FDA delays deeming rule deadlines; focuses on regulating nicotine

Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb has unveiled changes in tobacco regulatory policy in addition to a new plan to reduce the addictive potential of combustible cigarettes.

In 2016, the “deeming rule” extended the regulatory authority of the FDA to all previously unregulated tobacco products. These products included e-cigarettes, cigars, hookah and pipe tobacco. The deeming rule brought newly regulated products under the provisions of the Tobacco Control Act of 2009, such as placing health warnings on packages and advertisements; prohibited the sale of newly regulated tobacco products to consumers under the age of 18; and required products on the market after February 15, 2007 to receive marketing authorization from FDA, among other regulations.

With the Commissioner’s new announcement, the deadline for submission of approval applications is extended until August 8, 2021 for combustible products and until August 8, 2022 for noncombustible products such as e-cigarettes. However, this new announcement does not affect other provisions such as the age restriction or the requirement for warning labels.

Commissioner Gottlieb also announced the Comprehensive Approach to Nicotine and Tobacco, which is a plan to reduce the concentration of nicotine in cigarettes to a “non-addictive level”. The goal is to reduce the addictive potential of cigarettes to enable current cigarette smokers to quit, reduce the likelihood that youth who experiment with cigarettes will become addicted, and shift cigarette smokers who still crave nicotine to less toxic products. This plan is only directed at reducing the nicotine concentration in cigarettes.

Going forward, the FDA will seek public comment on the risks, benefits and unintended consequences of lowering the level of nicotine in cigarettes. The FDA will also seek public comment about how flavors attract youth to tobacco products and how flavors may influence how adults switch from cigarettes to less harmful “forms of nicotine delivery”.

In the Commissioner’s public statement, he also said that during this initiative, the FDA will consider whether to exempt premium cigars from regulation.

How you can help

AADR will alert members when the FDA publishes requests public for comment on these issues. In the meantime, please send Science Policy Analyst Seun Ajiboye (sajiboye@iadr.org) information regarding the following as well as any other relevant information:

  • Previous research or public health experience with nicotine reduction in cigarettes
  • “Non-addictive” levels of nicotine in cigarettes
  • Unintended consequences of this initiative, especially regarding youth, vulnerable populations and health disparities.

FDA Comprehensive Approach to Nicotine and Tobacco Resources

AADR, research community encourages Congress to raise spending caps

The American Association for Dental Research joined over 200 organizations in a letter to House and Senate leaders encouraging them to raise the defense and non-defense spending caps established under the 2011 Budget Control Act. The letter also encourages Congress to override sequestration, which will return in 2018. This will significantly hamper scientific research. From the letter:

Whether the challenge before us is fiscal, economic, health or security-related, Americans do not acquiesce to threats, we end them. Our nation must not block its own path by forsaking strategic investments. We urge you to forge another bipartisan budget deal that increases the spending caps and overrides sequestration, setting the stage for a safe, prosperous and healthy future.

The Coalition for Health Funding provides a helpful explanation of sequester here. AADR will continue to follow the FY18 appropriations process and provide updates. Please continue to follow the Government Affairs and Science Policy blog for developments.

AADR opposes tobacco policy riders in agriculture appropriations bill

The American Association for Dental Research joined with over 50 organizations to oppose tobacco policy riders in the House of Representatives Agriculture Appropriations Bill that would weaken tobacco regulation. Specifically, section 752 of the bill would exempt large and premium cigars from oversight by the Food and Drug Administration (FDA) and could provide a loophole for other tobacco products to escape regulation. Section 753 would exempt tobacco products on the market before a certain date from FDA oversight and weaken the ability of the FDA to remove non-compliant tobacco products from market. Both would weaken the deeming rule that extended the FDA’s regulatory authority to all tobacco products.

During House appropriations committee markup of the bill, an amendment was offered to strike section 753. That amendment was voted down, and the House appropriations bill was approved with the two provisions. The Senate version of the bill, however, does not include either provision.

AADR will continue to track the tobacco policy riders during the appropriations process. Please continue to check the Government Affairs and Science Policy blog for updates.

AADR joins 63 organizations to support CDC OSH

The American Association for Dental Research joined 63 other organizations to support the Centers for Disease Control and Prevention (CDC) Office on Smoking and Health (OSH). In letters sent to both the House and the Senate, health and research organizations requested $210 million in appropriations for CDC OSH, citing the financial and public health burden of tobacco use. The letter also opposed President Trump’s proposal to eliminate the office. From the letters:

OSH plays a critical role in reducing the death and disease caused by tobacco by funding activities that help to prevent youth from starting to use tobacco and help adult tobacco users to quit. For example, OSH funds the highly successful national media campaign, Tips from Former Smokers. This media campaign has motivated about five million smokers to make a quit attempt, helped approximately 500,000 smokers to successfully quit, and saved at least 50,000 people from premature death since its inception in 2012. The campaign is highly cost-effective with a cost of just $393 per year of life saved, far below the $50,000 that is an accepted benchmark for cost-effective public health programs.

AADR will continue to monitor the appropriations process and provide updates as they become available.

House Labor-HHS bill includes $1 billion NIH, $6 million NIDCR increases

The House Appropriations Subcommittee on Labor, Health and Human Services has released its fiscal year 2018 funding bill. The bill includes $35.2 billion for the National Institutes of Health (NIH), an increase of $1.1 billion above the fiscal year 2017 enacted level, and $432 million for the National Institute of Dental and Craniofacial Research (NIDCR), an increase of $6 million over fiscal year 2017.

Subcommittee members articulated support for the NIH during hearings earlier in the summer and indicated that it would reject the $7 billion cut in the President’s fiscal year 2018 budget proposal.

The text of the funding bill can be found here.

Gert Quigley Fellowship Experience

By Tanner Godfrey

For the past six weeks, I have had the opportunity to serve as the Gert Quigley Fellow with the American Association for Dental Research (AADR). This fellowship is designed to give exposure to government affairs and science policy work. It also provides many other opportunities to get to know the organization driving dental research and progress in dentistry. Below I’ve included a summary of the different activities I’ve been involved in through this fellowship:

Government affairs

  • Attended House and Senate appropriations hearings with Dr. France A. Córdova, Director of the National Science Foundation; Dr. Thomas Price, Secretary of Health and Human Services; and Dr. Francis Collin Director of the National Institutes of Health as witnesses.
  • Visited Senators Richard Shelby and Luther Strange of Alabama and discussed our concerns regarding the President’s FY2018 proposed budget.
  • Attended coalition meetings for the Coalition for National Science Funding and the Campaign for Tobacco-Free Kids.

Science Policy

  • Attended National Academy of Sciences workshops on sugar-sweetened beverages and diversity in science.
  • Updated AADR science policy statements

Organization Visits

  • Visited NIH intramural and extramural research campuses and met with Principal Deputy Director of the NIH Dr. Lawrence Tabak; NIDCR Director Dr. Martha Somerman; NIDCR Acting Deputy Director Dr. John Kusiak; and directors of other NIDCR operations including intramural research, extramural research, clinical research, and dental public health residency
  • Visited and toured the American Dental Education Association

Research Project

  • Completed a project analyzing funding sources of AADR members reported on AADR/IADR abstract submissions

These experiences and relationships will prove valuable to me as I seek a career in dental academics. It has also been very fun to be in our nation’s capital and see the many amazing things here! I would highly recommend this experience to those interested in government affairs or science policy, as well as to those interested in a career in dental academics.

Advocating for NIH on Capitol Hill – Update from AADR Gert Quigley Fellow

By Tanner Godfrey

Recently, I had the chance to go and visit the offices of my senators from Alabama, Senators Richard Shelby and Luther Strange. During these meetings, we discussed the President’s proposed budget for the National Institutes of Health (NIH) and accomplishments in research within Alabama. As the President’s budget proposes a cap on indirect costs, we discussed the potential dangers of this proposal to the researchers and universities of Alabama. Both offices were truly splendid and very supportive of our cause to support NIH! Senator Shelby was kind enough to take a picture with me, even though he and his wife had just barely gotten off a plane from France!

 

 

NIH director testifies before Senate LHHS

by Tanner Godfrey

During this Senate Labor, Health and Human Services (LHHS) hearing, the focus was on the President’s FY2018 proposed budget cut of $7 billion to the National Institutes of Health (NIH). Recently reappointed director Dr. Francis Collins was the witness. I’ve previously described the commitment of the Senate LHHS subcommittee to preserve funding for NIH, so in this post I want to focus on some key points raised by Dr. Collins. In his testimony, he described three moving examples of the transformational power of investing in NIH basic science.

Cystic Fibrosis – Cryo Electron Microscopy (Cryo-EM), a powerful magnification technique, has enabled the discovery of the precise molecular structure of the protein channel that regulates water and salt balance. This protein is misfolded in cystic fibrosis (CF), our nation’s most common fatal genetic disease. Dr. Collins discovered the genetic mutation, or misspelling, responsible for this disease. Now, structural information is allowing the design of better drugs to treat cystic fibrosis patients like 2-year-old Avalin Mahoney.

“Just a few decades ago she probably wouldn’t have made it beyond her teens; no longer! Today we have two targeted drugs for CF, and more to come, all building on NIH-supported basic research. And we’re not done; the goal is to turn CF into a 100% curable disease,” Dr. Collins said.

Among the next generation of scientists tackling the problem is Dr. Steven Aller from the University of Alabama. He uses computer science and biomedical science to better design targeted drugs for such diseases.

Sickle Cell Disease – Sickle cell is a disease in which red blood cells are sickle shaped due to a genetic misspelling. These misshapen cells can block small arteries. Currently, the only cure for the disease is a bone marrow transplant. However, what of the many patients without a match? That is where current research using CRISPR gene editing by NIH’s Dr. Courtney Fitzhugh comes into play. She is attempting to correct the genetic misspelling associated with sickle cell disease in a patient’s own blood stem cells.

Alzheimer’s Disease – The NIH BRAIN Initiative aims to create a detailed understanding of the 86 billion neurons in the human brain. Using the BRAIN Initiative, scientists hope to identify early warning signs of Alzheimer’s disease, which is estimated to cost $259 billion this year, rising to over $1.1 trillion by 2050. Using advanced warning, effective means of preventing this disease. Current research is tracking a family with inherited Alzheimer’s living in the mountains of Columbia. Using PET scans of the brain they compare those who carry mutations and those who do not in hopes of identifying early warning signs of Alzheimer’s.

Dr. Collins concluded his testimony by telling the senators, “You are all a part of this, your emphasis on Alzheimer’s and related dementias research in fiscal 2016 & 2017 is enabling progress towards our mutual goal of preventing and effectively treating these devastating conditions.”

While taking questions from committee members, Dr. Collins again addressed the issue of capping indirect costs. He said the NIH will look for ways to reduce administrative costs brought on by regulations, but he does not think it will amount to the proposed dramatic rate reduction. Asked about the effect of capping indirect costs at the proposed 10% rate, Dr. Collins replied, “I’m having a hard time imagining how we would manage that.”