Drug Makers Reportedly Cut Deal with FDA on Fees

[Peterb]

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! --- ------ ------ ------ ------ ------
------ ------ ------ ------ ------ ------ ------ ------ ------
------ ------ ---

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and painkillers such as Merck & Co.'s withdrawn Vioxx were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repealed."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.

=A9 Copyright 2006 Globe Newspaper Company.

[Tc]

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! --- ------ ------
> ------ ------ ------ ------ ------ ------ ------ ------
> ------ ------ ------ ------ ------ ------ ---
>
> 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.
>
> =A9 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".

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

TC

[Peterb]

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! --- ------ ------ ------
> > ------ ------ ------ ------ ------ ------ ------ ------
> > ------ ------ ------ ------ ------ ---
> >
> > 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.
> >
> > =A9 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

[coonskin]

To charge medical drug companies fees for drug approval and
oversight is a form of tax, better them then citizens. The
current administration wanted to weaken the laws without
changing them by reducing oversight funding.

In a similar way the currant supplement drug industry already
weak law is even less enforced for similar reasons. It too
should be charged fees to fund oversight of it.

I would propose broadening the supplement drug oversight by
requiring that labels and actual amounts of contents and
levels of the drugs be confirmed, just like aspirin is
required. I would suggest too a rating system to reflect how
well the drug has scientific backing for its claims. Vitamin c
would get the highest rating for example while the many fly by
night snake oil nostrums would get the lowest.

An informed consumer is a better consumer and better
positioned to take control of his health decisions. Marketing
alone now rules the supplement drug industry which leaves the
consumer the least informed.