Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response

Drug Approval Trends at the FDA and EMEA - Process improvements, heightened scrutiny and industry response

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Some key findings from this report...

- 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.

Drug Approval Trends at the FDA and EMEA

Drug safety has become a major industry concern following the market withdrawal of Merck’s Vioxx in 2004 and several other discontinuations of COX-2 inhibitors. Although adverse reactions were previously considered a relatively minor risk compared to a drug’s wider benefit, both newly approved and established drugs are now under intense scrutiny.

Drug approvals in the US and Europe have become subject to approval delays, rising requests for further clinical data, and greater chances of rejection. Regulators are currently attempting to reconfigure review processes in order to minimize delays in recognition of the potential mass benefit of new applications. Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response is a new report published by Business Insights that provides a comprehensive review of current drug approval trends in the US and Europe with case studies highlighting successful and unsuccessful applications. Emerging regulatory developments and process improvements are examined and the strategic measures implemented by developers to enhance the approval potential of their drugs are assessed. This report also evaluates the future regulatory landscapes of the FDA and EMEA, with a review of anticipated developments through to 2012.

Understand the changing landscape for FDA and EMEA drug approvals, discover the implications of process changes upon your drug applications and anticipate future regulatory developments with this new report...

Top five reasons to order your copy today

- 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.

Key issues examined in this report...

- 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.

Your questions answered...

- 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?

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

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