US FDA head Hamburg declares no one can inspect world on its own
This article was originally published in SRA
The US Food and Drug Administration recently signalled its desire to work more closely with other drug regulators in assessing the quality of pharmaceutical manufacturing facilities around the world.
FDA commissioner Margaret Hamburg told a gathering of regulators from around the world in Geneva in May1,2 that: "Together, we can all do our jobs that much better, for as you know, no one country is capable of inspecting the world on its own, nor can we assure quality with inspections alone."
[The meeting was held to celebrate the 40th anniversary of the international Pharmaceutical Inspection Convention (PIC), which since 1995 has operated jointly with the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) – the two instruments are jointly referred to as PIC/S.]
Dr Hamburg went on to raise the question of how the quality of manufacturing can be assured as drug companies attempt to address production cost issues by relocating their facilities. "As manufacturers and distributors strategically relocate to countries with lower operational costs — and often countries with less mature regulatory systems and historically less active engagement in drug quality assurance — all PIC/S members must continue to think strategically about how we can pool our resources and truly work together for the common good."
Dr Hamburg believed the work of the PIC/S is "more important than ever, given the realities of globalization". In the US, she noted that a "stunning" 80% of active pharmaceutical ingredients (APIs) in US drugs come from outside US borders and about 40% of the finished drugs themselves. The FDA only joined PIC/S in January this year3.
The FDA chief told the PIC/S meeting of "a recent example" of its joint working in the good manufacturing practice field that was "unprecedented" for the US agency. In that case, the FDA relied on the European Directorate for the Quality of Medicines to place a firm under an Import Alert and prevent its API from entering the US.
Dr Hamburg said: "We made this decision solely on EDQM’s information, even though FDA had never inspected the manufacturing site. To make this decision, which was an unprecedented one for us, we learned about the deficiencies by monitoring an EU database; requested and reviewed EDQM’s establishment inspection report; and had detailed technical discussions with the inspectors. Now, we are working to conduct a joint inspection of the firm with EDQM."
The FDA has also recently made efforts to share more of the data it has on GMP inspections, by making public its COMSTAT database, which contains its inspection results. "This means that every country, as well as every citizen, now has the benefit of knowing whether FDA has previously inspected a manufacturing facility and whether we found the facility to be in or out of compliance with our requirements and standards," Dr Hamburg said.
FDA application was "long road" process
Dr Hamburg described the PIC/S application process as a "long road" for the FDA but the agency believes that the PIC/S too learnt something along the way.
The FDA commissioner said: "Though not always easy, the PIC/S application process helped FDA to mature as an organization. The process required us to engage in rigorous self-examination. We improved our quality systems, focused on gaps in our regulatory processes, and became more cohesive internally." She added, however, that the FDA believed the application process was "challenging and illuminating for PIC/S" as the FDA's system was so different from Europe's. "It took a lot of work to consider how to compare our system to those of many of the existing members. There was a great deal of productive dialogue ...[the PIC/S assessment team] were tough, but they were fair, and were willing to accept that different systems could be comparable and could get us to the outcome to which we all aspire."
Globalisation and outsourcing
Dr Hamburg encouraged others to join the PIC/S, reminding delegates that the "world is poised for even further globalization. ... These realities challenge virtually all nations and make us increasingly connected and interdependent. In the US, at FDA, we tell Americans that there is no longer such a thing as an American drug supply; there is a global drug supply."
The FDA commissioner highlighted how globalisation and outsourcing have "redrawn the path that drugs navigate to reach the citizens of all of our countries, and the supply chain from manufacturer to consumer has become more and more complex ... involving a web of re-packagers and redistributors, including those online, that make oversight significantly more difficult."
An FDA spokesperson told RA Pharma in February that the agency did not plan to acquire GMP certificates from other PIC/S countries, but that it would benefit from membership to PIC/S by having access to other members' inspection reports, participating in training events and through networking opportunities4.
China, India and Japan?
PIC/S (ie the PIC and the PIC Scheme together) has 39 members and could have a further nine more in the coming years.
Some key countries that are still missing from the PIC/S list are India and China (two major manufacturers of affordable APIs and finished pharmaceutical products) as well as the world's second largest pharma market, Japan. Others include Brazil (it has applied) and Mexico (RA Pharma sister publication Scrip Intelligence reports that no contact has ever been made)5.
References
1. PIC/S press releases, PR 01 2011 & PR 02 2011, 9 June 2011, www.picscheme.org/publication.php?id=7
2. The Importance of PIC/S in Our Globalized World (remarks by Margaret Hamburg, 40th Anniversary of PIC/S,31 May 2011, Geneva), www.fda.gov/NewsEvents/Speeches/ucm257974.htm
3. US and Ukraine regulators set to join PIC/S in New Year, Regulatory Affairs Pharma, 24 November 2010
4. US FDA has no plans to acquire GMP certificates from other PIC/S members, Regulatory Affairs Pharma, 4 March 2011
5. www.scripintelligence.com, 17 June 2011