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Healthy Skepticism Library item: 12719

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Schmit J.
FDA caution, 'research drought' cuts drug approvals
USA Today 2008 Feb 3
http://www.usatoday.com/money/industries/health/2008-02-03-fda-drugs_N.htm


Full text:

Federal approvals of new drugs last year sank to the lowest in five years, a drop some industry analysts attribute to more cautious regulators and less innovation by drugmakers.
The Food and Drug Administration last year approved 17 new molecular entities – active ingredients that weren’t marketed in the USA before.

The FDA also approved 65 original new drug applications last year, the fewest since 1999, according to data from BioMed Tracker of Sagient Research Systems.

Drug applications include new molecular entities as well as new formulations or new manufacturers of existing drugs. The FDA approved 64% of the applications it decided last year, down from 73% the year before, BioMed data show.

Industry analysts say the FDA is more cautious after drawing criticism in recent years for approving some drugs whose risks were found to outweigh their benefits after they went on the market. Examples include painkillers Vioxx and Bextra. Both are now off the market.

“It appears from the outside that the hurdles have been raised,” says Michael Levesque, pharmaceutical analyst at Moody’s Investors Service. (MCO)

The FDA may be less likely to approve drugs that lack clear advantages over older treatments and may carry unknown risks, adds Linda Bannister, health care analyst at Edward Jones.

Drugs that hit FDA roadblocks last year included diet drug Acomplia, also known as Zimulti in the USA. While pegged a potential blockbuster by industry analysts, an FDA panel in June recommended against its approval due to concerns it that increases the risk of suicidal thoughts. Sanofi-Aventis (SNY) then withdrew the application.

Potential approvals for depression drug Pristiq and schizophrenia drug Bifeprunox were both delayed after the FDA asked for additional data, Levesque says.

The FDA’s standards for approving drugs haven’t changed, spokesman Christopher DeFrancesco says. He says the rate of approvals to submissions remained steady at about 80% from 1997 through 2005.

Ira Loss of research firm Washington Analysis says the industry’s “research drought” has led to weaker applications, thus fewer approvals. An explosion of drug discoveries started in the late 1980s, peaked in the mid-1990s, then “petered out.”

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909