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FDA plan would make more drugs available OTC

US regulator is also considering expanding its accelerated approvals programme

The US Food and Drug Administration (FDA) is weighing whether to allow more pharmaceuticals to be available over-the-counter and will convene a two-day public meeting later this month to debate the idea.

The agency is also considering expanding its accelerated approvals programme to make it easier for pharma companies to bring new medicines to market in a timely manner.

The overall aim is to look at ways to improve access to medicines for the US public, according to FDA Commissioner Margaret Hamburg, who noted that wider availability of medicines could help improve management of diseases like diabetes. More than a quarter of all diabetics in the US are undiagnosed and untreated, she told reporters yesterday.

Prescription medicines which could be suitable for a switch to OTC status could include drugs for chronic rather than acute conditions, such as blood pressure, elevated cholesterol and diabetes.

Patients would be able to secure access to these medicines without a prescription, with the pharmacist taking a greater role in ensuring safe and appropriate use of the drugs. The shift could also be facilitated by greater use of technology such as touchscreen kiosks within pharmacies that could aid self-diagnosis.

Pharma manufacturers would be responsible for applying for prescription-only to OTC switches, and the FDA would review applications on a case-by-case basis.

Meanwhile, changes to the FDA's accelerated approval system are being considered that could see its expansion to include drugs such as antibiotics and Alzheimer's disease therapies, according to Janet Woodcock, director of the the regulator's Center for Drug Evaluation and Research (CDER).

The system was set up in 1992 to speed access to new drugs for life-threatening conditions like cancer, but the agency has been criticised for allowing too much red tape in its approvals process compared to its counterparts elsewhere in the world.

Other proposals under consideration include allowing antibiotic trials to involve fewer patients - in order to bring new drugs through quickly to help tackle the growing issue of antibiotic resistance - as well as labelling that would combat overprescribing. Similar labelling may be introduced for weight-loss drugs.

The FDA said it is seeking comments from stakeholders on the proposals.

9th March 2012

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