Ad pre-approvals for therapeutics stay… for now

red and yellow capsules

A controversial TGA bill that would have seen advertising pre-approvals removed has been passed by the Senate

The Therapeutic Goods Amendment Bill 2017 was passed with an amendment, negotiated by the Labor Party, to keep current conditions regarding the mainstream media advertising pre-approval process for therapeutic goods for two years.

An evaluation of the new advertising framework is set to be conducted in 18 months.

Several stakeholders had expressed concern that the removal of advertising pre-approvals could put consumers at risk.

Friends of Science in Medicine member and pharmacist Ian Carr had recently told the AJP that the removal of pre-approvals would give unproven medicines a “free kick” and undermine pharmacy professionalism.

Labor Senator Helen Polley said that “Labor are satisfied that the amendment we have negotiated with the government addresses our primary concern”.

Greens leader Senator Richard Di Natale had moved that all indications citing “traditional evidence” be required to display the following statement: “This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective”.

He said the Greens support a Sansom Review recommendation which would have required a range of pre-approved indications and “that sponsors need to indicate that they’re going to choose one of those pre-approved indications rather than simply stating in their own words what they believe a product might do, which on a number of occasions has been found to be misleading”.

“The Sansom review said: ‘Get rid of this free text. Don’t allow sponsors of products to say what they want about a particular drug. That can be misleading and give the false impression to an individual that a product has a scientific basis behind it, so you’re going to have to basically tick a list of pre-approved indications, but you also need to make sure that you make it very clear to the individual purchasing the product that it hasn’t been scientifically tested’,” he said.

The amendment was rejected, with Nationals deputy leader Bridget McKenzie explaining that, “the bill itself introduces a new pathway for products to have evidence assessed and be able to have a positive claim on their label.

“Hence, consumers will be able to differentiate between ones that have had the evidence assessed and those that have not, and at the end of the day it will be up to the consumer.”

Other amendments were moved, including by libertarian Senator David Leyonhjelm, who proposed removing the ban on vaping nicotine. This amendment was also rejected.

Friends of Science in Medicine’s Ken Harvey expressed concern about “the TGA’s endorsement of an industry supplied list of ‘permitted’ indications for complementary medicines”.

“This resulted in 1019 indications of which only 14% require the manufacturer to have scientific evidence to back them up,” he told the AJP.

“For the rest, evidence of ‘traditional’ use sufficed; that is, use for more than 75 years in an alternative medical tradition like Traditional Chinese Medicine, Ayurveda, Unani, Western Herbalism or Homoeopathy.

“This despite concerns from consumer advocates and health professionals who argued the list endorsed pseudoscience, encouraged industry to evade the need to have scientific proof, and would boost consumer spending (now more than $4.5 billion a year) on medicines of unproven efficacy.

“The Government noted that complementary medicines are a $4 billion export industry and so they appeared to have no problem with a likely flood of medicines that claim to, ‘soften hardness’, ‘tonifies kidney essence’, ‘open body orifices’, ‘replenish the gate of vitality’ and ‘moistens dryness in the triple burner’,” he said.

“Meanwhile, the TGA have yet to circulate a draft of the new, legally enforceable, Therapeutic Goods Advertising Code.

“This might provide another opportunity to raise advisory statements. In addition, the permitted indications mentioned in the Bill must be activated by Regulation. This will require the permitted indications list to be tabled in each house of Parliament where Members of Parliament are able to move that the regulation be disallowed.

“In short, controversy about this Bill will continue.”

Meanwhile, Complementary Medicines Australia welcomed the passing of the Bill, particularly the provision of the new approval pathway for CMs with higher therapeutic indications and health claims.

“The goal is to encourage and reward greater investment in research and development by industry and be an incentive to further expand the clinical research base for complementary medicines, enabling Australian companies to expand business opportunities,” said Mr Gibson.

“Achieving an appropriate regulatory regime – one that is supportive of innovation but that doesn’t undermine the current high standards for Australian complementary medicines – will assist the complementary medicines industry to bring innovative new products to both the Australian and global markets.”

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1 Comment

  1. Bringing innovative new products to both the Australian and global markets…Chicken comb extract as an active ingredient (now approved by the TGA as a permissible Listed ingredient):

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