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Minor Use
Minor Species (MUMS) bill has no application to transgenics
Bill
allows effectiveness of approved medicines to be tested on the
farm
April 11,
2003
WALTHAM,
MA – Legislation that would give fish farmers and other producers
of so-called “minor species” access to proven veterinary
medicines for short-term trials has no relationship to the Food
and Drug Administration’s regulation of animal biotechnology,
according to a leading developer of advanced fish hybrids.
“MUMS
is just the animal version of orphan drug development. It’s
about protecting animal health and welfare in markets that are
too small to attract significant pharmaceutical interest,”
said Elliot Entis, the president of Aqua Bounty Farms, Inc. “There’s
nothing in the MUMS process that would ‘fast track’
transgenic animals and we wouldn’t support any provision
that did so.”
S741, sponsored
by Sen. Jeff Sessions (R-AL), allows veterinarians to try medicines
already proved effective for animals like cattle, horses and dogs
on less common species like sheep, goats and fish. Instead of
requiring a pharmaceutical company to demonstrate the medicine
is broadly effective in advance, the bill would allow vets to
test a drug for up to five years to see if it works in other animals.
The bill makes no changes to existing protections for human food
and environmental safety.
“If a
fish farmer wanted to try one of the new flea repellants that
are used on millions of dogs and cats to treat sea lice on fish,”
Entis explained, “Sen. Sessions’ bill would permit that,
provided there is a ‘reasonable expectation’ the treatment
would work. But FDA would still require information demonstrating
that the medicine is safe, properly manufactured and presents
no environmental threat.”
The bill also
allows FDA to create an “index” of therapeutic compounds
– products like hydrogen peroxide and clove oil – that
are already on the market but have never been formally approved
for veterinary use, usually because they are already in the public
domain and not protected by patents. Indexed drugs would still
havc to meet existing human and environmental safety standards
and could not be used on food animals, except in their infancy.
Activists
attacked the bill last week, claiming it would weaken FDA regulation
of food animals improved through biotechnology. The opponents
include groups like the Pacific Federation of Fishermens’
Associations (currently pushing legislation to outlaw marine aquaculture
in California), the Mangrove Action Project (campaigns for the
abolition of tropical shrimp farms), and the Friends of Blue Hill
Bay (oppose fin and shellfish farming in Maine). In a letter to
Senators sent on April 4, 2003, the activists claimed Aqua Bounty’s
current application for fast-growing salmon “would not need
full FDA approval before proceeding to market.” However,
the bill specifically prohibits applicants like Aqua Bounty from
swiching to the MUMS process. “Neither the orphan drug nor
the index provisions would change the safety requirements for
transgenics,” Entis said. “If a developer couldn’t
prove efficacy, he wouldn’t have a product at all and certainly
wouldn’t spend millions to conduct FDA’s safety tests.”
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