US FDA Considers Creating New Drug Class
The US Food and Drug Administration made an announcement on the 3rd October 2007 that hinted at the creation of a new class of drugs that could be purchased, without a prescription, at pharmacies. Stipulated within this, however, would be a requirement that a pharmacist is still consulted before the drugs are dispensed.
The next stage in the US FDA’s possible implementation of this is a meeting which will be held on the 14th November. Here, the regulatory body will be presented with the public’s response to the proposed “behind the counter” system, which could ultimately provide patients with greater accessibility to drugs currently restricted to prescribed supply.
However, the move is expected to be condemned by the dominant pharmaceutical firms involved in the marketing of “over-the-counter” products. It has already met opposition from the Consumer Healthcare Products Association – the group responsible for representing companies such as Johnson and Johnson, and Kimberly-Clark Corporation. "We believe the current two-class system is the best system for consumers," stated Elizabeth Funderburk – an association spokeswoman.
In the US, behind-the-counter drugs are now only represented by a very small number of products. They include the Plan B birth control pill, which is manufactured by Barr Pharmaceuticals. Such drugs, however, are more widely available in Britain, Australia, New Zealand and Canada – to name but four.
Among pharmacist groups, the general sentiment is one that backs a programme in which their role in drug provision is a more prominent one. As per Charlie Sewell: "Other countries have this approach and it's worked fairly well".
Mr Sewell is a National Community Pharmacists Association official.
In the words of the National Association of Chain Drug Stores, the measure could "offer yet another way for pharmacists to serve their patients."
According to the US FDA, the proposal, if implemented, could offer assistance to patients not in possession of health insurance, given that, otherwise, the drugs they need would only be available via prescription.
The regulatory body is now seeking input from several communities in respect both of the drugs suitable for behind-the-counter sale, and how they would affect the way patients take them. To this end, the participation of medical sources, advocacy groups and the drug industry at large has been requested.
Additionally, the US FDA wants advice in respect of the level of counselling that the pharmacist should provide, and how the safety of patients could be ensured.
Source – Pharmaceutical International’s US Correspondent
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