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CPSC Rx-To-OTC Switch Final Rule Published As Gall Loses Chair Nomination

This article was originally published in The Tan Sheet

Executive Summary

Manufacturers cannot be ensured confidentiality when submitting child-resistant packaging (CRP) exemption requests for oral Rx-to-OTC switches, the Consumer Product Safety Commission clarifies in its final rule requiring CRP for all such drugs.

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CPSC chair

Consumer Product Safety Commission could receive a new head by May 1. Senate Commerce Committee nomination hearing for Harold Stratton was held April 25; Sens. Byron Dorgan (D-N.D.) and Ron Wyden (D-Ore.) questioned Stratton about free-market stands he has taken to protect businesses from government interference. Stratton appeared to satisfy concerns, though, noting as AG of New Mexico, he oversaw state's only consumer protection agency. Committee likely will send nomination to Senate for full vote; deadline to fill CPSC post is May 1, which signals expiration of six-month quorum period for two commissioners. Stratton's smooth hearing contrasts with that of President Bush's original nominee, Mary Sheila Gall, who faced stiff opposition from committee Democrats (1"The Tan Sheet" Aug. 6, 2001, p. 6)...

CPSC

President Bush nominates Harold Stratton to chair Consumer Product Safety Commission. Albuquerque lawyer is "known consumer advocate" who served as New Mexico's AG (1987-1990) and in state's House of Representatives (1979-1986), White House says. Stratton is a partner with the law firm Stratton & Cavin. No Senate confirmation hearings have been scheduled. Bush Administration abandoned its push to appoint Mary Sheila Gall as commission chair after her nomination was defeated in committee by Senate Democrats (1"The Tan Sheet" Aug. 6, p. 6). Commissioner Thomas Moore named acting chairman after Ann Brown's previously announced resignation took effect Nov. 1...

Rx Antihistamine Switch Consumer Cost Increases Unlikely, Insurer Tells FDA

Switching Rx low- and non-sedating, second-generation antihistamines over-the-counter is unlikely to increase out-of-pocket costs for U.S. consumers based upon OTC pricing of the drugs in foreign countries, a health insurance rep told FDA June 29.

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