As Gottlieb leaves, what’s next for FDA?
As Norman “Ned” E. Sharpless, MD, prepares to become acting FDA commissioner in a few days, experts are divided in how he should address the explosion of e-cigarette use among minors and the devastating opioid epidemic whose tide has not turned.
He also faces the challenges of reinvigorating antibiotic development and lowering drug prices.
These areas were some of his predecessor, Scott Gottlieb, MD’s, main focus.
Though Sharpless has indicated elsewhere he would follow Gottlieb’s lead, it’s unclear if Sharpless will be the permanent nominee. Some have also suggested that Gottlieb’s efforts did not align with the Trump administration’s goals.
“Rest assured that our shared goals for patients and the public health will translate into my new duties,” Sharpless wrote in a tweet on March 12 after the announcement he would replace Gottlieb.
Healio Primary Care Today asked experts in these areas discussed where they think the FDA should go next in regards to e-cigarettes, opioids, antibiotic development and drug prices.
Earlier this year, the CDC said e-cigarette use among youth was a “mounting crisis” responsible for a significant increase in overall tobacco use in that age group.
“About 4.9 million middle and high school students were current users in the past 30 days of some type of tobacco product in 2018, up from 3.6 million in 2017,” a CDC Vital Signs report stated. “This increase — driven by a surge in e-cigarette use — erased past progress in reducing youth tobacco product use.”
Gottlieb oversaw multiple efforts to keep these products away from youth, including authorizing undercover blitzes that targeted retailers and taking another look at policies that extend the premarket application compliance date for newly regulated non-combustible tobacco products, electronic nicotine delivery systems (ENDS), and e-cigarettes to August 2022, and oversee most flavored ENDS that are sold online without additional, heightened age verification and other restrictions in place.
In a CBS This Morning podcast that aired 6 months ago, Sharpless acknowledged some of the debate surrounding e-cigarettes but stopped short of indicating what the government’s role in regulating these products should be.
“Nobody is certain yet what the national policy on e-cigarettes should be regarding tobacco control,” he said. “It’s going to be years more before we have a clear answer as to what our recommendations ought to be.”
Even after announcing his departure, Gottlieb maintained focus on e-cigarettes, writing in a tweet that “The FDA will not allow a generation of children to become addicted to nicotine. This effort will carry on.” Sharpless retweeted the comment, but there is concern that no one will be as aggressive in taking on the e-cigarette issue.
“Gottlieb was becoming a very serious threat to the tobacco industry,” Stanton Glantz, PhD, of the Center for Tobacco Control, Research and Education at Stanford University said told Healio Primary Care Today. “I fear with Gottlieb leaving, whatever happens next may be very muted,” he added.
Harold Farber, MD, MSPH, ATSF, associate professor of pediatrics at Texas Children’s Hospital, wants the FDA to be even more proactive in addressing e-cigarettes.
“The agency needs to mandate premarket review, require graphic warning labels, ban flavors on these products, regulate marketing that is accessible to young people and strictly and aggressively enforce age-for-sale laws,” he said in an interview.
Another tobacco policy researcher, Michael B. Siegel, MD, of the Boston University School of Public Health, said the FDA’s actions on tobacco products need to be more balanced, rather than focused primarily on e-cigarettes.
“The FDA needs to reverse the current message that Marlboros are less dangerous and easier to get than vaping devices. It also needs to remember that millions of adults use e-cigarettes to quit traditional smoking,” he said.
Sharpless takes acting control of the FDA as the opioid epidemic shows no signs of abating, with the related death toll at 130 lives a day. By some researchers’ estimates, the crisis may get worse before it gets better.
Nancy Nielsen, MD, PhD, a former senior advisor at CMS during the Obama administration, hoped Sharpless would continue Gottlieb’s efforts to turn the tide of the crisis.
“Sharpless must pick up where Gottlieb left off to reduce barriers associated with medication-assisted therapy, eliminate stigmas associated with opioid addiction and revisit prescribing guidelines for opioids already on the market,” she told Healio Primary Care Today.
Conversely, Lawrence Greenblatt, MD, FACP, a physician at Duke Health in North Carolina, said a new approach might be needed.
He encouraged the FDA to force health care providers to prove familiarity with safe opioid prescribing procedures; audit those with prescription rates outside of accepted norms; cultivate the development of medications that target allopathic pain, neuropathic pain, and pain originating from a central origin; and create packages with modest quantities of low-to-moderate dose opioids that could be readily prescribed and dispensed for common acute pain needs.
“The FDA also needs to reduce the quantity and availability of illicit fentanyl and fentanyl analogues that are typically smuggled into the United States,” Greenblatt said in an interview.
“I would also hope the FDA would partner with pharmaceutical companies to develop additional effective pharmacologic therapies to treat opioid use disorder. We need more choices and more effective therapies so that patients and their providers have an array of appropriate treatment choices,” Greenblatt continued.
The Infectious Diseases Society of America and WHO have long advocated for increased antibiotic development, with the latter society saying this past November “there is an urgent need for more investment in research and development for antibiotic-resistant infections including TB.”
A spokesperson for the Infectious Diseases Society of America agreed, and explained some of the obstacles that keeps the antibiotic market from reaching its full potential.
“The research and development pipeline for antibiotics is unbelievably slim even though there are many infectious diseases that lack safe and effective treatment options. There is very little opportunity for companies to earn a return on their investment for antibiotic research and development, and thus many have left this line of product development,” Amanda Jezek, senior vice president of public policy and government relations at Infectious Diseases Society of America told Healio Primary Care Today.
“We need Sharpless to be the champion Gottlieb was in this area, by improving clinical development pathways for novel antibiotics, calling for economic incentives that support antibiotic research and development and speeding the availability of antimicrobial susceptibility tests. We also hope the FDA will move to reclassify viral load tests for transplant associated viruses as Class 2 or moderate risk which could increase commercial development of these tests that are essential for managing transplant patients,” she added.
The FDA’s role in implementing the president’s plan for lowering drug prices includes requiring manufacturers to include list prices in advertising; improving the generic and biosimilar markets; and maximizing scientific and regulatory clarity on generic drugs.
Though the administration has previously said the president’s plan is producing results, last month high drug prices were in the news again, with the FDA’s recent approval of the first-ever drug for postpartum depression with a potential price tag of $37,500. The amount, according to some experts, makes the drug inaccessible to many, especially those who need it most.
Gottlieb’s track record was impressive in this area, according to Nielsen.
“He streamlined the drug approval process, and helped produce a healthy increase in the speed of the approval process. This was welcome to see and I hope it continues,” she said.
Robin Feldman, author of “Drugs, Money, and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices,” suggested other ways the FDA can become involved in lowering drug prices.
“Other countries have agencies that do consider whether an innovation provides much of a benefit to patients, but the FDA shies away from that role. Perhaps it is time for the FDA to encourage Congress to give it that power,” Feldman continued, adding the FDA should exercise greater authority when REMS abuses or bad citizen petitions are filed and continue to push for more generic drug approvals.
She said whatever Sharpless chooses to do in this area, the pushback would be significant.
“By stepping into the role of FDA commissioner, Sharpless is walking into the center of the storm,” she said.
Sharpless has been National Cancer Institute director since June 2017. During his tenure, supplemental funding was provided, and research moved forward in a broad spectrum of cancer-related areas, according to the National Cancer Institute’s website.
Before assuming that position, he had been at the University of North Carolina Lineberger Comprehensive Cancer Center since 2002, becoming its director in January 2014.
“Ned brought immunotherapy programs into focus, promoted development in key areas like HPV research, and advocated for increasing support to the funding pool for investigators. He has also been a champion for population science, particularly the development of real-world data resources,” Ethan Basch, MD, practicing oncologist, and professor of medicine at Lineberger said in an interview.
He added Sharpless’ multiple roles make him an ideal commissioner for physicians.
“Ned is a clinician as well as a clinical investigator and has first-hand drug development experience. This positions him ideally to understand the clinical context for products, and the importance of appreciating impact on patients,” Basch said.
Sharpless has had sound preparation for the acting FDA commissioner position, Keysha Brooks-Coley, MA, a vice president at American Cancer Society’s Cancer Action Network told Healio Primary Care Today.
“He demonstrated a clear understanding of the importance of moving new and innovative treatments, therapies and diagnostics from ‘bench to bedside’ in an efficient manner that prioritizes patient safety. He’ll be able to use that perspective in his new role as new products for patients are brought through the regulatory approval process,” Brooks-Coley explained.
Scope of power, possibility of confirmation
The decision to announce Sharpless as only ‘acting’ commissioner position suggests he may only be in the role temporarily, according to Jon Bigelow, executive director of the Coalition for Healthcare Communication.
“Why did the administration appoint Sharpless only to the ‘acting’ role (retaining his position at National Cancer Institute) rather than nominate him for the position on a permanent basis? Perhaps they simply wanted to get someone into the FDA quickly while working through the vetting process. Or the Trump administration may be interested in considering other candidates,” he said in an interview.
Another question is whether or not Sharpless has the political and professional charisma that turned many critics of Gottlieb into fans.
“I knew of Gottlieb’s connections to the pharmaceutical industry and had read some articles he had written and was very worried about him becoming FDA commissioner. I was really wrong,” Nielsen said.
“Public health advocates are worried that his replacement may not be so tough in some areas,” she continued.
“Gottlieb did a remarkable job leading the agency during a difficult time. He was able to advance several important public health objectives regarding tobacco control and promoting treatment for opioid addiction,” Joshua M. Sharfstein, MD, a former deputy FDA commissioner under Barack Obama, told Healio Primary Care Today.
Even if Sharpless was nominated for the commissioner position, he likely faces a longer wait to be confirmed than Gottlieb, another FDA observer said.
“There is an enormous confirmation backlog,” Fran Hawthorne, author of “Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat” explained.
“Almost one-fourth of Trump’s cabinet has acting as part of their title. About 40% of other presidential appointees in other areas are vacant, according to the Partnership for Public Service,” she said in an interview.
“Trump has to officially nominate Sharpless, the FBI has to vet him, then the Health, Education, Labor and Pensions Committee and the full Senate have to confirm him. Autumn would probably be the earliest a confirmation hearing would be held,” she said.
The hyperpartisan nature of the current political arena is a concern, but not an insurmountable one.
“C. Everett Koop was nominated by former Republican President Ronald Reagan for surgeon general because he was very anti-abortion. But when Koop made his stance on AIDS known, Democrats ended up defending him more,” Glantz said.
“Polarized DC is a concern, but I believe opioid use, teen vaping, and other public health concern will receive bipartisan support. Polarized DC allowed national right-to-try laws to pass. So, compromises can be made,” Raymond March, PhD, research fellow at the Independent Institute and director of FDAReview.org added.
Sharpless was not available for an interview prior to his making the transition to FDA to discuss how he would address these areas.
Healio’s Health Care and Politics Resource Center includes the latest news on health care laws, proposals, regulations and policies in the United States and how they are likely to affect clinicians and patient care. In addition, this page features expert opinions on the impact of health care reform on clinical practice across a wide range of specialties. Be sure to bookmark the page for future reference. – by Janel Miller
CBS This Morning. “CBS This Morning Podcast.” https://soundcloud.com/cbsthismorning/nci-director-on-the-need-for-more-research-on-e-cigarettes. Accessed March 22, 2019.
CDC.gov. “Progress erased: Youth tobacco use increased during 2017-2018.” https://www.cdc.gov/media/releases/2019/p0211-youth-tobacco-use-increased.html. Accessed March 21, 2019.
CDC.gov. “Opioid overdose.” https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 22, 2019.
HHS.gov. “American Patients First. The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.” https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf. Accessed March 24, 2019.
National Cancer Institute. “NCI director Dr. Norman E. Sharpless.” https://www.cancer.gov/about-nci/leadership/director. Accessed March 8, 2019.
National Cancer Institute. "Reflections on my first year as NCI director." https://www.cancer.gov/news-events/cancer-currents-blog/2018/sharpless-first-year-nci-director. Accessed March 9, 2019.
University of North Carolina School of Medicine. “President Trump intends to appoint Norman Sharpless, MD, director of National Cancer Institute.” https://www.med.unc.edu/medicine/news/dept-news/2017/uncs-ned-sharpless-md-is-named-head-of-the-national-cancer-institute. Accessed March 22, 2019.
Disclosures: Neither Farber, Seigel, Greenblatt, Nielsen, Jezek, or Hawthorne report any relevant financial disclosures. Healio Primary Care Today was unable to determine to determine March, Basch or Feldman’s relevant financial disclosures prior to publication.