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Dangerous Medicine
So what if the speedup at the FDA is putting poisons on pharmacy shelves?
Congress doesn't want to know.
By Daniel W. Sigelman
Issue Date: 9.23.02
Print Friendly | Email Article
Thirteen dangerous prescription drugs have been withdrawn from the market in
the last decade -- but not before hundreds of patients died and thousands
were injured. Yet no congressional committee has investigated why the U.S.
Food and Drug Administration approved these dubious medicines or why they
were not withdrawn right away.
In fact, just this past May, Congress opted instead to renew the arrangement
that's a major source of the problem. For 10 years, drugmakers have provided
much of the FDA's own funding by paying "user fees." In exchange, the FDA
speeds up its regulatory reviews. If this Faustian bargain was a factor in
the recent drug calamities, Congress was not about to find out. Instead, the
lawmakers allowed the drug companies and the FDA to decide, in closed-door
negotiations, how much the industry would have to pony up this time around
and just what concessions it would get from its regulators in return. Then
Congress tacked the agreement onto an unstoppable bioterrorism bill and --
without a hearing, debate or vote in any committee -- passed it.
The legislators' indifference reflects the immense power of the drug
industry, even though drug regulation can be a life-and-death matter. Among
drugs recently withdrawn from the market were the infamous diet pills
Pondimin and Redux, manufactured by Wyeth-Ayerst Laboratories, then a
division of American Home Products Corporation. When taken in the deadly
"fen-phen" combination, the drugs regularly caused heart-valve damage, and
many patients who took them developed a devastating lung disorder that's
fatal in more than 50 percent of cases. These two drugs generated the most
massive wrongful-conduct litigation against a pharmaceutical manufacturer in
American history, as a result of which the corporation expects to pay claims
and legal costs totaling, thus far, $13.2 billion.
And that's only one story. Los Angeles Times reporter David Willman won a
Pulitzer Prize last year for his investigation exposing the costs of FDA
speedups. Placed under unremitting time pressure, regulators frequently
approve drugs without regard to their dangers.
Surely something here needs fixing. But all Congress seems to want from the
FDA is what former Commissioner Jane E. Henney assured the Senate it was
getting: an agency that "enhances U.S. competitiveness in global markets ...
and strengthens the domestic economy as a whole by inviting increased
foreign investment" in the U.S. drug market.
Not so long ago, things were drastically different. Public-health disasters
used to spur lawmakers to action. The slaughterhouse scandals at the turn of
the last century prompted the FDA's creation. More than 100 deaths from a
poisonous "elixir" spurred the 1938 passage of legislation requiring that
drugs be proven safe before they can be marketed. The thalidomide tragedy
led Congress to pass legislation in 1962 requiring the FDA to ensure that
drugs are effective as well as safe.
From the mid-1960s through much of the 1980s, Congress played an integral
part in drug safety. Lawmakers meticulously probed the regulatory histories
of dubious drugs, uncovered FDA weaknesses and ordered corrections. It was
congressional investigators who discovered that the FDA, when it approved
Eli Lilly's anti-arthritis drug Oraflex in 1982, had missed six reports in
its own files warning of serious liver and kidney disease. After the drug
went on the market, congressional investigators alerted the FDA that the
manufacturer was not reporting deaths and adverse reactions in a timely
fashion. Both Eli Lilly and Hoechst AG, which was doing the same thing with
its antidepressant Merital, were criminally prosecuted. In other instances,
such as the one involving the catastrophically defective Dalkon Shield IUD,
massive civil litigation was built on the findings of congressional
overseers.
Nowadays, however, Reps. W. J. "Billy" Tauzin (R-La.), chairman of the House
Committee on Energy and Commerce, and James C. Greenwood (R-Pa.), who leads
the committee's investigative panel, seem to construe oversight not as
protecting lives but as protecting investments. They are currently
investigating whether the biotechnology company ImClone Systems Inc. misled
investors about the FDA approval prospects for its anticancer drug Erbitux.
They have yet to investigate a drug-safety issue.
Unfortunately, this shift in priorities has been bipartisan. Drug-safety
oversight began to decline in the late 1980s when the Democrats controlled
the House. The real nosedive in 1992 -- when user fees were first
authorized -- also occurred on the Democrats' watch. With those industry
fees, the FDA was able to hire nearly 600 people to expedite new drug
applications, increasing the existing staff by 60 percent. But in exchange,
the industry insisted that the FDA hasten new drug approvals to meet
deadlines that would become more stringent each year. Moreover, user-fee
revenues could only be spent on new drug reviews, and the legislation
required diversion of public funds to new drug approvals at the expense of
FDA safety programs.
After the Republicans took control of Congress in 1994, lawmakers indentured
to the pharmaceutical industry went even further, targeting the FDA as their
prime example of regulatory excess. Then-House Speaker Newt Gingrich dubbed
the agency "the leading job-killer in America" and its activist commissioner
at the time, Dr. David A. Kessler, a "thug" and a "bully." The right-wing
Washington Legal Foundation accused the agency of committing homicide by
denying Americans access to new drugs. The Pharmaceutical Research
Manufacturers Association flew dying patients to Washington to plead for
less thorough testing of new medicines.
Soon only a handful of legislators -- led by Sen. Edward Kennedy
(D-Mass.) -- opposed proposals to "reform" the FDA. Kennedy called these
plans a "blueprint for demolition, not modernization." Congress, he said,
was being "driven by powerful and well-funded interests [to] gut the
regulatory agency that stands between them and increased profits." He won
some modifications, but he couldn't stop the train.
In 1997, Congress reauthorized user fees as part of a "modernization"
package that reduced the legal standard for new drug reviews: Instead of
requiring two clinical trials, the FDA could accept just one. The new law
also allowed manufacturers to promote drugs for "off label" uses the FDA had
never approved. Other provisions greased the fast track; none enhanced the
safety of the drug-review process. It was the first time in its 91 years
that the Food and Drugs Act's public-health protections had been rolled
back.
The 1997 law codified the FDA's fast-track procedure for reviewing new
drugs, and it continued to prohibit the spending of user-fee revenues to
monitor drugs once they were on the market. With government appropriations
for the FDA essentially flat, the effect was to deny the agency the ability
to monitor the new drugs it was speeding to market. Nonetheless, Sens.
Kennedy and Jack Reed (D-R.I.) were the only senators to vote against the
measure.
By 1995, the median time for FDA review of "priority" drugs -- those
offering significant therapeutic advances over available medicines -- had
already been reduced to a record low of six months. In 1996, the agency
approved 53 new drugs, almost twice the largest number approved in any
previous year.
By 1997, Congress should have been examining to what extent those numbers
reflected compromised safety rather than increased efficiency. Was the FDA
taking big risks only in desperate situations, or in ordinary ones, too?
Congress, however, was largely responsible for the problem.
Industry's investments in politicians had by then skyrocketed. Total
political contributions from pharmaceutical and health-products businesses
rose 86 percent, from more than $7 million to more than $13 million, just
from the 1994 to the 1996 election cycle, according to the Center for
Responsive Politics. From 1997 to the present, pharmaceutical and
health-products companies have spent $51 million on campaign contributions,
more or less doubling their spending in each successive election cycle. And
between 1997 and the last available report (in June 2000),
pharmaceutical-manufacturing companies spent at least $322 million -- more
than any other industry -- on lobbying Congress and the president. It's
surely no coincidence that in five years, congressional "oversight" of FDA
drug regulation has been confined to four hearings -- three in the House and
one in the Senate -- each of which was called to ensure that the FDA
continues to expedite its drug approvals.
The FDA's pace, as a result, has been frantic. In the words of Dr. Janet
Woodcock, director of the FDA's Center for Drug Evaluation and Research, the
push for speed has created a "sweatshop environment that's causing high
staffing turnover." And, of course, in the parts of the FDA that are not
user-fee funded, staffing problems have been worse. In the current fiscal
year, the FDA has only 10 professionals trained as physicians or
epidemiologists to assess the safety of the thousands of medicines now being
sold, and to review the hundreds of thousands of "adverse event" reports
that regulators receive each year. The division responsible for policing
false and misleading prescription-drug advertising has only 14 people to
review 32,000 pieces of promotional material annually.
Ten years ago, Dr. Alan Lisook, then a senior FDA investigator, admitted to
The New York Times that the agency had no good way to tell when clinical
study summaries submitted by pharmaceutical manufacturers misrepresented
underlying patient-safety data. Because regulators base their decisions on
the summary information, this flaw struck at the very heart of their ability
to ensure drug safety. Yet the FDA today still does not have a single
employee responsible for auditing the accuracy and completeness of such
data.
The user-fee reauthorization that Congress passed in May has been presented
as a reform. Even Kennedy celebrated it on the Senate floor as meeting "our
obligation to assure the safety" of drugs brought to market quickly. But the
accolades are misplaced. True, Congress has finally agreed to increase
public funding for the FDA's understaffed divisions, and industry
negotiators for the first time agreed to allow a portion of user-fee
revenues to be spent on drug-safety monitoring and drug-advertising review.
But what's still not allowed is crucial.
The FDA is prohibited from drawing on user-fee funds to monitor the safety
of any drug submitted for review before October -- so the overwhelming
majority of drugs on or entering the market cannot be scrutinized using
these funds. In the few cases where user-fee-supported monitoring is
allowed, it is limited to only two years (three years if the drug presents
unusual risk concerns). The FDA is barred from relying on user-fee dollars
to monitor side effects that were unanticipated at the time of approval. For
the first time, the agency may spend user-fee money to check a
manufacturer's compliance with a post-marketing safety plan. But if
unanticipated safety concerns arise after marketing begins, user-fee
revenues may not be used to assess them. The safety of drugs already on the
market is hardly thus ensured by this legislation. And the safety of new
drugs is not even addressed.
In the meantime, under congressional and industry pressure, the number of
new drugs approved by the FDA has soared. In 1988, only 4 percent of all new
drugs introduced throughout the world were cleared for marketing in the
United States before they were approved elsewhere. Last year, 80 percent of
all new drugs were approved here first. But is this a good thing? The FDA's
Woodcock concedes that "'U.S. first in the world' means our population is
placed at greater risk because we are [initially] going to discover" adverse
drug reactions here, rather than learn about them as they crop up elsewhere.
For drugs that represent no significant therapeutic advance, this hardly
seems a risk worth taking. Yet among the 13 dangerous drugs withdrawn from
the U.S. market in the last decade, not one filled an otherwise unmet
medical need. The diabetes drug Rezulin, produced by Parke-Davis, a unit of
Warner-Lambert, was approved in 1997 on a fast track despite warnings from
an FDA medical officer that it could cause liver and heart damage. Moreover,
it was kept on the market for three years despite mounting evidence of its
deadly liver toxicity -- and even though at least nine safer diabetes drugs
of comparable effectiveness were already available. The nonsteroidal
inflammatory drug Duract, a Wyeth-Ayerst product, which was also known to
cause liver damage, was approved although 19 similar drugs were already on
the market. The anesthetic Raplon, produced by Organon, was implicated in
reports of fatal lung muscle spasms but approved anyway. What's more, its
risks were understated in the information sent to physicians -- despite the
fact that equivalent anesthetics were available.
For pharmaceutical companies whose patents are expiring on blockbuster
drugs, there is much to gain from rushing even unnecessary new drugs to
market. But the FDA should not be complicit in this business strategy, nor
should Congress force it to be.
Some in the House -- notably Reps. Sherrod Brown (D-Ohio), Bart Stupak
(D-Mich.) and Henry Waxman (D-Calif.) -- have questioned the wisdom of
forcing the FDA to financially depend on, and to promote, the U.S.
pharmaceutical industry. But these minority party members are not empowered
to run investigations or hearings. The one legislator with the power to
finally step into the breach is Kennedy, the Senate's liberal stalwart and
chairman of the Health, Education, Labor, and Pensions Committee. Earlier
this year, Kennedy considered holding hearings on drug safety. When renewal
of the user-fee program whisked through Congress, those plans were shelved,
perhaps indefinitely.
But the need for congressional attention is, if anything, greater now than
ever. The FDA lacks authority to levy civil penalties for violations of the
nation's drug laws, to subpoena industry records when it's necessary to
investigate industry wrongdoing, or to mandate drug recalls. Under the bill
just passed, companies that don't perform the mandated follow-up research on
drugs the FDA approves "pending further study" still won't be fined or
otherwise penalized. Instead, the FDA will now have the authority to post
their names on its Web site and try to embarrass them into compliance.
The pharmaceutical industry and the legislators beholden to it will bitterly
resist investigations of the FDA's pressure-filled drug-approval
"sweatshop." And many lawmakers will be loath to examine too closely the
effects of their own ideological preoccupations. But the drug calamities of
recent years raise real doubts about the FDA's ability to uphold safety
standards in an environment where global competitiveness and industry
profitability are the reigning concerns. Such incidents instill no
confidence in the agency's willingness to say no to distinctly toxic and
questionably necessary drugs. It is Congress that put the FDA in this
position, and it is Congress that must investigate and undo the damage.
Daniel W. Sigelman
Dangerous Medicine
So what if the speedup at the FDA is putting poisons on pharmacy shelves?
Congress doesn't want to know.
By Daniel W. Sigelman
Issue Date: 9.23.02
Print Friendly | Email Article
Thirteen dangerous prescription drugs have been withdrawn from the market in
the last decade -- but not before hundreds of patients died and thousands
were injured. Yet no congressional committee has investigated why the U.S.
Food and Drug Administration approved these dubious medicines or why they
were not withdrawn right away.
In fact, just this past May, Congress opted instead to renew the arrangement
that's a major source of the problem. For 10 years, drugmakers have provided
much of the FDA's own funding by paying "user fees." In exchange, the FDA
speeds up its regulatory reviews. If this Faustian bargain was a factor in
the recent drug calamities, Congress was not about to find out. Instead, the
lawmakers allowed the drug companies and the FDA to decide, in closed-door
negotiations, how much the industry would have to pony up this time around
and just what concessions it would get from its regulators in return. Then
Congress tacked the agreement onto an unstoppable bioterrorism bill and --
without a hearing, debate or vote in any committee -- passed it.
The legislators' indifference reflects the immense power of the drug
industry, even though drug regulation can be a life-and-death matter. Among
drugs recently withdrawn from the market were the infamous diet pills
Pondimin and Redux, manufactured by Wyeth-Ayerst Laboratories, then a
division of American Home Products Corporation. When taken in the deadly
"fen-phen" combination, the drugs regularly caused heart-valve damage, and
many patients who took them developed a devastating lung disorder that's
fatal in more than 50 percent of cases. These two drugs generated the most
massive wrongful-conduct litigation against a pharmaceutical manufacturer in
American history, as a result of which the corporation expects to pay claims
and legal costs totaling, thus far, $13.2 billion.
And that's only one story. Los Angeles Times reporter David Willman won a
Pulitzer Prize last year for his investigation exposing the costs of FDA
speedups. Placed under unremitting time pressure, regulators frequently
approve drugs without regard to their dangers.
Surely something here needs fixing. But all Congress seems to want from the
FDA is what former Commissioner Jane E. Henney assured the Senate it was
getting: an agency that "enhances U.S. competitiveness in global markets ...
and strengthens the domestic economy as a whole by inviting increased
foreign investment" in the U.S. drug market.
Not so long ago, things were drastically different. Public-health disasters
used to spur lawmakers to action. The slaughterhouse scandals at the turn of
the last century prompted the FDA's creation. More than 100 deaths from a
poisonous "elixir" spurred the 1938 passage of legislation requiring that
drugs be proven safe before they can be marketed. The thalidomide tragedy
led Congress to pass legislation in 1962 requiring the FDA to ensure that
drugs are effective as well as safe.
From the mid-1960s through much of the 1980s, Congress played an integral
part in drug safety. Lawmakers meticulously probed the regulatory histories
of dubious drugs, uncovered FDA weaknesses and ordered corrections. It was
congressional investigators who discovered that the FDA, when it approved
Eli Lilly's anti-arthritis drug Oraflex in 1982, had missed six reports in
its own files warning of serious liver and kidney disease. After the drug
went on the market, congressional investigators alerted the FDA that the
manufacturer was not reporting deaths and adverse reactions in a timely
fashion. Both Eli Lilly and Hoechst AG, which was doing the same thing with
its antidepressant Merital, were criminally prosecuted. In other instances,
such as the one involving the catastrophically defective Dalkon Shield IUD,
massive civil litigation was built on the findings of congressional
overseers.
Nowadays, however, Reps. W. J. "Billy" Tauzin (R-La.), chairman of the House
Committee on Energy and Commerce, and James C. Greenwood (R-Pa.), who leads
the committee's investigative panel, seem to construe oversight not as
protecting lives but as protecting investments. They are currently
investigating whether the biotechnology company ImClone Systems Inc. misled
investors about the FDA approval prospects for its anticancer drug Erbitux.
They have yet to investigate a drug-safety issue.
Unfortunately, this shift in priorities has been bipartisan. Drug-safety
oversight began to decline in the late 1980s when the Democrats controlled
the House. The real nosedive in 1992 -- when user fees were first
authorized -- also occurred on the Democrats' watch. With those industry
fees, the FDA was able to hire nearly 600 people to expedite new drug
applications, increasing the existing staff by 60 percent. But in exchange,
the industry insisted that the FDA hasten new drug approvals to meet
deadlines that would become more stringent each year. Moreover, user-fee
revenues could only be spent on new drug reviews, and the legislation
required diversion of public funds to new drug approvals at the expense of
FDA safety programs.
After the Republicans took control of Congress in 1994, lawmakers indentured
to the pharmaceutical industry went even further, targeting the FDA as their
prime example of regulatory excess. Then-House Speaker Newt Gingrich dubbed
the agency "the leading job-killer in America" and its activist commissioner
at the time, Dr. David A. Kessler, a "thug" and a "bully." The right-wing
Washington Legal Foundation accused the agency of committing homicide by
denying Americans access to new drugs. The Pharmaceutical Research
Manufacturers Association flew dying patients to Washington to plead for
less thorough testing of new medicines.
Soon only a handful of legislators -- led by Sen. Edward Kennedy
(D-Mass.) -- opposed proposals to "reform" the FDA. Kennedy called these
plans a "blueprint for demolition, not modernization." Congress, he said,
was being "driven by powerful and well-funded interests [to] gut the
regulatory agency that stands between them and increased profits." He won
some modifications, but he couldn't stop the train.
In 1997, Congress reauthorized user fees as part of a "modernization"
package that reduced the legal standard for new drug reviews: Instead of
requiring two clinical trials, the FDA could accept just one. The new law
also allowed manufacturers to promote drugs for "off label" uses the FDA had
never approved. Other provisions greased the fast track; none enhanced the
safety of the drug-review process. It was the first time in its 91 years
that the Food and Drugs Act's public-health protections had been rolled
back.
The 1997 law codified the FDA's fast-track procedure for reviewing new
drugs, and it continued to prohibit the spending of user-fee revenues to
monitor drugs once they were on the market. With government appropriations
for the FDA essentially flat, the effect was to deny the agency the ability
to monitor the new drugs it was speeding to market. Nonetheless, Sens.
Kennedy and Jack Reed (D-R.I.) were the only senators to vote against the
measure.
By 1995, the median time for FDA review of "priority" drugs -- those
offering significant therapeutic advances over available medicines -- had
already been reduced to a record low of six months. In 1996, the agency
approved 53 new drugs, almost twice the largest number approved in any
previous year.
By 1997, Congress should have been examining to what extent those numbers
reflected compromised safety rather than increased efficiency. Was the FDA
taking big risks only in desperate situations, or in ordinary ones, too?
Congress, however, was largely responsible for the problem.
Industry's investments in politicians had by then skyrocketed. Total
political contributions from pharmaceutical and health-products businesses
rose 86 percent, from more than $7 million to more than $13 million, just
from the 1994 to the 1996 election cycle, according to the Center for
Responsive Politics. From 1997 to the present, pharmaceutical and
health-products companies have spent $51 million on campaign contributions,
more or less doubling their spending in each successive election cycle. And
between 1997 and the last available report (in June 2000),
pharmaceutical-manufacturing companies spent at least $322 million -- more
than any other industry -- on lobbying Congress and the president. It's
surely no coincidence that in five years, congressional "oversight" of FDA
drug regulation has been confined to four hearings -- three in the House and
one in the Senate -- each of which was called to ensure that the FDA
continues to expedite its drug approvals.
The FDA's pace, as a result, has been frantic. In the words of Dr. Janet
Woodcock, director of the FDA's Center for Drug Evaluation and Research, the
push for speed has created a "sweatshop environment that's causing high
staffing turnover." And, of course, in the parts of the FDA that are not
user-fee funded, staffing problems have been worse. In the current fiscal
year, the FDA has only 10 professionals trained as physicians or
epidemiologists to assess the safety of the thousands of medicines now being
sold, and to review the hundreds of thousands of "adverse event" reports
that regulators receive each year. The division responsible for policing
false and misleading prescription-drug advertising has only 14 people to
review 32,000 pieces of promotional material annually.
Ten years ago, Dr. Alan Lisook, then a senior FDA investigator, admitted to
The New York Times that the agency had no good way to tell when clinical
study summaries submitted by pharmaceutical manufacturers misrepresented
underlying patient-safety data. Because regulators base their decisions on
the summary information, this flaw struck at the very heart of their ability
to ensure drug safety. Yet the FDA today still does not have a single
employee responsible for auditing the accuracy and completeness of such
data.
The user-fee reauthorization that Congress passed in May has been presented
as a reform. Even Kennedy celebrated it on the Senate floor as meeting "our
obligation to assure the safety" of drugs brought to market quickly. But the
accolades are misplaced. True, Congress has finally agreed to increase
public funding for the FDA's understaffed divisions, and industry
negotiators for the first time agreed to allow a portion of user-fee
revenues to be spent on drug-safety monitoring and drug-advertising review.
But what's still not allowed is crucial.
The FDA is prohibited from drawing on user-fee funds to monitor the safety
of any drug submitted for review before October -- so the overwhelming
majority of drugs on or entering the market cannot be scrutinized using
these funds. In the few cases where user-fee-supported monitoring is
allowed, it is limited to only two years (three years if the drug presents
unusual risk concerns). The FDA is barred from relying on user-fee dollars
to monitor side effects that were unanticipated at the time of approval. For
the first time, the agency may spend user-fee money to check a
manufacturer's compliance with a post-marketing safety plan. But if
unanticipated safety concerns arise after marketing begins, user-fee
revenues may not be used to assess them. The safety of drugs already on the
market is hardly thus ensured by this legislation. And the safety of new
drugs is not even addressed.
In the meantime, under congressional and industry pressure, the number of
new drugs approved by the FDA has soared. In 1988, only 4 percent of all new
drugs introduced throughout the world were cleared for marketing in the
United States before they were approved elsewhere. Last year, 80 percent of
all new drugs were approved here first. But is this a good thing? The FDA's
Woodcock concedes that "'U.S. first in the world' means our population is
placed at greater risk because we are [initially] going to discover" adverse
drug reactions here, rather than learn about them as they crop up elsewhere.
For drugs that represent no significant therapeutic advance, this hardly
seems a risk worth taking. Yet among the 13 dangerous drugs withdrawn from
the U.S. market in the last decade, not one filled an otherwise unmet
medical need. The diabetes drug Rezulin, produced by Parke-Davis, a unit of
Warner-Lambert, was approved in 1997 on a fast track despite warnings from
an FDA medical officer that it could cause liver and heart damage. Moreover,
it was kept on the market for three years despite mounting evidence of its
deadly liver toxicity -- and even though at least nine safer diabetes drugs
of comparable effectiveness were already available. The nonsteroidal
inflammatory drug Duract, a Wyeth-Ayerst product, which was also known to
cause liver damage, was approved although 19 similar drugs were already on
the market. The anesthetic Raplon, produced by Organon, was implicated in
reports of fatal lung muscle spasms but approved anyway. What's more, its
risks were understated in the information sent to physicians -- despite the
fact that equivalent anesthetics were available.
For pharmaceutical companies whose patents are expiring on blockbuster
drugs, there is much to gain from rushing even unnecessary new drugs to
market. But the FDA should not be complicit in this business strategy, nor
should Congress force it to be.
Some in the House -- notably Reps. Sherrod Brown (D-Ohio), Bart Stupak
(D-Mich.) and Henry Waxman (D-Calif.) -- have questioned the wisdom of
forcing the FDA to financially depend on, and to promote, the U.S.
pharmaceutical industry. But these minority party members are not empowered
to run investigations or hearings. The one legislator with the power to
finally step into the breach is Kennedy, the Senate's liberal stalwart and
chairman of the Health, Education, Labor, and Pensions Committee. Earlier
this year, Kennedy considered holding hearings on drug safety. When renewal
of the user-fee program whisked through Congress, those plans were shelved,
perhaps indefinitely.
But the need for congressional attention is, if anything, greater now than
ever. The FDA lacks authority to levy civil penalties for violations of the
nation's drug laws, to subpoena industry records when it's necessary to
investigate industry wrongdoing, or to mandate drug recalls. Under the bill
just passed, companies that don't perform the mandated follow-up research on
drugs the FDA approves "pending further study" still won't be fined or
otherwise penalized. Instead, the FDA will now have the authority to post
their names on its Web site and try to embarrass them into compliance.
The pharmaceutical industry and the legislators beholden to it will bitterly
resist investigations of the FDA's pressure-filled drug-approval
"sweatshop." And many lawmakers will be loath to examine too closely the
effects of their own ideological preoccupations. But the drug calamities of
recent years raise real doubts about the FDA's ability to uphold safety
standards in an environment where global competitiveness and industry
profitability are the reigning concerns. Such incidents instill no
confidence in the agency's willingness to say no to distinctly toxic and
questionably necessary drugs. It is Congress that put the FDA in this
position, and it is Congress that must investigate and undo the damage.
Daniel W. Sigelman