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Executive Summary

The Washington State Pharmacy Board is proposing a regulation that would require retailers in the state to provide in-store information to consumers on tamper-resistant packaging for OTC products. A regulation drafted by the state pharmacy board on March 18 would require OTC drug retailers in Washington to designate a contact person to respond to consumer inquiries about tamper- resistant packaging; display at least one sign alerting consumers to inspect products for signs of tampering; and provide informational brochures. The board will review the proposed rulemaking at an April 25 hearing. In addition, the board has asked manufacturers of vitamin and diet supplement products sold in capsule formulations to voluntarily include tamper-resistant features now mandated for OTC medications. The pharmacy board agreed at a March 14 meeting to require TRP compliance from vitamin manufacturers by asking the state legislature for increased authority over all non-prescription drugs, vitamins and food supplements. The proposal, however, was vetoed by the governor's office and will not be considered by the legislature this year, Pharmacy Board Executive Director Donald Williams said. To date, the tampering incidents involving Burroughs Wellcome's Sudafed 12-Hour capsules have been confined to Washington state. The American Pharmaceutical Association indicated that it is unaware of widespread interest in other states for following Washington's activist approach in pursuing additional anti-tampering measures. The Washington state board decided against an outright ban on OTC capsules at a four-hour emergency meeting March 14 in Seattle. The decision was reached after hearing testimony from Nonprescription Drug Manufacturers Association President James Cope, Washington State Secretary of Health Kristine Gebbie, and FDA District Director Roger Lowell, in addition to testimony from local retailers and pharmacists. Gebbie sided with NDMA's position on capsule banning, declaring that such action "will not prevent all incidents of tampering. You cannot regulate against someone who is devious and determined." FDA is still considering whether to limit the availability of OTC hard shell capsules. An FDA task force studying the tampering incident plans to hold meetings every week for the next month. The task force is considering a ban on capsules as well as requirements for additional tamper-resistant packaging features. Any action concerning packaging would probably be discussed with industry and consumer groups, a task force member said after the first meeting March 14. The task force chairman is Associate Commissioner for Public Affairs Jeff Nesbit. Other members include: Chief of Staff Joseph Levitt, Office of Executive Operations Director of Program Management Staff William Hubbard, Regulatory Affairs Deputy Associate Commissioner Gary Dykstra, emergency operations head Richard Swanson, drug center compliance chief Dan Michels, product quality division staffer Paul Vogel, Drug Standards Division Director James Morrison, Linda Horton from the General Counsel's office and Center for Food Safety and Applied Nutrition Director of Regulatory Guidance Janice Oliver. Another potential challenge to the continued marketability of OTC capsules is a suit filed by the family of a Sudafed tampering victim. It maintains that OTC capsule manufacturers are liable because of the "known foreseeable risk of serious injury or death" from an "unnecessary" dosage form. The suit charges that Burroughs Wellcome is aware that Sudafed 12-Hour capsules are "no more effective in any substantial way than in caplet or tablet form, but chooses to continue to market it because it could make more money" and that the company has "deceived the public" with advertising that suggests capsules are "somehow more potent, effective, and faster acting" than caplets or tablets. The suit, Kenneth Daneker v. Burroughs Wellcome, was filed in Tacoma, Wash. district court by Sullivan & Golden March 7.

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