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Quality and generics

Posted 11/05/2010 by RoseS

The pharmaceutical industry can’t have it all ways. it has resisted the drive towards generics with some justification as without the revenues from blockbuster drugs where will future R&D spending come from to develop the next major therapy breakthroughs?

Generics do feed off the R&D spends and clinical testing costs of the pharma majors so it is not surprising that those same pharma majors have moved into the generics sector using their financial muscle – if there is any money to be made out of generics then they want their fair share.

But one of the criticisms used by the pharma majors in the past to combat the spread of generics has been based on concerns about quality. And the focus has been particularly on the quality of pharmaceutical raw materials and even formulated drug products produced in emerging countries that are eager to gain their share of the global pharmaceutical market.

But with recent quality and related production problems appearing in those same pharma majors, can they continue to direct such criticism towards their emerging competition?

In the past 12 months we have seen production problems occurring at a number of majors, for example, the on-going problems at the Allston Landing plant of US biotech concern Genzyme. Those problems have resulted in the company facing severe US fines, as detailed in C&I Issue 9, but more importantly, shortages expected to last into 2011 in terms of critical therapies. More recently, McNeil Consumer Healthcare, a division of Johnson & Johnson, again in the US, has been asked by the Food & Drug Administration to recall infant and children’s liquid products, including Tylenol and Benadryl, due to manufacturing deficiencies, which may affect quality, purity or potency.

If the pharma majors cannot demonstrate to governments and society as a whole that their higher prices are due to the requirements for the development of more advanced therapies that are then produced to the highest quality levels, then they risk losing the argument that they should be allowed to charge those higher prices.

They also risk alienating those very consumers that they hope will support them by requesting their specific branded products when doctors write their prescriptions.

So far European pharma majors have managed to maintain a good record in production and quality, perhaps they need to revisit their operations once again to ensure that they too do not have the spotlight turned on them.

Neil Eisberg - Editor

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  • Anonymous said:
    16/05/2010 06:24

    Nice Reading. Thanks.

  • Anonymous said:
    14/05/2010 06:38

    Many institutions limit access to their online information. Making this information available will be an asset to all.

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