additional disincentive, innovators typically lose-years of patent exclusivity because of testing requirements and regulatory review. We are mindful of the paradox that the careful and time-consuming scientific review needed to confirm safety and effectiveness may be reducing initiatives to develop drugs that come to FDA for review. Streamlining the regulatory process will help. However, our premarket approval system must continue to be thorough enough to assure the safety and efficacy of new drugs and devices and the safety and functionality of food and color additives, even if that means living with a process that takes longer than we would ideally prefer. We want to encourage innovation, but not at the expense of safety. Consequently, the Department of Health and Human Services supports patent extension legislation as a means of encouraging innovative research. Title II of S. 2748 As with the ANDA portion of S. 2748, we believe the patent restoration provisions in the bill reflect a major step toward equitable legislation in this area. We do have some concerns that we would like to share with you, however, about the impact that this legislation would have on the operation of FDA. We also understand that the Patent and Trademark Office of the companion bill to S. 2748, which we would commend to the Committee's attention. 1. FDA Need Not Determine the Regulatory Review Period for Every Product S. 2748 would require an applicant for patent extension to submit to the Commissioner of Patents a brief description of the applicant's activities during the premarket regulatory review period and the dates of certain significant milestones that occurred during this period. The Commissioner of Patents would be required to send a copy of the application containing this information to the Secretary of Health and Human Services, who would be required within 30 days to determine the applicable regulatory review period. Having to determine and confirm the regulatory review period for each product would be burdensome to FDA because the Agency would have to store and retrieve information in a form which otherwise would be of little or no utility to it. We believe this burden could be eliminated by requiring the applicant, rather than FDA, to determine the regulatory review period in its application to the Commissioner of Patents. The formula for doing so is provided in the bill, and the applicable dates would be well known to the applicant. The applications could be made available to FDA for inspection or audit at FDA's discretion on the same enforcement basis that other reports, such as income tax filings, are regulated. Since the patent term extension is added on to the end of the patent term, we can perceive no public health reason to require FDA to determine the regulatory review period under a restrictive 30-day time schedule. The regulatory review period may be adequately determined and validated through a submission by the applicant and a discretionary review by FDA. 2. The Determination of "Due Diligence" Should Be Deleted S. 2748 would require the Secretary to determine whether an applicant acted with "due diligence" during the regulatory review period if the Secretary were petitioned to do so within 180 days after a patent extension determination is published. If the Secretary were to find that an applicant did not act with due diligence for some period of time, the amount of patent extension that the applicant would be entitled to could be reduced. The concept of "due diligence" is a laudable attempt to make patent restoration as fair as possible by disallowing time during which the development of a product was not vigorously pursued. However, we believe that the overwhelming majority of applicants would be entitled to the five-year maximum allowable patent restoration in S. 2748. This is true because the regulatory review period will generally be longer than necessary to confer the full extension period even assuming a reasonable attempt by both the applicant and FDA to assure prompt evaluation of the applications. A deduction for lack of due diligence would reduce the time that may be counted toward patent restoration down toward this five-year maximum, but probably not below it. Nonetheless, under the bill, FDA would be required to promulgate regulations, review petitions, prepare due diligence determinations and conduct hearings. As a practical matter, ther.fore, it appears that a complex system would be established that would require FDA resources to implement and maintain for no net public benefit. We therefore strongly urge that this feature of the bill be deleted. EXPORT OF UNAPPROVED DRUGS I turn my comments next to the issue of the export of unapproved new drugs. We appreciate receiving a draft of proposed legislation that would authorize such export. Before commenting specifically on the draft, however, I would first like to put this issue into some perspective. As the Subcommittee recognizes, the FDC Act does not presently permit the export of unapproved new human and animal drugs except for certain carefully controlled exports for investigational use abroad. Similarly, the Public Health Service Act does not permit the export of unlicensed biologicals. The Department of Health and Human Services (DHHS) and the FDA have in the past been asked to consider statutory amendments to permit the export of unapproved new drugs and unlicensed biologicals. For example, the proposed Drug Regulation Reform Act of 1978 contained a provision for the export of unapproved new drugs. Although the Department has no current legislative initiative on this subject, we will be pleased to work with you in providing comments on the current proposal or any other specific proposal this committee should advance. Let me now take a few moments and discuss our current thinking on this issue. We believe we have an excellent precedent right in the FDC Act, that being the provision authorizing the export of unapproved medical devices. We believe that provision contains adequate public health safeguards, and our experience with medical device exports under this provision of the FDC Act has been quite favorable. For example, we are not processing approximately 250-300 export requests per year under the medical device provision. We will be happy to provide more specific information regarding our export experience with medical devices for the record, if you feel that would be useful. The Medical Device Amendments of 1976 permit the export of certain classes of medical devices, including unapproved medical devices, if they: (1) accord to the specifications of the foreign purchaser; (2) are not in conflict with the laws of the country to which they are intended for export; (3) are labeled on the outside of the shipping package that they are intended for export; |