of the Constitution, the Government is barred from passing laws which impair such rights of contract. - Patent rights are also recognized as property rights. The retroactive deprivation of one of these rights, i.e., the exclusive right to develop information for FDA submissions, constitutes an uncompensated "taking" in violation of the Fifth Amendment of the Constitution, as well as a violation of the Due Process Clause of that Amendment. - Section 202 also violates the Constitutional principles concerning the Separation of Powers, in that it would reverse the decision of the Federal Circuit Court of Appeals in Roche Products Inc. v. Bolar Pharmaceutical Company, Inc., even though that case is still pending. Section 202 intrudes Congress into the District Court proceedings where that case has been remanded to deny the relief to the patentee to which the Federal Circuit has ruled it is entitled. As we discussed earlier today, we are working An example of the variety of patent law issues This is only one of many issues that require thorough hearings and independent judgment by the Judiciary Committee. A fuller discussion of the patent law issues which the bill proposes to resolve in a manner inconsistent with established patent policy is provided in the second memorandum I am attaching to this letter. For these reasons, we think it would be appropriate for the Judiciary Committee to ask for a period through the end of July in which to study the bill and, once received, to ask Chairman Kastenmeier's Subcommittee to promptly commence an appropriate set of hearings. I am sure that all the parties concerned with these issues will be prepared to present witnesses at the hearings. In this regard, it is significant, as you know, that no hearings at all have been held before the Judiciary Committee on these important issues. Indeed, representatives of the Pharmaceutical Manufacturers Association and the Generic Pharmaceutical Industry Association were scheduled to testify last week on these very issues before Chairman Kastenmeier's Subcommittee, but at the last moment declined to testify. We think it is imperative that a record be made on these important Judiciary Committee issues and, as I said, that your Committee make an indepenent call on these troubling provisions of the proposed legislation. Thanks so much for your consideration. I hope you will share these concerns with Chairman Rodino. POSITION PAPER The companies, which are among the nation's leading research-based pharmaceutical companies, favor a patent term restoration abbreviated new drug application bill which: (1) Restores patent life lost to regulatory review for innovative drug products; and (2) Accelerates the availability of safe and effective generic drug products. The companies are prepared to support a bill that addresses the following issues: LIMITS ON FDA AUTHORITY TO ASSURE SAFETY AND EFFICACY Background Unlike current ANDA regulations for drugs approved before 1962, the June 2 discussion draft precludes FDA from requesting information from an ANDA applicant concerning its drug product beyond the limited information specifically set forth in the draft. This does not permit FDA to request safety and effectiveness data other than bioequivalence data. In addition, the draft does not authorize rejection of an ANDA for most drugs on grounds of lack of safety or effectiveness. Recommendations Congress should maintain FDA's explicit discretionary authority: (1) to require safety and effectiveness information from an ANDA applicant when needed to protect the public health; and (2) in such instances, to disapprove any ANDA if the applicant is unable to demonstrate that its drug product is safe and effective. We believe that failure to include simple clear authority in the bill will: (1) raise questions about the scope of FDA's authority; (2) probably result in litigation; and (3) perhaps create a separate class of products subject to premarket - 1 approval requirements post-1962 ANDAS - for which FDA will be unable to obtain adequate safety and efficacy data. Simply stated: The FDA, which is charged by statute with protecting public health, should have the same authority for all products it approves to properly protect consumers. ENCOURAGEMENT OF PATENT LITIGATION Background Under the discussion draft, an ANDA applicant can force the patent holder to litigate the validity of the patent well before the ANDA filing date and at a time when the applicant has incurred only minimal investment. The bill permits the ANDA applicant, in effect, to compel the patent owner to commence litigation on the validity of a patent within 45 days of receiving notice of formulation occur only upon the "filing" of a complete ANDA. As used in the |