"ESSENTIAL TESTING" FOR EXCLUSIVE MARKETING PROTECTIONS UNDER WAXMAN/HATCH

"ESSENTIAL TESTING" FOR EXCLUSIVE MARKETING PROTECTIONS UNDER WAXMAN/HATCH would be defined by PMA (Pharmaceutical Mfrs. Assn.) to exclude (1) reports from the literature which were not sponsored by an ANDA or NDA applicant and (2) bioavailability studies. ln recent comments to the FDA two types of studies specifically be denied consideration by FDA as support for marketing exclusivity rights. Overall, PMA addressed 15 regulatory topics in its suggestions to FDA.

PMA urged FDA to set up procedures for making the "essential study" decision automatic for IND trials. PMA suggested that if FDA fails to notify a sponsor within 30 days of submission of an IND proposal that the studies are not essential, the sponsor shall assume that "one or more of the proposed studies shall be considered essential."

The assn. also argued that "unpublished clinical studies previously conducted by or for the applicant may be considered essential if the studies satisfy" the requirement for new information to support an approval.

"The definition of sponsorship of a study should be broadened to include providing financial, technical, or in-kind support to the scientific studies underlying the reports or investigations," PMA said. "Such support need not comprise the major funding of the reports or investigations," PMA proposed. The assn. added a provision that would allow sponsors to acquire the rights to a study after it has been concluded. The assn. said that support for an essential study "need not be received in advance of the performance of such studies.

The Generic Pharmaceutical Industry Assn. (GPIA) attacked the broad interpretation of "rights of reference" in comments to FDA, dated July 23. "To suggest that any kind or amount of financial, technical or in-kind support whenever rendered establishes that a study was conducted on one's behalf misses the point entirely." The key determining factor to whether a sponsor can claim that it is submitting a study is essential to approval of a product must be "whether one sponsored, commissioned or ordered and thereafter supported the investigations at issue," GPIA contended.

The generic industry group maintained that if the investigations had been "conducted in the absence of such sponsorship and support, they cannot be said to have been conducted on behalf of the party claiming the exclusive interest in them."

The after-the-fact sponsorship of an essential study should not be allowed as a basis for marketing exclusivity, GPIA said. The generi group argued that PMA's support for that approach runs "entirely counter to the intent of Congress to reward those who place themselves at risk in conducting research." GPIA said: "PMA ignores the fact that Congress provided non-patent periods of exclusivity to stimulate research and reward those who successfully conduct it." GPlA further suggested language that would prevent use of govt.-funded studies for an exclusive indication.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1985 F-D-C Reports, Inc., The Pink Sheet, July 29, 1985 (NEW DOCUMENT)9991AD933EFAFA02:$=C00C9000100001F4D0000(ITEM 001)Copyright (COPYRIGHT) 1985 F-D-C Reports Inc.(ITEM 002)The Pink Sheet(ITEM 010)47(30): T&G-3(ITEM 020)July 29, 1985(ITEM 030)TRADE & GOVT. MEMOS(ITEM 050)527 words(ITEM 120)

GPIA's SUGGESTIONS FOR DEFINING "ESSENTIAL" STUDIES TO QUALIFY FOR EXCLUSIVE RIGHTS

Reprinted by "The Pink Sheet" from July 23 comments to FDA. GPIA prefaced the criteria by pointing out that it believes "the staturory language is clear" and further regulations on essentiality are dot necessary. If the agency decides to provide regulatory guidance, GPIA said: "We suggest [that FDA] take into account the following factors."

(1) A right of reference or use in reports of in- vestigations must be obtained from the person or persons by or for whom the investigations were conducted, or their successors in interest.

(2) Persons authorized to provide such a right of reference or use are those who sponsored and supported the investigations and without whose sponsorship and support the investigations would not have been conducted, or their successors in interest.

(3) Government sponsored and funded research is public property in which no private person may secure or claim any exclusive interest.

(4) No applicant or holder of an approved application may claim exclusive rights in any investigation that he did not sponsor and support, unless he is a successor in interest of such a sponsor.