Crisis management in pharma
Lessons learned from drug recalls and other controversies (1,572 words, 7.5 minutes)
Drug recalls and controversies present significant challenges to pharmaceutical companies. Though rare, these occasions may threaten patient safety and negatively affect a company’s reputation and financial stability. Selected high-profile cases underscore the critical need for robust crisis management strategies.
Effective crisis communication is another vital aspect of managing pharmaceutical controversies. Johnson & Johnson’s handling of the asbestos contamination scandal in its talc products exemplifies the importance of transparency and openness in addressing safety concerns. In 2018, a Reuters investigation reported that the company had known the presence of asbestos in its products for decades. This led to a flurry of lawsuits and a major reputational crisis. The Guardian reports that Johnson & Johnson agreed to pay a US$6.5 billion global settlement deal to resolve most ovarian cancer claims related to talc powder. The company’s initial defensive response, denying its talcum powder products cause cancer and insisting on its safety, was a lesson in the need for transparency and proactivity in crisis management. Promptly acknowledging issues, providing accurate information to stakeholders, and implementing corrective actions are companies’ best actions to maintain public trust and credibility.
Price controversies also pose significant challenges to pharma. In 2016, the Mylan EpiPen pricing scandal highlighted the public outcry over elevated life-saving drug costs and the need to address consumer concerns empathetically. A report in Forbes notes the company’s CEO at the time, Heather Bresch, defended the price increase, insisting it was justified by the improvements made to the product. This response was perceived as inadequate and insensitive, exacerbating the crisis. This case highlights the need for companies to be cautious about the ethical implications of their pricing policies and be ready to respond to public concerns.
Maintaining regulatory compliance is also fundamental to crisis prevention and management in the industry. The Ranbaxy Laboratories scandal illustrates the severe consequences of ethical lapses and non-compliance with regulatory standards. According to Reuters, in 2013, the generic drug manufacturer pleaded guilty to U.S. federal drug safety violations at two of its plants in India. The resulting US$500 million fine from the U.S. FDA underscored the critical role of regulatory compliance and the severe consequences of neglecting ethical manufacturing practices.
THIS WEEK 05/28/24
The U.S. FDA approved aflibercept-jbvf (Yesafili and Opuviz) as interchangeable biosimilars to Eylea to slow down or reduce damage to the retina and help preserve vision. Aflibercept products often treat adults with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
The U.S. FDA approved Amgen’s tarlatamab-dlle (Imdelltra) for treating adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
Shanghai Henlius Biotech and Organon announced the European Medicines Agency has validated the marketing authorization applications for HLX14, an investigational denosumab (Prolia and Xgeva) biosimilar. Denosumab has been approved in many countries under different trade names for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among other conditions.
Prime Minister Justin Trudeau highlighted measures in Bill C-64, part of the Budget 2024, to make contraception and diabetes medications available at no cost to Canadians.
LISTEN UP
In season 12 of the NPC Podcast, Rami Fayed, Vice President and General Manager of Canada at AbbVie, gives insights into patient support programs in Canada, diversifying therapeutic pipelines, and giving back to the community. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. In Healthbiz Rewind, you’ll read bold life sci predictions made during the renowned “Prognostication Korner” segment of the NPC Podcast.
Lindsay Williams,
Vice President & Managing Director
Stryker Canada
Ottawa
Season 03, episode 04
Listen to this episode here
You’re the first female lead of Stryker in Canada, proving that our collective life science leadership profile is changing. What are your thoughts on that? (This episode was recorded in February of 2021)
I’m honoured and pleased to be the new VP of Stryker Canada and happy to be a role model. I do feel some of the weight of being a first. Leadership in life sciences is changing, but in my opinion, it is not fast enough. The boards of directors at industry associations, usually the leaders of individual companies, are still predominantly men. We must keep the pressure on for gender balance on boards, panels, and leadership teams. It’s not okay anymore to be at a conference, and the people at the front of the room all look the same. We’ve been discussing gender equality and diversity for decades, but we still have some work to do.
I was reading the latest Globe and Mail investigative series called The Power Gap, and they identified reasons why women still face barriers in leading organizations, such as penalties for having kids or taking maternity leaves during the promotion cycle and personality traits that are deemed positive for men but are disliked in women like ambition or self-assuredness.
Research has also shown that women don’t typically negotiate their starting salaries and rarely ask for raises. All of these put women behind their male colleagues. So, we have the Stryker Women’s Network called SWN at Stryker. It’s an employee resource group that’s been in place for about a decade, and we work hard to help our female employees develop and grow in their professional and personal lives. We also have mentorship programs and other things to help us move closer to gender balance across the organization.
Register now for tomorrow’s NPC Spring Webinar on Pharmacare
🔔 National Pharmaceutical Congress Spring Webinar on Pharmacare – May 29 🔔
Topic: Unpacking Bill C-64: Myths, Realities, and the Future of Canadian Pharmacare
As Canada buzzes with discussions on the proposed national #Pharmacare program, join us for a crucial session to demystify the complexities surrounding Bill C-64. This is your chance to dive deep into the critical issues at the heart of this national debate.
What to Expect:
Expert Panel Discussion: Hear from leading experts who will explore the pressing concerns related to drug shortages, their impact on workplace benefits, and the pharmaceutical industry: Dr. Mihai (Mike) Csaki of the Council for Continuing Pharmaceutical Education, patient advocate Zal Press, lawyer Eileen McMahon of Torys LLP, and consultant and board member Pamela Fralick, former president of Innovative Medicines Canada—Médicaments novateurs Canada.
- Fact vs. Fiction: Gain clarity on the myths and realities of how a national pharmacare program could reshape healthcare in Canada.
- Comparative Insights: Learn from existing universal drug plans to understand the potential outcomes of the proposed policy.
Interactive Q&A Session: Our panellists will answer your questions in real time. This is your chance to voice your concerns and get direct feedback from healthcare leaders. The moderators are Mitchell Shannon of Chronicle Companies and Ben Parry of The Pangaea Group. The NPC Institute organizes the event and background research.
📅 Date: May 29, 2024
🕒 Time: 11:00 a.m. EDT
📍 Location: Online – Join from anywhere!
This free webinar is a must-attend for healthcare life sciences managers and executives, policymakers, industry experts, and anyone interested in the future of healthcare in Canada. Whether you support the bill, oppose it, or seek more information, this event will provide valuable insights into one of the most significant healthcare reforms under consideration.
✅ Register now to secure your spot.
👥 Please share this event with colleagues and anyone who might benefit from this critical discussion.
NEXT WEEK
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