JAN 15, 2020 8:21 PM PST

FDA Approves Drugs Faster than Ever- But is That Good?

WRITTEN BY: Annie Lennon

The Food and Drug Administration (FDA) is approving new drugs for patients on less and less evidence thanks to special programs that streamline their approval. This comes as the FDA has also become increasingly reliant on funding from pharmaceutical companies- from $300 million in the 1990’s to over $4 billion in the 2010’s. But what does this mean for patients? 

In a new study, researchers from Harvard Medical School analyzed principal federal laws and FDA regulations alongside FDA databases on approved drugs between 1984 and 2018, to understand how the drug approval process has changed over time. Whereas the average drug approval time in the late 1980’s was just 2.8 years, by 2019, they found that the same figure was reduced to just 7.6 months. Moreover, they found that whereas the share of new drugs supported by two strong clinical trials, as opposed to just one, was 81% in the 1990’s, by the 2010’s, it was just 53%. 

Although good news if it would enable highly effective new drugs to reach the market faster, research shows that many of these new drugs instead have marginal effects on health outcomes. In fact, the large majority of these newly approved drugs may have few, if any, benefit over pre-existing therapies. 

So how did this happen? This comes as the special programs expediting their progress accept more flexible evidence. Today for example, evidence of a drug’s efficacy in modulating cholesterol levels or tumor size is sufficient to gain FDA approval, as opposed to demonstrating evidence that it may help people live longer, feel better over longer periods of time, or avoid emergency medical situations such as heart attacks. 

Rather than requiring drug companies to report this information before approval, the FDA now urges them to collect it after their drugs have reached the market. Lead researcher, Jonathan Darrow, said, “In the meantime, the agency is allowing doctors and patients to use the drug while the additional information is being collected...Once drugs are available, they are available to all patients due to off-label prescribing, and those patients may not realize those drugs were approved on the basis of limited evidence or that more evidence is still being collected."

Such practices of quickly approving new drugs with limited research has, according to Dr. Joshua Sharfstein, from the John Hopkins Bloomberg School of Public Health, needlessly driven up healthcare costs. He said, “I think that it's very important for FDA to study which incentives, under what circumstances, really lead to medications that make a huge difference for patients, and propose more efficient ways to apply those incentives.”


Sources: WebMD, JAMA Network and NPR

About the Author
  • Science writer with keen interests in technology and behavioral biology. Her current focus is on the interplay between these fields to create meaningful interactions, applications and environments.
You May Also Like
JAN 02, 2021
Drug Discovery & Development
Drug Re-purposed for COVID-19
JAN 02, 2021
Drug Re-purposed for COVID-19
Pralatrexate, a chemotherapeutic drug originally developed to treat lymphoma, could be repurposed to treat COVID-19&mdas ...
JAN 24, 2021
Cannabis Sciences
Cannabis Compound CBD Shows Promise as Antibiotic
JAN 24, 2021
Cannabis Compound CBD Shows Promise as Antibiotic
Researchers from the University of Queensland, in collaboration with Botanix Pharmaceuticals Limited, have found that ca ...
FEB 26, 2021
Microbiology
Good Bacteria Fights Bad Bacteria in a Clinical Trial
FEB 26, 2021
Good Bacteria Fights Bad Bacteria in a Clinical Trial
Eczema is a skin condition that causes a chronic, itchy rash. The most common form of the disorder, atopic dermatitis, i ...
FEB 18, 2021
Drug Discovery & Development
Weight-Loss Hormone Prevents Muscle-Loss
FEB 18, 2021
Weight-Loss Hormone Prevents Muscle-Loss
Scientists from the University of Southern California Leonard Davis School of Gerontology, show that a hormone known to ...
MAR 04, 2021
Infographics
All You Need to Know about COVID-19 Vaccines
MAR 04, 2021
All You Need to Know about COVID-19 Vaccines
After over a year lockdowns brought on by the pandemic, hopes for returning to something even similar to ' ...
MAR 06, 2021
Genetics & Genomics
Green Tea Extract Can Affect Facial Development in Kids With Down Syndrome
MAR 06, 2021
Green Tea Extract Can Affect Facial Development in Kids With Down Syndrome
Individuals with Down syndrome often have certain facial features. New research has suggested that green tea supplements ...
Loading Comments...