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BIOTECH DRUG EXCLUSIVITY VIA WAXMAN/HATCH EXTENSION

Executive Summary

BIOTECH DRUG EXCLUSIVITY VIA WAXMAN/HATCH EXTENSION will be considered by Sen. Hatch (R-Utah) in the coming months. The co-sponsor of the Patent Term Restoration and Drug Price Competition Act is planning to meet with industry and government experts, possibly in December, to discuss ways of adjusting the law. Former staffer Doug Campbell, speaking on behalf of Sen. Hatch at an American Pharmaceutical Association symposium Sept. 16, said that "the arrival of the age of biotechnology has presented us with issues which we couldn't have forseen legislatively even four years ago." He pointed out that "FDA has to grapple with how to handle market exclusivity for drugs which incorporate minute molecular alterations, sometimes of questionable therapuetic effect, to pioneer biological drugs." Campbell is now with the public relations firm Fleishman Hillard. The Utah senator will solicit input from PMA, the Industrial Biotechnology Association and generic drug trade associations, as well as from patent experts, on if and how the law might be changed to address the problem, according to a Hatch staffer. IBA has been actively supporting biotechnology drug-related adjustments to Rep. Waxman's (D-Calif.) Generic Animal Drug and Patent Term Restoration Act (HR 4982), which was recently reported out of the House Judiciary Committee's subcommittee on Courts, Civil Liberties and the Administration of Justice. The association, for example, is supporting an amendment that exempts animal drug and biological products derived from biotechnology processes from the provisions of the bill. Sponsored by Rep. Moorehead (R-Calif.), the amendment also contains a provision that denies FDA approval for generic animal drugs made through biotechnology methods. A corresponding Senate version of the bill has been introduced by Sens. Kennedy (D-Mass.) and Hatch (R-Utah). In addition to outlining the impact of Waxman/Hatch, the speech notes other problems that have arisen since the law was passed in 1984. The speech points out that FDA is now "being required to reconcile the language of the law, which focuses on molecular composition, with the emerging recognition that different foldings of the same complex molecule may give rise to therapeutic differences." It adds that "the resolution of these issues will widely affect the course of development of the biotechnology industry." One of the senator's concerns with the uncertainty surrounding exclusivity for biotech drugs is the result that more funds are being devoted to litigation than research. "I am disturbed by the confusion concerning patents for different versions of the same chemical compound," Hatch said. He noted that the "result seems to be that the key research decisions are being made by patent lawyers rather than by scientists." Hatch suggested that one possible solution is "to give a period of exclusivity to pioneer biotech products unless a subsequent version shows a substantial improvement in benefit. This, of course, would require legislation. And I will be looking at this and other proposals in the coming months." Hatch indicated that legislative changes would not be considered for all the problems that have resulted from the law's implementation, including FDA's application of the law's bioequivalence standard. "Some difficulty arises . . . in applying the concept of bioequivalence for drugs not absorbed into the bloodstream," he pointed out. "Also," he continued, "there are questions about whether certain hormone products are fairly treated because of the difficulty of distinguishing blood levels due to therapy, from blood levels due to the body's natural production."
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