AARP Hearing Center
Scott Gottlieb’s tenure as the protector of the nation’s food and drug supply comes to an end Friday. As commissioner of the Food and Drug Administration (FDA) for nearly two years, Gottlieb has presided over an agency that regulates nearly $2.5 trillion worth of consumer goods — from food to drugs to medical devices, vitamins, supplements, tobacco and even pet products and cosmetics. Before a new medicine can be marketed, the FDA must approve it. The agency also monitors the safety and labeling of the nation’s food supply.
Gottlieb, who is a medical doctor and former health investment adviser, will join the American Enterprise Institute, a Washington, D.C., think tank, as a resident fellow focusing on drug pricing. The commissioner sat down with AARP in his last week in office to discuss his tenure and what he expects of the FDA in the future.
What are you most proud of that you’ve done at the FDA?
We started to talk explicitly about the agency having a role in reducing the rate of new [opioid] addiction by taking a more activist role and trying to address inappropriate prescribing, trying to reduce the total number of prescriptions, making sure that when doctors wrote a prescription, it was for an appropriate medical purpose and that when prescriptions were written, they were for a duration that comported with why the doctor was prescribing the opioids in the first place.
What do you wish you had accomplished that you won’t be here to see through?
I would have liked to have been around to continue to try to modernize how we regulate over-the-counter drugs, open up the market to more innovative OTC solutions and make it easy to move prescription drugs over the counter with more accessibility to consumers and potentially lower costs.
One of the requirements for bringing a drug over the counter is “can the consumer pick up the drug at the pharmacy, read the label, self-select the drug and know that they are indicated for it.” For a headache, you can self-select for ibuprofen, Tylenol. For allergies, you can self-select for symptoms of seasonal allergies.
For chronic conditions like elevated cholesterol or blood pressure, it’s hard to self-select without a diagnosis. The question is: Can you use technology at the pharmacy to help patients get more information about their health to help them opt for over-the-counter drugs? So we’ve put out regulations that might allow a patient to get a cholesterol test and then self-select for a statin, or it might allow a patient to go through a checklist at the pharmacy rather than just reading the label. They could then maybe get a coupon to buy the drug.
How far away do you think we are from something like that?
I think we’re close. The regulation is being developed. I think we’re pretty close to these kinds of opportunities being more widely available.