FDA Commissioner Margaret Hamburg and the agency’s director of the Center for Drug Evaluation and Research, Janet Woodcock, are trying to think outside the box in order to get drugs into patients’ hands faster.
They are debating two ideas and weighing whether or not to allow more medicines to be available to consumers over the counter, for some chronic conditions; as well as speeding up approvals of drugs for infection, Alzheimer’s disease and rare conditions.
Both have stressed that the ideas still are in the formative stages. “We’re trying to get feedback from various stakeholders,” Dr. Hamburg told reporters, about “how to improve access” to a wider range of drugs.
Idea #1- More OTC Medications
“The process of transferring FDA-approved prescription medications to nonprescription, over-the-counter (OTC) status is known as Rx-to-OTC switch. This process provides consumers with convenient, cost-effective access to safe and effective medicines, without the required assistance of a healthcare provider,” according to the Consumer Healthcare Products Association.
Idea #2- Faster Approval
The FDA plans to expand its accelerated approval program based on relaxed standards for effectiveness, which is now largely limited to AIDS and cancer drugs, according to Woodcock.
The accelerated approval system, which requires further testing after products are on the market, would benefit treatments for rare diseases and Alzheimer’s, Hamburg and Woodcock stated.