Analysis of the The FDA Amendments Act (FDAAA)

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Receipt of a CRL slows approval, causing increased costs and lost sales, and may prompt withdrawal. The FDA Amendments Act (FDAAA) provided the FDA with new powers in relation to drug safety, including the authority to impose postmarketing requirements (PMRs) and Risk Evaluation and Mitigation Strategies (REMS) on drug manufacturers, which took effect on March 25, 2008.

The FDAAA has increased the costs of drug development due to a rise in post-approval spending: the average number of PMRs issued per drug was four in 2011 compared to two in 2008.

Complex REMS, which are issued relatively infrequently, require a significant investment from the applicant compared to REMS that only require medication guides and/or communication plans, and the impact on drug sales is almost certainly negative.

Key Topics Covered:

EXECUTIVE SUMMARY

• Overview of US drug approval regulations and procedures

• Complete Response Letters and impact on approval

• Take-home messages to avoid Complete Response Letters

REGULATIONS AND PROCEDURES OF RELEVANCE TO COMPLETE RESPONSE LETTERS

• The FDA regulatory burden is increasing

• US drug submissions process

• References

COMPLETE RESPONSE LETTERS AND IMPACT ON APPROVAL

• Trends in Complete Response Letters

• FDA advisory committee meetings and Complete Response Letters

• References

TAKE-HOME MESSAGES TO AVOID COMPLETE RESPONSE LETTERS

• Common deficiencies that trigger a Complete Response Letter

• Case studies

• Neutroval (tbo-filgrastim)

• Bydureon (exenatide)

• Nucynta ER (tapentadol)

• Lamictal (lamotrigine)

• Menveo (meningococcal ACWY vaccine)

• Horizant (gabapentin enacarbil)

APPENDIX

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