The past several months have been trying for the $2 billion-a-year compounding pharmacy industry. First, it was a multi-state meningitis outbreak caused by contaminated steroid injections from the New England Compounding Center (NECC). The outbreak, due to unsanitary conditions at NECC, has sickened 730 people, killing more than 50 – and six months later, people continue to fall ill. Investigators examined foreign materials from unopened vials and found fungal matter, which caused the meningitis.
More recently, several additional compounding pharmacies have announced product recalls for a wide range of medications due to similar contamination issues. While the number of people sickened by the tainted medications is still being determined, federal regulators and state pharmacy boards are scrambling for stricter compounding pharmacy rules.
Last year, Congressman Ed Markey (D-Mass.) introduced legislation to strengthen compounding pharmacy guidelines, and plans to reintroduce the bill this congressional session. U.S. senators also have announced plans for tougher regulations, and the U.S. Food and Drug Administration has requested increased oversight to protect patients. Many individual states are proposing their own new laws to prevent similar outbreaks.
For decades the industry has largely evaded the kind of stringent oversight established drug makers face, according to the Boston Globe. The report also stated, “Federal regulators have long been flummoxed by the growth of the compounding pharmacy industry, which is made up of thousands of small outfits that specially mix medicines for patients, along with an expanding class of industrial-scale manufacturers that ship products to health care providers nationally.”
With the industry staring down the barrel of sweeping regulatory changes, compounders are at a crossroads and facing a daunting public relations challenge. Many pharmacies might face guilt by association, and public pressure is being magnified by surprise inspections, increased media scrutiny and more. All the while, compounding pharmacies are receiving a crash course in crisis and issues management.
The bottom line is: if compounding pharmacies have not formulated a crisis communications plan to handle product recalls or immediate problems, they had better “get after it.” Developing and regularly updating a comprehensive crisis plan is imperative – no matter the industry.
Additionally, issues involving increased oversight and scrutiny should serve as a wake-up call for carefully reviewing company guidelines for a product recall. While there are too many examples of poorly managed product recalls to recount here, a story by Peter Vanden Bos of Inc.com about how to survive a product recall is worth the read.
Compounders should also take this opportunity to develop strategic external communication pieces, such as fact sheets, presentations, videos, etc., to differentiate themselves from the companies in question. Collateral/marketing pieces should be tailored to specific target audiences (investors, customers, lawmakers and more) and highlight best practices, use of technology and safety measures. Also, leveraging these materials during individual meetings with legislators, regulators and other opinion leaders is critical, as they are being bombarded with negative press about the industry.
In closing, the near-term PR outlook for the compounders remains dire, but there are several strategies and tactics these companies can implement to avoid becoming another NECC. The overall industry faces an uphill battle for many years; however, if compounders can play a role in crafting beneficial and meaningful regulations that protect patients, it would go a long way in repairing its image.
Image credit: Flickr user Lidor