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“Threats to everyone everywhere, is a threat to the individual anywhere”


Quote by Dr Margaret Hamburg, 21st Commissioner of the US FDA at the MHRA Annual Lecture, Royal College of Physicians (London), 6 March 2014


To a packed auditorium, Dr Margaret Hamburg focused her keynote speech on globalisation.


She started by stating that she has “such deep respect for the MHRA’s leadership and service it provides for this great country and around the world”.  In the past, she has had many mentors, colleagues and friends within the MHRA and she is “looking forward to building the same strong relationship with the new [MHRA] team”.  She also emphasised that it is now time “for us to work together to ensure we’re ready for the challenges which face us.”


She spoke about there being “new realities” and “fundamental shifts”, namely:


  • emerging markets and developing economies;
  • increased flow of people and products across the world;
  • supply chains becoming increasingly complex; and
  • imports which have increased exponentially.


She recognised that it is a struggle to keep up with rapid changes in technology and increased complexity.  With so many imports it’s no longer possible to inspect at the border, inspections must happen beforehand.

There is a general consensus that there must be more transparency but unfortunately, there is also a hostile attitude to regulations in general which is not made any easier with skeletal regulatory systems in other parts of the world.  Dr Hamburg made it clear that “greater commitment at senior political level is needed.”


She shared some interesting statistics with the delegates.  In the US:


  • 40% of finished products and 50% of medical devices are made elsewhere
  • 80% of API manufacturers are ex-USA and supply more than 150 countries which have less sophisticated regulatory systems
  • It is expected that there will be a 400% increase in product exports by 2020 (mainly from India and China)
  • China makes the fourth highest volume of devices to the US


Clearly the world has changed and the “idea of a wholly domesticated drug is no longer feasible.”  Of course, globalisation brings greater risk to the public because more people and companies are involved in the process.  For the ‘faint hearted’ the task in hand would be impossible but Dr Hamburg stated that she felt it was a “daunting and exciting time” and repeatedly said the word “opportunity”.


She stated that the first priority is to develop a plan to respond to globalisation and import challenges.  As a first step the FDA has “transformed from a domestic agency serving global needs to a truly global agency serving global needs”.  She emphasised the need to share information and workload between agencies and for greater co-ordination. 


To allay anyone’s fears about there being one global regulatory agency applying the same regulations worldwide without taking into account cultural differences and differing healthcare needs she said that we “need not apply identical standards but work towards the common goal of quality and safety” and that we need to find “new ways to collaborate, to stay ahead of the curve for public health.”  In Dr Hamburg’s opinion, she believes that by strengthening regulatory capacity in the developing world, this can contribute to a stronger economy.  She also encouraged regulators to “partner with non-traditional partners and work together”.


As many of us know, India has been in the news a lot recently because of substandard medicines.  It’s worthy of note that India is the second largest supplier of OTC and prescription drugs exporting to more than 200 countries worldwide.  The challenge is how to work together to ensure quality meets with US or EU standards.  Inspections carried out by the FDA with the MHRA are only part of the solution.  The reality is that there simply aren’t enough people to regularly inspect all the manufacturers around the world.


Dr Hamburg sent out a clear message that “manufacturers must embrace quality.  It should be a given for a company to produce quality, to build their brand.” 


In theory, yes this is commendable but the reality is that, in some instances, drug prices are being driven down to such an extent that companies are looking to reduce costs no matter what in order to maintain or increase productivity.  This can result in substandard products which can endanger patients’ lives.  This has also resulted in an increasing number of counterfeits which is an extremely worrying trend especially when Dr Hamburg stated that “30-50% of available drugs are counterfeit or substandard” which is a “particularly significant threat in the developed world”.


She described how regulators must have more than a presence: all regulatory agencies need to engage with each other and industry.  The FDA has made some progress by establishing offices across the world and setting up more than 60 agreements to share information on inspection reports and other non-public information.  This ‘sharing’ increases regulators’ investigative power and also provides an opportunity to share investigation techniques i.e. the sharing of best practice.


On a recent visit to India, one of Dr Hamburg’s high profile Indian colleagues stated “good regulators make good companies”.  Dr Hamburg agreed with this but expanded the statement further to:


“Good and smart regulators, make good companies, make strong and healthy nations”


She concluded that we “need a global mechanism which assures and sustains the collaborative mechanism” because we “can’t regulate the world effectively without collaboration”.


The focus of her speech was globalisation.  Clearly science is now globalised and therefore, the regulators need to be globalised.  It is going to be a significant challenge for the regulators to oversee new products and emerging technologies but, to quote Dr Hamburg, it is also an “opportunity to work across nations”.


Dr Hamburg's speech is also available on YouTube.


Author: Greer Deal, Director of Global Regulatory Services (GRS)