The Devil in the Detail: 5 Routine Recall Risks Faced by Modern Pharma

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With the steely eyes of the regulators firmly trained on everything that life sciences organisations do, the last thing firms want is to incur fines, market delays or worse because of overlooked mistakes in labelling and product information. Yet incidences of labelling issues and associated product recalls are rising sharply, now accounting for over 50% of all recalls according to the FDA. The conditions are rife for the trend to continue, due to growing complexity in life sciences firms’ operations and external market requirements.

Below are just some of the scenarios that are driving up the risk of labelling errors, with potential for regulatory intervention or danger to human life.

1.      Increased market volatility

The make-up of the life sciences industry is changing[1]. As a result, traditional firms are looking at a range of strategies to reduce their reliance on blockbuster drugs and staple revenue streams, while maintaining market share and profits. Approaches include expansion into additional and emerging markets, the addition of new product lines, new forms of collaboration, and increased merger and acquisition activity[2].

Digital transformation is rising up the agenda, as well as the need to adapt to new sweeping trends such as wellness and preventative medicine (including digital health)[3].

More personalised care is resulting in growing demand for drug personalisation, resulting in smaller batch numbers. All of these scenarios are putting pressure on drug labelling, which is becoming increasingly complex to manage as the numbers of markets, sales channels, product lines and variations continues to multiply. Each new side line, each new market, has its own special requirements for labelling – from the claims made and symbols used, to the agreed wording and accuracy of local translations. Trying to fulfil all of these conditions while containing the risk of error or omission is to navigate a minefield. It has become a full-time job.

Meanwhile public pressure, enforced by industry regulators, is driving new demand for transparency on everything from clinical trials and manufacturing processes, to more detail about what goes into modern drugs and how sustainable and ethical an organisation’s practices are.

All of this has a bearing on what companies need to say about themselves, where and how. Labelling requirements are far from static.

2.      Image updates (rebranding)

Companies rebrand themselves all the time. This could be the result of a merger, an attempt to refresh the organisation’s image or distance itself from previous associations, or to appeal to new markets abroad if the old name doesn’t work well in other languages or cultures....

This article is taken from International Pharmaceutical Industry January 2017