AARP s Interview With FDA Commissioner Scott Gottlieb
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We think it would be helpful to have mandatory ingredient listing so you have disclosure of what is in dietary supplements. That’s something that could make it more efficient to get new products on the market, but also allow us to provide more oversight when new products and new ingredients come onto the market. We think having mandatory recall authority, the ability to recall products, could help us take action more quickly. We certainly think that the industry has grown very big and created more potential opportunity, but also, more potential risk. I want to talk about off-label medicines. Are brand-name drug companies skirting safety when they sell a drug for something other than what it was approved for, basically eliminating the need for new scrutiny? Are they allowed to urge doctors to prescribe a drug for something that it wasn’t approved to treat? Legally, they can’t urge doctors to prescribe them for unapproved uses. That would constitute off-label marketing. They can get in trouble with the law. That doesn’t mean that they don’t do it. I think that there is less and less of that behavior going on in the market. That doesn’t mean that it doesn’t still go on. We send warning letters on it, but I think that there has been so much scrutiny that you see less of it. What can the average consumer do to ensure that the drug their doctor is prescribing for their illness has been approved for that purpose? I think consumers should always ask their doctors for the information for the particular use of the drug. It’s a very straightforward question to ask: Is the drug approved for that use? When it comes to food safety, we constantly hear about food being contaminated — from romaine lettuce to chicken to baking flour. Should people be more concerned than ever about the safety of their food? What should the average person out there do? I think that the food is safer than it has ever been. The food supply chain has also gotten more complex, like the drug supply chain, but we are able to identify many more foodborne outbreaks than we’ve ever been able to because what we’re able to do now is use genomic tools to correlate outbreaks of human illness together. AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. More on health AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. AARP VALUE & MEMBER BENEFITS See more Health & Wellness offers > See more Flights & Vacation Packages offers > See more Finances offers > See more Health & Wellness offers > SAVE MONEY WITH THESE LIMITED-TIME OFFERS
A Conversation With Outgoing FDA Chief Scott Gottlieb
Commissioner assesses medicine and food safety
STEPHEN VOSS Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. 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. AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. Flowers & Gifts 25% off sitewide and 30% off select items See more Flowers & Gifts offers > That said, the world is getting much more complex. Much more of the active pharmaceutical ingredients are manufactured overseas. A facility overseas is harder to inspect. It’s harder to get resources over there, although we do it.Fast facts br
Career Medical doctor FDA deputy commissioner for medical and scientific affairs Senior adviser, Centers for Medicare and Medicaid Services Clinical assistant professor, New York University School of Medicine Fellow at the American Enterprise Institute Chief health care investment officer, New Enterprise Associates Personal Born in New Jersey Bachelor’s degree from Wesleyan University Medical degree from the Icahn School of Medicine at Mount Sinai Married with three daughters. When it comes to dietary supplements, do you think the FDA needs more authority to regulate them and provide more public education?We think it would be helpful to have mandatory ingredient listing so you have disclosure of what is in dietary supplements. That’s something that could make it more efficient to get new products on the market, but also allow us to provide more oversight when new products and new ingredients come onto the market. We think having mandatory recall authority, the ability to recall products, could help us take action more quickly. We certainly think that the industry has grown very big and created more potential opportunity, but also, more potential risk. I want to talk about off-label medicines. Are brand-name drug companies skirting safety when they sell a drug for something other than what it was approved for, basically eliminating the need for new scrutiny? Are they allowed to urge doctors to prescribe a drug for something that it wasn’t approved to treat? Legally, they can’t urge doctors to prescribe them for unapproved uses. That would constitute off-label marketing. They can get in trouble with the law. That doesn’t mean that they don’t do it. I think that there is less and less of that behavior going on in the market. That doesn’t mean that it doesn’t still go on. We send warning letters on it, but I think that there has been so much scrutiny that you see less of it. What can the average consumer do to ensure that the drug their doctor is prescribing for their illness has been approved for that purpose? I think consumers should always ask their doctors for the information for the particular use of the drug. It’s a very straightforward question to ask: Is the drug approved for that use? When it comes to food safety, we constantly hear about food being contaminated — from romaine lettuce to chicken to baking flour. Should people be more concerned than ever about the safety of their food? What should the average person out there do? I think that the food is safer than it has ever been. The food supply chain has also gotten more complex, like the drug supply chain, but we are able to identify many more foodborne outbreaks than we’ve ever been able to because what we’re able to do now is use genomic tools to correlate outbreaks of human illness together. AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. More on health AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. AARP VALUE & MEMBER BENEFITS See more Health & Wellness offers > See more Flights & Vacation Packages offers > See more Finances offers > See more Health & Wellness offers > SAVE MONEY WITH THESE LIMITED-TIME OFFERS