A Senate Food and Drug Administration reform bill that virtually sailed through the Labor and Human Resources Committee will receive a rougher reception on the Senate floor this week, as growing numbers of members and interest groups battle to preserve or target the more contentious provisions in the legislation.
The most controversial and high-profile issue continues to be the bill's so-called national uniformity language, which was adopted as an amendment by the committee. The national uniformity standard in the legislation pre-empts state and local laws governing warnings on cosmetics and non-prescription drugs, prohibiting "different or additional requirements" than those in the federal Food, Drug and Cosmetic Act.
Consumer, public interest and environmental groups have launched an aggressive campaign to strip the language from the bill, charging that it undermines states' rights and will gut strong, pro-consumer laws such as California's Proposition 65. That law, enacted by referendum in 1986, mandates that businesses either inform the public that they are being exposed to carcinogens or reproductive toxins or remove those chemicals. The statute most recently was credited with forcing manufacturers to eliminate lead in calcium supplements.
Supporters, such as the Environmental Defense Fund's David Roe, point out that the Reagan and Bush administrations resisted efforts by industry to pre-empt the law. Also, noted Roe, a review panel convened in 1991 by California Gov. Pete Wilson concluded that "by federal standards," the statute had resulted in "100 years of progress" in hazard identification, risk and exposure assessment.
But proponents of the national uniformity language in the Senate bill counter that, far from being new, uniform federal laws have long existed for medical devices and meat and poultry inspection and should be expanded to include over-the-counter drugs and cosmetics.
A coalition of some 60 organizations, led by the Nonprescription Drug Manufacturers Association, this week launched a letter-writing campaign to senators asking that they preserve the national uniformity language.
"This is a pro-consumer provision, it's having one [standard] versus 50 mini-FDAs," said a spokeswoman for the NDMA.
Senate aides say the issue still is being negotiated, and there may be a possibility for compromise.
However, if no agreement is struck, Sen. Dianne Feinstein, D- Calif., reportedly will offer an amendment to delete the provision.
Another contentious issue is off-label uses for drugs, which a Labor and Human Resources Committee spokesman described as "one of the bigger outstanding issues" that, ironically, is not even in the bill.
Sens. Connie Mack, R-Fla., and Bill Frist, R-Tenn., reportedly will offer a floor amendment that would allow pharmaceutical companies to provide physicians with information about scientific studies showing that a drug has benefits in addition to those for which it was approved.
One Democratic source charged the provision would lead to "unfettered promotion of unproven drug uses" and added that if the issue cannot be resolved, it will be "tough for [Labor and Human Resources Chairman Jeffords] to get a time agreement" on the bill.
Senate Majority Leader Lott, concerned about the tight floor schedule, outstanding appropriations and reconciliation bills and the looming August recess, has encouraged Jeffords to get a time agreement with Democrats.
The legislation may be brought to the Senate floor as early as Tuesday, but aides said it is more likely to come up Wednesday, depending on the status of reconciliation and appropriations bills.
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