I
Ilena
Guest
Note from Ilena: Miller has been an Industry Junk Science Voice for
years ... both Hoover and ACSH are corporate funded front groups with
silicone money greasing their well financed and distributed
"opinions".
Unfortunately, McClellan's brave stand on failing Inamed's silicone
gel implants may have cost him the FDA position, it appears.
~~~~~~~~~~~~
http://www.latimes.com/news/opinion/commentary/la-oe-miller1mar01,1,2656259.story
Lackadaisical FDA Needs a Dose of Vitality From a New Chief
The outgoing commissioner did little to address the agency's
problems.
EXCERPT: Another abject failure was the FDA's unexpected decision —
contrary to the advice of an advisory committee — to leave in place
severe restrictions on silicone breast implants imposed more than a
decade ago because of safety concerns. Those concerns were unfounded,
virtually destroyed an industry and needlessly terrified tens of
thousands of American women.
~~~~~~~~~~~~~~~~~~~~~~~
By Henry I. Miller, Henry I. Miller, a fellow at the Hoover
Institution, is the author of "To America's Health: A Proposal to
Reform the FDA" (2000, Hoover Institution Press). From 1979 to 1994,
he was an official at the
FDA Commissioner Mark McClellan is leaving his position after only 16
months in office, far less time than it took for the search committee
to find him. Although few would question that McClellan is engaging
and smart, he leaves with mediocre accomplishments and with the agency
little better off than he found it.
McClellan did little to reform the culture of risk-aversion and the
fear of innovation that pervades the FDA. The subtext of regulatory
agencies — not just the FDA — is that career bureaucrats generally
care more about staying out of trouble than about public health. That
biases them against timely approvals of innovative products. Yet
McClellan removed not a single senior career bureaucrat.
Despite increasingly more powerful and precise technologies for drug
discovery, purification and production, development costs have soared.
One reason is that the highly risk-averse FDA keeps raising the bar
for approval, especially for innovative, high-tech products. Human
gene therapy and other treatments tailored to individual patients have
been hit especially hard. Americans are literally dying for reform.
On McClellan's watch, the FDA continued to throw rigid,
one-size-fits-all solutions at non-problems. An example is the
agency's decision to deny any drug company the ability to obtain
multiple trademarks for the same drug — for example, Sarafem/Prozac
and Propecia/Proscar — even if they are different formulations for
different ailments.
McClellan also failed to modernize the FDA's bureaucratic approach to
regulating old drugs that have been on the market for decades without
significant concerns about safety or efficacy but still lack FDA
approval.
The FDA has said that if the manufacturer of one of these drugs
expends the effort and expense to obtain an approval, all of its
competitors will be forced off the market until they also obtain
approvals. This recently occurred with extended-release guaifenesin, a
well-known cough suppressant. The FDA justified forcing competitors
off the market as necessary to "protect the integrity of the drug
approval process," but the outcome has been exactly the opposite: With
no incremental protection of public health, the approved product now
sells for 700% of the price of comparable products prior to the FDA's
action.
There were other failures of policy and decision-making during
McClellan's tenure. One is the FDA's record on the regulation of
biotech foods. At the same time that U.S. Trade Representative Robert
Zoellick and other senior officials in the Bush administration were
working for more science-based treatment of biotech foods (that is,
those produced from gene-spliced organisms) internationally, they were
outflanked by European and American bureaucrats at the deliberations
of the food standards agencies of the United Nations. The U.S.
delegation to these negotiations was led by a senior FDA food
regulator, Robert Lake, whom McClellan repeatedly refused to rein in.
Another abject failure was the FDA's unexpected decision — contrary to
the advice of an advisory committee — to leave in place severe
restrictions on silicone breast implants imposed more than a decade
ago because of safety concerns. Those concerns were unfounded,
virtually destroyed an industry and needlessly terrified tens of
thousands of American women.
Still another was the agency's unwillingness to permit the Plan B
morning-after contraceptive to be sold over the counter, a decision
that reeks of politics.
These are not the actions of an FDA head who believes in
science-driven public policy, data as the basis for regulatory
decisions, the right of patients and physicians to assume a modicum of
responsibility for the risk of medical interventions, and banning
politics from regulation. But that is what we need in McClellan's
successor.
years ... both Hoover and ACSH are corporate funded front groups with
silicone money greasing their well financed and distributed
"opinions".
Unfortunately, McClellan's brave stand on failing Inamed's silicone
gel implants may have cost him the FDA position, it appears.
~~~~~~~~~~~~
http://www.latimes.com/news/opinion/commentary/la-oe-miller1mar01,1,2656259.story
Lackadaisical FDA Needs a Dose of Vitality From a New Chief
The outgoing commissioner did little to address the agency's
problems.
EXCERPT: Another abject failure was the FDA's unexpected decision —
contrary to the advice of an advisory committee — to leave in place
severe restrictions on silicone breast implants imposed more than a
decade ago because of safety concerns. Those concerns were unfounded,
virtually destroyed an industry and needlessly terrified tens of
thousands of American women.
~~~~~~~~~~~~~~~~~~~~~~~
By Henry I. Miller, Henry I. Miller, a fellow at the Hoover
Institution, is the author of "To America's Health: A Proposal to
Reform the FDA" (2000, Hoover Institution Press). From 1979 to 1994,
he was an official at the
FDA Commissioner Mark McClellan is leaving his position after only 16
months in office, far less time than it took for the search committee
to find him. Although few would question that McClellan is engaging
and smart, he leaves with mediocre accomplishments and with the agency
little better off than he found it.
McClellan did little to reform the culture of risk-aversion and the
fear of innovation that pervades the FDA. The subtext of regulatory
agencies — not just the FDA — is that career bureaucrats generally
care more about staying out of trouble than about public health. That
biases them against timely approvals of innovative products. Yet
McClellan removed not a single senior career bureaucrat.
Despite increasingly more powerful and precise technologies for drug
discovery, purification and production, development costs have soared.
One reason is that the highly risk-averse FDA keeps raising the bar
for approval, especially for innovative, high-tech products. Human
gene therapy and other treatments tailored to individual patients have
been hit especially hard. Americans are literally dying for reform.
On McClellan's watch, the FDA continued to throw rigid,
one-size-fits-all solutions at non-problems. An example is the
agency's decision to deny any drug company the ability to obtain
multiple trademarks for the same drug — for example, Sarafem/Prozac
and Propecia/Proscar — even if they are different formulations for
different ailments.
McClellan also failed to modernize the FDA's bureaucratic approach to
regulating old drugs that have been on the market for decades without
significant concerns about safety or efficacy but still lack FDA
approval.
The FDA has said that if the manufacturer of one of these drugs
expends the effort and expense to obtain an approval, all of its
competitors will be forced off the market until they also obtain
approvals. This recently occurred with extended-release guaifenesin, a
well-known cough suppressant. The FDA justified forcing competitors
off the market as necessary to "protect the integrity of the drug
approval process," but the outcome has been exactly the opposite: With
no incremental protection of public health, the approved product now
sells for 700% of the price of comparable products prior to the FDA's
action.
There were other failures of policy and decision-making during
McClellan's tenure. One is the FDA's record on the regulation of
biotech foods. At the same time that U.S. Trade Representative Robert
Zoellick and other senior officials in the Bush administration were
working for more science-based treatment of biotech foods (that is,
those produced from gene-spliced organisms) internationally, they were
outflanked by European and American bureaucrats at the deliberations
of the food standards agencies of the United Nations. The U.S.
delegation to these negotiations was led by a senior FDA food
regulator, Robert Lake, whom McClellan repeatedly refused to rein in.
Another abject failure was the FDA's unexpected decision — contrary to
the advice of an advisory committee — to leave in place severe
restrictions on silicone breast implants imposed more than a decade
ago because of safety concerns. Those concerns were unfounded,
virtually destroyed an industry and needlessly terrified tens of
thousands of American women.
Still another was the agency's unwillingness to permit the Plan B
morning-after contraceptive to be sold over the counter, a decision
that reeks of politics.
These are not the actions of an FDA head who believes in
science-driven public policy, data as the basis for regulatory
decisions, the right of patients and physicians to assume a modicum of
responsibility for the risk of medical interventions, and banning
politics from regulation. But that is what we need in McClellan's
successor.