The secret to drug approval

T

Each generation is built on trends. Different in it’s uniqueness, like a manifesto set apart from the one before. Popular trends only need to be mentioned once or twice before the herd mentality takes over. Like fashion, cars and the financial world, the scientific world is also susceptible to the whims of trends.

So here is a piece of research announcing how trends have influenced FDA (US Food and Drug Administration) approvals over the past two decades (see below for the abstract). It is not surprising that cancer drugs (see Figure below) and biologics dominate the market; anyone who has suffered from cancer or has a loved one who has been affected would find it difficult to not make a case for finding a cure for cancer. But, it does mean that another generation is spent not finding the cure for Parkinson’s, Alzheimer’s, and other neurodegenerative conditions (fortunately MS has benefited from the biologics wave). Drug approvals focus money and research, attracting the best for the job in a way that even the largest European Framework or NIH grant cannot muster.

If we were ethically minded, shouldn’t there be equipoise. Doesn’t every disorder deserve it’s time in the limelight?

The key is in the knowing. The authors in this ask the question, ‘is it discovery-driven or market-driven approach?’ Their excerpt below I believe answers this question:

Number of new cancer patients will rise to 23.6 million by 2030. In 2018 alone, estimated 1,735,350 new cancer patients were diagnosed in U.S. and 609,640 people have died. Diabetes is not behind in the race. There will be 54% rise in number of diabetic patients in America by 2030 and total deaths due to diabetes will be increased by 38%. Annual and societal costs will reach to $622 billion by 2030.

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Figure: Trend in anticancer drug approval over a period of years

Abstract

J Family Med Prim Care. 2020 Jan 28;9(1):105-114. doi: 10.4103/jfmpc.jfmpc_578_19. eCollection 2020 Jan.

Trends in FDA drug approvals over last 2 decades: An observational study.

Batta A, Kalra BS, Khirasaria R.

Introduction:

The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important goal. Systematic investigation and comprehensive analysis of approved drugs could provide valuable insights into trends in the discovery and may contribute to further discovery of newer drugs systematically. Food and drug administration (FDA’s) Center for Drug Evaluation and Research (CDER) every year summarizes novel drugs, some of which are truly innovative and help in advancing clinical care. This study was conducted to find a trend in drug approvals by FDA in the last 2 decades. Awareness of these new drugs amongst the primary care physicians is also crucial as they have been prescribing these agents in the past.

Methodology:

In this cross-sectional study, we collected, surveyed, and analyzed drugs approved by U.S. Food and Drug Administration (USFDA) from the year 2000 till 2017 identified from ClinicalTrials.gov and online database of FDA. Drugs approved every year were assessed for total number, class of drug, indication, and category of approval. Type of accelerated regulatory pathways and reasons for speedy approvals every year were also studied. Microsoft Office Excel 2007 was used for tabulation and analysis.

Results:

Total 209 were approved from 2000 to 2008. Out of these 9.09% were indicated for cardiovascular disorders and 12.91% for neurological disorders. Antibiotics (5.26%) and antivirals (5.74%) were least contributed, whereas anticancer drugs (11.96%) and biologics (7.17%) approval remained constant. Whereas, out of three hundred and two drugs approved during 2009–2017, 5.29% were for cardiovascular disorders, 9.93% for neurological disorders. Antibiotics (5.29%) and antivirals (5.96%) were least in number, whereas anticancer drugs (17.54%) and biologics (15.56%) approval took a steep rise in these years. Also, a wide variation in the number and category of approval was observed over a period of years. The use of fast track, accelerated approval, and priority review programs have also been steadily increasing since 2000.

Conclusion:

There has been a steady rate of introduction of new drugs by CDER over the last two decades. Expedited approval of anticancer and biologics is seen as recent trend in drug development. Relatively, slow progress in approval of drugs for neurological disorders (depression, psychosis, multiple sclerosis, etc.) and lifestyle diseases like obesity, atherosclerosis, diabetes, etc., were seen. These findings reflect more emphasis being laid down in research for anticancer drugs and biologics.

About the author

Neuro Doc Gnanapavan

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