This Subcommittee has done an outstanding job under your leadership, Mr. Chairman, and the leadership of the ranking minority member, in the stewardship of our intellectual property laws. The Congress has recognized that while virtually all other innovators can immediately seek a market return upon receipt of a patent, innovators of pharmaceutical products must also meet the requirements of our food and drug laws prior to market entry. In fact, Mr. Chairman, it is the unique interaction of these two legal schemes our patent laws and our food and drug laws which gives rise to the legislation before you today. - Specifically, I am here today in support of legislation that provides a five-year patent extension on behalf of our lipid regulating drug Lopid. This proposal is embodied in both the legislation before you today, H.R. 3074, as well as Title 36 of the Senate Trade Bill. It is our firm belief that Lopid's unique regulatory history, based on additional testing required by the FDA for approval testing which will make very significant contributions to medical science and to patients suffering from coronary artery disease clearly supports such an fatal extension. - - As background to H.R. 3074, Mr. Chairman, I would like to of Warner-Lambert's research and begin with an explanation development efforts which culminated in the discovery of gemfibrozil, or Lopid. As you know, heart disease is the nation's leading killer, annually claiming the lives of more than half a million Americans. Heroic efforts are now underway to reduce that toll by promoting exercise and diet regimens, as well as screenings for high blood pressure and cholesterol. Lopid is an active participant in this all-out war to conquer coronary heart disease. In 1956, Warner-Lambert's pharmaceutical subsidiary, ParkeDavis, began a basic research program aimed at developing agents which can manage cholesterol concentrations in the blood, thereby reducing the risk of arteriosclerosis ΟΙ hardening of the arteries. Lopid is the result of that 30-year R&D effort. Within that program, we have synthesized and screened some 15,000 novel compounds at our research center in Ann Arbor, Michigan. We have expended approximately $140 million in this effort. We have also underwritten the most extensive privately financed medical study in history, to demonstrate Lopid's ability to prevent heart attacks. Lopid was synthesized in 1968, and toxicology workups were initiated in 1969, the same year that our patent application was filed. Consistent with the overall pattern of drug development, the investigation of Lopid and its ultimate approval took years. The Investigational New Drug Application (IND) was submitted to the FDA in 1971, and the New Drug Application (NDA) was submitted in 1980. Ultimately, the FDA deemed that Lopid was approvable on September 25, 1981. The NDA was officially approved on December 21, 1981. History of Legislative Effort The Senate Judiciary Committee, after substantial public discussion, voted out our Lopid amendment by a unanimous 13-0 vote as part of a substitute amendment for the Process Patent incorporated into S. 1420, the Omnibus Trade and Competitiveness Act of 1987. And as I have noted, the Lopid provisions are found in Title 36. 1/ Senators involved in this debate or voting to report this legislation from committee, in person or by proxy, included Senators Biden, Kennedy, Metzenbaum, DeConcini, Leahy, Heflin, Simon, Thurmond, Hatch, Simpson, Grassley, Specter and Humphrey. 5 FDA Approval of Lopid Two issues surrounding FDA approval of Lopid are key elements to the unique hardship upon which Our request for this legislation rests. First of all, the terms of the 1981 FDA approval were extremely narrow. While the Lopid clinical experience demonstrated its utility over a broad range of blood fractions (low-density lipoproteins, very low-density lipoproteins, triglycerides, and high-density lipoproteins), the approved claim was for adults with elevated triglycerides at risk for pancreatitis. That's a very small segment of the population at risk for coronary heart disease. We had sought approval, and indeed developed the drug, to treat a much broader range of cholesterol related health problems. Secondly, the terms of even that limited approval were contingent upon agreement to conduct an extensive post-marketing or Phase IV study. In that study we were required to demonstrate further Lopid's safety and that its use results in decreased morbidity or mortality from heart disease. As far as we have been able to determine, this is the only Phase IV study ever required by FDA to investigate an unapproved claim. It is also our understanding that it is the longest Phase IV study ever mandated by the FDA. 6 The Phase IV study requirement is amply demonstrated in the letters from FDA to Warner-Lambert on September 25, 1981 and December 21, 1981. For example, the September 25 letter states: "Approval of this application is also contingent upon your commitment to conduct an appropriate Phase IV study of certain aspects of effectiveness and long-term safety of gemfibrozil. Satisfactory completion of the ongoing Finnish study would be expected to meet this condition." These letters are included as attachments to my testimony. The study in Finland, to which the FDA approval letter refers, was preceded by a five-year open label study, which began in 1974, among 254 high-risk males in Finland. That study was underwritten by Warner-Lambert. At that time, Finland had the world's highest rate of coronary heart disease among that population group, and was seen as an excellent clinical Results of that unblinded laboratory for such an investigation. pilot study showed a 70 percent reduction in the anticipated rate of heart attacks. |