Breaking News
March 22, 2018 - Researchers explain link between 2 key Alzheimer’s proteins
March 22, 2018 - Patients on replacement therapy with thyroid hormone may have more comorbidities
March 22, 2018 - Higher online patient ratings linked to urologists who saw fewer Medicare patients
March 22, 2018 - FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis
March 22, 2018 - Beer Raises Heart Rate; KardiaBand Hyperkalemia Test; CHD Clinics
March 22, 2018 - A retinal implant that is more effective against blindness
March 22, 2018 - New system based on artificial intelligence provides reliable detection of breast cancer
March 22, 2018 - Research offers new understanding about cause of Parkinson’s disease
March 22, 2018 - HORIBA’s Microsemi CRP analyzer improves quality of care in emergency pediatric units, study shows
March 22, 2018 - Range of Vaginal Dryness Products Can Help Postmenopausal Women: Study
March 22, 2018 - Higher Dose Tx Deemed Safe in Pulmonary TB
March 22, 2018 - Discovery of new ALS gene points to cytoskeleton as potential target for drug development
March 22, 2018 - Diet soda associated with higher odds of diabetic retinopathy
March 22, 2018 - LSD reduces ‘sense of self’
March 22, 2018 - Vitamin D deficiency linked to metabolic syndrome in postmenopausal women
March 22, 2018 - Changes in the intestines may be responsible for reversal of diabetes after bariatric surgery
March 22, 2018 - iPads and Cancer; Clot Retrieval and Stroke: It’s PodMed Double T!
March 22, 2018 - Premature births linked to changes in mother’s bacteria
March 22, 2018 - Brain SPECT scans predict treatment outcomes in patients with depression
March 21, 2018 - Researchers succeed in integrating artificial organelles into cells of living organism
March 21, 2018 - Researchers discover ‘missing mutation’ in severe infant epilepsy
March 21, 2018 - Researchers develop statistics-based computational scheme to zoom in on brain function
March 21, 2018 - Verge joins Genomics England’s Discovery Forum industry partnership
March 21, 2018 - Trovagene Announces First Patient Successfully Completes Cycle 1 of Treatment with PCM-075 in Combination with Low Dose Cytarabine (LDAC) in AML Trial
March 21, 2018 - Congenital Cardiac Cath Tx Often Strays from Guidelines
March 21, 2018 - Marked increase in cardiovascular risk factors in women after preeclampsia
March 21, 2018 - New app may help predict, track manic and depressive episodes in bipolar patients
March 21, 2018 - Discovery of genes could lead to development of novel therapies for EBV-related cancers
March 21, 2018 - High-fat, high-cholesterol diet depletes ranks of artery-protecting immune cells
March 21, 2018 - Research misconduct allegations shadow likely CDC appointee
March 21, 2018 - Most Breast Ca Patients Fail to Get Genetic Counseling
March 21, 2018 - Lopsided ear function can lead to lopsided brain development
March 21, 2018 - Acupuncture helps manage menopausal symptoms, review finds
March 21, 2018 - Motor skill training may contribute to reading skills in obese children
March 21, 2018 - Poor dental health may be related to increased diabetes risk
March 21, 2018 - Chronic opioid users at increased risk of complications after spinal fusion surgery
March 21, 2018 - Study uncovers potential therapeutic target against large family of parasites
March 21, 2018 - NSAID use linked to increased risk of atrial fibrillation
March 21, 2018 - Scientists develop brain “stethoscope” that can detect silent seizures
March 21, 2018 - New method predicts effects of global warming on disease
March 21, 2018 - Insurance Company Hurdles Burden Doctors, May Harm Patients
March 21, 2018 - Renal Transplant from HCV-Positive Donors Feasible
March 21, 2018 - Myelodysplastic syndrome: MedlinePlus Medical Encyclopedia
March 21, 2018 - Research reveals brain mechanism involved in language learning
March 21, 2018 - Many parents still hesitate to try early peanut introduction, survey finds
March 21, 2018 - Audiologist urges tinnitus sufferers facing ‘revolving door healthcare’ to seek support
March 21, 2018 - Study reveals impact of prostate cancer on wives and partners of sufferers
March 21, 2018 - ‘Almost a Miracle Drug’: What We Heard This Week
March 21, 2018 - Study shows NIH spent >$100 billion on basic science for new medicines
March 21, 2018 - Columbia researchers identify nerve cells that drive fruit fly’s escape behavior
March 21, 2018 - Sartorius Stedim Biotech selected by ABL Europe to supply single-use process technologies
March 21, 2018 - Increase in coffee consumption may help battle against colon cancer
March 21, 2018 - Hydrogel may accelerate healing of diabetic ulcers
March 21, 2018 - Dermira’s Two Phase 3 Trials Evaluating Olumacostat Glasaretil in Patients with Acne Vulgaris Did Not Meet Co-Primary Endpoints
March 21, 2018 - DePuy Synthes introduces ACTIS Total Hip System for improving initial implant stability
March 21, 2018 - ‘Oh, It Was Nothing’
March 21, 2018 - Herbal drug kratom linked to salmonella illnesses, CDC says
March 21, 2018 - New optical point-of-care device could enhance screening for thyroid nodules
March 21, 2018 - FDA Expands Approval of Adcetris (brentuximab vedotin) for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination with Chemotherapy
March 21, 2018 - Eosinophilic Esophagitis: Late Manifestation of Allergic March
March 21, 2018 - Signaling pathway involving the Golgi apparatus identified in cells with Huntington’s disease
March 21, 2018 - Quintupling inhaled steroid doses may not benefit children with asthma
March 21, 2018 - Study shows clear connection between cardiovascular fitness in middle age and dementia risk
March 21, 2018 - Premature babies have higher risks of health complications in Bangladesh
March 21, 2018 - Child’s temperament and parenting influence weight gain in babies
March 21, 2018 - Researchers find the heart to be capable of arrhythmia termination after local gene therapy
March 21, 2018 - Inhealthcare to provide digital infrastructure for NHS to help protect people from falls
March 21, 2018 - Flu Season Finally Slowing Down
March 21, 2018 - Mixed Results for Shorter DAPT in ACS Patients
March 21, 2018 - Scientists discover fish scale-derived collagen effective for healing wounds
March 21, 2018 - Genomics England announces new partnership to improve efficiency of next-generation sequencing analysis
March 21, 2018 - Adjuvant AC chemotherapy found to be effective in treating HRD-positive breast cancer patients
March 21, 2018 - Researchers identify new treatment targets for lung diseases using big data
March 21, 2018 - Kids see more women in science than five decades ago
March 21, 2018 - Research shows link between chronic fatigue syndrome and lower thyroid hormone levels
March 21, 2018 - Alzheimer’s disease on the rise
March 21, 2018 - Two Agents Equal as Pretreatment for Adrenal Tumor Surgery
March 21, 2018 - ‘Icebreaker’ protein opens genome for T cell development, researchers find
March 21, 2018 - Women in medicine shout #Metoo about sexual harassment at work
March 21, 2018 - Mother’s pre-pregnancy waist size may be linked to child’s autism risk
FDA’s Tobacco Policy Pivot, Five Months Later

FDA’s Tobacco Policy Pivot, Five Months Later

image_pdfDownload PDFimage_print

In late July, FDA Commissioner Scott Gottlieb, MD, announced a major pivot in tobacco policy aimed at shifting the federal government’s regulatory focus from nicotine to combustible tobacco products. Click here to read MedPage Today‘s original report on the announcement. In this follow-up story, we review what has transpired in tobacco regulation since then.

In that announcement, Gottlieb outlined a multi-pronged strategy:

  • Reducing the nicotine in traditional cigarettes to non-addictive levels
  • Increasing the number of approved nicotine replacement therapies (NRT)
  • Acknowledging the potential of other, non-combustible nicotine-delivery products to help smokers quit — recognizing a “continuum of risk for nicotine-containing products,” as Gottlieb put it

“The regulatory framework for reducing harm from tobacco must include nicotine — as a centerpiece,” Gottlieb wrote in an editorial explaining the policy shift published in the New England Journal of Medicine.

“Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kills hundreds of thousands of Americans each year,” he wrote. “The FDA’s approach to reducing the devastating toll of tobacco use must be rooted in this foundational understanding: other chemical compounds in tobacco, and in the smoke created by combustion, are primarily to blame for such health harms.”

Specific actions outlined by the agency in the late July announcement included a plan to formally seek input on dramatically lowering nicotine levels for combustible cigarettes under an Advanced Notice of Proposed Rule Making, and the delay of key regulatory actions on electronic cigarettes, cigars, and previously unregulated tobacco products.

Movement ‘Slower than Promised’

The comprehensive tobacco policy was generally praised by anti-tobacco groups at the time as a potentially positive step forward for reducing tobacco-related death and disease in the United States, while they uniformly criticized the plan to delay key deadlines for the regulation of electronic cigarettes and other tobacco products that came under the FDA’s authority in 2016.

In a press release issued in response to the FDA’s shift in tobacco policy, Robin Koval of the anti-tobacco group Truth Initiative agreed with Gottlieb’s conclusion that reducing the addictive ability and appeal of combustible tobacco products “is a cornerstone of protecting the public health.”

“Ultimately, while we are strongly supportive of the goals set forth by Commissioner Gottlieb today, our optimism is tempered by the ongoing delays in implementing measure that will have an impact on the death and disease caused by tobacco.”

Campaign Tobacco-Free Kids’ (CTFK) president Matthew Myers called Gottlieb’s sweeping tobacco regulatory agenda “a bold and comprehensive vision with the potential to accelerate progress” in reducing tobacco-related disease and death.

But, in a press release, Myers also noted that with regard to implementing the vision, “the devil is in the details.”

Five months later, Myers says that, while there are signs the FDA moving forward with key areas of the agenda, it’s been slower than promised.

“I would now say the devil is in the follow-up,” Myers told MedPage Today in a Dec. 27 telephone interview.

He said the FDA had promised to issue an Advanced Notice of Proposed Rule Making (ANPRM) by the end of the year to formally begin the dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.

Other proposed ANPRMs include seeking public comment about whether FDA should eliminate flavors, including menthol, from little cigars and other tobacco products and seeking comment on whether the agency should reconsider its jurisdiction over certain forms of cigars.

Myers said CTFK received notice about a week ago that the ANPRM proposals have been sent to the Office of Management and Budget, but they have not been published yet.

“The public hasn’t seen them, so it is impossible to know how effectively they will move the ball forward,” Myers said.

“Whether Dr. Gottlieb’s July announcement turns into a significant and meaningful step forward depends on what happens in 2018 — not what he said in 2017,” Myers added.

NRT Steering Committee Appointed

One step forward came late last month. Gottlieb, along with Mitchell Zeller, JD, and Janet Woodcock, MD — heads of the FDA’s tobacco and drugs divisions, respectively — announced formation of a Nicotine Steering Committee with the aim of increasing the number of nicotine replacement therapies (NRTs) available for smokers who want to quit.

The FDA officials noted that while around 70% of adult smokers in the U.S. report wanting to quit and nearly half try to quit each year, only a small percentage succeed.

Myers said the goal of streamlining the reviewing process for NRTs regulated under Woodcock’s Center for Drug Evaluation and Research is a good one.

“We have over 36 million smokers, yet during the last 15 years there have only been three products approved to help smokers quit,” he said. “FDA has to do more to encourage innovation for smoking cessation.”

But he added that any effort to recognize electronic cigarettes or other recreational, non-combustible devices as nicotine delivery therapies for smoking cessation would be premature.

The studies examining the potential of e-cigarettes to help smokers quit have been contradictory and, Myers said, largely poor in quality.

“The bias of the researcher going in is the biggest predictor of what they will find,” he said. “It’s the FDA’s job to be the independent arbiter and demand good science. So far, it has been slow to do that.”

Tobacco researcher Stanton Glantz, PhD, told MedPage Today that while the research conducted to date suggests e-cigarettes can help a subset of smokers quit, they also have been shown to suppress smoking cessation among a larger group of adult smokers and promote the initiation of cigarette smoking among teens.

Glantz, who has long been critical of nicotine products, directs the Center for Tobacco Control Research and Education at the University of California San Francisco.

“If the FDA comes to the conclusion that smokers should be encouraged to shift to these less dangerous forms of nicotine, that would be inconsistent with what the evidence shows,” he said.

Considering Approval of ‘Heat-not-Burn’ Products

The FDA is currently reviewing tobacco giant Philip Morris’ proposal to sell its ‘heat-not-burn’ product IQOS in the U.S., and to market it as a reduced-harm device for nicotine delivery.

While news reports suggest that approval could come as early as February, both Myers and Glantz indicated that this timeline is wildly optimistic, given that the application is not complete and has not been considered by the FDA’s tobacco science advisory committee.

“Anyone who makes that prediction is shilling for the company,” Myers said. “Philip Morris International is spending literally millions of dollars to promote the notion that [IQOS] should and will be approved. There is no objective evidence that FDA has a point of view on this product yet.”

Earlier this month, Reuters published an investigative report detailing Philip Morris’ efforts to promote IQOS to health officials around the world as a safe alternative to combustible cigarettes.

Reuters said it “identified shortcomings in the training and professionalism of some of the lead investigators in the clinical trials that underpin the tobacco giant’s application to the FDA.”

Glantz recently sent a letter to the agency’s Tobacco Products Scientific Advisory Committee (TPSAC) urging it to delay action on the application until all public comments have been submitted and the application process is complete.

The TPSAC is scheduled to meet late next month to consider the IQOS application.


Tagged with:

About author

Related Articles