Why Do New Drugs take SO LONG to be Developed?

Written by on June 16, 2011 in New Rosacea Treatments with 1 Comment

For everyone waiting on the latest and greatest new treatment for rosacea, new drugs seem to take forever to make it to the market.

Taking a step back and looking at new drug development in general, it is very sobering to read how few drugs actually make it to an approved product;

THE DRUG DISCOVERY , DEVELOPMENT AND APPROVAL PROCESS

From the 2011 Report, Medicines in Development for Skin Diseases, PhRMA (Pharmaceutical Research and Manufacturers of America).

It takes 10-15 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.

It takes 10-15 years, on average, for an experimental drug to travel from lab to U.S. patients, according to the Tufts Center for the Study of Drug Development, based on drugs approved from 1994 through 1998.

Only five in 5,000 compounds that enter preclinical testing make it to human testing. And only one of those five is approved for sale.

On average, it costs a company $1.3 billion to get one new medicine from the laboratory to U.S. patients, according to a 2007 study by the Tufts Center for the Study of Drug Development.

So as you can see the odds are well and truly stacked against new drugs for rosacea making it to the market.

For those drugs that do make it to market, it is a slow and expensive route.

Fabulously Expensive and Painfully Slow

clinical-trials-how-long-does-it-take

Image Credit: Medicines in Development for Skin Diseases.

Typically a drug is in discovery for 6.5 years, Phase I for 1.5 years, Phase II for 2 years, Phase III for 3.5 years and FDA Approval for 1.5 years.

That is 15+ years at around $90m a year. Wow.

No wonder that only a rich few companies can see a drug from the lab to the pharmacist’s counter.

Additionally, I feel some sympathy for those few successful companies trying hard to make a return in the period bounded by the last box on the right hand side (Phase IV), before any patents protecting their discovery expire.

A Dose of Reality

Perhaps this sheds some light on why so few new rosacea drugs seem to surface.

In recent memory the only drugs for rosacea that have made it to market are Oracea, Finacea and Metrogel 1%. This list is rather short!

Kind of makes me want to appreciate the drugs we currently have just a little bit more, rather than obsess too much on what might be coming.

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About the Author

About the Author:

David Pascoe started the Rosacea Support Group in October 1998.

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1 Reader Comment

  1. Matt says:

    Amen!

    I wish more people new the sobering reality of “big pharma.” The sheer number of failures would be enough to make anyone’s head spin, but only through the hard work, perseverance, and scientific innovation of these companies do we, as consumers, reap the rewards.

    True, we have a long way to go in health care reform but attacking pharmaceutical companies for the rewards after 15 years of trials, millions of dollars in investment, and loads of hard work by dedicated employees is just plain hogwash.

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