Drug Makers Near Old Goal: A Legal Shield
In keeping with the theme of 'if we say it's okay, it is,' the Bush administration is pushing for a policy known as 'pre-emption' which would declare that pharmaceutical companies could not be sued over drugs that had been approved by the FDA.
The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
This theory, or course, works off the assumption that if the FDA has investigated a drug and approved it and its label, the courts are in no position to rule in opposition to the medical experts of the federal agency. But that relies on the FDA being provided with all of the facts and studies of the pill, something that drug companies are demonstrably opposed to complying with.
Consider Ortho Evra, the birth control patch made by Johnson & Johnson, around which this article is centered:
Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.
Allowing for the FDA to be the final voice on all things pharmaceutical is based on the presumption that there is no pertinent information withheld. Clearly that isn't the case. Johnson & Johnson is not the first drug maker to be outed as having held back information, and they won't be the last. The makers of OxyContin actually marketed their drug (an opiate) as non-addictive, a laughable proposition for a drug of its sort, but approved as such by the FDA nonetheless.
If we expect the FDA to act as the only oversight arm of the entire drug business, we have to be assured that its acting well-informed and as an operative of the public. That isn't happening, and if lawsuits are a vehicle toward achieving an end better suited to the needs and expectations of American citizens then pre-emption is a disastrous precedent to set.
But pharmaceuticals aren't the only area where the protective arm of pre-emption is being extended, as this AP story details.
If you think the prescription drug you took for headaches caused your heart attack, the Food and Drug Administration says you can't sue the maker for injury if it met agency standards.
The Consumer Product Safety Commission says you can't sue a mattress maker if your mattress bursts into flame despite meeting commission standards. Companies making sport utility vehicles would get similar protection from suits brought by people injured or the families of those killed in rollovers under National Highway Traffic Safety Administration proposals for stronger roofs.
Plaintiffs' attorneys call it "silent tort reform."
Tort reform has been a platform for the Republican Party in recent years, and certainly supported by Bush. But for all its clamoring about judicial activism and laws made by fiat instead of legislation, the Party seems to be quietly utilizing that very same method to achieve its own ends. Obviously, its not activist judges they're worried about, its judges who aren't activist in their direction.
Surely frivolous lawsuits abound in the United States, but eliminating them altogether removes just one more bullet in the arsenal of consumer protection in the midst of a continual volley by the Bush administration.
Supplier Under Scrutiny on Arms for Afghans
Sure, fighting terrorism costs a lot of money, but what's the price of freedom, smart guy?
If you're a 22-year old arms dealer with a massuer for VP, about $300 million.
But to arm the Afghan forces that it hopes will lead this fight, the American military has relied since early last year on a fledgling company led by a 22-year-old man whose vice president was a licensed masseur.
With the award last January of a federal contract worth as much as nearly $300 million, the company, AEY Inc., which operates out of an unmarked office in Miami Beach, became the main supplier of munitions to Afghanistan’s army and police forces.
Since then, the company has provided ammunition that is more than 40 years old and in decomposing packaging [sic]. Much of the ammunition comes from the aging stockpiles of the old Communist bloc, including stockpiles that the State Department and NATO have determined to be unreliable and obsolete, and have spent millions of dollars to have destroyed.
The ends of eliminating terrorism (however much a fantasy that may be) has always been held to justify the means of its incredible expense in the eyes of those that would have the United States police the world. Whether or not that is the case, shouldn't that expenditure come attached to a bit of research?
If it's not granting no-bid contracts to former employers of the Vice President, the Defense Department is shelling out money to a man just old enough to have finished college for worn-out arms made in China between 1962 and 1974. The Soviet Union, which designed the ammunition that AEY bought, developed similar tests, which are still in use. But when the Army wrote its Afghan contract, it did not enforce either NATO or Russian standards. It told bidders only that the munitions must be “serviceable and issuable to all units without qualification.”
What this meant was not defined. An official at the Army Sustainment Command said that because the ammunition was for foreign weapons, and considered “nonstandard,” it only had to fit in weapons it was intended for.
“There is no specific testing request, and there is no age limit,” said Michael Hutchison, the command’s deputy director for acquisition.
In purchasing munitions, the contractor has also worked with middlemen and a shell company on a federal list of entities suspected of illegal arms trafficking.
Bang-up job, fellas. Another case that screams out for the elimination of anyone watching how the government conducts its business.
Judge dismisses challenge to lobbying disclosure law
The National Association of Manufacturers suffered a major blow Friday in its legal battle against the new ethics and lobbying law.
Judge Colleen Kollar-Kotelly of the U.S. District Court dismissed the group’s challenge to a key provision of the law. The group took issue with the clause that would require disclosure of the member companies of “stealth lobbying” coalitions.
Part of the Honest Leadership and Open Government Act, the measure would require public disclosure of members of such coalitions who gave at least $5,000 every quarter to the group and participated actively in lobbying campaigns.
On what grounds would lobbyists oppose transparency of this sort? Why, free speech protection, of course.
The NAM argued the provision was constitutionally vague, hindering protections for free association and speech, and could lead to harassment of its member companies.
Yet again we are faced with an argument centered on free speech centered not on the ability to express yourself, but rather on the ability of others to respond to that expression. The First Amendment doesn't say anything about no one being able to react to free speech, but that's essentially the position the NAM has taken here.
In regards to free association, the new law--effective April 21--again says nothing about lobbyists not being able to associate or give money. It just says people have the right to know to whom and by whom.
That there is opposition to that premise illustrates the need for it by virtue of its very existence.
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