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Healthy Skepticism Library item: 20458

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Magazine

Bramwell N
TGA reform delays slammed
Medical Observer 2013 Mar 5

Full text:

INDEFINITE delays to several key elements of the blueprint for reform of the
Therapeutic Goods Administration (TGA) have been slammed by a prominent
industry expert.

Of 33 recommendations regarding reforms to the TGA, due to be completed by
the end of June, five are not now expected to be completed in time.

These include a key transparency recommendation proposing changes to the
labelling and packaging of medicines to address consumer safety risks, and
four recommendations on complementary medicines reform.

A statement on the TGA website said some of the complementary reforms, such
as updating guidelines on evidence requirements and requiring sponsors to
use only available coded indications, needed amendments to the Therapeutic
Goods Act 1989.

La Trobe University adjunct associate professor of public health Dr Ken
Harvey said the TGA was focusing on initiatives that will make little
difference to unethical advertising and consumer protection and failing to
provide a timeline for those measures that would make a real difference.

Enhanced sanctions for regulatory violations and improved labelling should
be made the priority, he said.

“There were some easy and important things which could have been completed
much more quickly and there is a concern that some of these things will
lapse until after the election. If the government changes there might not be
the incentive to do anything,” he said. “I’m very disappointed with
the lack of timely and effective progress.”

A spokesperson for the health department said the “legislative
timescale” had changed because of the limited number of parliamentary
sitting days available in an election year.


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