Washington DC
DRUG regulators in the US are showing a new willingness to embrace herbal
medicine. The Food and Drug Administration last week agreed to allow a British
company to test a herbal eczema treatment on people, even though its active
ingredient is not known.
Many of today鈥檚 drugs originally came from plants. Previously, the FDA has
only been willing to approve trials once the active ingredients have been
purified or synthesised in the lab. But Phytopharm of Godmanchester, near
Cambridge, has now been given Investigational New Drug approval for its product
Zemaphyte, which contains extracts from 10 traditional Chinese medicinal plants.
It will be tested on people with eczema in 20 medical centres across the US.
鈥淲e鈥檙e seeing the emergence of a new class of medicine,鈥 says Richard Dixey,
Phytopharm鈥檚 chief executive officer.
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Realising that herbal remedies can be effective, the FDA is already working
with three researchers who are testing herbal mixtures in clinical trials, says
Freddie Ann Hoffman of the FDA鈥檚 Office of 午夜福利1000集合 Affairs. However, the
Zemaphyte approval is the first given to a drugs company.
The FDA鈥檚 move into herbal medicine has thrown up difficult issues of quality
control. With a purified product, it is relatively easy to check the quality of
the active ingredient. The FDA is working with Phytopharm to develop suitable
quality control methods, such as making sure the plants used are grown, stored
and processed in the same way each time. 鈥淭he type of information that is
available for the product will not be the same as for a single ingredient with a
small molecular weight,鈥 says Hoffman.