Drug Approval Trends At The FDA And EMEA: Process Improvements, Heightened Scrutiny And Industry Response

Published by: Business Insights

Published: Apr. 1, 2008 - 147 Pages

Table of Contents

Drug Approval Trends at the FDA, EMEA

Executive Summary

The shifting regulatory landscape

Drug approval trends at FDA

Drug approval trends at EMEA

Industry response

Global drug approval trends through 2012

Chapter 1 The shifting regulatory landscape

Summary

Drug usage in the U.S. and Europe

New molecular entities

Generic drugs

Rising usage of generics

Generic drug application trends

Indication expansions

Drug approval issues

Ensuring drug safety

Safety shortfalls: rising adverse drug reactions

Safety failures: drug withdrawals

The importance of time to market

Impact of cost constraints

Conclusion

Chapter 2 Drug approval trends at the FDA

Summary

Drug approval process

Pressure to approve drug candidates

Future directions in the FDA drug approval process

Ensuring drug safety

Evolution of drug safety testing

Pediatric safety testing

Future directions in drug safety reviews

Reducing time to market

Fast track approvals

Orphan drug approvals

Decreasing FDA drug approvals

Future directions in speeding drug approvals

Delaying risky applications

Rising data requirements

Case study: hormone replacement therapy

Case study: Galvus

The future for risky drug applications

Biosimilars

The future of biosimilar approvals

Canadian biosimilars legislation

Rx-to-OTC switches

New OTC drug categories

Antihistamines

Emergency contraceptives

Hyperosmotic laxatives

Ophthalmic allergy medications

Proton pump inhibitors

Weight loss medications

Switch rejections

Statins

Future directions in nonprescription drug approvals

Creation of a pharmacist dispensed class

Marketing withdrawals

Application withdrawals

Future directions in marketing and application withdrawals

Conclusion

Chapter 3 Drug approval trends at the EMEA

Summary

Drug approval process

History of European drug regulation

The formation of the EMEA and the MRP

The EMEA

The Mutual Recognition Procedure (MRP)

The National Competent Authorities

The Common Technical Document

Ensuring drug safety

Creation of Scientific Advisory Groups

Future directions in drug safety testing

Reducing time to market

Accelerated opinions

Pediatric testing exemptions

Decreasing EMEA approvals vs. FDA approvals

Current EMEA approval levels

Future directions in speeding drug approvals

Delaying risky applications

The future for risky drug applications

Biosimilars

New biosimilar guidelines

Future directions in biosimilar approvals

Rx-to-OTC switches

Future directions in nonprescription drug approvals

Marketing withdrawals

Application withdrawals

Future directions in marketing and application withdrawals

Conclusion

Chapter 4 Industry response

Summary

Background

Improving safety testing

Genomics

Stem cell approaches

Future drug safety testing improvements

Raising investment in R&D

Improving R&D productivity

Contract research organizations

Repositioning

Future directions in R&D investment

Public reporting of clinical study results

United States

Europe

Association of the British Pharmaceutical Industry

Future directions in clinical data reporting

Strengthening regulatory processes

Coalition for a Stronger FDA

Future directions in regulatory support

Conclusion

Chapter 5 Global drug approval trends to 2012

Summary

Background

Trends at the FDA

Focus on drug safety

New technology-based standards for drug application review

Decreasing application review times

Boosting integrity and accountability

Trends at the EMEA

Focus on drug safety

Product Information Management (PIM) Project

Cooperation with other regulators

Incentives for small drug developers

Convergence of regulatory approaches

Orphan drug approvals

Conclusion

Chapter 6 Appendix

Index

List of Figures

Figure 1.1: Drug safety risk spectrum

Figure 1.2: Growth in U.S. reported adverse drug reactions, 1995 - 2007

Figure 1.3: U.S. R&D spending versus new drug approvals, 1995 - 2007

Figure 2.4: U.S. drug approvals, 1995 - 2007

Figure 3.5: Average number of days for centralized procedure positive opinions, 2004 - 2006

Figure 3.6: Average number of days for orphan drug designation opinions, 2004 - 2006

Figure 3.7: EMEA marketing withdrawals, 2000 - 2007

List of Tables

Table 1.1: Selected indication expansions for U.S. commercialized drugs, 2002 - 2007

Table 1.2: Potential safety risks of popular drug classes

Table 1.3: Significant drug discontinuations and affected patient groups, 1997 - 2007

Table 2.4: Timeline of key FDA legislations

Table 2.5: CDER Advisory Committees, 2008

Table 2.6: U.S. New Molecular Entity (NME) Approvals, 2000 - 2007

Table 2.7: Key U.S. Rx-to-OTC switches, 1997 - 2007

Table 2.8: Key events in the approval of OTC nonsedating antihistamines

Table 2.9: Recent withdrawals of U.S. marketing applications, 2002 - 2007

Table 3.10: Leading European National Competent Authorities, 2008

Table 4.11: U.S. Clinical trials and R&D spending, 2000 - 2007

Table 4.12: Selected repositioning specialists

Abstract

• The FDA and EMEA are asking for more data in drug applications that pose heightened safety concerns, although there have been no official changes in overall drug approval standards.
• The number of new molecular entities approved in the US each year has declined from 36 to 18 since 2004, despite a sustained increase in the amount of clinical trials conducted.
• The EMEA is approving fewer products than the FDA even though processing speed and volume have been significantly improved. System reforms include reduced review times, faster approvals for innovative drugs and relaxed requirements in pediatric trials.
• Information about new drug candidates is being increasingly shared by the FDA and EMEA as globalization continues throughout the pharma industry. Such convergence is prominent in the orphan drugs area, where evaluations require considerable resources.
• Biosimilar approval structures in the EMEA are significantly more comprehensive than those of the FDA. Europe is now becoming the global center for biosimilar development and production.

• Examine the latest developments in US and European drug approval processes with this report’s detailed analysis of the key regulatory issues surrounding new molecular entities, generic drug applications, indication expansions and drug safety.
• Understand the implications of rising adverse drug reactions by exploring the issues surrounding safety failures and measuring the potentially affected patient populations of recent discontinuations.
• Measure the future impact of drug approval trends on R&D programs using this report’s extensive review of anticipated changes to FDA and EMEA approval frameworks over the 2008-12 period.
• Evaluate the strategies that companies are using to accelerate drug approvals by understanding the latest industrial approaches to safety test improvements, outsourcing, repositioning and the management of clinical study results and data reporting.
• Benchmark successful drug applications and avoid approval delays with this report’s case studies featuring numerous profiles for issues such as risky drug applications, biosimilar approvals and Rx-to OTC switches.

• Delayed approvals. Regulators are requesting more data to validate or refute conclusions about product risks. This is creating a rise in the size and number of clinical trials as well as overall research budgets.
• Rising R&D costs. Drug developers are continually increasing their R&D expenditures to generate approvable drug applications, despite rising financial pressures in the industry. Emerging technologies such as stem cells, genomics and proteomics are among the most prevalent initiatives being used to identify appropriate drug candidates.
• US generics focus. The FDA is allocating resources to generic drug approvals in an attempt to speed these products to market. However, although Europe has recently developed a clear regulatory path for generic versions of biologicals, this is yet be achieved in the US.
• Regulatory process improvements. Regulators are enhancing their drug review processes with new technologies such as electronic drug applications and technology-based standards for drug review.

• Why are new molecular entities experiencing growing approval delays?
• How is the FDA responding to allegations that reviewers are being influenced by the intense pressure to approve new products?
• In which therapy areas are the FDA currently showing the greatest flexibility for novel product approval?
• How will the FDA encourage Rx-to-OTC switches of novel medicines?
• What technologies are drug makers utilizing to help speed the drug development process?
• What new processes has the EMEA recently established to significantly speed drug approvals?
• What emerging trends are companies using to bypass early-stage drug testing?
• How has the convergence of FDA and EMEA approaches benefited European drug marketers?

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