FDA Unveils New "Strategic Plan for Regulatory Science"
August 19th, 2011
The United States Food and Drug Administration (FDA) today released it's new Strategic Plan for Regulatory Science available for download from Obesity PPM by clicking here. Priorities include developing medical countermeasures to protect threats to global security, stimulating personalized medicine programs, and ensuring agency capability to evaluate innovative technologies.
This plan is at least in part a reaction to the Institute of Medicine's (IOM) recent report recommending the total retirment of the 510(k) process, Medical Devices and the Public's Health: The FDA 510(k)Clearance Process at 35 Years, available by clicking here. Despite having been iniated at the request of the FDA, its findings were not well received.
Obesity PPM is beginning its evaluation of the FDA's new strategic plan. Please stay tuned for Obesity PPM's position on the impact to obesity-focused medical device and pharmaceutical companies, the health care delivery infrastrucuture, and American consumers suffering from obesity.
FDA Proposes Draft Menu Labeling Requirements, Invites Public to Comment
Updated July 25th, 2011: Excellent public comment submitted by Starbuck's Coffee Company is available here.
Updated June 22nd, 2011: Reminder that the deadline for public comment on second of the two proposed regulations is fast approaching: July 5th. Instructions to comment are below.
On Friday, April 1st, the US FDA opened up a forum for public discussion of their two new proposed regulations, lasting until June 6th and July 5th, respectively. Quite significantly, these regulations specifically remove the rights of state and local governments to impose regulations different from the Federal requirements.
- Click here for the full text of FDA-2011-F-0172, proposed regulation that addresses menu labeling in restaurants and retail food establishments.
- Click here for the full text of FDA-2011-F-0171, proposed regulation that addresses nutrition labeling for vending machines.
A regulatory enactment of the Affordable Care Act, these proposed regulations seek to provide consumers with nutritional data to inform their food choices. The following statement must appear on compliant menus, "A 2,000 calorie diet is used as the basis for general nutrition advice; however, individual calorie needs may vary.” Unfortunately, by using the word "may," and reflecting calories as percentages of this arbitrary number, this statement continues to enforce the incorrect but commonly held notion that there is a single portion size appropriate for everyone.
In order to submit comments electronically, visit this page, and:
1. Choose “Submit a Comment” from the top task bar;
2. Enter the following docket numbers in the “Keyword” space: docket number FDA-2011-F-0172 for menu items in restaurants and similar retail food establishments, and docket number FDA-2011-F-0171 for vending machines;
3. Select “Search.”
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IOM Report on Early Childhood Obesity Prevention Policies
UPDATED June 23rd following live webcast: now access the complete IOM report, Childhood Obesity Prevention Policies, by clicking here to download the PDF.
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On June 23rd, 2011, the Food & Nutrition Board of the Institute of Medicine (IOM) will release a new strategic report: "Early Childhood Obesity Prevention Policies." All members of the public are invited to participate in the live event at the National Press Club, click here to register online. Interested parties may also view the live webcast: please click here to watch the event at 1:00PM EDT.
To read the IOM's previous report issued in March 2011, "Hunger and Obesity: Understanding a Food Insecurity Paradigm," click here.
International Diabetes Federation (IDF) Issues Statement on Bariatric Surgery
On March 28th, at the 2nd World Congress on Interventional Therapies for Type 2 Diabetes in New York, the IDF Taskforce on Epidemiology & Prevention issued their first statement on bariatric surgery. The central theme of the report is reflected in this quote from paragraph 2.15: "...bariatric surgery for the severely obese with type 2 diabetes should be considered early as an option for eligible patients, rather than being held back as a last resort."
Some additional interesting points from the statement:
- The report asserts that access to bariatric surgery for obese type 2 diabetics is restricted both financially and clinically, due to the lack of provider awareness of efficacy and low risk profiles.
- The statement echos guidelines for bariatric surgery in adolescents made by the Australian and New Zealand Colleges for paediatric physicians and surgeons, and the Obesity Surgery Society of Australia and New Zealand (BMI > 40 with severe comorbidities, only LAGB & RNY considered appropriate). VSG still excluded for adolescents due to lack of long term data.
- In paragraph 3.1.1, the report states that "under some circumstances people with a BMI 30-35 should be eligible for surgery," but falls short of explicitely describing those circumstances.
- The Taskforce redirects the requirements for economic analysis back to "each health system," who must individually "determine whether bariatric surgery with its support services is economically appropriate." Based on their reported data, bariatric surgery is indeed cost effective in the treatment of type 2 diabetes, yet this guidance suggests that new economic analysis be undertaken at the initiation of each program.
- Section 2.18 addresses "Novel extra-luminal and endo-luminal procedures and devices and novel bariatric metabolic devices."
Type 2 diabetes is one of the world's fastest growing diseases, with obesity as its greatest single risk factor -- 450 million people worldwide are forecast to have the disease by 2030.
The full report is available here.
