutic Interventions and Vaccines programs. Hahn noted, however, that FDA has established a “barrier” between itself and these public-private partnerships to reinforce the agency’s regulatory independence. “We will prioritize based on science, we will not prioritize based on who comes through the door,” he said. “We are agnostic with respect to the sponsor, but we are very much aligned with where the science appears to us to be the highest level.”

Hahn said he understands the “enormous amount of pressure” related to the pandemic; however, the agency’s “North Star” will be data and science. The agency may have to update decisions as new data are available, he noted, but will continue to make decisions based on science.

Reference

1. BIO, Fireside Chat with FDA Commissioner Dr. Stephen M. Hahn, BIO 2020 Digital Event, June 10, 2020.

Article Details

Pharmaceutical Technology
Vol. 44, No. 7
July 2020
Page: 10

Citation

When referring to this article, please cite it as R. Peters, “Navigating Uncharted Waters" Pharmaceutical Technology 44 (7) 2020.

 

 

Download Issue PDF
Articles in this issue

Qualification of a Swab-Sampling Procedure for Cleaning Validation
Leigh Prather - stock.adobe.com
Performing Remote Audits During the Pandemic
Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy Facilities
Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy Facilities
Demand for Custom Dosage Forms Fuels Innovation
Demand for Custom Dosage Forms Fuels Innovation
Learning Regulatory Lessons in Times of a Crisis
Learning Regulatory Lessons in Times of a Crisis
Business on Hold? EMA’s Full Recovery in Question
Taking a Controlled Approach
Taking a Controlled Approach
Unprecedented Times in Vaccines
No Business, Like Brexit Business
No Business, Like Brexit Business
Innovating Continuous Twin-Screw Granulation with Foam Delivery
Innovating Continuous Twin-Screw Granulation with Foam Delivery
Can RNA Simplify Gene Therapy Development?
Can RNA Simplify Gene Therapy Development?
karramba production - stock.adobe.com
Navigating Uncharted Waters
Contractors Balance Increased Demand During COVID-19
Contractors Balance Increased Demand During COVID-19
Shimadzu_PR_A-ENG-20023_Figure_1 copy 2_225-New-1594219492212.jpg
Triple Quadrupole Mass Spectrometer
AdvantaPure-GORE-STA-PURE-Pump-Tubing-7x5-300dpi copy 2_225-New-1594219339822.jpg
Pump Tubing System
Recent Videos
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Related Content

Old rusty shovel in the ground on the building | Image Credit: © photolink - stock.adobe.com

Piramal Pharma Holds Groundbreaking at Kentucky Facility, Part of $90 Million Investment Plan

Patrick Lavery
July 2nd 2025
Article

The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Susan Haigney
June 27th 2025
Article

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

Related Content

Old rusty shovel in the ground on the building | Image Credit: © photolink - stock.adobe.com

Piramal Pharma Holds Groundbreaking at Kentucky Facility, Part of $90 Million Investment Plan

Patrick Lavery
July 2nd 2025
Article

The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Susan Haigney
June 27th 2025
Article

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.