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Friday, June 06, 2008

Rule for Safer Pregnancy Drugs Would Prevent Damages Claims

Another story on preemption — a hot issue this week (see here and here for previous posts) — brought to you by the Food and Drug Administration (FDA).

Last week, FDA proposed new rules on drug labeling that aim to better convey potential risks to pregnant women and their fetuses and breast-feeding mothers and their newborns. The rule would eliminate the current risk communication design for pregnancy and lactation labeling, which FDA says could potentially be misleading, and would replace it with brief and straightforward risk characterizations.

Based on a reading of FDA's summary of the proposed rule, it seems to be above board and beneficial. "A number of doctors said they believed the new labeling would be a boon for pregnant and lactating women, many of whom take multiple prescriptions," according to ABC News.

But the rule also includes an unfortunate caveat. The rule would preempt tort lawsuits, brought as a failure-to-warn claim, at the state level. In other words, if a mother or child were harmed by a drug, the rule would legally prohibit them from seeking damages from the drug maker, so long as that company abides by the regulation.

The preemption language is actually reaffirmation of a policy FDA finalized in January 2006. That rule applied the preemption theory to the labeling for all prescription drugs. FDA's decision to include preemption in this rule proves just how callous the Bush administration is when it comes to protecting the legal rights and ensuring the health of U.S. citizens: even pregnant women, fetuses, new mothers, and new babies are fair game. All to the benefit of special interests, of course.

FDA's decision to protect drug makers from damages claims is problematic for a number of reasons. In an article for the American Constitution Society, Georgetown law professor David Vladeck argues preemption in this arena "would undermine the incentives drug manufacturers have to change labeling unilaterally to respond to newly-discovered risks, or to seek labeling changes from the FDA." He goes on, "Drug manufacturers have significant authority — and indeed a responsibility — to modify labeling when hazards emerge and may do so without securing the FDA's prior approval."

Vladeck also argues, "[S]tate damages litigation helps uncover and assess risks that are not apparent to the agency during a drug's approval process, and this 'feedback loop' enables the agency to better do its job."

FDA published the rule on May 29 — just in the nick of time to meet a White House imposed deadline on new regulations intended for completion during the Bush presidency. The rule is open for public comment until August 27.