Efforts to boost drugs' lifespans face growing scrutiny, study finds

Efforts to boost drugs' lifespans face growing scrutiny, study findsNEW YORK -- Pharmaceutical companies will need to pay closer attention to lifecycle management for their drug products in order to compensate for a shortfall in drug development and increased generic competition, a recent study issued by research and consulting firm Capgemini has found.

"The importance of this issue should not be underestimated, stated Paul Nannetti, global life sciences leader at Capgemini. "The pharmaceutical industry's success to date has been built on a consistent flow of high earning innovative products. However, as the industry faces up to the challenge of weaker [research and development] pipelines and likely reduced returns from new products, there is an imperative to drive greater value from existing portfolios."

In addition to declining R&D productivity, pharmaceutical companies face increasing competition from other branded products and from generics, the report stated. And those companies employing strategies designed to extend a drug's life are coming under increased scrutiny.

Indeed, according to the report, many lifecycle strategies are becoming less effective as they "antagonize many physicians, payors and regulators." These health care consumers are increasingly resistant to lifecycle strategies that add little value to the health care system or their patients. "Regulators 'me too' products entering an already saturated market," the report reads. One physician critical of patent-extending strategies commented: Stop conning us! Dirty tricks like changing capsules to tablets to extend the patent make me ensure that I prescribe generically as soon as possible.

With that in mind, the strategy most favored by branded pharmaceutical executives is that of expanding a drug's use indication, the study found. Two-thirds of executives surveyed cited this strategy as having a significant impact on the profitability of a product line.

However, looking forward, licensing agreements with generic drug makers and alliances (such as authorized generics, for example) may become a more prevalent strategy to extend the lifecycle of a particular drug. Almost half of all executives polled--45 percent--predicted this strategy would become the leading strategy for extending the profitability of a pharmaceutical, compared with 31 percent who suggested indication expansion would continue to be a leading profit-building strategy.

Conversely, switching a drug from the prescription-only market to over-the-counter has become less appealing, according to 40 percent of respondents, because of its low returns for suppliers