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FDA HEADQUARTERS AS WELL AS FIELD OFFICES SHOULD BE ALERTED OF TAMPERING, P-A ADVISES IN REVISED CRISIS GUIDES; PUBLIC SERVICE ADS BEING CONSIDERED

Executive Summary

OTC manufacturers should alert both FDA field offices and the agency's Rockville headquarters when faced with the report of a product tampering incident, according to a new crisis management guideline from the Proprietary Assn. The FDA headquarters should be alerted, P-A suggests, to assure that top agency officials hear about tampering situations from companies before being contacted by outside sources. "The call to FDA headquarters," P-A says, "is 'insurance' to guard against the FDA commissioner learning about a company's problem from the press before he hears about it through 'field office' channels." P-A advises its members to use the FDA emergency contact in Rockville, Dick Swanson. P-A's advice reflects the experience of this most recent tampering incidents. At a mid-April meeting, for example, FDA Com. Young emphasized that "one of our problems" in dealing with tampering incidents and other emergency situations "is that we occasionally hear things on the radio before we find out" what has happened from the company. Noting that he first heard about tampering with P&G's Encaprin "in the car radio coming in," the Commissioner said that getting reports after the general public is alerted "is the greatest problem that I can see in managing emergencies because FDA is not also to get the data and a good percentage of the updates." The advice on how to alert FDA is one of several recent additions to P-A's crisis management guideline. The association originally produced the guideline in 1983 after the first Tylenol tamperings. Revised guidelines are now being distributed to P-A member firms. P-A also has added several checklists to the guideline to help company employees receiving the first notification of a product tampering. One of the checklists was prepared by Procter & Gamble for taking information from someone claiming to have tampered with a product or planning to tamper with one. The association also has a checklist for taking information from a third party, such as a consumer or local health official, reporting a product tampering. The trade association acknowledges the continuing threat of tampering. "Experts in criminal behavior," P-A observes, "say the product tampering threat is not over. There is no such thing as tamper-proof packaging, and copy-cats are likely to try to prove the point." After the 1982 Tylenol tamperings, P-A devoted the majority of its effort to collecting and spreading information about new packaging alternatives. Through that effort, the trade association worked to preserve the industry's ability to choose from a number of options for changing packaging. In the wake of the second round of high-visibility tampering incidents, the association appears faced with a different set of educational projects. While the industry shied away from a high-visibility consumer education program about tampering in 1982-1983, there may now be more interest in that type of public service campaign. P-A staff is reportedly working with a number of the firms affected by the tampering crises to look at consumer survey data. One of the first questions the industry must address prior to initiating a public education effort is what are the fears and concerns of consumers about tampering. A second issue is the timing of a public education program: it is difficult to identify an appropriate time to raise the subject of tampering. In recent years, though, there has been increased media interest in the subject during the early autumn in preparation for Halloween. P-A and the OTC industry are likely to use a public service intermediary, such as the Council on Family Health, to prepare and coordinate a consumer education campaign, if one is undertaken. Another type of educational project for P-A in the wake of the tamperings appears to be in the area of relations with FDA and the drug distribution and retailing businesses -- specifically to try to work out standardized responses for dealing with reports of tampering. Based on the experience of the two industrywide tampering scares, it might be possible to identify certain levels of response to tamper threats. One of the difficulties for OTC companies has been the different types of responses in the trade to reports of tampering. Some chains, for example, react quickly and publicly to reports of tampering -- whether or not the suspect lots of the product were distributed to their area. In that type of atmosphere, it is difficult to restrict a tamper threat to one region until the extent of the threat is understood. In its crisis guideline, P-A notes tht the trade response is a key issue. "No crisis occurs in a vacuum," the association observes. "There are suppliers and wholesalers and retailers in the chain of production and distribution. All are affected by crisis anywhere along the line. And all will react for better or for worse according to their information and their own needs." The major firms affected by tampering scares have met individually with the distribution chain. J&J execs, for example, reportedly met quickly with the NACDS board in February to discuss the Tylenol tampering situation. However, some firms feel it could be useful for representatives of marketers as a group to meet with other trade groups to review past tampering experiences. Similarly, some firms feel that an effort should be made to discuss levels of response with FDA so that both sides have better benchmarks to work with at the outset of a tampering threat. FDAers familiar with the tampering experiences, however, are reluctant to try to put any advice on handling a situation down in writing. They see some common denominators, such as P-A's advice on whom to call first, but they feel that each situation and each company's response is likely to be different. The agency is actively meeting with groups interested in the tampering situation. FDA Associate Com. for Regulatory Affairs Joseph Hile, for example, reportedly met with representatives from the Grocery Mfrs. Assn. during the first week of May to discuss general issues about tampering. FDAers are ready to talk with companies about types of responses, but they want to avoid dictating specific responses. As one FDA veteran of the tampering crises puts it, "There is a system in place. It is flexible intentionally so that you can accommodate any screwy situation that comes along." While P-A has to deal with the question of educational activities on an industrywide basis, several companies face related issues for specific products. SmithKline, in particular, faces a fine balancing act as it prepares to bring back the Contac line. SmithKline has said that it is committed to bringing back Contac in time for the next cold/allergy season in the autumn. The firm is reportedly nearing a relaunch announcement later this month and plans to have the product back to the trade in August. The firm is understood to be leaning toward two forms of the product: a capsule and a tab. The full product withdrawal was forced on SmithKline by the timing of the event in the wake of the second Tylenol scare. However, the firm may be able to take advantage of the withdrawal to renew a major product line while has been lagging in recent years. With the Contac withdrawal and reintroduction, SmithKline has the opportunity to take a 25-year-old product with a well-established name and remake the product image with new packaging and new dosage forms. The tricky question for SmithKline is how strongly to portrary any new safety measures or formulations. If the firm tries to stimulate media interest in the relaunch by stressing product/packaging changes in response to the tamperings, it may simultaneously be stimulating copycat attempts on the new product. Although Contac was a major OTC line for SmithKline, the perception of the company's responsibility to the public is probably of more significance in the long term for its overall health care business. As the second company to bring back capsules after a tampering-inspired withdrawal, SmithKline would be in a more precarious position for second guessing if followup tampering attempts were made. SmithKline's position is exacerbated because of the full product withdrawal in March. Other firms, like Thompson Medical, also have stated their intention to add caplet forms to capsule lines. Thompson says a Dexatrim caplet is on the way.

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