Opinion > Columnists > Davis Merritt

  Davis Merritt  

FDA getting more duties, less money

The Food and Drug Administration is about to be handed more responsibility for our well-being at the same time its budget is declining and our legal right to protect ourselves is being limited.

The situation exposes the contradictions lurking within the notion that "starving the beast" of government and relying wholly on market forces will, in every case, make our lives better and safer.

The latest iteration of that philosophical and moral deception is a federal case involving Ortho Evra, a Johnson & Johnson birth control drug. Unsafe levels of estrogen in the drug may have killed at least 40 women, and more than 3,000 women and families have sued the company because of strokes and heart attacks.

The company, predictably backed by the Bush administration, is asking the court to adopt a legal theory called pre-emption, which would hold all drug companies immune from lawsuits because the FDA approves drugs in advance of their sale.

In other words, the company is arguing that "if we make a bad drug but the FDA says it's OK, it can't be our fault, can it?" If you think that's a reach in logic, understand that the U.S. Supreme Court this year ruled precisely that way in the case of medical devices such as heart catheters.

The administration, in what is a near-record for disingenuousness even for it, argues that the FDA is the only entity capable of regulating drugmakers, and that courts should not second-guess it. If that sounds like a White House vote of confidence in the FDA, think again. For seven years the Bush administration has been systematically (in real terms) eroding the FDA's budget in response to drug company lobbying.

There's more to the illogic. In 1992, under pressure to approve drugs faster despite limited resources, the FDA established user fees whereby drug companies pay for inspections. By 2007, this had grown to one-fifth of the agency's budget, in part because of shrinkage elsewhere in its funding. Drug companies hate the profit-cutting user fees and are lobbying to have them limited or eliminated.

So it all comes down on the heads of the public: Drug companies and the White House want to reduce FDA resources but lay full responsibility for our safety on the FDA's doorstep.

But even that's not the whole tragic story. In the case of Ortho Evra, as with too many other drugs in recent history, the maker knew about the drug's estrogen overload problem even before FDA approval but failed to notify the agency until women starting dying and families started suing.

In other words, J&J wants a game of "catch me if you can" while lobbying to ensure that the FDA lacks the resources to do so, then brazenly argues that it should not be responsible when the FDA doesn't catch it.

It's like putting Willie Sutton in charge of bank security budgets and insisting that the courts not get involved as he drives away with the money.

Blameless people who suffer and die because of drug company greed and the administration's callousness must retain at least a long-shot chance of recourse.

Davis Merritt is a former editor of The Eagle. Reach him at dmerritt9@cox.net.