AMA opposes down-scheduling of Sildenafil
The AMA has strongly opposed a proposal to make Sildenafil, the prescription drug more commonly known as Viagra, available over-the-counter.
The AMA has again lodged a submission opposing the proposal to down-schedule Sildenafil.
This is the fourth application to down-schedule the drug since 2017, however no new information has been provided to justify the change. The risk profile for Sildenafil remains significant given the broad range of contraindications, particularly among the key consumer market of older men.
The AMA submission highlighted that the prescription of sildenafil requires a comprehensive medical assessment to address the causes, contraindications and potential risks,
The AMA’s position is that the down-scheduling of prescription drugs should only occur when patient benefits and safety are demonstrated and supported by data.
The submission also contends that allowing the drug to be accessible over the counter sends a signal to consumers that it is low risk when there is no evidence to support this.
The application notes that down-scheduling would minimise the numbers of patients likely to order it from unregulated online sources. However, there is no evidence making the drug available over the counter will discourage this activity, particularly when this solution would require discussing the issue with a pharmacists in a public retail setting.
