Building a 21st Century FDA A better way to fast track new pills for old ills

Reason ^ | April 24, 2012 | Ronald Bailey

[neverdem]

“FDA is relying on 20th century regulatory science to evaluate 21st century medical products,” declared Food and Drug Administration Commissioner (FDA) Margaret Hamburg back in October 2010. One result: As biotech and medical discoveries accelerate, the number of new drugs approved by the agency remains basically flat.

A 2010 study in the Journal of Clinical Oncology by researchers from the M.D. Anderson Cancer Center in Houston, Texas found that the time from drug discovery to marketing increased from eight years in 1960 to 12 to 15 years in 2010. Five years of this increase results from new regulations boosting the lengths and costs of clinical trials. The regulators aim to prevent cancer patients from dying from toxic new drugs. However, the cancer researchers calculate that the delays caused by requirements for lengthier trials have instead resulted in the loss of 300,000 patient life-years while saving only 16 life-years. If true, this is a scandal.

How much higher are the costs of getting a new drug through the FDA gantlet? A new study, "Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials," by Manhattan Institute senior fellow Avik Roy points out that in 1975 the pharmaceutical industry spent about $100 million on research and development (R&D) before getting a new drug approved by the FDA. By 1987, that had tripled to $300 million and that has since quadrupled to $1.3 billion. But even these figures may be too low. Roy cites calculations done by Matthew Herper of Forbes, who divides up the R&D spending of $802 billion by 12 big pharma companies since 1997 by the 139 drugs that have since gotten FDA approval to yield costs of $5.8 billion per drug.

Currently, new pharmaceuticals typically go through Phase I trials using fewer than 100 patients to get preliminary...

[lentulusgracchus]

[Art.] One result: As biotech and medical discoveries accelerate, the number of new drugs approved by the agency remains basically flat.

That's because they know that under Obamacare, only one drug will be needed for geriatric cases. Cyanide.