NATIONAL UNIFORMITY PROTECTION FROM STATE ACTIONS BEING SOUGHT BY NDMA ON CAPITOL HILL: FOOD LABELING BILL IS ONE VEHICLE, DINGELL GENERIC BILL COMING

The Nonprescription Drug Manufacturers Association has two slim chances to tag a provision for national uniformity of regulation for products under FDA's purview onto pending bills in the food and generic drug areas. One opportunity in the Senate, Sen. Metzenbaum's food labeling bill (S 1425) appears recently to have slipped past. Metzenbaum's bill moved through markup in the Labor & Human Resources Committee on April 25. NDMA sought to extend a national uniformity provision for food labeling in the bill to other FDA regulated products. The proposed extension, however, was not considered during markup. The national uniformity provision for food regulations stayed in the bill through markup and remains a possible hook for future NDMA efforts as the bill moves through the Senate and companion legislation is considered in the House. Rep. Dingell's soon-to-be-introduced generic drug emergency bill provides another possible vehicle for a national uniformity provision. Dingell is reportedly preparing to introduce the bill on May 15. The Dingell bill is perhaps a more logical vehicle for NDMA's efforts because it deals with drug regulation. However, Dingell has been adamant about keeping his bill trim and addressed exclusively to issues raised by his investigations of the generic drug industry. At this point, he does not appear likely to permit the addition of amendments that could open the bill to a wide array of changes in FDA rules. The Bush Administration through HHS has suggested a broader bill in response to the generic drug investigations. The HHS proposal would permit FDA to disbar any firm that makes an FDA-regulated product for submitting false information on product applications or for committing fraud or bribery during a product review ("The Pink Sheet," April 9, p. 3). The broader scope of the HHS proposal would make it a more palatable choice for a national uniformity amendment. The Administration's bill does not appear yet to have the sponsors to be a viable alternative to Dingell's bill. NDMA's interest in a legislative solution to the national uniformity issue indicates its frustration with fighting the brush fires of individual states' attempts to require different forms of labeling and/or warnings. NDMA reports addressing "63 bills over the last two years which could have broken uniformity." The major challenge has been regulations under California's Prop 65 toxic enforcement act. NDMA worked with FDA to encourage publication of an expedited third-trimester warning for aspirin similar to the current ibuprofen warning against use without recommendation by a doctor ("The Pink Sheet" April 9, T&G-12). NDMA President Jim Cope reported to a May 7 session at the annual meeting that "the word" has come back from California that the state "would probably find [that] FDA's planned third-trimester language satisfies the requirements of Proposition 65 -- our goal." If the FDA warning works to satisfy California, Cope said, "we will have avoided confrontation between federal and state authority. But, only on labeling. Only for one ingredient. In one state." California's pressure on the aspirin warning and the effect that that pressure had on expediting FDA action relates to an argument that NDMA makes against individual states' regulatory prerogatives. In a backgrounder on its main issues, NDMA notes that initiatives by the states are often accepted into federal practice. "Any state can expect FDA," NDMA says, "to convert a good idea for product regulation into a nationwide requirement -- e.g., the national pregnancy/warning originated as a California proposal."