Yesterday I wrote in the Washington Examiner that, “A Grand Canyon exists between reality and hope in our new age of personalized medicine. Today, former FDA Commissioner Andy Von Eschenbach writes in the Wall Street Journal that, ”Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them
Von Eschenbach points to a troubling statistic that, according to the Tufts Center for the Study of Drug Development clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002. “Longer (and more complicated) trials have led to skyrocketing drug-development costs. High costs discourage investment in much-needed new therapies for conditions like obesity, diabetes and heart disease.”
Is this regulatory leadership? That’s debatable. Not according to a new California Biomedical Industry study that reports about 80% of life sciences CEOs surveyed don’t believe the FDA regulatory approval process "is the best in the world." Of equal import is that 81% of those surveyed believe that "within five years, another country could conceivably recreate the ecosystem that has made the U.S. the leading biomedical region in the world.” Investors talk with their feet.
Andy writes that, “Other countries such as Israel, Singapore and China are already preparing to leapfrog the U.S. for leadership of the global life-sciences industry.”
“Preparing” is one thing, doing it is another. But it is a real threat that we ignore at our own peril. As Sanofi CEO Chris Viehbacher said during his closing remarks at last year’s annual PhRMA meeting, “The question isn’t will our companies be successful? It’s will they continue to be successful in the United States?”
In January of 2010, I was part of a group of a group government regulators, health care policy experts, industry leaders, health economists, health care attorneys, patient advocates, and academics convened to study and offer new solutions to the hurdles to patient access and to develop high-impact global solutions.
(The report from this meeting, “Expediting Patient Access to New Medicines: A Call to Action,” was published in Drug Information Journal and can be found here.)
One of the ideas that discussed was for a new Asia-Pacific pan-regional regulatory agency that would provide centralized regulatory support outside of North America, Japan, and Europe. The goal would be to create an agency with sufficient resources and scale to accelerate drug approval in a region for which drugs are not usually designed. We suggested that the first embodiment of the idea could be an Asia-Pacific regulatory agency in Singapore that serves Australasia and Asia (ex-Japan). The creation of an additional new agency (similar in scale to the FDA and EMA) would continue to drive regulatory excellence but, more importantly, serve the needs of geographies that are underserved or dependent on guidance from the developed countries. This would encourage biopharmaceutical companies to invest in innovative medicines that may have a different regulatory pathway to approval, resulting in faster access to critical medicines in emerging markets.
Game on.
View PDF Here
Von Eschenbach points to a troubling statistic that, according to the Tufts Center for the Study of Drug Development clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002. “Longer (and more complicated) trials have led to skyrocketing drug-development costs. High costs discourage investment in much-needed new therapies for conditions like obesity, diabetes and heart disease.”
Is this regulatory leadership? That’s debatable. Not according to a new California Biomedical Industry study that reports about 80% of life sciences CEOs surveyed don’t believe the FDA regulatory approval process "is the best in the world." Of equal import is that 81% of those surveyed believe that "within five years, another country could conceivably recreate the ecosystem that has made the U.S. the leading biomedical region in the world.” Investors talk with their feet.
Andy writes that, “Other countries such as Israel, Singapore and China are already preparing to leapfrog the U.S. for leadership of the global life-sciences industry.”
“Preparing” is one thing, doing it is another. But it is a real threat that we ignore at our own peril. As Sanofi CEO Chris Viehbacher said during his closing remarks at last year’s annual PhRMA meeting, “The question isn’t will our companies be successful? It’s will they continue to be successful in the United States?”
In January of 2010, I was part of a group of a group government regulators, health care policy experts, industry leaders, health economists, health care attorneys, patient advocates, and academics convened to study and offer new solutions to the hurdles to patient access and to develop high-impact global solutions.
(The report from this meeting, “Expediting Patient Access to New Medicines: A Call to Action,” was published in Drug Information Journal and can be found here.)
One of the ideas that discussed was for a new Asia-Pacific pan-regional regulatory agency that would provide centralized regulatory support outside of North America, Japan, and Europe. The goal would be to create an agency with sufficient resources and scale to accelerate drug approval in a region for which drugs are not usually designed. We suggested that the first embodiment of the idea could be an Asia-Pacific regulatory agency in Singapore that serves Australasia and Asia (ex-Japan). The creation of an additional new agency (similar in scale to the FDA and EMA) would continue to drive regulatory excellence but, more importantly, serve the needs of geographies that are underserved or dependent on guidance from the developed countries. This would encourage biopharmaceutical companies to invest in innovative medicines that may have a different regulatory pathway to approval, resulting in faster access to critical medicines in emerging markets.
Game on.
View PDF Here
