A couple of weeks ago, as I’m sure you heard, the FDA held an advisory committee meeting that concluded that there should be no use of cough/cold products for children under 6. There is a good amount of evidence that the drugs (including antitussive, expectorant, nasal decongestant, antihistamine and combination products) were not effective and are harmful in some cases. Now what happens?
A couple of signs: Most manufacturers took all under 2 cough/cold medicines off the shelf. Many, like Wyeth who makes Dimetapp and Robitussin have recalled Children’s Dimetapp and some Robitussin to replace the dosing cups with those that have half-teaspoon marks (the recommened dose for kids 2-6). A bit of a digression here: The Children’s products came with a dispenser that only had marks for the adult amounts? That’s rediculous! No wonder there are accidents with dosing (one of the main concerns of the panel). I should note that Dimetapp has only had a dosing cup for a couple months; Robitussin has had one since the early 90s.
You’ll note that medicines for 2-6 weren’t taken off the shelf voluntarily. The FDA has hinted in the press that changing the regs to disallow under 6 use (or even under 2 use) would take years. Years? Unacceptable, I say! I’m not the only one; Sen Dodd sent a letter to the FDA Commissioner saying, basically: Unacceptable! Get your ass in gear! Of course, he said it in much nicer language. He also said:
In response to the strong votes by the FDA’s advisory committees, officials at the FDA are quoted in press reports as merely urging parents to continue following directions on these products. I find FDA’s comments deeply troubling as it is these very directions that have been identified as misleading to parents.
It’s sad that someone has to point this out. And because he says it so well, I’ll include this left jab that lands nicely:
As you will recall, I, along with Senator Jack Reed, have written you and your predecessors at the FDA for more than 10 years in an effort to push the FDA to issue a final monograph on sunscreen products that would inform consumers about sunscreen protection from both UVA and UVB rays. All in all, it took the FDA nearly 30 years to issue the final sunscreen monograph for UVA and UVB protection. I am deeply troubled by reports that the FDA may consider a similar regulatory process before informing parents about the risks and benefits of using OTC cough and cold products. Children and their families should not be forced to wait on a lengthy, bureaucratic process, when action can and should be taken quickly to protect our nation’s children from possible harm.
Yeah, that’s right. 30 years. Something’s rotten at the FDA and it smells like bureaucracy. Here’s my take on why bureaucracy is so bad at the federal government: because it is so dang fair and has to justify every little thing it does was the best possible decision. I know that doesn’t sound so bad but hear me out. The government can’t make decisions that it thinks is right; it has to prove beyond all reasonable doubt that it is right. It also has to make sure that it is completely consistant all the time so as not to give advantage to one party over the other. These constraints would kill any business. In a business, you make the best decision with the information you have at hand. With public institutions, however, there needs to be a balance between responsibility to the public in terms of fairness and accountability with efficiency and public service. Unfotunately, they are not completely compatible. Both are necessary but can’t be fully served. It seems to me that when agencies are routinely saying they “get back to you in a coulple of years” with things that they know are problems now, we’ve swung way too far into the legalistic fairness and assuredness territory (see FDA and food and OTC drugs; CDC and formaldehyde trailers; EPA and phthalates; DoD and armor…ETC).
We need to have some more flexible agencies paired with some strong IG offices so that fairness is given a more critical eye. In that vein, Sens. Waxman, Kennedy and Allen have introduced a bill that would allow the FDA to quickly ban the marketing of the drugs while the rulemaking takes place and put the authority for OTC ads under FDA’s jurisdiction (it’s currently under the FTC; go figure). It’s a good thing, but it would be nice if it didn’t take an act of Congress to make any decision in DC.
Of course, right now we have political interference that makes things unfair/unsound and more burecratic hurdles. Isn’t it ironic, that the people that complain about big government the most are the same ones who throw the most barriers in the way of governence, creating a larger burecratic morass?