Healthy Skepticism Library item: 7348

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: Journal Article

Carpenter D, Chernew M, Smith DG, Fendrick AM.
Approval times for new drugs: does the source of funding for FDA staff matter?
Health Aff (Millwood) 2003 Jul-Dec; Suppl:
http://content.healthaffairs.org/cgi/reprint/hlthaff.w3.618v1

Abstract:

The Food and Drug Administration (FDA) has been criticized for injudicious and excessively rapid approval of new drugs as a result of pharmaceutical industry influence. Many critics focus on the Prescription Drug User Fee Act (PDUFA) of 1992, which augmented the FDA’s budget through the charging of user fees. We assess the effect of FDA staffing patterns and attributes of submitting firms on approval times for 843 new drug applications (NDAs) submitted between 1977 and 2000. NDA review times shortened by 3.3 months for every 100 additional FDA staff. The amount of funding for FDA staff appears to be a much more important influence on NDA review time than the source of funding.

Keywords:
Drug Approval*/economics Drug Approval*/legislation & jurisprudence Drug Industry Personnel Staffing and Scheduling Time and Motion Studies* United States United States Food and Drug Administration

Please
Click to Register

(read more)

then
Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts

If there is something you don't like, please tell us. If you like our work, please tell others.

Announcements

PharmedOut’s annual conference: Missing The Target: When Practitioners Harm More Than Heal

No Free Lunch is merging with Healthy Skepticism

Conference program: Pharma Knows Best? Managing Medical Knowledge

Prescrire’s proposals for France’s national conference on medicines policy

Pharmed Out Conference ‘Pharma Knows Best? Managing Medical Knowledge’

More announcements

What's new on this site

Library Home

Library Search

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