E-DRUG: Scores of unessential drugs - the main game (3)
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I was also very disturbed (but not necessarily surprised) by these
findings. The key issues for consideration in medicines registration are
quality, safety and efficacy. This research shows that the US FDA is
apparently failing to deliver on 2 of these - safety and efficacy.
For the purposes of its Prequalification Programme, the FDA is recognised
by WHO as one of the Stringent Regulatory Authorities (SRAs) (see
http://apps.who.int/prequal/info_applicants/Guidelines/PQProcGenericSRA_July2011.pdf).
In order to improve medicines access, WHO, under the “accelerated
registration” pilot project - a new collaboration between medicines
regulators in developing countries and international experts working with
WHO’s Prequalification of Medicines programme - national regulatory
authorities are encouraged to fast track registration of medicines that
have already been assessed and approved by WHO’s stringent prequalification
procedure. The Global Fund also makes reference to SRAs in its Guide to the
Global Fund’s Policies on Procurement and Supply Management.
In the WHO Policy Perspectives on Medicines (December 2003): Effective
medicines regulation: ensuring safety, efficacy and quality, it states . .
. 'National Regulatory Authorities must be responsive to the needs of the
general public, and effective and efficient in discharging their duties.
Any deficiency or delay in decision-making may enable harmful medicines to
reach the market or lead to shortages of vital medicines, endangering
lives'.
SRAs have been rightly recognised as regulatory role models for countries
striving to improve medicines regulation. The behaviour and practices of
the FDA highlighted by this recent research may cast doubt on this
perception.
With the research conclusion that 'the FDA cannot be trusted to carry out
its historic mission to protect patients from harmful and ineffective
drugs', should the status of FDA as a reputable MRA and particularly as an
SRA now be questioned?
Chris Forshaw
Senior Pharmaceutical Advisor
Ministry of Health,
Kenya
Chris Forshaw <forshaw.chris@gmail.com>