FDA's Winckler talks about the agency's goals

In September 2006, Susan Winckler, R.Ph., J.D., joined the Food & Drug Administration as acting chief of staff. She had served as the American Pharmacists Association's staff counsel and VP for policy and communications. Drug Topics sat down with Winckler to get her answers to the following burning questions:

As the FDA commissioner's acting chief of staff, what's a day in your life like?

I spend a lot of time on the agency's priorities, which include food safety, medical product safety, and personalized medicine, as well as strengthening the FDA. I am involved in discussions that could be about peanut butter one minute, pet food the next, and pandemic flu right after that.

In switching from APhA to FDA, were you trying to create a better liaison between the two groups?

The commissioner attaches a high priority to outreach with the agency stakeholders, and that includes pharmacists. In February, he went to the Joint Commission of Pharmacy Practitioners (JCPP) quarterly meeting for a dialogue about areas where the agency and the pharmacist profession can collaborate. I am certain that process will continue with the profession as well as with physicians, food safety experts, consumers, and patient groups.

Pharmacists are concerned about the FDA's proliferating demands for risk management. Can we expect more standardization of the FDA's requirements?

FDA's goal in risk management is to focus medication use on the right population of patients-where the benefits outweigh the risks. The agency is continuing to refine those approaches to ensure that result, getting feedback from patients, pharmacists, and physicians about what works and what could be improved.

Plan B went OTC in pharmacies last year, creating a de facto third class of drugs. Is the new commissioner receptive to the establishment of a third class of drugs?

At the Consumer Healthcare Products Association (CHPA) annual meeting, the commissioner shared the agency's willingness to explore a way to expand consumer access to some Rx medications.

What are your goals at FDA?

My goal is to do my best to serve the agency and the commissioner as well as the public.

What can the FDA do to help prevent medication errors?

The FDA has a role, certainly, as we think about things like the naming of medications. We talk about the FDA's role in identifying the right population, where the benefits outweigh the risks of certain products. We know that products, specifically drugs, are approved because they are safe and effective. But they also need to be used in the right way. There is an opportunity for collaboration between the agency and healthcare professionals-pharmacists, doctors, and other prescribers-to see that we have the right information as well as the expertise of the agency available to them. Perhaps we can even look at systems and what contributes to medication errors and what we can do to limit those errors.

What impact do you think FDA will have in the future?

Think about the era of personalized medicine. It's something the commissioner calls our metamorphosis-the drugs of tomorrow really will look quite different from our drugs of today. We'll have a lot of additional information about them. While that is exciting from the agency perspective, perhaps it will prove even more exciting from the pharmacists' perspective. We have very powerful medications on the market that do great things. The sophistication of those products is only going to increase.