Regulatory in brief | FDA, TGA, MHRA

Regulatory in brief | FDA, TGA, MHRA

24 October 2019 - Deborah Wilkes

The US Food and Drug Administration (FDA) has updated its approach to homeopathic products, Australia’s Therapeutic Goods Administration (TGA) is consulting on a proposal affecting supports supplements, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced a promotion.

FDA acts on homeopathic products

The US FDA has taken two steps to “clarify” its risk-based enforcement approach to drug products labelled as homeopathic.

Ned Sharpless, acting FDA commissioner, said the homeopathy industry continued to grow at a rapid pace and the FDA wanted to “clarify for both consumers and industry how we assess the potential safety risks of these products”.

Firstly, the FDA has revised its 2017 draft guidance on the approach and is seeking public input. The regulatory agency said the finalised guidance would “help provide transparency regarding the categories of homeopathic drug products that we intend to prioritise under our risk-based enforcement approach”.

Secondly, the FDA is withdrawing a compliance guide titled “Conditions under which homeopathic drugs may be marketed”. The agency pointed out that since the guide had been introduced in 1988 there had been “multiple situations” where homeopathic drug products appeared to meet the conditions but “posed a significant risk to patients”.

Commenting on the two steps, Sharpless said: “These products have the potential to cause significant and even permanent harm if they are poorly manufactured – since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labelled and/or safe – or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations.”

“In addition, some products may be labelled as homeopathic that do not conform to traditional homeopathic principles,” added Sharpless.

TGA consults on sports supplements

Australia’s TGA is consulting on a proposal to declare that certain sports supplements are therapeutic goods “when used, advertised or presented for supply in a particular way”.

The regulatory agency said sports supplements “often carry explicit or implied claims relating to sport, fitness or recreational performance that mean they are likely to be consumed for therapeutic use, yet some of them may be considered to be food under law”.

“It is appropriate that those sports supplements that are taken to be for therapeutic use are subject to the same national system of controls that are established for other therapeutic goods,” added the TGA.

Responses to the consultation must reach the TGA by close of business on 3 December 2019.

UK’s MHRA promotes Branch

The UK’s MHRA has appointed Sarah Branch as interim director of vigilance and risk management of medicines (VRMM).

She takes over from June Raine who was recently named interim chief executive officer of the MHRA (click here to read the News story).

Branch has been deputy director and head of operations in VRMM for six years. She joined the regulatory agency in 1994 after a career in academia.

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