The US regulatory agency will hold a public meeting to discuss whether to reclassify drugs for high blood pressure, high cholesterol, asthma and migraine in order to ease patient access.
The FDA is also considering ways to accelerate the approval of drugs for Alzheimer’s disease and rare conditions, and to improve the targeting of antibiotics to specific patient groups.
FDA Commissioner Margaret Hamburg commented: “As the science is unfolding in new and exciting ways that will give us new tools, I think we are in a position to do things differently than we have historically.”
The shifting of some long-term condition medications to OTC status would require drug companies to carry out consumer use studies in order to show that customers are able to use the medicines correctly.
Despite this hurdle, the new policy could create a new OTC market opportunity for ‘blockbuster’ branded drugs such as Lipitor, which is facing a major drop in sales due to patent expiry.
This could create a new medical model for long-term condition management where the patient consults with a pharmacist rather than a doctor.
According to Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, the FDA intends to expand its accelerated approval programme – currently limited to AIDS and cancer drugs – to drugs for Alzheimer’s disease and rare conditions.
Woodcock also said that in order to counter the spread of antibiotic resistance, which has “reached crisis proportions”, the FDA plans to allow companies to test new antibiotics on smaller patient groups, and to restrict prescribing to more closely defined patient populations.
These changes, which have implications for many pharmaceutical companies selling into the US market, are intended to address urgent unmet medical needs in the US population.