It’s been widely acknowledged both inside and outside the FDA that increased globalization is putting enormous pressure on the agency and its resources. In 2011, FDA published a Special Report entitled “Pathway to Global Product Safety and Quality” which outlined the challenges the agency faces from globalization, and its planned response to those challenges. The report is eye-opening to say the least. This is sentence #4:
“Half of all medical devices used in this country are imported, while 80% of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere.”
Even if you don’t get past the Executive Summary, you’ll get a feel for just how monumental a task it is, and will continue to be, to ensure the safety of our food, drugs, biologics, and medical devices. The world may be shrinking but the pressures of globalization are growing. Imports of both finished product and product components are increasing, foreign manufacturing facilities are proliferating, supply chains are getting more complex, and opportunities for contamination, adulteration, and fraud are expanding. Keeping pace means FDA has to adopt a new international operating model that fundamentally, as the Special Report says, “changes the way it fulfills its mission to protect and promote the health of the American people.”
Harmonization with the EMA is one of the strategies FDA is pursuing to fulfill that mission. To maximize their resources, FDA and EMA have stepped up efforts to coordinate their inspection visits and rely on each other’s results, It’s little surprise that in the course of performing these activities, the two agencies have identified some of the differences between them. Traditionally, FDA has focused heavily on inspecting data and verifying compliance. EMA, on the other hand, has concentrated on inspecting the systems and processes in place to obtain the data, an approach toward which FDA may be migrating. Aligning the agencies’ approaches to inspections has obvious advantages to their increased cooperation, but for FDA and the industries that it regulates, there is an added advantage. Data, by nature, is study-specific; processes are not. A focus on processes makes it easier to apply lessons learned from past inspections and to confer knowledge to future inspections. This extends the value of inspection resources that FDA invests beyond the individual inspection.
Keeping pace with globalization also means doing more with less domestically, because it seems the only thing that’s not growing by leaps and bounds in this global economy are FDA resources. At industry forums such as ACRP, DIA, and RAPS this year, FDA announced its intent to perform inspections earlier in the clinical trial process than it has in the past. There are a number of benefits to this shift. First, only a mid-trial inspection could uncover an issue that the sponsor or investigator could correct in time to save the study; an inspection after the NDA is filed cannot. Earlier FDA inspections argue for earlier internal and third-party audits, increasing the likelihood that problems can be identified and corrected before the cost of doing so becomes prohibitive. Also, earlier inspections mean they will be conducted even if the study results in no submission, which benefits clinical research as a whole. Aborted studies cost the industry tremendous amounts of money and time, much of which is wasted when there is no resulting new drug or device. When inspections are conducted before NDA submission, both FDA and the inspected party will be able to add to their knowledge base from the experience, even if the study is canceled post-inspection.
The challenges of globalization aren’t just growing, they’re accelerating. In this work-smarter-not-harder, bigger-bang-for-the-buck world, we’re all being forced to look for inventive ways to wring every last bit of value out of the resources we invest. By focusing on processes instead of data and conducting inspections earlier, FDA is increasing the value that both the agency and the industry derive from its compliance enforcement efforts.
by Laurie Meehan
This blog discusses trends and issues in the pharmaceutical and dietary supplement industries. Click the SIGN UP link to subscribe to occasional notifications of new blog posts.
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