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Antibiotic Resistance: Incentives for Antimicrobial Development

Antibiotic Resistance: Incentives for Antimicrobial Development. Mark J Goldberger MD MPH CDER/FDA. Current situation. Problem: Antibiotic resistance is increasing Solutions: Facilitate development of antimicrobial therapy for resistance and related claims

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Antibiotic Resistance: Incentives for Antimicrobial Development

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  1. Antibiotic Resistance: Incentives for Antimicrobial Development Mark J Goldberger MD MPH CDER/FDA

  2. Current situation • Problem: • Antibiotic resistance is increasing • Solutions: • Facilitate development of antimicrobial therapy for resistance and related claims • Preserve usefulness of current and new drugs

  3. Issues in Development • Regulatory/clinical trial • Scientific/medical • Economic

  4. Regulatory Tools • Early Guidance • Formal and informal communication • Advisory committee input • Regulatory Tools • Subparts “E” & “H” • Fast Track designation • Exclusivity

  5. Clinical Trial Issues • Reduce the size of the clinical trial program • Address the tradeoff between our ability to assess effectiveness and the resources required to perform a trial. • Substituting quality for quantity in at least some clinical studies • Strengthening the link to clinical inference • How studies and data fit together as a package

  6. Consequences of the Preceding • Serious illness = Expedited development • Expedited development = Reduced costs • Does expedited development = Less certainty re benefit and risk? • Consequences of uncertainty

  7. Scientific Issues • Validation of surrogates • The use of pre-clinical and early clinical trial data in combination with clinical trial data • The role of infections due to susceptible organisms in the study of drugs for resistance claims • Enhancing early discovery

  8. Economic Incentives • Exclusivity • Orphan Drugs: Seven years marketing exclusivity • Waxman-Hatch: Now available for “new” antibiotics • Pediatric Exclusivity: Six additional months added on to existing exclusivity

  9. Other Potential Economic Incentives • Expanding eligibility for orphan designation • Bioshield like purchase arrangements • “Wildcard Exclusivity” • Other exclusivity or enhanced patent protection

  10. Economic Downside to Antimicrobial Development • Short course Rx • Highly effective Rx • Need is greatest for resistant and related infections: Market is most attractive for infections in the primary care setting • Contrast with HIV Rx

  11. An Unresolved Dilemma • There is a basic tension between encouraging antimicrobial development and preserving the usefulness of current and new drugs • Absent sufficient balance between these activities, adequate investment may not occur or the benefits of such investment may be short-lived

  12. Limits of our Authority • We can’t develop a drug • New types of exclusivity/patent protection would require new legislation • Reminder: Promotional claims derive from statements in labeling

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