February 2, 2007
The Wrong DIrection for the FDA
I am frequently and consistently disappointed by Republicans. They forget their principles routinely. When their hearts and mind are in the right place, they seem ineffective and pusillanimous compared to the folks across the aisle.
Yet I can never credibly threaten to abandon them (though I stand by my pledge) because the Democrats are effective, just at moving the wrong way. Yes, the Democrats won the 110th fair and square. Yes, I knew there would be legislative consequences. Yes I knew my beloved pharmaceutical sector would be severely threatened.
But right out of the chute, I see Senator Kennedy on the front page of the Wall Street Journal in Drug Industry Faces Bitter Pill. (Paid link, sorry!) Keep in mind that this is the fairly liberal news division, not my right wing wackos on the Editorial Page.
Congress is kicking off efforts to pass big reforms of the Food and Drug Administration, and that could produce some bitter pills for the pharmaceutical industry: potentially, tougher safety rules and provisions to reduce the cost of medicines.
Uh-oh,
Proposals to beef up regulation have stalled before, often due to skepticism from Republican allies of the industry. This year is likely to be different. Democrats aren't reluctant to give expanded authority to federal regulators and see the drug industry as a tempting target because of its tenuous popularity with consumers and its traditional ties to Republicans. And they're getting support from some Republicans upset by a series of high-profile drug-safety problems, including the 2004 withdrawal of the painkiller Vioxx.Also, lawmakers have a ready-made vehicle for the changes: legislation that must be approved this year to renew the deal under which the industry pays fees to fund much of the FDA's drug-review process. The current user-fee agreement expires later this year.
"It's pretty clear we have drug-safety problems, and it's clear we need to address those matters," says Rep. John Dingell (D., Mich.), chairman of the House Energy and Commerce Committee, which has jurisdiction over the FDA. Several lawmakers say the agency's latest drug-safety initiatives, announced Tuesday, need to be bolstered with new legislation.
"Pretty clear we have a safety problem is Rep. Dingell-speak for "It's pretty clear my committee needs to take over this sector of the economy."
So we will cut their profits with price controls, scare off their investors with endless Congressional hearings, then regulate the crap out of what's left. But we're going to raise subsidies for stem-cell research, as long as the researcher can categorically prove that it will disturb the President.