Health Advisory Council Dec. 2017 meeting minutes



Discussion Highlights:
Fireside Chat between FDA Commissioner Scott Gottlieb and NCL Executive Director Sally Greenberg

Q:  How does the FDA balance facilitating the timely review and approval of new drugs and medical technologies while ensuring their safety and effectiveness?

A: Commissioner Gottlieb explained that it is possible to get products to market more quickly while ensuring their safety and efficacy. Saying “it’s not a zero sum game,” Dr. Gottlieb noted that FDA can make the product review process more timely and efficient without sacrificing safety and effectiveness. FDA is focused on ensuring scientifically rigorous product reviews.      

17_dsp7737_lr.jpgQ:  A major area of focus for you as Commissioner has been encouraging competition in order to lower drug costs. What are some of the FDA’s initiatives to spur competition in the marketplace?

A: Commissioner Gottlieb stated that he supports market-based pricing in order to encourage innovation. However, he recognized that it is important to preserve the careful balance struck by the Hatch-Waxman Act between access and innovation. Dr. Gottlieb expressed concern that some innovator companies have been gaming the system in order to deliberately slow down the public availability of generic drugs. In order to spur competition in the marketplace, FDA is taking a number of actions, including improving the efficiency of FDA’s generic drug review process so that more generics can be approved during the first review cycle; prioritizing review of ANDAs for those drugs that do not currently have an approved ANDA; and developing new guidances on drug-device combinations and the development of generic versions of complex drugs.     

Q:  We know that in an effort to save money, many consumers search online for cheaper drugs, making themselves vulnerable to counterfeit drugs being sold by rogue online pharmacies. A few months ago, FDA cracked down on hundreds of these websites, particularly those that are selling opioids through the U.S. Postal Service to U.S. consumers. Could you talk a bit about this operation and FDA’s efforts to protect consumers from counterfeit drugs?

27_dsp7765_lr.jpgA: Commissioner Gottlieb referenced Operation Pangea X, in which FDA, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, and injectable epinephrine products to American consumers. To combat counterfeit drugs, FDA’s criminal investigators are policing the dark web. In addition, FDA has recently stepped up its inspections of International Mail Facilities, devoting 3 times as many FTEs and inspecting 4 times as many packages. However, Dr. Gottlieb expressed frustration that FDA is not able to pull and test every suspicious package to prove it is illicit, so a certain amount of counterfeit drugs do make it through. Dr. Gottlieb called for legislative changes to FDA’s seizure authority to allow the agency to seize and test a suspicious package and then be able to destroy all of the same packages without having to test every single one.             

Q:  In August, NCL facilitated a meeting for advocates including WomenAgainstAlzheimer’s and AARP with Dr. Woodcock and other CDER staff to discuss the state of the Alzheimer’s drug pipeline and ways to encourage the development of Alzheimer’s treatments. NCL was pleased to hear your remarks on the topic indicating that FDA would be clarifying the guidance for the development of safe and effective Alzheimer’s treatments. Can you elaborate on that as well as steps FDA can take to encourage the development of drugs for diseases that currently have no treatments?

28_dsp7766_lr.jpgA: Dr. Gottlieb explained that as a science-based organization, FDA is committed to modernizing its review processes and helping sponsors to lower the costs of drug development. FDA plans to issue a guidance for the development of safe and effective Alzheimer’s treatments. Dr. Gottlieb also explained how advocates can help the FDA to develop guidances in specific disease areas. For example, the ALS Association developed a guidance on ALS drug development that it shared with the FDA. Because the guidance was so good, FDA was able to use it to form the basis for its own ALS guidance, which it issued sooner than would otherwise have been possible. 

Q:  Can you comment on cosmetics reform?

A: Dr. Gottlieb explained that when he was Deputy Commissioner of the FDA, there was a proposal to eliminate the FDA’s cosmetics program. Rather than abolishing the Office of Cosmetics, however, Dr. Gottlieb decided to increase the number of FTEs in the Office from 10 to 20, which is about where it stands today. Recognizing that cosmetics are now more complex and carry more risk, Dr. Gottlieb acknowledged that FDA could use more resources and tools to ensure that cosmetics are safe and properly labeled. However, he stressed that OTC monograph reform is a higher priority for the agency. He doesn’t want to see the cosmetics legislation prevent OTC reform from moving forward in Congress. Dr. Gottlieb foresees a longer timeline for cosmetics legislation to pass.     

Q:  Is FDA open to receiving the input of independent pharmacies into the agency’s implementation of the compounding guidance?

A: Commissioner Gottlieb noted that the compounding guidance is designed to address those compounders who are inappropriately manufacturing drugs. He explained that FDA has been considering how much leeway it is able to give to pharmacies, and plans to issue a policy in early January that will be more accommodating.  

25_dsp7759_lr.jpgQ:  How has your experience as a cancer survivor influenced you as a policy maker and as a physician?

A: Commissioner Gottlieb was very candid about his experience as a cancer patient. As a physician, he was fortunate to have self-diagnosed lymphoma very early when he had a 90% – 95% chance of a complete cure. Investigating all the treatment options available to him, Dr. Gottlieb chose ABVD chemotherapy and Rituxan, and was able to avoid radiation, which would have increased the chance of developing a second cancer. Despite the high likelihood of a complete cure, Dr. Gottlieb said that uncertainty was the hardest part for him. This experience changed how he talked to his patients.