FDA to consider easing Rx drug rules

Having previously rejected the idea of a third category of medicines, other than prescription-only or over-the-counter, the US Food and Drug Administration has announced a public meeting to obtain comments regarding what it describes as "behind-the-counter" availability of drugs. This will be held on November 14.

The FDA says it aims to explore the public health benefit of certain drugs being available BTC that were previously prescription-only. These could include products available at the pharmacy without a prescription and require the intervention of a pharmacist before dispensing. It notes that variations of a BTC status are already in effect in other countries, including Australia, Canada, France, New Zealand, the UK, Denmark, Germany, Italy, Netherlands, Sweden and Switzerland.

The consumer organization Public Citizen recalled the FDA's earlier rejection of a new drug status, when it said more research on the idea is needed, stating that this is still the case now. It pointed to possible risks of BTC sales due to inadequate counselling by pharmacists, the costs, usefulness and logistics of adding this third layer for distribution, and said that there is little evidence that these concerns have been addressed.