FDA’s initiative aims to clarify HRT

ROCKVILLE, MD: The US Food and Drug Administration (FDA) has launched a national education campaign in a bid to clarify the risks and benefits of menopausal hormone replacement therapy (HRT).

Although Congress required the FDA to launch the programme last summer – when a landmark Women’s Health Initiative HRT study was discontinued over concerns about increased risk of heart disease, strokes and breast cancer – neither legislators nor Wyeth, the largest maker of hormone products, have yet confirmed funding.

FDA head of external relations Peter Pitts said the budget for the programme, which is being funded by the FDA and several healthcare organisations, was ‘under discussion’.

The FDA’s in-house comms team will handle information dissemination and media relations, assisted by partner organisations.

Along with bodies such as the National Institute of Health and the National Women’s Health Information Center, the FDA has produced information guides on HRT based on the latest scientific findings.

Wyeth spokeswoman Natalie deVane said: ‘We are not formally involved, but cleary the initiative is important. Hopefully this information will empower women to have discussions with their doctors so they can make informed decisions about HRT.’

The FDA is also developing its own ads, which it hopes publications will run on a pro bono basis.

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