Posted by AndrewB on November 25, 2000, at 22:46:17
The following excerpt details the lack of availablity of many good drugs in the US and goes on to explain why this has occurred and suggests a means of rectifying this unfortunate situation. To view the full article (entitled, "The Economics of Psychotropic Drug Development") go to www.acnp.org/G4/GN401000182/default.htm.
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Psychopharmacological innovations are not disseminated to all countries at even roughly the same time. In some instances, the lag between the availability of a psychotropic drug in two countries is substantial. A number of studies have specifically examined the availability of new drugs in the United States in relation to other industrialized countries. Wardell (44) documented a U.S. lag with respect to the United Kingdom in the availability of new drugs introduced in either market during 1962 to 1971. He found that, of 28 psychotropic NCEs approved in either country, 13 were exclusively available in the United Kingdom, while only four were exclusively available in the United States.Later studies updated the Wardell analysis for more recent periods. Wardell (45) examined NCEs approved in the United States and the United Kingdom during 1972 to 1976. Of the 14 psychotropic NCEs made available during this period, eight were exclusively available in the United Kingdom and three were exclusively available in the United States. The most recent update in this series (25) found that, of 29 psychotropic NCEs made available during 1977 to 1987, 12 were exclusively available in the United Kingdom and five were exclusively available in the United States. Of the 12 psychotropic NCEs that were mutually available during this period, nine had been introduced in the United Kingdom first.
More recently, Kessler et al. (29) of the FDA compared the availability in four countries (United States, Germany, Japan, United Kingdom) of drugs introduced onto the world market from 1990 to 1994. The therapeutic value of these drugs was assessed based on the FDA’s therapeutic rating system and the expert judgment of the study’s authors. Overall, the availability of drugs that entered the United States market and the markets of at least one of the other three countries was obtained more quickly in the United States than in Germany and Japan. The speed with which drugs entered the U.S. and U.K. markets was similar.
Moreover, in two-country comparisons of drugs that were available in one country but not the other, the authors found that the United States had more exclusively available important drugs when compared to each of the other countries. However, when we examined the drugs in the Kessler et al. (29) sample that were available in the United States and not in one of the other three countries (as of April 1995) we found few psychotropic drugs. Of the 18 drugs that were available in the United States but not the United Kingdom, none are psychotropics. Additionally, of the 31 drugs that were available in the United States but not in Germany, three are psychotropics (nefazodone, sertraline, and venlafaxine). Finally, of the 62 drugs that were available in the United States but not in Japan, five are psychotropics (nefazodone, paroxetine, risperidone, sertraline, and venlafaxine). Among the psychotropics that were available in the United States and not in at least one of the other three countries, the United States was the first market worldwide for only one (venlafaxine).
The availability of psychotropic drugs was the focus of two recent studies. Vinar et al. (43) surveyed clinical pharmacologists about the usefulness of 50 psychotropic drugs that were either marketed or in late stage clinical trials in Europe, but not available in the United States, for therapy or as a research tool. Twenty of these drugs were judged to be of particular interest after experts rated the drugs on the basis of novelty of mechanism of action and probable safety in comparison with drugs available in the United States. Some of the drugs have been available in Europe for decades. As of the end of October 1998, none of these drugs had been approved in the United States.
Many of the drugs in the Vinar et al. (43) list have lost, or are close to losing, patent protection. They therefore likely have limited economic potential. Vinar et al. argue for the creation of a board of pharmacological experts that would make recommendations to the FDA about foreign drugs that should be considered for accelerated regulatory review and, like compounds now given orphan drug designation, be granted a period of marketing exclusivity.
Glick et al. (17) examined the controlled clinical trial literature and surveyed 61 expert clinicians (from six West European and two East European countries), European regulatory authorities, and representatives of the pharmaceutical industry to identify psychotropic drugs with apparent advantages over conventional treatments that are available in Europe but not in the United States. The authors identified 12 compounds, eight of which had been approved in three or more of six countries whose approvals were examined. As of this writing, none of the 12 drugs have been approved for marketing in the United States. As in Vinar et al. (43) the authors recommend that a board of experts be established in the United States that would be empowered to extend marketing exclusivity for promising compounds (if approved by the FDA) that are available abroad. Additionally, for compounds that have lost patent protection they suggest government support of clinical trials in academic centers.
Many of the psychotropic drugs that do make it to the U.S. market have had lengthy periods of prior foreign marketing. The CSDD database on NCEs approved in the United States contains information on the country in which the NCE was first marketed and the date of first marketing. Figure 10 shows how psychotropic NCEs approved in the United States are distributed according to the number of years of prior foreign marketing. The United States was the first market for only 29% of the drugs. The proportions of drugs approved first in the United States or within one year of approval in the
United States are similar for all NCEs as for psychotropic drugs (33% approved in the United States first and 15% approved within one year of first foreign marketing for all NCEs). Proportionately many more of the psychotropic drugs that have been approved in the United States, however, have been available in a foreign market for a very long time. Only 10% of all NCEs have six to ten years of prior marketing, and 9% of all NCEs have been marketed in another country for more than ten years prior to U.S. approval. The lengthiest periods of prior foreign marketing for the psychotropics were for some of the most innovative drugs in this class. Clozapine was available in a foreign market (Switzerland) 17 years prior to U.S. approval, and clomipramine was first available 20 years before U.S. approval (Finland).
poster:AndrewB
thread:49426
URL: http://www.dr-bob.org/babble/20001115/msgs/49426.html