FDA PATENT EXTENSION REGS: TIME TO RESPOND TO A DUE DILIGENCE PETITION

FDA PATENT EXTENSION REGS: TIME TO RESPOND TO A DUE DILIGENCE PETITION is increased to 30 days under the final regulations, published in the March 7 Federal Register. The final rule notes that FDA received six comments on the proposed rule, which was published in July 1986, "urging that the 10-day period allowed a patent extension applicant to respond to a due diligence petition be increased." The final rule also modifies the section on due diligence petitions to require that a patent extension applicant submit a response to a due diligence petition. "As modified, the section imposes a duty, rather than simply an opportunity, to respond to applicants who wish to oppose a due diligence petition," the rule states. FDA explained that the change was being made in response to comments that pointed out that the proposed rule "could be construed as creating a presumption that the applicant acquiesces to a reduction [in patent extension] by failing to reply to a due diligence petition." Under the final rule, a "failure to respond will not be treated as acquiescence to the due diligence petition," FDA said. "In such cases, FDA will decide the matter on the basis of the materials presented in the patent extension application, due diligence petition, and FDA records." The final rule retains the provision that the date of approval, for purposes of determining the regulatory review period, occurs on the date that FDA notifies the firm that the NDA is approved, regardless of the status of drug scheduling. FDA received four comments on the proposed rule requesting that drugs regulated by the Drug Enforcement Administration should not be considered to be approved until they are scheduled. "The agency declines to adopt the suggestion," the rule states. "The statute specifically defines the approval phase of a regulatory review period for a human drug product as 'the period beginning on the date an application was initially submitted . . . and ending on the date such application was approved'" under the FD&C Act and Public Health Service Act. "The statute makes no reference to the Controlled Substances Act," FDA said. "One cannot assume that Congress meant to include scheduling under the Controlled Substances Act as a necessary condition to a drug's marketing approval under the FD&C Act or the Public Health Service Act," FDA continued. The agency also noted that its position is supported by the recent appeals court decision that the date of approval for Norwich Eaton's Buprenex was the date FDA issued an approval letter, and not the date of DEA scheduling. Norwich Eaton had filed suit against the agency claiming that the patent extension determination for the drug should be based on the date of approval of final printed labeling incorporating DEA scheduling.