Jim Greenwood on Data Exclusivity and Healthcare Innovation
Biotechnology Industry Organization CEO Jim Greenwood appeared on CNBC’s SquawkBox defending the case for data exclusivity protection for novel biologic drugs. The video appears below. Interestingly, he used the Aspirin vs. Epogen comparison from my book, Building Biotechnology, when he was explaining the difference between small molecule and biologic drugs to members of congress.
If the marketing authorisation is withdrawn for a medicinal product, does it still have Data Exclusivity?
This morning I just saw your query, and would provide the following clarification that I hope may be helpful:
Regardless of the regulatory status of the medicinal product, the regulatory dossier represents the substantial effort of the innovator, shared with the FDA or other regulatory authorities in recognition of the compelling public interest in evaluation of the safety / efficacy of the healthcare product, and otherwise considered ‘undisclosed information.’
After expiration of the marketing exclusivity associated with the healthcare product the regulatory dossier remains the property of the innovator and may not be shared or disclosed by regulatory authorities to a third party.
In case the product has been withdrawn due to safety or other concerns, however, presumably the FDA or other regulatory authority also would not accept an abbreviated new drug application (ANDA) which would ordinarily rely on the innovator’s findings of safety and effectiveness for fast-track approval.