TC wrote:
PeterB wrote:
Another laughable shell game putting more money into the pockets of
bureacrats accountable to no one. This is like giving a guy with a
severed arm a bigger box of band aids. FDA doesn't need more money, it
needs to be purged of former drug execs and to have the threshold for
drug efficacy and safety raised at least one order of magnitude. Until
that happens, properly prescribed and dispensed medication will
continue to be the third or fourth leading cause of death in the USA.
Advise your congressman and other legislators that you won't continue
to support politicians who permit a corrupt FDA to cut deals with
anyone. FDA must be dismantled, restructured to more effectively
accomodate CAM practices, managed by multidisciplinary medical experts
with no ties to the drug makers (including stock ownership), and
required to submit annually to an external audit to certify both
financial and administrative integrity. As taxpayers, we have a right
to accept nothing less!
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Drug makers reportedly cut deal with FDA on fees
By Bloomberg News | November 22, 2006

WASHINGTON -- Drug makers agreed to a 29 percent increase in payments
to U S regulators to ensure speedy approvals of new medicines and step
up safety monitoring, according to a person familiar with the accord.

Representatives of drug makers and their trade associations also agreed
for the first time to pay fees to have their consumer television
commercials reviewed in advance by the U S Food and Drug
Administration, the person said. The terms are spelled out in
agreements between the industry and the FDA that are subject to
approval by the Bush administration and Congress.

The FDA wants to use some of the extra money to step up safety
monitoring of drugs after they go into use. Democrats and Republicans
in Congress criticized the agency's performance after antidepressants
were linked to increased risk of suicide and painkillers such as Merck
& Co.'s withdrawn Vioxx were tied to heart attacks and strokes. The new
fees would be part of the renewal of a 14-year-old law that expires
next year.

The drug maker payments make it impossible for the FDA to be a
"vigilant regulatory agency," said Sidney Wolfe, director of the health
research group of the consumer group Public Citizen, an FDA critic .
"The whole thing needs to be repealed."

Public interest groups including Public Citizen say the FDA's $1.88
billion budget is inadequate for the agency to provide sufficient
oversight of drugs. The FDA also regulates medical devices, food, and
cosmetics.

Payments to the FDA for new-medicine applications would increase by at
least $87.3 million to $392.8 million in the fiscal year starting next
October, the person said. About $30 million of the increase would be
spent to upgrade the agency's monitoring of drug safety, according to
this source.

The FDA hopes to use some of the funds to improve detection and
evaluation of harmful side effects after drugs are on the market, the
person familiar with the agreement said.

© Copyright 2006 Globe Newspaper Company.


Sounds like they went from just allowing corruption to flourish amongst
individuals working for the FDA to actually allowing the bureaucracy to
systematically extort massive sums from pharma to help "speed up"
approvals. Sounds like a third world country requiring bribery at all
levels to get red tape "taken care of".

"Fast tracking" was enacted 13 years ago, so this latest ruse is just a
slimely response to public outcry. How they plan to prevent another
Vioxx is not even the question, since thousands of deaths are not
enough for them. Merck is still profiting from these deaths with FDA
approval.

Do they not have any people in staff that understand the basics of
ethics?

David Graham did, and there are others. More scandal is coming.

PeterB