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February 17, 2005
Bankruptcy and Credit Marketing
The Washington Post reports on the bankruptcy bill, which was twice stopped in earlier Congresses. This bankruptcy bill has left the station, and it's perilous for many Americans, because it's going to make it even harder to get out of sticky financial problems.
A lot of people side with the credit card industry--after all, people get themselves into bad situations. But are you fully aware of how the credit card companies target those who are vulnerable? Check out this personal information list being sold. It makes it pretty clear that those listed overuse credit. These are the type of people who are on edge, the people who go bankrupt if anything bad happens (as Elizabeth Warren argues: "Every 30 seconds in the United States, someone files for bankruptcy in the aftermath of a serious health problem. Time is running out. A broken health care system is bankrupting families across this country.").
Consumers Who Charge It From MetaBaseMetaResponse Group
08-FEB-05New List
Description: This file contains adults who use their credit lines to
live a life that otherwise might be out of reach. They seek credit
opportunities that will give them products and services they desire
but could not afford if they had to pay all at once. These
individuals are involved in credit purchases that let them live the
good life, one monthly payment at a time. Those with credit
continuously look for ways to raise their credit worthiness so that
they can increase their spending power. They think credit is the way
to make all purchases and look forward to investigating and buying
items to enhance their lives and the lives of their family. These
consumers are users of flex pay, installment systems and finance
plans.Selects: 6.11 million credit card users, monthly hotline, age,
income, marital status, presence of children, homeowner vs. renter,
length of residency, mail-order buyers, interest, gender, state, SCF
and ZIP...
January 17, 2005
Region Coding Limiting Products
Another beauty from the Journal.
...Some consumer-electronics companies are designing products so they will work only in the U.S. For example, some of the latest printers from Hewlett-Packard Co. refuse to print if they aren't fed ink cartridges bought in the same region of the world as the printer. Nintendo Co.'s latest hand-held game machines are sold in the U.S. with power adaptors that don't work in Europe.Such measures prevent thrifty foreign consumers and gray marketers -- traders who sell goods through channels that haven't been authorized by the manufacturer -- from taking advantage of the decline of the dollar against the world's major currencies to buy lower-price products in the U.S. In terms of euros, pounds or other strong currencies, U.S. retail goods are much cheaper today than they were two years ago.
U.S. multinational companies want Europeans to continue to buy their goods in Europe, however, rather than seeking out bargains in the U.S. The companies make more money if Europeans pay in euros for their goods at current exchange rates...
Consumer groups are also opposed to the latest region-coding measures. "Manufacturers don't like global commerce when it doesn't line their pockets," says Phil Evans, principal policy adviser at Which?, a British consumer watchdog. "In the long term, it's not a clever thing to do from a customer-relations standpoint."
January 13, 2005
Food Industry Lobbying a Part of Dietary Guidelines
The Wall Street Journal continues to amaze me. Where else can you routinely read about big business' influence over government? It could really give one a jaded view of life!
Anyway, today's article of interest is on the dietary guidelines, the advice our government gives us on food and exercise:
...The new guidelines arrive after a year of research by a government-appointed advisory panel, intense food-industry lobbying and extensive comment from the public. The guidelines, which hew closely to the draft put out by the advisory panel in August, are the basis for the school lunch and other federal food programs, and are widely hoped to be a vehicle for stemming America's growing problem of obesity...In a move that was a major win for the dairy industry but angered some health experts, the guidelines also recommend that everyone except small children consume three cups of milk or its dairy equivalent a day, up from two to three servings per day. Some nutritionists have pointed out that a diet high in dairy products has been linked to an increased risk for ovarian and prostate cancers.
When it comes to added sugar, the 2005 guidelines stop short of directly addressing soft-drink consumption, which has been widely blamed for contributing to the country's obesity epidemic. Instead, they tell Americans "to chose and prepare foods and beverages with little added sugars or caloric sweeteners" and suggest various limits as part of Americans "discretionary calories."
While an earlier draft of the guidelines had recommended that Americans should limit their daily intake of trans fats -- the most vilified of all fats -- to less than 1% of all calories, the final guidelines don't put a cap on the amount of trans fat Americans should eat. They say only to consume less than 10% of calories from saturated fats, and to keep trans fats as low as possible. Trans fats are found in hydrogenated vegetable oils that often are used to make snack and fried foods or margarine...
January 11, 2005
Corporate Governance Movement Creates Its Own Scandal
Mark points us to this institutional oped at the New York Times:
If there is any upside to the forced resignation of Florencio López-de-Silanes from his post as director of Yale's International Institute for Corporate Governance, it is this: corporate governance, a relatively obscure issue a few years ago, has now grown big enough to generate its own scandalsBig enough, indeed, to have inspired an institute, which Yale's School of Management created in mid-2001. Yale wooed Mr. López-de-Silanes from Harvard to run the center, reportedly outbidding other suitors.
As Yale had hoped, the energetic young academic, now 38, soon put the institute on the map, churning out scholarly papers and trotting energetically around the globe to one forum after another. Mr. López-de-Silanes has also been a consultant to the World Bank, and he was recently honored by the World Economic Forum as one of the 100 Global Leaders for Tomorrow.
The problem was that Mr. López-de-Silanes reportedly billed both his hosts and Yale for his travel expenses - about $150,000 altogether, according to The Wall Street Journal. Upon discovering these irregularities, Yale quietly orchestrated his resignation for "financial misconduct and irregularities."
Mr. López-de-Silanes has apologized, is said to have made restitution and, through his attorney, attributes his behavior to "the intensity of my focus on my work." There has been much gnashing of teeth among corporate governance experts, who say this is simply another case of leaders' failing to lead by example. A more upbeat take is that only an issue that everyone is now interested in could have generated so many trips.
December 17, 2004
Target Bans the Ringers; Wal-Mart Matches Donations
The Wall Street Journal reports:
The world's largest retailer said yesterday that it would match customers' donations up to a total of $1 million to the Salvation Army's red-kettle holiday drive. It is no coincidence that the retailer's beneficence comes on the heels of Target's decision to ban the Salvation Army from outside its 1,313 stores."The Salvation Army red kettles and the bell ringers are truly a holiday tradition worth keeping," said Wal-Mart spokeswoman Betsy Reithemeyer in a statement that was a subtle jab at the chain's largest competitor...
The money goes to local Salvation Army efforts to help needy families, which at the holidays usually means providing food, toys and clothing -- no doubt purchased at local discount stores like Wal-Mart. Who says charity doesn't begin, and end, at home?
The irony here is that Wal-Mart's anti-employee practices creates more and more needy families. We need a Salvation Army because of companies like Wal-Mart.
Update on Graham, FDA Drug Approval
I blogged earlier on David Graham (here and here), the FDA scientist who did the unthinkable--he said something of consequence at a Congressional hearing. In a hearing on Vioxx, Graham testified that five other drugs should be aggressively addressed by the FDA: Crestor, Meridia, Bextra, Accutane, and Serevent.
Today's Wall Street Journal reports that "About two-thirds of Food and Drug Administration scientists lack confidence in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey:"
The survey was conducted by the Department of Health & Human Services Office of Inspector General, or OIG, but the full results were released to the public only after an advocacy group filed a Freedom of Information Act petition...About 66% of the experts surveyed said they were not at all confident or only somewhat confident that the FDA adequately monitors the safety of prescription drugs once they are on the market...
The survey also asked the scientists if they had ever been pressured to approve a drug even though they had reservations about its safety, efficacy or quality. Of 360 responses, 297, or 82%, of the scientists said they did not feel they had been pressured. Sixty-three, or 18%, said they did come under such pressure.
You can read the report here.
December 09, 2004
Can Money in Politics Kill You?
This latest Ouch! from Public Campaign asks, can money in politics kill you?
Can money in politics kill you? Just ask one of the millions of people who took Vioxx to treat their arthritis pain, thinking it was safe, and who must now be wondering if they’ve unknowingly cut years from their lives..."A look at what has happened at the Food and Drug Administration (FDA) ever since the pharmaceutical industry started pushing to loosen the agency’s process for reviewing the safety of new drugs suggests the answer is yes."
In our chapter on drug safety, we documented how pressure throughout the 1990s from the drugmakerspowered by tens of millions in targeted campaign contributions and hundreds of lobbyistsled the FDA to approve twice as many new medications in half the time they used to take, allowing several deadly drugs onto the market where they have since been linked to the deaths of over 1,000 patients...
According to David Graham, the associate director of the FDA’s office of drug safety, between 88,000 and 139,000 Americans probably experienced heart attacks or strokes after taking Vioxx, and 30 to 40 percent probably died. That’s anywhere between 26,400 and 55,600 people whose lives were prematurely ended. Even if Graham’s estimate exaggerates the drug’s deadly effects by a factor of ten, that’s still a death toll that matches or exceeds those killed on September 11, 2001...
Though questions about Vioxx first arose in 2000, a year after it was made available in the US, little action was taken by the FDA until recently because the drug industry had so successfully shifted the agency’s priorities. Under that pressure, Monday’s New York Times reported, the FDA had “slash[ed] its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs.”
Back in 2001, Public Citizen’s Health Reform Group warned that problems with Vioxx were more prevalent than Merck admitted, and criticized the company for not doing long-term studies comparing it to older, more proven drugs. The consumer group put the drug on its “DO NOT USE” list. But the FDA only sent the company a warning letter for running ads for Vioxx that didn’t mention the fact that patients taking it had five times as many heart attacks as patients taking a different pain reliever, naproxen. Merck preferred to tout research by its own employees and paid consultants claiming that Vioxx was safe and by sponsoring talks at national medical meetings aimed at selling doctors on the drug’s value.
The Times story shows that the FDA’s failure to police Vioxx’s dangers more thoroughly was part of a larger pattern of inattention. “Dozens of former and current FDA officials, outside scientists, and advocates for patients say that the agency’s efforts to monitor the ill effects of drugs that are on the market are a shadow of what they should be,” the Times’ Gardiner Harris reported...
December 07, 2004
Lawyers Beat Advertisers on Public Perception of Honesty
All I can say about this survey is that at least lawyers beat advertisers. Then again, the results of this poll are all messed up.
POLL RESULTS
Americans ranked public service professions highest in honesty and ethics.
1. Nurses
2. Grade school teachers
3. Druggists, pharmacists
4. Military officers
5. Medical doctors
6. Policemen
7. Clergy
8. Judges
9. Day care providers
10. Bankers
11. Auto mechanics
12. Local officeholders
13. Nursing home operators
14. State officeholders
15. TV Reporters
16. Newspaper reporters
17. Business executives
18. Congressmen
19. Lawyers
20. Advertising practitioners
21. Car salesmen
Source: Gallup Poll
December 05, 2004
Update on Wal-Mart
Earlier, I blogged Harold Meyerson's excellent oped discussing Wal-Mart's acceptance of a union in China. That oped ran in today's San Francisco Chronicle. Anyway, the New York Review of Books has an article about a series of recent works focusing on Wal-Mart. It covers a conference on Wal-Mart, Nickled and Dimed, the recent House Democrat report on the company, and a lawsuit filed in California alleging widespread discrimination at the company. The full review is worth a read.
FWIW, when I worked at Hechinger in Maryland in high school and college summers, I found a manager's anti-union toolkit. It was a detailed booklet describing how a manager should address calls for a union, deal with the media, and report to headquarters about organizing. Hechinger drug tested employees (it's really fun to pee in front of another person) and did personality tests. I was a very hard working employee at Hechinger, and didn't think that the company needed to be organized. But finding that booklet was a real wake up call. The tactics seemed unfair; they were designed to squash the debate instead of having some form of democratic choice or dialogue. In retrospect, I realize that Hechinger was taking advantage of me and other employees. They kept me on part-time status, despite my weekly hours that often hit overtime. That not only stopped me from having benefits, it also displaced the normal full times who did get benefits. I worked really hard there for no good reason. Hechinger went bankrupt when faced with competition from Home Depot and Lowe's. Anyway, back to Wal-Mart:
...While its [Wal-Mart's] workforce has one of the best productivity records of any US corporation, it has kept the compensation of its rank-and-file workers at or barely above the poverty line. As of last spring, the average pay of a sales clerk at Wal-Mart was $8.50 an hour, or about $14,000 a year, $1,000 below the government's definition of the poverty level for a family of three.[4] Despite the implied claims of Wal-Mart's current TV advertising campaign, fewer than half— between 41 and 46 percent—of Wal-Mart employees can afford even the least-expensive health care benefits offered by the company. To keep the growth of productivity and real wages far apart, Wal-Mart has reached back beyond the New Deal to the harsh, abrasive capitalism of the 1920s...One of the most telling of all the criticisms of Wal-Mart is to be found in a February 2004 report by the Democratic Staff of the House Education and Workforce Committee. In analyzing Wal-Mart's success in holding employee compensation at low levels, the report assesses the costs to US taxpayers of employees who are so badly paid that they qualify for government assistance even under the less than generous rules of the federal welfare system. For a two-hundred-employee Wal-Mart store, the government is spending $108,000 a year for children's health care; $125,000 a year in tax credits and deductions for low-income families; and $42,000 a year in housing assistance. The report estimates that a two-hundred-employee Wal-Mart store costs federal taxpayers $420,000 a year, or about $2,103 per Wal-Mart employee. That translates into a total annual welfare bill of $2.5 billion for Wal-Mart's 1.2 million US employees.
...Every store manager at Wal-Mart is issued a "Manager's Toolbox to Remaining Union Free," which warns managers to be on the lookout for signs of union activity, such as "frequent meetings at associates' homes" or "associates who are never seen together...talking or associating with each other."
The "Toolbox" provides managers with a special hotline so that they can get in touch with Wal-Mart's Bentonville headquarters the moment they think employees may be planning to organize a union. A high-powered union-busting team will then be dispatched by corporate jet to the offending store, to be followed by days of compulsory anti-union meetings for all employees. In the only known case of union success at Wal-Mart, in 2000 workers at the meat-cutting department of a Texas Wal-Mart somehow managed to circumvent this corporate FBI, and voted to join the UFCW in an election certified by the National Labor Relations Board. A week later Wal-Mart closed down the meat-cutting department and fired the offending employees, both illegal acts under the National Labor Relations Act. The NLRB ordered Wal-Mart to reopen the department, reemploy the fired workers, and bargain with the union, but Wal-Mart has appealed the NLRB decision and the litigation continues.
December 01, 2004
Wal-Mart Likes Unions (Chinese Ones)
A must-read oped by Harold Meyerson on Wal-Mart appears today in the Washington Post.
Wal-Mart has finally found a union it can live with.Up to now America's largest employer has opposed every effort of its employees to form a union...
But that was the old Wal-Mart. Last week Wal-Mart announced that if its associates wanted a union to represent them, that would be hunky-dory -- as long as the union was affiliated with the All-China Federation of Trade Unions, a body dominated by the Chinese Communist Party...
...Wal-Mart...[has a]...preference for old-line communist-dominated unions in authoritarian communist states over any other kinds of unions anywhere else...
...Unions affiliated with the All-China Federation seldom push for wage increases or safer machinery. Indeed, the locals are often headed by someone from company management...
The leaders of genuine workers' movements in China don't end up running the All-China Federation. They're to be found in prison, in exile or in hiding...
When a company such as Wal-Mart is so plainly comfortable with authoritarianism abroad, it tells you something about that company's values at home. Bentonville regards the prospect of employee free association and organization within its stores with the same fear and loathing that Beijing feels at the prospect of free elections in China...
The noblest of the Bush administration's goals, surely, is that of spreading democracy. If it's serious about that task, though, there are places closer to home than the Middle East that could use a little democracy-spreading, and the American workplace is high on that list. Strengthening labor law would make it harder for employers such as Wal-Mart to thwart their workers' desire for an organized voice on the job. When America's largest employer feels more affinity for the political legacy of Mao Zedong than for that of Franklin D. Roosevelt, it's time to start democratizing our own back yard.
Bernie Wants to Know About Credit Card Abuse
Bernie Sanders (I-VT) wants to know whether you are being ripped off by credit card companies:
Have you been ripped off by your credit card company? Congressman Sanders wants to know your story.Congressman Sanders is fighting hard in Washington to end the dirty tricks often used by card card companies to rip off American consumers. We need your help.
- Have you been treated unfairly by your credit card company?
- Have your interest rates been raised?
- How high?
- Have you been hit with late fees?
Why is Bernie asking this? Because everyone else in the House and Senate has been purchased by the credit card companies. The data are here at the Center for Responsive Politics.
Finance/Insurance/Real Estate: Money to Congress
The top two recipients in the 2004 cycle were Gephardt and Isakson.
Gephardt, Richard A (D) $1,812,192
Isakson, Johnny (R-GA) $1,180,708
Meanwhile, Bernie comes in close to last.
Sanders, Bernie (I-VT) $18,000
The lesson: credit card companies should give Bernie some money!
November 17, 2004
Troy Resigns from FDA
Good News: Daniel Troy is resigning from the Food and Drug Administration. The Washington Post reports:
Daniel E. Troy, the Food and Drug Administration's chief counsel, criticized by a congressman in July for intervening on the side of drugmakers in legal cases, will resign effective Nov. 24, the agency said. Troy, who was named to the post in 2001, planned to stay with the agency just a few years, acting FDA Commissioner Lester M. Crawford said in an interview after speaking at a Senate hearing on flu vaccine.
Why is this good news? Troy is in the pocket of industry. He is one of the big forces behind creating constitutional protections for drug advertising, thus placing it outside of consumer protections that currently exist (such as disclosing adverse side effects and requiring proof of effectiveness). Representative Maurice Hinchey has assembed quite a dossier on Troy:
For the first time in FDA's history the FDA's Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which the FDA can intervene in support of drug and medical device manufacturers. The cases he is seeking out are private state civil litigation cases. These are cases in which in which drug companies and medical device manufacturers are being sued by people harmed by their products. The court has not asked for FDA involvement in these cases. In other words, FDA is spending taxpayer dollars to defend drug companies who are being sued in state court. Since August 2001, the FDA has expended over 600 hours to file at least six briefs on behalf of these companies in four such cases across the country...
On August 20, 2001 President Bush appointed Daniel Troy to be Chief
Counsel of the Food and Drug Administration. Previously, civil servants
held this position. Troy was the first political appointee to the FDA
post.
Troy's activities for several years now and has done extensive research
and investigative work beginning in early 2004.
with protecting the public by ensuring that foods are safe, wholesome,
sanitary and properly labeled; and by ensuring that drugs and medical
devices are safe and effective.
part because of a radical new direction that Daniel Troy has taken
FDA's Office of Chief Counsel, at the behest of the pharmaceutical
industry.
For the first time in FDA's history the FDA's Chief Counsel is actively
soliciting private industrial company lawyers to bring him cases in
which the FDA can intervene in support of drug and medical device
manufacturers. The cases he is seeking out are private state
civil litigation cases. These are cases in which in which drug
companies and medical device manufacturers are being sued by
people harmed by their products. The court has not asked for FDA
involvement in these cases.
to defend drug companies who are being sued in state court. Since
August 2001, the FDA has expended over 600 hours to file at least six
briefs on behalf of these companies in four such cases across the
country.
shut down these cases before they can even begin and has stated that
there is a well-documented precedent. Yet when Congressman Hinchey's
office contacted several former FDA officials and Justice
Department officials, not one had ever heard of such an action by the
United States before Dan Troy came to power. Moreover, Mr. Troy's
immediate predecessor stated clearly in 1997 that FDA long had a policy
against preempting courts in this way. Explaining the
reason for that policy she wrote, "Even the most thorough regulation of
a product such as a critical medical device may fail to identify
potential problems presented by the product. ... Preemption of all such
[tort liability] claims would result in the loss of a significant layer
of consumer protection."
O'Reilly from the University of Cincinnati Law School is one of the
country's preeminent legal scholars on FDA issues. He is also
acknowledged by the Supreme Court as an expert on FDA legal matters and
is a former drug industry lawyer. Professor O'Reilly has stated that he knows of no precedent for FDA's actions.
the Supreme Court that the private lawsuits Mr. Troy is seeking to kill
should be allowed and are necessary to hold companies accountable for
their actions (Medtronic v. Lohr). For Mr. Troy to now be arguing the
opposite, and to do so without any precedent, is completely outside the
bounds of normal jurisprudence.
lawyers is that what he is doing represents a radical departure from
past government efforts. Not one person Mr. Hinchey's
office spoke with could identify anything remotely similar to what
Troy is doing at FDA.
Prior to Mr. Troy's appointment to the FDA he was a partner at Wiley,
Rein and Fielding - a large Washington, DC law firm. He was also
involved with the Washington Legal Foundation, which is a "public
interest" that supports weaker government regulations of drug companies
and medical device manufacturers.
Pfizer, which in the three years prior to his appointment at FDA paid
Wiley, Rein $415,000 for "services provided directly by" Mr. Troy.
Pfizer, called Mr. Troy, then FDA's chief counsel, and requested that
FDA get involved in a private state lawsuit against Pfizer that was
ongoing in California. Mr. Troy obliged and in September, less than two
months later, FDA, through the Department of Justice, filed a court
brief in support of Pfizer.
and Foerster, one of the world's largest firms, is based in California.
At the time of this meeting, it was representing Glaxo Smith Kline in a
private lawsuit in California that revolved around California's
Proposition 65 or the Safe Drinking Water and Toxic Enforcement Act.
Michele Corash was the lead attorney. On September 12, less than two
months after that meeting, Mr. Troy's FDA filed a brief in support of
Ms. Corash's client - GSK.
2003 FDA filed a Statement of Interest in the case of Murphree v.
Pacesetter in support of the medical device manufacturer Pacesetter.
The company was being sued in Tennessee state court for a faulty
pacemaker. Congressman Hinchey's office obtained a letter to FDA,
dated November 25, 2003 from the law firm of Feldman, Gale and Weber
directing FDA on how it should assist its case. The firm was
representing Pacesetter.
FDA submitted an unsolicited. According to remarks by Mr. Troy, he
involved FDA because he thought a California state judge's ruling in
the case was "crazy."
conflicts of interest and a pattern of collusion between a federal
agency and the industry it is supposed to regulate. If FDA did for some
reason need to get involved in these cases, it should have done so
independently of the drug companies, not in coordination with them. Mr.
Troy is supposed to be acting to protect the public's health, not his
former drug company clients. Instead, he is actively seeking
opportunities to help the drug companies.
speaker at the 8th Annual Conference for In-House Counsel and Trial
Attorneys, entitled "Drug And Medical Device Litigation."
Conspicuously, this event was not noted on FDA's public calendar, which
listed 44 other speeches Mr. Troy has delivered. The conference program
uses his official title.
a signed affidavit of a conference participant Mr. Troy took credit for
FDA's involvement in private civil litigation cases and solicited cases
in which the FDA could intercede. He told the audience "we can't
afford to get involved in every case, we have to pick our shots," so
"make it sound like a Hollywood pitch."
involved in these cases: tort reform. He specifically stated that FDA
is "deeply immersed in tort reform issues," and that it was FDA's goal
to "control the flow of risk info regarding these [drug and medical
device] products."
Congressman Hinchey raised this issue with acting-FDA Commissioner
Lester Crawford when he testified before the House Appropriations
Agriculture Subcommittee on March 11, 2003. He asked about Mr.
Troy's relationship with Pfizer prior to his appointment. The answer FDA provided for
the record sought to minimize that relationship. According to FDA, Mr.
Troy worked an average of less than 80 hours per year on matters
related to Pfizer. Congressman Hinchey later discovered that
Pfizer paid Mr. Troy's law firm $415,000 over three years for work
performed directly by Mr. Troy. This included over $358,000 in 2001,
the year Mr. Troy was appointed to his FDA post.
Committee included language written by Congressman Hinchey in the
Agriculture Appropriations report, expressing concern about the
misleading nature of FDA's answer.
evidence that FDA provided misleading or even false answers
on the record.
"became involved in a case affecting Pfizer more than a year after
leaving private practice." According to press reports,
however, Pfizer's lawyer contacted Mr. Troy in July of 2002 about
his case, which was less than a year after Mr. Troy left his firm.
about FDA's history of involvement in these lawsuits, FDA again
provided a misleading answer. The response sought to imply precedent
for FDA actions by citing previous cases, failing to note that these
cases were in response to court requests. None of the pre-Troy cases
cited involved the FDA actively seeking to intervene in private
lawsuits.
Rep. Marcy Kaptur, FDA provided a list of cases and stated that those
"that do not name the government (FDA, United States or HHS) are cases
in which FDA has been subpoenaed to produce a witness or documents."
This is simply false. There are at least four cases in which FDA got
involved without being subpoenaed. Mr. Troy himself has even stated
that he was "the initiator" of such cases.
answers in response to questions from members of Congress are deeply
troubling and severely undermine the credibility of the FDA.
Over the last few months it has been widely reported that drug
companies are providing the public and federal officials with less and
less information about possible harmful side effects of their products.
We know that these companies often do not share the results of clinical
trials that demonstrate problems with their drugs. This has spurred the
American Medical Association and the editors of several major medical
journals to call for a public registry of all clinical trials for
FDA-approved drugs.
down have become the last line of defense to get that information and
hold companies accountable for misleading consumers. With
whistleblowers becoming more and more rare, most scandals involving
consumer products are uncovered through lawsuits just like these. Our
country has relied on them for decades to ensure that consumers have a
remedy and an avenue to defend their interests.
Mr. Hinchey stated his intention that the funds be cut from FDA's
Office of General Counsel, which is housed in the Commissioner's
office, and added to FDA's Division of Drug Marketing, Advertising, and
Communication, the office responsible for monitoring drug
advertisements. The amendment was accepted without opposition.
sought to restore the funding. Mr. Troy has visited legislators
on Capitol Hill, distributing a copy of a letter from five former FDA chief counsels.
This letter has also been submitted to the Congressional Record to
refute Congressman Hinchey's assertions. The letter contains
several false claims.
the letter from the counsels, which reads in part, "Representative
Hinchey states that Mr. Troy 'has taken the agency in a radical new
direction' by submitting amicus curiae briefs in cases in which courts
have been asked to require labeling for pharmaceutical products that
conflicts with FDA decisions about appropriate labeling for those
products." That is not what Rep. Hinchey has argued. The "radical new
direction" refers to Mr. Troy's practice of soliciting lawyers for
drug companies and medical device companies to come to him with cases
in which to intervene; and submitting briefs in private civil cases in
which FDA has not been asked for its opinion.
show that in fact this type of activity on the part of the FDA predates
Mr. Troy's term in office. None of the cases, however, provide such
precedent.
Weinberger v. Bentex: FDA had no choice but to file
briefs since the agency was the defendant, not an intervener. Rep.
Hinchey is arguing that the FDA never before intervened without
being requested to do so.
Jones v. Rath Packing: The FDA submitted a brief to
the U.S. Supreme Court in a case involving a government agency and the
labeling of flour. Again, far different from interceding in a state
civil case between two private parties about product liability.
Bernhardt v. Pfizer: The court requested FDA's statement of interest.
Eli Lilly v. Marshall: According to the court's
decision, FDA did not submit anything in this case and the case had
nothing to do with product liability.
these cases did any court request FDA's opinion. Thus, there is ample
precedent for the actions that Mr. Troy has recently been undertaking.
His action is not radical or even novel." That assertion is inaccurate.
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