Chalk up another profitable victory for those promoting the legal drugging of America's children -- also known as the good folks of the pharmaceutical industry. Earlier this month, a federal judge struck down a Food and Drug Administration regulation that required drug makers to test medicines routinely given to children.
As a result, America's legal drug pushers are once again free to offer their potent concoctions for our kids' consumption without having to prove that they are safe or effective for pediatric use.
This is no small matter, given the skyrocketing number of children being prescribed heaping helpings of powerful mood-altering drugs. For instance, 1.5 million kids are currently taking Prozac and its equivalents even though the FDA hasn't approved these drugs for use by anyone under 18.
In making his ruling, U.S. District Judge Henry Kennedy Jr. made it clear that the problem wasn't the FDA's attempt to protect our kids, but Congress's failure to authorize them to do so. He pointed out that earlier this year Congress considered but passed on the chance to require drug companies to make sure that products designed for grown-ups but regularly given to kids are, in fact, safe for children to take.
Instead, our elected representatives -- no doubt under the influence of the $18 million drug companies have donated to congressional campaigns this election cycle -- approved an industry handout, offering "financial incentives" to companies willing to take the trouble to find out if their products are dangerous for kids. Rewarding companies that bother to behave with ordinary civic responsibility is becoming a bad habit for Washington and it reveals their scary baseline assumption that, left alone, big business can never be expected to do the right thing.
Sens. Christopher Dodd, Mike DeWine and Hillary Clinton are co-sponsoring a new bill that would supersede the federal court's ruling and give the FDA legal authority to require drug testing for children. "Children will be harmed if we don't pass this legislation," warns DeWine. So far, the troika's efforts to bring the bill to a vote have been thwarted by the drug companies' loyal beneficiaries in the Senate.
But Capitol Hill is not the only pharmaceutical industry-friendly place in Washington. The drug companies also appear to have found an ally inside the highest echelons of the FDA.
In keeping with the White House's habit of assigning foxes to guard the henhouses they used to stalk -- including the très vulpine Harvey Pitt and Gale Norton -- last summer the president appointed lawyer Daniel Troy as the FDA's general counsel. While in private practice, Troy had successfully challenged the agency's power to regulate drug companies -- particularly the companies' ability to freely promote and market their products.
It probably shouldn't come as too much of a surprise then that, from his lofty post, Troy has overseen a dramatic decrease in the number of drug companies that have been reprimanded for running false or misleading commercials -- even as the drug ads filling our TV screens and magazines have multiplied. Of course, it could just be that the drug companies have all joined the Boy Scouts and are now being meticulously honest and trustworthy.
One of the pharmaceutical industry's weapons of choice in its fight to free itself from federal oversight has been the First Amendment, a tactic once favored by none other than Daniel Troy. Groups aligned with the industry have successfully used free speech arguments to convince courts to strike down regulations barring drug companies from advertising so-called compounded drugs and from telling doctors about unapproved uses for its products -- such as giving adult drugs to children. The founding fathers would have had to pop a lot of pills to conceive of this perversion of the Bill of Rights.
Reeling from these rulings and under increasing pressure from the drug industry, this spring the FDA invited interested parties to comment on whether any of its other rules raise "First Amendment issues." Among the flurry of feedback the agency received was a suggestion from the ever-helpful gang at Pfizer that the FDA do away with those pesky rules requiring drug companies to list a product's side effects and replace them with a cheerful reminder that since all medications come with some risks, patients should always check with their doctor before taking them.
Makes sense. Why bother letting consumers know that downing a brightly colored, widely advertised little pill might cause nervousness, anxiety, insomnia, restlessness, suicidal thoughts, self-mutilation, manic behavior, and bad breath when a simple and direct "Consult your doctor" -- or rather "consult your overworked, underpaid, HMO-tormented physician" -- will suffice? Who on earth takes a prescription drug without consulting their doctor? It's not like patients can prescribe the drugs for themselves, although now that I've said it, I fear I've given drug companies and Daniel Troy an idea for the ultimate regulatory rollback.
This kind of self-serving, the-public-be-damned thinking is precisely why we need strong drug industry oversight in Washington, not appointees and politicians beholden to their deep-pocket patrons. Especially when our children's health and well-being are at stake.
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