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P-A FORESTALLED CONGRESSIONALLY MANDATED AD WARNINGS FOR ASPIRIN PRODUCTS IN LOBBYING EFFORT v. REYE's SYNDROME LAWS: DANGEROUS PRECEDENT AVOIDED

Executive Summary

The Proprietary Assn.'s efforts against Reye's Syndrome legislation prevented the precedent of congressionally dictated mandatory ad warnings for OTCs and left the door open for further scientific review of the relationship between the disease and aspirin use, P-A Chairman James Luther stated in his address to the assn.'s annual meeting on May 14. The proposed legislation would have specified a 47-word warning and would have required that warning in an advertisements, Luther noted. "The specific language of the warning and even its location were dictated by Congress," Luther said, "a clear and improper usurpation of FDA's authority, expertise and responsibility." By focusing on common denominator issues of ad warnings and the protection of FDA prerogatives in the scientific/regulatory area, P-A preserved "intact the essential principles" that the assn. stands for, Luther maintained. The P-A chairman distinguished between the general issues embodied in the Reye's Syndrome debate, which affected all of the OTC industry, and the specific scientific debate, which affected aspirin and non-aspirin marketers. Luther, a senior VP at Sterling, noted that "the aspirin makers did not urge the association to defend aspirin on the merits." The aspirin makers handled that part of the regulatory fight on their own through the Aspirin Foundation. P.A. Chairman Praises J&J For Keeping Assn. Out of Capsule Debate During his speech, Luther twice praised Johnson & Johnson for not using the association to take positions for its own competitive advantage. In the Reye's Syndrome situation, Luther commented on J&J's position indirectly, pointing out that "the non-aspirin makers did not urge the association to stay out of the controversy altogether, not to take sides against aspirin." Similarly, Luther commented on J&J's abstention from using P-A in the capsule debate after the most recent round of tampering publicity. "In this crisis," Luther declared, "and despite its great loss, I am proud to say that J&J did not beseech the association to recommend that capsules be banned for all OTC medicines, nor urge that the association take no position on this critical point." Luther said that J&J's restraint permitted P-A "to adopt whatever position our Board of Directors decided was in the best interests of the industry as a whole, and free also to take a leadership role in advocating the adoption of that position." The P-A chairman pointed out that the association fought efforts to legislate against the use of capsules and put together a fund for rewards of up to $700,000 to help catch and jail those responsible for the tamperings. Luther noted that P-A also began work "to explore further improvement in our tamper-resistant packaging." At the annual meeting, P-A handed out a short summary of tamper-resistant improvements since the 1982 crisis. The association noted, for example, that at least five changes make outer box packaging more tamper-evident, including "thinner/more rippable paper for cardboard boxes" and "use of a more free-flowing glue to cover the entire end flap area of outer boxes in order to make entry more tamper-evident." On the related subject of a public service ad campaign on tampering, Luther commented indirectly. He noted that part of the continuing industry response should include working "with govt. and with allies to help to insure that Americans know what to do for their own protection." Luther declared: "Clearly, any real solution to such nightmares must begin with the informed and alert consumer." FDA leaders have been warm to the concept of a public service ad to warn consumers of ways to be aware of signs of tampering. The P-A board, however, reportedly did not address the public service campaign at its annual meeting sessions. The board did discuss a course of action in response to aggressive enforcement of the California slack-fill packaging laws. The 1969 state law is aimed at preventing packaging containers which are "non-functionally" under-filled. The state district attorneys have been aggressively enforcing the law and reportedly are actively looking at certain cosmetic and toiletry packages. The Cosmetic, Toiletry and Fragrance Assn. is understood to have sought help from P-A against the law. The P-A board declined from court action against the law but reportedly was in favor of exploring other solutions, such as legislative remedies. Luther also reported in his chairman's address that P-A is beginning to look into a captive insurance company to provide liability insurance for OTC companies which cannot get coverage. Noting that the association membership has been surveyed twice on the issue, Luther said, "we have contracted with an actuarial firm to analyze your responses and to study the feasibility of a captive insurance company or some similar arrangement." Three P-A cmtes. are tracking the liability issue, Luther reported: (1) a task force headed by Schmid Labs' Bill Moran; (2) a legislative subcmte. of the Govt. Affairs Cmte.; and (3) the Standing Cmte. on Small Business. Luther was re-elected to serve as chairman of the assn. in 1986-1987. William Bergman, exec VP of Rich-Vicks, was chosen as chairman-elect to head the assn. in 1987-1988. Bergman's presence in the assn. hierarchy indicates Procter & Gamble's decision to give Rich-Vicks' officials the opportunity to remain active in P-A affairs. Rich-Vicks has traditionally been a major supporter of the association. POST-1982 EXAMPLES OF TRP CHANGES A list of recent tamper-resistant packaging changes compiled by P-A. Since the introduction of the first types of tamper-resistant packaging, industry's commitment to high quality tamper-resistant packaging has been sustained. Below are some examples of TRP changes that have been made with respect to certain products since 1982. Evolution of TRP to permit tamper-evidency with accessibility for the elderly and disabled. For example: Introduction of a "rip-here" tab on the neck seal to enhance accessibility; Replacement of certain "low accessibility" ring-sealed metal caps with high quality plastic neck seals with enhanced accessibility; Introduction of more fragile break-away caps; and Introduction of tear strips to make TRP removal easier. Improvement in adhesive materials for blister (strip) packs. Replacement of neck seal with more tamper-evident material, e.g., plastic neck band replaced with ring-sealed metal cap. Sealed, banded and locking capsules. Thinner/more rippable paper for cardboard boxes. Use of a more free-flowing glue to cover the entire end flap area of outer boxes in order to make entry more tamper-evident. Change from glued end flaps of outer boxes to the tamper-evident tape across the flaps. Second generation sealing tape of greater fragility. Taping of side seams with tamper-evident tape. Use of induction sealed blind-end plastic tubes. Enlargement of neck bead of bottle to a size equal to or larger than the base of the cap to give a larger obstacle over which to put the neck band and therefore a stronger bonding of the neck seal. Use of shrink wrap of the entire bottle. Use of metal cants for the outer container, which were subsequently replaced with a shrink wrap of the box. Improvements of the inner seal material to enhance fragility without minimizing adhesiveness. Improvements in reliability of TRP in manufacture through new applications in statistical quality control, including, for example, use of computers to rapidly assess patency of seals during manufacture thus minimizing the potential for factory release of defective TRP. Use of unique logos, printed on TRPs to minimize the chance for interchangeable use of TRP materials.
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