Rep. Henry Waxman (D-Cal) introduced the Non-Prescription Drug Modernization Act of 2007 (H.R. 4083) legislation in the House. The bill was co-sponsored by Rep. Tom Allen (D-ME) and was referred to the House Energy and Commerce Committee.

The bill will “amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration’s (FDA) authority to regulate drug advertising.”

The Act is a reaction to a recent FDA advisory panel recommendation that the FDA should ban OTC cough and cold medications for children under the age of six. Under current law, if the FDA wants to follow its committee’s recommendations, the Agency would have to go through a lengthy rulemaking process that could take years to complete.

The Non-Prescription Drug Modernization Act would give the FDA the authority to act quickly to remove unsafe or ineffective OTC drugs, by allowing the Agency to revoke authorization to market such drugs without a lengthy rulemaking process.

The Act would allow FDA to bypass these procedures and amend or repeal a monograph in a more timely fashion in two circumstances:

1)  When FDA, on its own initiative, finds that a monograph must be amended or repealed because a drug under the monograph may pose a significant risk; or

2)  After a meeting of one of the Agency’s Advisory Committees, when FDA finds that a drug under the monograph lacks evidence of effectiveness.

The Modernization Act would also give the FDA the authority to regulate OTC drug advertisements. Currently, the FDA regulates advertisements for prescription drugs, while the Federal Trade Commission (FTC) regulates advertisements for OTC drugs. It would also provide for civil monetary penalties for direct-to-consumer OTC drug advertisement violations.

The bill would also require the FDA to report to Congress on whether any of the current OTC drug monographs are in need of review, amendment, or repeal.

(Side Note:  Join a Fantasy Congress League and you can follow the progress of this bill here.)

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