By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.
Over the years, pharma’s key objective has changed very little: getting active pharmaceutical ingredient to the patient. Although we no longer dose extracts of willow tree bark, the practice of blending API with excipients to add bulk or facilitate flow dates back to the Romans. The Remington tablet press or gelatin capsules of 1875 remain virtually unchanged today. Regulations haven’t changed that much either, in the fifty years since most of them were drafted.
One thing that needs to change, and which could spur more innovation and positive change in the future, is the way that drug manufacturers and regulators communicate with the end users of pharmaceuticals. Both profess to care about the consumer, yet patients can find it very difficult to participate in any real discussion or dialogue with them.
Consider labelling and package inserts, which have not been optimized for the average consumer. Or look at how some companies have communicated product recalls. For instance, when Novartis voluntarily recalled batches of some over-the-counter products in January, some news reports explicitly mentioned the most serious reason for the recall: the fact that opioid drugs might have been mixed up with the OTC analgesic and put in packages by mistake.
It would have been too much, perhaps, to expect the manufacturer to state, outright, that for a period of time the controls at its facility completely failed. But consider the company’s bland statement, which left out the critical safety information and also appeared to justify the recall as a “precautionary measure”:
“Mixing different products in the same bottle could result in taking an incorrect product or receiving a higher or lower strength than intended or receiving an unintended ingredient, which could potentially result in overdose or an allergic reaction.”
The statement is truthful, accurate and designed to prevent people from panicking. But is it informative or valuable? Why is it that we can justify and accept direct-to-consumer advertising, including litanies of potential side effects, yet fail to inform consumers effectively, via mass media outlets, when we make a mistake?
I am active in this industry, have registered and receive recall notices from the FDA and other e-news media—and yet have not seen many recall notices for more recent events. So what are the chances of an average person seeing them? Recalled product may still be sitting on a number of medicine cabinet shelves today. Isn’t communication and patient outreach just another aspect of an archaic system in desperate need of innovation and modernization?
Is the Public Ready?
I can envision a day when some indication of a manufacturer’s capacity to control its processes is placed, in graphical form, along with other key information, right on the product label so that consumers can judge for themselves which manufacturers to trust. You may say that the public isn’t ready for this information, but people have adjusted well to nutritional information labels.
I’ve often asked whether innovation and modernization are related to, or even possible, in our industry. Is “design space” really a new fashion, or little more than the old process validation range?
Perhaps pharma’s approach to innovation has not progressed because the industry has failed to address the most important factor, the people, underlying its business. Over time, this has prevented technology from improving and evolving.
For a glimpse of what is possible, look at other industries. Steve Jobs revolutionized telecom by reinventing the phone. The leap was not in technology, but Apple’s way of looking at customers’ needs. Indeed, Apple has proven most capable of defining customers’ needs through innovative thinking, and considering both problems and technology in a different light. Pharma, in contrast, still clings to traditional thinking, impeding its adoption of such concepts as continuous manufacturing.
If we can modernize our thought processes, embrace diversity and reach out to the customers who buy the products we make, we may soon have a very different, and innovative, industry. What do you think? Please write me at aafnan@stepchangepharma.com.
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