1) Teen vaping crackdown/nicotine reduction
Vaping regulation aims to strike the delicate balance between weaning smokers off cigarettes and keeping flavored nicotine out of young peoples’ hands. Gottlieb moved to end sales of flavored e-cigarette products to teens and urged companies to voluntarily withdraw them. He pressed Altria and Juul for not doing enough to prevent teens from getting addicted. However, health groups criticized him for delaying the compliance deadline for the regulation of e-cigarette products to 2022.
2) Expediting generic-drug approvals
During his tenure, the agency announced new policies related to its Risk Evaluation and Mitigation Strategies program so branded-drug makers couldn’t block generic competitors. The FDA expedited review of generic-drug applications until there are three approved generics for a product. It also cleared the orphan-drug request backlog as it aimed to streamline its application process and has made a significant dent in the backlog of generic-drug applications. These endeavors contributed to the approval of a record-setting 971 generic drugs in fiscal 2018, up 3.6% from 937 in 2017, aided by a boost in staff following renewal of the Generic Drug User Fee Act.
3) Curbing opioid use
The FDA got the drugmaker Endo Pharmaceuticals to withdraw its opiate painkiller Opana ER, saying the medication’s risks outweigh its benefits. It’s one of the first times the FDA has tried to get an opioid pain medication off the market because of the public health consequences of abuse. The agency placed new restrictions on the use of opioids in children’s cold and cough products and warned nine companies that operate 53 websites that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications. New efforts to encourage the sale of the opiate-overdose reversal drug naloxone over the counter are in the works and the agency approved a more effective form of buprenorphine, which is used in medication-assisted treatment for opioid addiction, a strategy Gottlieb has championed.
Gottlieb stayed the course on an embattled Obama-era policy forcing restaurants to post calorie counts. He packaged that with the FDA’s Nutrition Innovation Strategy, which aims to provide all Americans with easier access to nutritious, affordable foods by arming consumers with information and encouraging manufacturers to produce healthier products.
5) Digital health support
Gottlieb’s guiding philosophy was “let’s prove the device is safe and then get it out in the market and use real-world evidence to show it is efficacious,” which has streamlined market entry, Chapman said. Toward the tail end of his tenure, the FDA pushed a new regulatory framework to promote medical devices that use “adaptive” artificial intelligence algorithms. And in 2018, the FDA authorized artificial intelligence-based devices for detecting an eye disease and for stroke care. Apple received clearance from the FDA in September for its latest Apple Watch, which can now conduct electrocardiograms and deliver alerts if atrial fibrillation is detected.
6) Drug shortage task force
Gottlieb said the task force will encourage companies to invest in more capacity to make drugs that are vulnerable to shortages. The task force will create several dedicated work groups to examine the FDA’s current regulatory authorities and reimbursement policies from the CMS and other payers, among other issues. It is also considering compiling a list of critical drugs that merit bolstered federal prevention strategies against shortages. Still, more could be done, according to the American College of Emergency Physicians. That is why the group sent a letter to the FDA, with the support of more than 100 members of Congress, to convene its Drug Shortage Task Force with other relevant federal departments to get ahead of shortages.
7) Biosimilar blemish
The FDA approved a record 59 new drugs and biologics in 2018, including 19 first-in-class therapies. But more than 500 off-patent brand drugs still lack competition, according to a list the agency published last year meant to increase transparency. Progress has been especially slow on the biosimilar front.
8) Cell and gene therapies
The FDA is working to expand a review group dedicated to investigational new drug applications to keep pace with the rapid growth in new cell and gene therapies like CAR-T therapy for cancer. The agency created new approval pathways for cell and gene therapies as well as some small-molecule drugs. It also formed technology and disease-specific regulatory frameworks to direct which pathways manufacturers should use. Those pathways aim to support multiple competitors.
9) Software precertification
The intent of the program is to streamline product review by assessing the overall quality of a software developer instead of trying to certify each iteration of the software. The program emphasizes real-world product use analytics and other post-market data collection.
Gottlieb was lauded as the most active and transparent leader of the FDA. While the standard will be difficult to maintain, observers hope that his active communication style could be used as a blueprint for future commissioners.
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