[india-drug] GAO Report Backs Link Between Drug User Fees and Higher

[Public.Citizen's.Health.Research.Group]

Rate of Drug Withdrawals in USA
Sender: owner-india-drug@usa.healthnet.org
Precedence: bulk
Reply-To: india-drug@usa.healthnet.org

(Copied from Public Citizen. Thanks. SS)

GAO Report Backs Link Between Drug User Fees and Higher
Rate of Drug Withdrawals
-------------------------------------------------------------
Statement of Peter Lurie, Deputy Director of Public Citizen's 
Health Research Group

A new government report shows that since the Prescription Drug User 
Fee Act (PDUFA) was implemented in 1992, a higher percentage of newly 
approved drugs has been withdrawn because the drugs were found to be 
unsafe. These findings echo criticisms we have had of the act for
years. In 1998, Public Citizen conducted a survey of the physicians who
review New Drug Applications and found that the reviewing physicians
had opposed the approval of 27 drugs approved in the previous three
years. The General Accounting Office's (GAO) conclusions confirm the
major public health consequences of PDUFA, which introduced private
money, and therefore influence, into the drug approval process,
creating a massive conflict of interest. One result of PDUFA has been
the diversion of agency funds to the review process from other areas,
including postmarketing safety surveillance.

The GAO report also documents that staff turnover is higher among Food 
and Drug Administration (FDA) scientists than among scientists in other

government agencies.  Our 1998 report documented how physicians were 
precluded from presenting data adverse to the drugs they were reviewing

at FDA Advisory Committee meetings.

Unwise drug approvals by the FDA, in part because of increased 
workloads due to PDUFA, have led to unnecessary patient deaths and
illnesses and poor morale among drug reviewers. Congress should
immediately conduct meaningful oversight hearings on each of the drugs
that has been withdrawn for safety reasons. Drug makers have benefited
from PDUFA, making millions in profits off drugs that should never have
been brought to the market. Congress must adequately fund the FDA's
drug approval activities and remove private influence from the
equation.







________________________________________________________________________
Missed your favourite TV serial last night? Try the new, Yahoo! TV.
       visit http://in.tv.yahoo.com
The INDIA-DRUG discussion group is a partnership between SATELLIFE
(www.healthnet.org), WHO Essential Drugs and Medicines Policy
(www.who.ch), and the Delhi Society for the Promotion of the
Rational Use of Drugs (DSPRUD) in India.

To send a message to india-drug, write to: india-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe india-drug OR unsubscribe india-drug
To contact a person, send a message to: india-drug-help@usa.healthnet.org