Showing papers by "Tufts Center for the Study of Drug Development published in 1997"

The new drug approvals of 1993, 1994, and 1995: trends in drug development.

Abstract: Growing concern within Congress, the pharmaceutical industry, and the Food and Drug Administration (FDA) over the excessive time and cost required to develop new drugs and bring them to market has led to several initiatives designed to speed the drug development process, e.g., the Prescription Drug User Fee Act of 1992 and recent efforts at legislative reform of the agency. To assess the impact of these initiatives, it is useful to examine recent trends in new drug development and review. This report is the fourth in a series in which we analyze new chemical entities (NCEs) recently approved by the FDA. In 1993, 1994, and 1995, the FDA approved 75 new drugs, 67 of which met the Tufts Center's definition of an NCE. Of the 67, 31 (46%) received priority review, 13 (19%) had orphan drug status, and 5 (7%) were approved under the accelerated approval regulations. For the 67 NCEs, the mean length of the clinical phase (investigational new drug filing to new drug application submission) was 7.1 years, and the approval phase (new drug application submission to approval) was 2.0 years. The mean approval phase for the 31 priority NCEs (1.5 years) was 38% shorter than that for the 36 standard NCEs (2.5 years). Compared with similar values for the previous 3-year period, the mean clinical phase for all NCEs increased by 16%, whereas the mean approval phase decreased by 23%. Of the 66 NCEs for which foreign marketing data were available, 34 (52%) were available in foreign markets one or more years prior to U.S. approval, with a mean of 7.7 years of earlier foreign marketing.

The prescription Drug User Fee Act of 1992 and the new drug development process.

Abstract: The Prescription Drug User Fee Act of 1992 (PDUFA) authorizes the US Food and Drug Administration (FDA) to levy user fees on manufacturers who submit applications to the agency. Revenues are dedicated to the achievement of a set of specific performance goals, documented by the FDA Commissioner and referenced in the Act. The FDA currently credits PDUFA with the agency's success in reducing new drug review times and eliminating the formidable new drug application (NDA) backlog. To provide an independent assessment of PDUFA's impact on the new drug development process, the Tufts Center for the Study of Drug Development established an annual user fee survey of over 50 major pharmaceutical and biotechnology firms with operations in the United States. As of December 31, 1996, survey data have been collected for fiscal years 1994, 1995, and 1996. Data from a cohort of user fee drugs approved in 1993-1996 were compared with data from all non-user fee drugs approved in 1990-1992. Whereas the mean approval phase (NDA submission to approval) for the user fee drugs was considerably shorter than that for the non-user fee drugs (14.5 versus 31.0 months, respectively), the mean clinical phase (investigational new drug application filing to NDA submission) was somewhat longer (88.0 versus 81.1 months, respectively). As a result, the total time from the start of clinical testing to drug approval (total phase) was only marginally shorter for the user fee drugs (102.0 versus 112.1 months, respectively). These results highlight the need for efforts to reduce lengthy drug development times.

The US orphan drug programme 1983-1995.

Abstract: The Orphan Drug Act has become a staple of food and drug law in the US. The experience with the US programme continues to serve as a useful reference point as interest in orphan drug incentive programmes expands globally. This article first reviews details of the legislation and orphan drug regulations, and then provides a 13-year overview (1983–1995) of orphan drug activity in the US, including descriptive data on the designated and approved orphan drugs, their indications and sponsors. In light of a recent challenge to the Food and Drug Administration’s (FDA’s) authority under the Act, we also examine the interplay between the exclusivity provision of the Act and the orphan drug regulations that define when 2 drugs will be considered the ‘same’ for the purposes of the Act. A recent court decision affirming the FDA’s interpretation of the clinical superiority provisions of the regulations suggests that orphan exclusivity may be less predictable and less certain than it has been in the past. Finally, we consider the usefulness to orphan drug sponsors of other initiatives such as FDA’s early access and fast-track approval programmes, and the extent to which the FDA’s discretion to waive, defer and reduce prescription drug user fees has worked to the benefit of orphan drug sponsors.

Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences

Abstract: Survey data were used to examine the effects that various factors may have on the length of the new drug development and approval processes. These factors include the use of formal conferences between the Food and Drug Administration (FDA) and drug manufacturers. Analyses were based on the type, number, and timing of formal FDA-sponsor meetings for new chemical entities (NCEs) approved from 1987 through 1995. The practice of holding formal conferences was widely applied; 91% of the NCEs were the subject of at least one conference during development or regulatory review, and 46% of the NCEs were the subject of at least three conferences. In addition to conferences, a number of other factors conjectured to have an effect on development and approval times were examined as explanatory factors in multiple regression analyses. The regression results for the new drug application (NDA) phase (NDA submission to NDA approval) indicated that pre-NDA meetings and NDA Days were associated with shorter approval times. Other factors that were shown to be associated with shorter approval times are a priority rating by the FDA, treatment IND status, the submission of a computer-assisted NDA (CANDA) simultaneously with the paper application, and inclusion in the user fee program. Regressions on the investigational new drug application (IND) phase (IND filing to NDA submission) showed that pre-IND meetings and end-of-Phase II conferences were associated with shorter clinical development times, while NCEs with treatment INDs and NCEs that were subject to the user fee program were associated with longer clinical development times. These results provide empirical support for the hypothesis that collaboration between the FDA and drug sponsors has generally expedited new drug development and regulatory review.

FDA Reform: Setting the Stage for Efforts to Reform the Agency

Abstract: Efforts within Congress, the Executive Branch, and the Food and Drug Administration (FDA) itself to reform agency function reflect a serious commitment to improve the new drug development process in this country and speed patient access to important new medical therapies. In this report, various factors that provide the underpinnings of these FDA reform efforts are considered. Important considerations are the increasing time spent in clinical development for new drugs, the growing trend for United States-based firms to initiate Phase I clinical testing overseas, and the delayed marketing of new products in this country relative to other markets. The result has been several strategic themes that are integral to most of the major reform proposals currently under consideration.

Issues in pharmaceutical lotteries: The case of interferon beta-1b

Abstract: Clinical Pharmacology & Therapeutics (1997) 62, 241–247; doi: