- The Washington Times - Friday, June 15, 2007

Democratic lawmakers raised the ire of their Republican counterparts this week when last-minute language was added to drug-safety legislation that would prevent drug companies from fending off civil lawsuits at the state level.

The two sides have very different ideas on the must-pass legislation renewing the Food and Drug Administration’s authority to charge drug makers for drug approvals and to strengthen a drug-safety monitoring system that is viewed as weak after several drugs recently have been found to have disastrous side effects.

Each side is committed to giving the FDA more powers to ensure drug safety, but House Democrats are taking an approach the pharmaceutical industry strongly opposes and the Senate ultimately did not approve.

The House bill runs counter to the Senate bill on some of the drug-safety provisions possibly setting up a contentious conference committee. The Senate displayed strong unity — a 93-1 vote — in passing its version of the bill last month.

The primary issue rankling Republicans is the so-called “pre-emption” language that would ensure the new, beefed up drug-safety laws will not pre-empt civil lawsuits against drug companies at the state level. Republicans are angry at their lack of involvement in crafting the legislation and claim the pre-emption language was added just hours before a hearing on the bill this week.

The pre-emption language is significant because, if enacted, it would allow the multitude of lawsuits against drug companies at the state level to continue and potential future civil actions against GlaxoSmithKline’s diabetes drug Avandia.

The Senate version of the bill is not as strong on the issue as the House and does not include “pre-emption” language. Instead, it has an obscure section that is supportive of not allowing the new drug-safety laws to interfere with various court cases against drug companies going on at the state level.

The FDA, not surprisingly, is against the language because it undermines their authority, which they believe to be the gold standard.

“We think the pre-emption language would essentially have the effect of formalizing in federal statute a collection of state actions that may be contradictory to or inconsistent with FDA actions on the safety and effectiveness of FDA-regulated products,” said Randall Lutter, associate commissioner for policy and planning at the FDA.

Consumers Union, a nonprofit organization, represents the other side.

“Repeatedly, company documents obtained through court discovery proceedings have shown companies internally acknowledging problems and dangers with drugs that they have not shared with the consuming public,” the group said in a draft paper on the bills. “The pre-emption language means that the fact that in these bills Congress is strengthening the FDA safety laws should not be used in court, pro or con, to argue whether FDA law pre-empts state tort laws that help protect consumers.”

Another battle between the parties will center around advertising. The Senate bill dropped language giving the FDA authority to prevent drug company advertisements from airing if the agency felt the ad was in any way misleading. But the House version contains a similar provision that gives the FDA new authority to approve ads for drugs before they air and place a moratorium on drug advertisements.

Rep. Michael C. Burgess, Texas Republican, said at the hearing that the bill’s proposed restriction on advertising is a violation of the Constitution, the same argument that led the Senate to drop the provision.

Contact Gregory Lopes at 202/636-4892 or gregorylopes@washingtontimes.com.



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