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ANDA PRIORITY TREATMENT AT FDA COULD PROVIDE OPPORTUNITY FOR Rx-TO-OTC SWITCHES, P-A's COPE TELLS ANNUAL MEETING: NEW SWITCH MOMENTUM NEEDED

Executive Summary

OTC marketers may be able to take advantage of FDA's heightened interest in abbreviated new drug application (ANDA) reviews to breathe new life into the Rx-to-OTC switch effort, Proprietary Assn. President Jim Cope suggested in his May 12 "Report From Washington" to the annual meeting. Calling the ANDA application "one of the routes to switch," Cope pointed out that "it has never been easier" to file one of the short-format applications for off-patent NDA products. Cope noted that the "Congress has told [FDA to] give ANDAs expedited consideration." He said that "the climate" for filing ANDAs is ripe; and "FDA has the resources to put against" ANDA reviews. The P-A president, in effect, exhorted assn. members to shift their new product approval efforts at FDA away from the OTC Drug Evaluation Division to an area of the agency with greater budget and management support. In late autumn last year, FDA reduced the authorized ceiling for employees in the OTC division from 38 to 25. The new employment level will be effective Oct. 1, 1986 ("The Pink Sheet" Nov. 18, 1985, "In Brief"). Although he was not openly critical of the continued winding down of the OTC Review mechanisms at FDA, Cope referred to the problem of dwindling resources. Cope observed that "some legislators and regulators . . . seem to feel that just because OTCs are work-a-day products, and are not on the cutting edge of science, they are not too important." He pointed out that that view "tends to put OTCs on the bottom of the pile for consideration." Restrictive Labeling Requirement For ANDAed Drugs Could Impede Switch From Rx To OTC In his prepared remarks, Cope said that the ANDA process has gotten less costly in the wake of the Waxman/Hatch amendments to the FD&C Act. He indicated that the ANDA route to a switch is untried but added that "there are several excellent consultants and firms available to help" in filing ANDAs. FDAers in the division responsible for ANDA reviews (the Generic Drug Div.) report that the abbreviated applications have not yet been used for an Rx-to-OTC switch attempt. One D.C. observer said that it might be difficult to get FDA to approve an OTC version of a previously Rx product through an ANDA application because the agency has been taking a very restrictive view of the requirements that ANDA products be the same as the original NDA products. One aspect of the agency's restrictive interpretation of ANDA applications is a requirement for labeling. The agency is not required to approve an ANDA if the labeling for the product is different from the referenced NDA product. That provision would appear to be a strong deterrent to switching an Rx to OTC through the ANDA process. Chattem, however, recently filed comments with FDA on the ANDA process to request that the sameness requirements for Rx labeling apply only to warning and directions for use if a switch to OTC status is sought. Chattem has been an aggressive proponent of a monograph approach to switching Rx ingedients to OTC status. Cope also suggested that FDA's recently released list of marketed Rx products approved before 1962 (prior to the NDA requirements) could also be a good source of product ideas for Rx-to-OTC switches. "FDA has released a list of 5,100 Rx products that are sold legally without NDAs," Cope observed. "Now, I have to believe," he said, "that some of those 5,100 are candidates for switch." He urged OTC marketers to further "mine" the Rx product bin to seek govt. approval for OTC products. The P-A president suggested the two sources of OTC product ideas as ways to jostle the industry into movement on the flagging switch process. Cope said he sensed "a certain hesitation, an uncertainty" in the switch effort. He maintained that the industry is in a "sort of lull." Cope identified the "loss of momentum in the switch trend" as one of the major problems facing the OTC industry. "We seem to be in a dead spot of water right now -- our sail hasn't caught a breeze telling us if more switches will follow as the OTC Review progresses," he said. A number of MDs, Cope said, are "ahead" of the OTC industry in promoting OTC switches. He said that "several MDs" at the P-A's two symposia on switch were "much stronger than we have been in urging . . . transfer of established Rx medications to OTC." At the 1982 symposium, for example, University of Wisconsin medical professor John Morrissey suggested that peptic ulcer was a good candidate for further OTC treatment. He maintained that H[2] antagonists could be labeled for OTC use with wording such as "If you have upper abdominal pain relieved by food and antacid for longer than five days, it is appropriate to take these medications." OTC Diagnostic Kits, Growth Of HMOs Provide Incentive For Self-Medication, Cope Says Balancing the short-term concern over a slowdown in switch activity, Cope pointed out that the concept of self-medication is expanding to include self-medication for the management of chronic or recurrent disease states. He noted that FDA's tentative final monograph for OTC Exocrine Pancreatic Insufficiency Products confirmed the patient's ability to self-medicate that condition after a professional's diagnosis. The tentative final monograph was issued in arly November ("The Pink Sheet" Nov. 18, T&G-10). FDA received comments on that monograph, Cope observed, which maintained that the products should be available Rx-only. However, "FDA said that, once the insufficiency is diagnosed, a consumer can safely and effectively self-treat the condition." Maintaining that there is developing evidence that patients can self-diagnose and self-treat certain recurrent conditions now treated by Rx medications, Cope cited a study reported in the Annals of Internal Medicine that showed that 35 of 38 symptomatic episodes diagnosed by patients as [urinary tract] infections were confirmed by lab tests. The increasing interest in OTC diagnostic and screening kits is further expanding the concept of self-medication, Cope said. "Kits are being used for both self-diagnosis . . . and for help in managing chronic conditions," Cope observed. A further incentive to OTC use in the future, Cope reminded the P-A meeting, is the growth of HMOs (health maintenance organizations). "These groups," Cope said, "have an incentive for you not to come see them. They teach people how to take care of themselves, teach them how to self-medicate, so they don't have to come and use the HMO for every ache and ailment. Self-care saves the HMO money -- an asset for self-medication."
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