US FDA Reform And The Pharma Industry

When US Bill S1477, the Food and Drug Administration Performance and Accountability Act, is debated in the Senate (which is currently expected to take place later this spring), it will be the subject of numerous amendments, including a national uniformity amendment offered on behalf of food and cosmetics industries, which were left out of the bill's national uniformity provisions. According to the US Nonprescription Drug Manufacturers Association these cover only over-the-counter medicines.

The national uniformity amendment for OTC drugs, the NDMA points out, was offered by Republican Senator Judd Gregg and adopted by a vote of 16 to 10. It provides that:

"No state or political subdivision thereof may establish or continue in effect any requirement relating to the regulation of a drug intended for human use that is not subject to the requirements of section 503(b) (1) which is different from or in addition to, or which is otherwise not identical with, a requirement of the Act or the Fair Packaging and Labeling Act, and the administrative implementation thereunder.