Showing papers by "Tufts Center for the Study of Drug Development published in 2000"

New Drug Innovation and Pharmaceutical Industry Structure: Trends in the Output of Pharmaceutical Firms:

Abstract: This study examines what is generally regarded to be the most important measure of innovation in the pharmaceutical industry—the extent to which new drugs are developed and marketed by pharmaceutical firms. Pharmaceutical industry output, as measured by new chemical entity (NCE) approvals in the United States since the 1962 Amendments to the Federal Food, Drug, and Cosmetic Act of 1938, is examined at the firm level. This long-term historical perspective permits us to observe the extent to which this industry has been concentrated with respect to innovative output and how stable company leadership positions have been over time. Databases containing detailed information on all NCEs approved in the United States from 1963 to 1999 and on a large sample of investigational NCEs taken into clinical testing since 1963 were utilized to examine productivity in developing new products at the firm level according to the following stratifications: period of approval, therapeutic class, whether the compounds were self...

The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era

Abstract: This is the fifth in a series of triennial reports by the Tufts Center for the Study of Drug Development (CSDD) examining various aspects of recent new drug approvals in the United States. In 1996, 1997, and 1998 the United States Food and Drug Administration (FDA) approved 122 new drugs, 110 of which met Tufts CSDD’s definition of a new chemical entity (NCE). Of the 110, 38 (35%) received priority review, while 72 (65%) had standard review. The mean length of the clinical phase (investigational new drug application [IND] filing to new drug application [NDA] submission) was 70.3 months (ie, 5.9 years), and the approval phase (NDA submission to approval) was 16.8 months (1.4 years). Both the clinical and approval phases represent decreases from those values for the previous three-year period (19% and 31%, respectively). The decrease in the clinical phase for the 1996 to 1998 NCEs represents the first such decline since the mid-1980s. The mean approval phase for priority NCEs (11.8 months) was 38% shorter than that for standard NCEs (19.5 months). Of the 107 NCEs for which foreign marketing data were available, 49% were first approved for marketing in the United States, while 26% were available in foreign markets one or more years prior to United States approval, with a mean of 5.7 years of prior foreign marketing. The percent of products first available in the United States represents a considerable increase over that number for previous years.

Measuring the Pace of New Drug Development in the User Fee ERA

Abstract: The Prescription Drug User Fee Act of 1992 (PDUFA) is credited with the dramatic reduction in new drug approval times seen since 1993. Despite the faster approval times, however, the total time required for new drugs to reach the marketplace had not changed appreciably. With passage of the FDA Modernization Act of 1997 (FDAMA), the United States Food and Drug Administration (FDA) expanded its focus from shortening the regulatory review phase to helping drug developers reduce lengthy clinical development times and increase the speed to market for new products. Our analyses document a sharp downward trend in approval times during the 1990s—average approval time for new drugs fell 58%, from 31.3 months in the period 1990 to 1991 to 13.2 months in the period 1988 to 1999. Moreover, the percentage of new drugs approved in less than six months increased from 4% in 1992 to 28% in 1999. The data also show that, while average clinical development times increased by 14% from the period 1990 to 1991 to the period 19...

Patient autonomy and social fairness.

Abstract: In this paper, an attempt is made to give patient autonomy added conceptual clarity. A concept of patient autonomy grounded in both negative and positive freedoms is defended. Amartya Sen's capabilities approach is used as a conceptual framework in which patient autonomy and fairness are defined compatibly. It is argued that in a socially fair healthcare system, everyone should have at least the degree of patient autonomy that affords access to those healthcare services necessary for survival and a minimally adequate level of quality of life, consistent with each person's naturally endowed health characteristics.

The Health of the World's Children: What Goes Around, Comes Around:

Abstract: Close to one-third of deaths worldwide are from diseases which are preventable or treatable with existing vaccines and drugs. Yet, half the world’s population, including some 1.5 billion children, lack regular access to essential therapeutic drugs. Due to the global economy, the ease and frequency of world travel, immigration, and the emergence of drug-resistant infectious diseases, the health problems of the developing world are now everyone’s problems. In order to ensure that our shared future is a healthy one, the world’s wealth and wisdom must be shared as well. One way in which the expenditure of resources in the developed world, in particular the United States, will result in a sharing of knowledge with the developing world is through the United States pediatric studies initiative, which will increase the availability of reliable prescribing information for drugs used in children. The ultimate goal is to make sure that drugs essential for the health needs of the world’s children are available, affordable, and properly used.

The Food and Drug Administration Modernization Act and the Food and Drug Administration: Metamorphosis or Makeover?

Abstract: The Food and Drug Administration Modernization Act of 1997 (FDAMA) is the first legislation to bring about significant and widespread modifications to the regulatory environment for drugs and biologicals in more than 35 years. The expectations of what FDAMA is to accomplish are high. This article reviews the results from the first two years of implementation of the major FDAMA provisions for drugs and biologicals. First, however, the elements of the adversarial culture that brought about the impetus to modernize FDA are discussed. Next the article focuses on FDA’s more “modernized” approach to the process of governing, through the use of such mechanisms as governance by guidance, direct final rules, national videoconferences, and stakeholders meetings. In addition, the process for implementing FDAMA and what the products of that process have been, both the rules themselves and the outcomes for the regulated community, are discussed. Lastly, the article considers whether FDA is capable of change and what the real message of FDAMA is.