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PPT : R&D Costs of Orphan Drugs
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* Evidence suggests orphan drugs have smaller and shorter clinical trials than other drugs
* The seven orphan drugs in 1999 were approved with an average of 588 patients
* By contrast, non-orphan approvals in the late 1990s had over 5,000 patients on average
Importance of Market Exclusivity
* FDA has characterized this as the most sought after incentive in the ODA
* It has been particularly important for many biopharmaceuticals with uncertain patents
* It is also important for older chemical entities with useful orphan drug indications
Health Benefits of Orphan Drugs
* Lichtenberg and Waldfogel (2003) find rapid growth since 1983 in prescription drug consumption by individuals with rare diseases
* Increased consumption of orphan drugs has resulted in fewer deaths and increased longevity
* Cost-benefit analysis of particular orphan drugs have found significant quality of life benefits
Conclusions – Orphan Drug Act
* The ODA has been a success in encouraging many new drug approvals for rare diseases
* But there have been only a few U.S. orphan drug approvals for neglected diseases
* Market pull incentives necessary to compensate for low expected sales
An Amended Orphan Drug Act Approach for Neglected Diseases
* Market incentive must be significant enough to overcome barriers to innovators and also insure broad access in poorer countries
* Three policy options
+ Purchase funds
+ Transferable patent exclusivity
+ Transferable priority review by FDA Funds
* Sachs and Kremer propose a purchase fund with a guaranteed price to companies that produce a new vaccine for malaria, TB, or AIDS
* This would require sizeable purchase funds for each disease area – $500 million or more
* Countries would provide a small co-payment to insure new vaccine met a market test
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