As the FDA moves into 2020, the agency is facing some hot button issues it failed to put to rest in 2019. Issues including NDMA, e-cigarettes and vaping, medical marijuana, the unregulated use of CBD oils, and asbestos in talc are all on the table.
Complicating matters, the fact that more people are using and depending upon homeopathic remedies, over-the-counter products and prescription drugs every day is driving consumer activists to put added pressure on the FDA and even members of Congress to do more to protect consumers. You don’t have to look further than the controversy around e-cigarettes to realize that one thing is for certain: the FDA will do anything to avoid a repeat of the vaping crisis.
While not viewed as a traditional pharmaceutical issue, the lessons we can learn from the e-cigarette and vaping crisis will set the stage for what is coming this year, both for new-product categories like cannabis and CBD, and even long-accepted ingredients like talc.
With all that in mind, here are a few predictions for 2020.
The FDA Will Place Greater Burdens on Drug Makers
Regulators are increasingly holding pharmaceutical companies accountable for ensuring the safety of products through their entire lifecycle – not just during the product development phase. As long as the product is on shelves or prescribed by doctors, the drug company remains the most responsible party.
That means increased burden on medical marijuana and CBD companies to prove their products are safe before they get the greenlight to go to market. It’s a step that activists would say was skipped when e-cigarettes and flavored cartridges entered the market.
It will likely also mean added pressure on cosmetic companies and drug makers who rely on talc as an ingredient. Because regardless of what the full body of scientific literature may say, activists are creating doubt and fear among consumers. Those emotions have certainly inspired lawsuits, and likely had a role in the FDA’s public disclosure of asbestos in talc samples.
Remember that while pharmaceutical companies outsource their manufacturing, they are unable to absolve themselves from legal and regulatory liability associated with the product. This places even greater burdens on companies of all sizes, but especially small startups and mid-sized manufacturers that don’t have the established reputation, credibility and trust – or the deeper pockets – to withstand a major reputational hit.
Recalls Will Increase Again
Impurities in Active Pharmaceutical Ingredients (APIs) will be one key driver. A close second will be actions related to violations in Current Good Manufacturing Practice (CGMP) regulations. How do we know that?
According to our Fourth Quarter Recall Index, pharmaceutical recalls increased nearly 30% in the fourth quarter alone. There were 93 recalls documented in the quarter, impacting 29 million units. Of those recalls, a dozen were the result of NDMA impurities, and those recalls impacted 4 million units.
When we look at the top recall causes, inconsistency in Current Good Manufacturing Practices (CGMP deviation) remained at the top, accounting for 23.7% of all recalls in the fourth quarter, while sterility issues were the top reason for recalled units impacting 68.8% of units or nearly 20 million units.
So, while the FDA seemed to turn its attention away from pharmaceuticals early last year, the agency’s focus on drug makers will return, in large part due to NDMA and impurity issues that are still unraveling. That takes us to another prediction.
NDMA Will Lead Us to More Impurities That Are Cause for Concern
Think for a moment about the growing concerns over the occurrence of probable carcinogen N-nitroso dimethylamine (NDMA) in some over-the-counter drugs. Now consider the growing list of potential carcinogens identified by consumer advocacy groups that are under discussion by international health organizations. Overlay the complexities of global supply chains. There is no doubt another impurity will be found. The questions are: what will it be, who will be shining the spotlight, and what brand will be named in the headlines?
Impurity concerns will have a direct impact on your ability to produce the medications customers and patients rely on. For certain they’ll lead to recalls. But questionable decisions or bad actions by API manufacturers, even in the absence of a quality assurance issue, are likely to attract the attention of inspectors, regulators, and plaintiffs’ attorneys. So regardless of the who’s, what’s, and when’s, the impact will be felt by everyone in the pharmaceutical industry.
The FDA is Not Your Only Worry
When it comes to drugs and pharmaceuticals, the e-cigarette crisis reminds us product safety is not just about the safety of a substance (the nicotine). It’s also about the delivery system. It’s about how consumers use (and possibly abuse) a product. It’s about how a product is marketed. It’s about who uses the product, how much, and for what purpose.
Yet another lesson we learned from the vaping crisis is that product safety crises in the drug industry aren’t just about the FDA. They have factors that invite scrutiny from the Centers for Disease Control and Prevention (CDC), Federal Trade Commission (FTC), and Congress. They inspire far-reaching regulatory investigations, lawsuits and class actions. Questionable actions by one company can bring into question the safety and efficacy of an entire product category.
While all of these elements are a headache, don’t ever lose sight of the fact that your product safety crisis impacts real people – and in their eyes, it could be a matter of life and death for their children, parents, friends, family and neighbors. And in those cases, emotion runs high.
And as long as drug makers of all sizes rely on global suppliers and production facilities, product quality will be a challenge. We appreciate that it’s likely the most effective way to operate, but with physical distance comes limitations on quality assurance.
Crisis Planning is Critical to Survival
Product safety issues are complex and distract workers from normal day to day business. If handled ineffectively, they can greatly damage your brand and reputation with customers, consumers, and regulators.
But hidden inside every crisis lies an opportunity. An opportunity to stand up and show customers and consumers that they are your priority, their concerns and opinions matter, and safety is your top concern. Unfortunately, words fall flat when your actions don’t follow through. That’s where thoughtful, strategic crisis planning comes in.
Now more than ever you need to consult product safety, legal and regulatory experts in advance. Ensure you are properly prepared and have the infrastructure needed to manage any challenge that may come your way, from a single adverse event that might signal a larger issue, to handling a regulatory action, product withdrawal or recall. And if you don’t have those capabilities in-house, develop relationships now with experts who can help you. It’s more costly and likely to lead to big mistakes when the crisis erupts on a Friday night.
Last year reminded us of everything at stake when we talk about product safety. Don’t forget those lessons. Instead, take this opportunity to learn from others both in and out of your product category, and make a disciplined effort to plan for challenges you know are sure to arise in the months ahead.