By Peter J. Pitts
The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing dialogue between manufacturers and the FDA, between doctors and patients, between doctors and academics, between lawyers and judges, and between advocates on all sides.
And the red thread that ties these conversations together is responsible off-label communications. Not sales strategies. Not DTC tactics. Not managed market negotiations – the responsible sharing of truthful and accurate information. Continue reading
By Peter J. Pitts
Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.”
So said, CDER Director Dr. Janet Woodcock during yesterday’s webinar, “Understanding CDER’s “Super” Office Of Pharmaceutical Quality and Its Effect on You.” Dr. Woodcock was joined by Dr. Lawrence Yu. I was honored to moderate the FDA News-sponsored session.
(Janet is the acting director of the OPQ and Lawrence is the acting deputy.)
Let’s put the new OPQ into some historical context. Continue reading
By Peter J. Pitts
I am putting in a lot of miles on behalf of international regulatory fraternity.
Over the last few months I’ve visited Egypt, Indonesia, Vietnam, Taiwan, Mexico, and Brazil, where I’ve had privilege to meet with regulatory and healthcare officials. (And boy, are my arms tired.) Many things were discussed and shared, but the red thread was the urgency of quality.
I’ve learned many things and met many remarkable people. Perhaps the most important thing I’ve come to appreciate is that we need to stop talking about regulatory “harmonization” and focus our time and attention on regulatory “convergence.” Just as every nation has it’s own unique culture and cuisine, so too must it design it’s own regulatory philosophy and structure. It’s not about replicating the USFDA or the EMA – it’s about converging towards best practices — and beware the danger of regulatory imperialism. Continue reading
Mobilizing medical insight, discovery and invention to help patients is a team effort. Patients and their families expect that we will work collaboratively and use our collective skills to improve health – as efficiently and quickly as possible. No doubt, collaboration is a skill and a challenge. Honing that skill and exploring the challenge requires conversation and expression. The DIA 2015 51st Annual Meeting gathering in Washington, DC, is the perfect place to pursue our shared mission to improve health and well-being, and to learn how to be great partners in drug development from each other. Continue reading
Disruptive innovation, creating new markets and displacing the old, is currently in the midst of a “big bang.” Technology is serving as the catalyst and helping to develop new breakthroughs, which in turn are spurring on further developments. Hardware, wearable gadgets, and new medical technologies are raising the level of innovation in health care product development. These rapid advances are creating opportunities to advance research and connect patients to their care. Continue reading
Have you read the April issue of Global Forum yet? Featuring a new look, and in-depth content from an expanded editorial board, this issue is available open access (no log in required) at www.globalforum-online.org.
The April issue takes a deep-dive look at the 10 industry trends for 2015 identified in our recent “What Lies Ahead” report (view pdf). In addition to a Special Section with feature articles on three of the top trends, we also asked experts from around the globe to comment on how they see these trends shaping up in their area of the world.
Dr. Silke Vogel, Associate Dean at Duke-National University of Singapore, providing insight into which of the identified trends resonated for ASEAN community.
Dr. Richard Day surveyed his colleagues and peers in Australia and New Zealand for their opinions on the trends as they impact the “down under.”
Dr. Ling Su and Fuyu Song offered their take on What Lies Ahead in China.
For the European Perspective, John Lisman weighed in with the themes he sees trending in Europe.
We also look at areas where the industry is still growing. Professor Ranjit Roy Chaudhury lends his extensive expertise in a commentary on the trends in India, while Vincent Ahonkhai offers perspective on industry trends in Middle East/Africa.
How do you see these trends impacting work in your corner of the world? Let us know in the comments.
The April issue of DIA’s Global Forum online magazine is now available at http://globalforum-online.org. In this issue, experts take a deep dive look into several of the “trends to watch” from DIA’s “What Lies Ahead” report which was released in February. The April issue is the first in our new reader-friendly and content-rich format, featuring fresh perspectives from industry experts.
Included in the issue, two articles look at the #1 Trend on our list, “The Rising Influence of Payers: Driving the Need for Evidence-Based Outcomes.” Continue reading
Have you seen DIA’s What Lies Ahead 2015 report yet? The third annual report was released earlier this year, providing experts’ insights into the year ahead for pharmaceuticals, biotechnology and medical devices. To read the full report, click here.
Who doesn’t love April in Paris? Join us as, for the first time ever, DIA’s EuroMeeting and Clinical Forum will run in parallel, from April 13-15 in Paris, France.
2015 marks 50 years since the first European pharmaceutical legislation and the founding of the European Directorate for the Quality of Medicines & Health Care. Our DIA EuroMeeting 2015 has organized special sessions honoring both the EMA and the EDQM, including our interactive Regulatory Town Hall Meeting moderated by Fernand Sauer, first Executive Director of the EMA.
How do you feel about social media in clinical research? Come Join the Debate: This House believes that people are unwilling to make their data available anonymously to aid the battle against serious diseases while carelessly sharing personal data through social media will be the subject of the Oxford-style plenary debate that will open our 8th Annual Clinical Forum: Clinical Development Riding the iWave, presented in parallel with our 27th Annual EuroMeeting: Development, Innovation, Access and Patient Safety, April 13-15 in Paris.
By Peter J. Pitts
The FDA is not a monolithic entity. The agency is comprised of over 11,000 dedicated public servants whose areas of expertise and responsibilities range from pharmaceuticals to food, veterinary products, cosmetics, medical technology, dietary supplements, and beyond.
No one person calls all the shots – but the Commissioner is in charge and sets the tone and direction of the body that regulates more than a quarter of the American economy. A really good commissioner is measured by the impact he continues to have once she has departed. By that measure Peggy Hamburg rates an “A.” Continue reading