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The US Food and Drug Administration is paid fees by the pharmaceutical industry to review brand-name and generic drugs. Now, the agency wants to collect money to review over-the-counter medicines.

Specifically, the agency wants companies to pay for reviewing OTC monographs. Unlike brand-name and generic drugs, which involve individual companies seeking approval to market individual drugs, the OTC monographs refer to multiple medicines that share the same ingredient for the same use. Moreover, numerous companies can make these drugs, but do not require FDA approval prior to marketing.


Although the agency first floated the idea two years ago, the issue emerges as the FDA struggles to cope with reviewing a steady stream of brand-name and generic drugs, despite industry fees that supplement government funding. There has been a large backlog of generic drug  applications, in particular, even though the number of full and tentative drug approvals has been rising each month over the past year.

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  • One category should DEFINITELY have to pay a fee: formerly prescription drugs that are converted to OTC, like Claritin and Flonase. These companies do this for one main reason: cut the market out from under generic makers and extend their Blockbuster Franchise. GSK extended that phony Flonase patent exclusivity by all means, legal and illegal (had to pay hundreds of millions to settle antitrust claims because it abused the Citizens Petition process), then dis an “authorized generic,” then converted to OTC. The amount of work they created for the FDA to maximize their billion-dollar profits was FAR inexcess of any fees thay had to pay. In other words, they socialized the rick and capitalized the reward. That MUST change.

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