E-DRUG: Harmonising registration systems
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Philippa Saunders makes a compelling argument for harmonization of
registration schemes among nations while avoiding compulsory adherence -- allowing
individual regulatory authorities to make their own best judgments on
behalf of the populations they serve. Some of us are old enough to remember
the regulatory climate in the first years of thalidomide, 1957-61. The drug
had earned wide use in first-trimester nausea after registration in Europe
and the British Commonwealth -- while FDA's Frances Kelsey held off, for
several reasons, one being the drug's effects on the developing nervous
system. Dr. Kelsey's reasoned prudence of course saved untold thousands of
lives and immeasurable heartache.
Certainly a strong argument exists for increased regulatory harmonization
-- for getting along by going along -- but the need to retain, as a
sovereign right, what might be called the Frances Kelsey exception ought never be
forgotten.
Cordially,
James B. Russo
Founding Executive Director
Partnership for Quality Medical Donations
146 Koenig Rd.
Bernville, PA 19506
USA
610 488 9060
jbrusso@aol.com