The Modified Risk Products. or Protectionism?

Size: px

Start display at page:

Download "The Modified Risk Products. or Protectionism?"

Kory James
5 years ago
Views:

1 The Modified Risk Products Provisions of the FDA Tobacco Act: Science Based Policy or Protectionism? Michael Siegel, MD, MPH Professor Boston University School of Public Health

2 Who Am I? Testified in more than 100 cities for smoke freebar and restaurant laws Testified in 7 tobacco lawsuits against the tobacco companies, including Engle No conflicts of interest

3 Two Pathways for Modified Risk Products Modified Risk Tobacco Product Reduced Risk Product Reduced Exposure Product

4 Requirements for Reduced Risk Products Demonstrate that product will significantly reduce harm and the risk of tobacco related disease to individual tobacco users Demonstrate that product will benefit the health of the population taking into account both users of tobacco products and persons who do not currently use tobacco products.

5 Scientific Standard: Demonstrate Reduction in Individual Disease Risk Long term epidemiologic studies with thousands of human subjects year time period required to demonstrate t reduction in cancer risk ik Clinical trials not possible There are no established biomarkers or other non epidemiologic (e.g., clinical or laboratory) markers for disease risk

6 A Cth22 Catch 22 You can t market the product until you demonstrate reduced disease risk You can t demonstrate reduced disease risk until you marketthe the product

7 Si Scientific ifi Standards d for Reduced Rd drisk: Far More Stringent than Pharmaceutical Product Requirements Pharmaceutical Products: 1 2 year follow up Reduced Risk Tobacco Products: year follow up

8 Scientific Standard: Demonstrate Benefit to Population as a Whole Long term epidemiologic studies with human subjects No way to tell if nonsmokers will take up product or smokers will use product instead of quitting unless the product is marketed

9 A Cth22 Catch 22 You can t market the product until you demonstrate population benefit You can t demonstrate population benefit until you marketthe the product

10 Prospect for Reduced Risk Products Virtually, if not literally impossible to meet scientific standards for approval Even if technically possible, would require extreme financial investment with no guarantee of success Will simply not happen under the current standard

11 Requirements for Reduced Exposure Products Demonstrate actual reduction in exposure Demonstrate that there is a reasonably likely chance that product reduces disease Demonstrate that as actually marketed, product will not make consumers think that it is safer (by virtue of the reduced exposure)

12 Scientific Standard: Demonstrate Actual Reduction in Exposure Easy: Can be done with simple laboratory testing of small number of subjects

13 Scientific Standard: Demonstrate Reasonably Likely Chance that Product Reduces Disease E C b d ith lb t Easy: Can be done with laboratory studies alone

14 Scientific Standard: Demonstrate That As Marketed, Consumers Will Not Think Product is Safer Can C be studied dwith consumer perception studies in laboratory setting HOWEVER, most consumers ARE, GOING TO THINK PRODUCT IS SAFER

15 A Cth22 Catch 22 You can t market the product as reduced exposure unless you show that consumers will not perceive ANY health benefit If consumers do not perceive p ANY health benefit, then you can t successfully market the product

16 Example: Electronic Cigarettes There is compelling scientific evidence that these products are much safer than regular cigarettes There is compelling evidence that thousands of ex smokers are using these products to quit smoking or substantially cut down

17 Implications of FDA Tobacco Act s Science Based Policies If regulated under the FDA Tobacco Act, electronic cigarettes will not be able to make ANY claims of reduced risk, improved health, or even reduced exposure. They will have to be marketed simply as alternatives to smoking.

18 Implications of FDA Tobacco Act s Science Based Policies The Act destroys any meaningful possibility of using harm reduction as a strategy in tobacco control The At Act protects t existing, iti high risk h ik products the highest risk products on the market fromcompetition from potentially lower risk products This strategy will result in increased disease and death

19 Relationship Between Product Risk and FDA Regulatory Action Product Evidence Base Action Electronic cigarettes Much safer than regular Effectively banned cigarettes (imports have been seized) No evidence youth are using these products Dissolvable tobacco products Probably safer than cigarettes No evidence youth are using these products Regular cigarettes Killing more than 400,000 people per year Clear documentation ti that t more than 3 million kids are regularly using these products Considering ban Approved for sale and marketing No action tk taken yet that t will substantially reduce the number of youth smokers or make cigarettes substantially safer to use

20 Relationship Between Product Risk and FDA Regulatory Action Flavored cigarettes, non menthol Menthol cigarettes Product Evidence Base Action No youths using any products made by major tobacco companies Tens of thousands of youth using these products Banned Approved for sale and marketing by FDA

21 Conclusions 1. The Act makes it virtually, if not absolutely, impossible to market a reduced risk tobacco product 2. The At Act makes it possible to sell a reduced exposure product, but virtually impossible to market it as such

22 Conclusions 3. The Act therefore sacrifices public health protection at the expense of protection of the dominant segments of the existing market

23 Conclusions 4. The Act, and the FDA s implementation efforts to date, are not science based. Instead, they have both served a protectionist purpose: to protect the current market share of the leading cigarette brands and insulate them from competition from potentially safer products

24 Final Conclusions The purpose of the legislation, and of the entire regulatory scheme, is to institutionalize and protect the existing tobacco market. The result is to ensure that current, high risk products are favored over products that could potentially save millions of lives.

RADM Patrick O Carroll, MD, MPH Senior Advisor, Assistant Secretary for Health, US DHSS

Ending the Tobacco Epidemic RADM Patrick O Carroll, MD, MPH Senior Advisor, Assistant Secretary for Health, US DHSS Tim McAfee, MD, MPH Senior Medical Officer, Office on Smoking and Health, CDC www.nwcphp.org/hot-topics