Exclusivity Period For NDIs Would Promote R&D, Consultants Claim
This article was originally published in The Tan Sheet
Executive Summary
A term of exclusivity for novel dietary supplement products would spur R&D investment by manufacturers, according to George Burdock, PhD, president of the Burdock Group
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A term of exclusivity for novel dietary supplement products would spur R&D investment by manufacturers, according to George Burdock, PhD, president of the Burdock Group. "This period of exclusivity will allow industry an opportunity for return on investment, without which there would be very little R&D and only the existing 'wild wild west'" marketplace would remain, Burdock said at an FDA public meeting on new dietary ingredient (NDI) submissions Nov. 15. Research and development spending currently accounts for a fraction of 1% of sales for the majority of companies within the dietary supplement industry. An exclusivity term would allow safety information to be disseminated to the public, but efficacy data would remain embargoed by FDA, Burdock explained. "If any other manufacturer wishes to sell an identical product using the same claim during the period in which the information is embargoed, [the manufacturer] must present its own efficacy information to the agency," Burdock noted. Absent such incentives, some firms already are increasing R&D spending. For example, Natrol announced last August that it planned to allocate 4% to 5% of revenues for internal pipeline development (1 (Also see "Natrol Stresses R&D Spending Hike As Part Of Core Strategy" - Pink Sheet, 25 Aug, 2003.), p. 17). Nevertheless, several meeting attendees agreed with the idea of exclusivity. "In the present situation, competitors can piggyback on established efficacy data and patent protection is rarely possible for these kinds of products," said Willi Hunziker, CEO of Hunziker Consulting. If FDA is unwilling to adopt a patent exclusivity period for products, the agency should make other concessions to create incentive for firms to bring new ingredients to market, Hunziker suggested. "Other possibilities would be prohibition of data 'piggybacking,' authorizing brand-specific claims and other ideas with the goal to allow the first mover to get his investment back," he maintained. |