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CDER's Drug Shortage Program; more on vaccines

FDA's news regularly reports on drug shortages of medically necessary products that significantly impact public health. From their FAQs webpage (1):

The Drug Shortage Program (DSP) program, within the Center for Drug Evaluation and Research (CDER), was established to address potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health. Through communication, facilitation and negotiation, DSP works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages.

Over the last ten years, the number of shortages has continued to increase. There are many reasons for this increase in shortages and some of the causes are as follows:
Manufacturing issues – this may include problems with manufacturing, enforcement activities, raw material shortages, packaging shortages, and other reasons
Business decisions may be made by firms to discontinue manufacturing of a drug – newer products continue to replace older products due to better safety profiles, better efficacy, more convenient dosing regimens, etc.
Limited manufacturing capacity – often multiple products are produced on the same equipment which means that an increase in production of one product will usually result in a delay for another product produced on the same production line
Market concentration – as firms discontinue manufacturing of various products, only one or two firms may remain as producers of a product.

Read more info. on DSP (1), for example:
How does the CDER Drug Shortage Program find out about shortages?
Once a drug is determined to be in shortage, what happens next?
What can FDA do about drug shortages?
Note: In the midst of much discussion regarding vaccine market dynamics, one interesting recent analysis/opinion for Datamonitor by Hedwig Kresse & Holger Rovini, as reported in the Nature Reviews on line news (2) briefly discusses several reasons why "the influenza vaccines market is a challenging sector....". They describe one key area of interest: ...an enhancement of vaccine immunogenicity through adjuvants. The key advantage in the influenza sector is a reduction in the amount of antigen required for protective immunization. This so-called dose-sparing effect helps to increase the number of available vaccine doses. This is particularly important in a pandemic, when the supply, limited by manufacturing capacity, cannot meet the demand.
(1) http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm
(2) http://www.nature.com/nrd/journal/v8/n11/full/nrd3026.htmlFrom Nature Reviews, Drug Discovery: News and Analysis w/ references
Nature Reviews Drug Discovery 8, 841-842 (November 2009) | doi:10.1038/nrd3026
From the analyst's couch: Influenza vaccine market dynamics

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This page contains a single entry from the blog posted on November 5, 2009 9:35 AM.

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