Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy

What can be done to lower development costs and drug prices?

| 4 min read

Register for free to listen to this article
Listen with Speechify
0:00
4:00
Share

© ISTOCK.COM/DANE_MARK

Drug approvals by the US Food and Drug Administration (FDA) dropped dramatically in 2016—down by 57 percent over the year before. While some of this decline was due to a record number of approvals in 2015, only 22 novel drugs were approved last year—fewer than in each of the previous five years. Striving to make returns on their investments—to gain FDA approval for a novel therapy averages around $2.6 billion and 10 years—pharmaceutical companies sometimes hike drug prices to offset low productivity. Prescription drugs are the fastest growing health-care expense, with costs increasing by 9 percent from 2014 to 2015, according to the latest report from the Centers for Medicare & Medicaid Services (CMS).

In addition to translating to high medication prices for patients, the ...

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to digital editions of The Scientist, as well as TS Digest, feature stories, more than 35 years of archives, and much more!
Already a member? Login Here

Keywords

Meet the Author

  • John Loike

    John D. Loike

    John Loike serves as the interim director of bioethics at New York Medical College and as a professor of biology at Touro University. His biomedical research focuses on how human white blood cells combat infections and cancer.
  • Jennifer Miller

    This person does not yet have a bio.

Published In

March 2017

Music

The production and neural processing of musical sounds, from birdsong to human symphonies

Share
A greyscale image of cells dividing.
March 2025, Issue 1

How Do Embryos Know How Fast to Develop

In mammals, intracellular clocks begin to tick within days of fertilization.

View this Issue
Discover the history, mechanics, and potential of PCR.

Become a PCR Pro

Integra Logo
Explore polypharmacology’s beneficial role in target-based drug discovery

Embracing Polypharmacology for Multipurpose Drug Targeting

Fortis Life Sciences
3D rendered cross section of influenza viruses, showing surface proteins on the outside and single stranded RNA inside the virus

Genetic Insights Break Infectious Pathogen Barriers

Thermo Fisher Logo
A photo of sample storage boxes in an ultra-low temperature freezer.

Navigating Cold Storage Solutions

PHCbi logo 

Products

The Scientist Placeholder Image

Gilead’s Capsid Revolution Meets Our Capsid Solutions: Sino Biological – Engineering the Tools to Outsmart HIV

Stirling Ultracold

Meet the Upright ULT Built for Faster Recovery - Stirling VAULT100™

Stirling Ultracold logo
Chemidoc

ChemiDoc Go Imaging System ​

Bio-Rad
The Scientist Placeholder Image

Evotec Announces Key Progress in Neuroscience Collaboration with Bristol Myers Squibb