Managing Product Supply Risks - Pharmaceutical Technology

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Managing Product Supply Risks
How to use geographic diversification and legacy technology transfers to avoid product shortages.


Pharmaceutical Technology
Volume 36, Issue 4, pp. 102-109

Conclusion

Systematically identifying risks to product supply and taking the necessary steps to mitigate these risks allows a company to proactively avoid product shortages. Multiple options to mitigate risk are available. Diversification by establishing backup manufacturing facilities in geographically distinct areas is one strategic approach to avoid product shortages in the event of an emergency situation at the primary manufacturing site. By carefully laying out the strategy for and potential challenges of conducting legacy technology transfers, companies can successfully implement diversification. It remains to be seen how companies and regulatory agencies such as FDA can work together to move forward in preventing and avoiding such product shortages and thus ensuring safe treatments for patients.

Acknowledgments

The author wishes to express sincere thanks to Arleen Paulino, Bill Keefe, Dan Rathman (Amgen), Ali Siahpush (Dendreon), and David Clark (MedImmune) for their active support and insightful comments in preparation of this paper.

Sushil Abraham is director of technology transfer at MedImmune, 636 Research Drive, Frederick, MD 21703, tel. 301.228.5183,
. At time of acceptance of this paper, the author was at Amgen, 4000 Nelson Road, Longmont, CO 80503.

References

1. J. Wechsler, BioPharm Intl., 24 (11), 12–14 (2011).

2. A. Federgruen, The Wall Street Jrnl., Mar. 2, 2011.

3. The White House, "Executive Order 13588–Reducing Prescription Drug Shortages," Press Release (Washington, DC, Oct. 31, 2011).

4. Johnson and Johnson, "Johnson & Johnson Provides Update on McNeil Consumer Healthcare Remediation; Announces Completion of Internal Assessment Phase of Comprehensive Action Plan," Press Release (New Brunswick, NJ, Jan. 14, 2011).

5. L. Bush, BioPharm Intl Bulletin, June 17, 2009.

6. M. Wiebe, presentation at West Coast Chapter of the PDA meeting (June 17, 2010).

7. B. Obsoj-Cardwell, The Pharma Letter online, http://www.thepharmaletter.com/file/96470/emea-recommends-replagal-as-alternative-fabry-treatment-due-to-fabrazyme-shortage-fda-approves-shires-daytrana-for-adolescents, July 7, 2010.

8. J. Woodcock, MD, Statement, House Committee on Energy and Commerce Hearing, Apr. 29, 2008.

9. FDA, Information on Heparin, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM112597, accessed March 5, 2012.


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