OTC Products in a Consumer Driven World


As any consumer can tell you, the array of over-the-counter (OTC) drug and dietary supplement products on a retail pharmacy shelf can be mind-boggling.  Whether single or multi-ingredient, the choice appears to be unlimited.  If you are like me, in the industry and familiar with the product labels, perhaps it is not so daunting.  But put yourself in the shoes of the average consumer trying to select a product for themselves or their child, with limited knowledge of the ingredients and indications, how do they decide what is most appropriate, particularly if there is no pharmacist on duty?  It is clear that more can be done to help the public in making that choice.

To that end, I recently had the pleasure of attending the annual Regulatory, Scientific and Quality Conference put on by the Consumer Healthcare Products Association (CHPA) in Washington DC.  For those that are not familiar with the organization, CHPA is one of the oldest trade associations in the USA, representing manufacturers and distributors of OTC drugs and dietary supplements.  As advocates for the industry, they provide input to government agencies regarding legislation and are also involved in consumer education promoting safe and effective use of these products.

The program included speakers from many different companies and disciplines as well as a strong showing from the Food and Drug Administration (FDA).  It was heartening to see the communication and desire for collaboration between the public and private sectors, each realizing that the other has a role to play in ensuring consumers have access to quality OTC products.  The topics ranged from new regulatory initiatives (e.g., updates to the OTC monographs), to challenges facing industry (such as supply chain issues), to the importance of quality metrics in manufacturing.  Due to the nature of the conference, not all sessions could be attended but, based on those that were, all were relevant and worthwhile.

The conference confirmed my belief that my job as a quality/regulatory professional is to not only help manufacturers and distributors understand the regulations, but how adherence to them will benefit both themselves and their customers.  In the end, if the labels are clear, concise and correct and that the product inside meets all required quality standards, both the FDA and consumer will be satisfied.