Category Archives: Uncategorized

FDA: e-cigarettes and children

From today’s American Association for Justice’s TRIAL magazine, FDA focusing on e-cigarette use by minors (see blue text below)

 

Trial

Top Story

FDA releases new action plans for medical devices, e-cigarettes

May 2018 – Kate Halloran

a stamper that stamps the word "HEALTH"

The FDA recently announced action plans for medical device safety and reducing sales and marketing of e-cigarettes to children under 18. The “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” outlines the agency’s priorities for addressing safety for the more than 190,000 devices that it regulates, and its Youth Tobacco Prevention Plan aims to hold manufacturers and distributors accountable for illegally selling these devices to children.

The FDA recently announced action plans for medical device safety and reducing sales and marketing of e-cigarettes to children under 18. The “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” outlines the agency’s priorities for addressing safety for the more than 190,000 devices that it regulates, and its Youth Tobacco Prevention Plan aims to hold manufacturers and distributors accountable for illegally selling these devices to children.

The medical device action plan highlights five areas: creating a patient safety net, improving the postmarket process for safety-related changes, encouraging development of safer devices, improving device cybersecurity, and enhancing the “total product life cycle” approach to device safety within the FDA.

Many of the plan’s objectives illustrate the role that technology will play in medical device oversight. For example, the patient safety net will rely on the National Evaluation System for Health Technology (NEST), which is run by the nonprofit Medical Device Innovation Consortium. NEST’s goal is to collect electronic health data from a variety of sources—such as medical records, device registries, and patient complaints—to share real-time data among providers and the agency to expose adverse events and safety issues more quickly. As part of its action plan, the FDA intends to devote more resources to its role in NEST and to seek additional funding for the system.

Another example is device cybersecurity, which has garnered increased scrutiny as more medical devices integrate internet-based features that place the device and the patient at risk when there are software vulnerabilities. The FDA’s plan includes possibly adding premarket cybersecurity requirements for medical device manufacturers, such as having to build into devices the ability to update software and address cybersecurity threats and having to disclose to the agency an inventory of the software in a device as part of the premarket submission process—information which also must be made available to the public. Other potential changes include updates to premarket guidance on protecting against cybersecurity risks that pose a danger to patients, developing standards for timely disclosing risks, and creating a separate entity that would oversee device cybersecurity and the response process with manufacturers when a risk is identified.

The agency also announced steps it is taking to address marketing and sales of electronic nicotine delivery systems (ENDS)—often called e-cigarettes—to minors. As part of a ramped-up Youth Tobacco Prevention Plan, the FDA is targeting e-cigarette use among minors to reduce nicotine addiction and to reduce the transition to traditional tobacco products in the next generation. The use of e-cigarettes—known as vaping—has become especially popular with teenagers, partly due to the discreet nature of the devices, which can resemble a USB drive, and the fruit and candy flavors of the liquid used in the devices.

A critical component of the FDA’s plan is increasing enforcement actions against companies that improperly market and sell e-cigarettes to children. One company, JUUL, has become a particular focus: Since March, the agency has sent JUUL 40 warning letters over its sales to minors and has requested documents about the company’s marketing tactics, health and behavioral research that it has conducted on its products, and information about whether design features or ingredients appeal to certain demographics.

Lawrenceville, N.J., attorney Domenic Sanginiti, who handles e-cigarette cases, noted that regulatory efforts initiated when e-cigarettes became popular left a loophole that has impacted minors. “When the FDA extended its tobacco regulation arm to include e-cigarettes, the industry was put on notice that selling and marketing to children under 18 would be banned. The FDA did not, however, issue a similar ban regarding the use of flavors known to appeal to children and young adults—as it did for cigarettes in 2009.” Sanginiti explained that as a result, products that would appeal especially to children “flooded” the marketplace. “JUUL has a sleek design like a flash drive, is easy to hide, and comes in cool colors and fruity flavors. This has caused its popularity in school-age children to skyrocket, prompting some schools to ban flash drives and doctors and educators to condemn JUUL as a major teen health threat,” he said.

Other elements of the FDA’s initiative include collaborating with online retailers such as eBay to remove listings that target children, requesting information from and increasing enforcement against additional manufacturers, and running an online e-cigarette prevention advertising campaign. Sanginiti noted that although these efforts are a step in the right direction, the agency should treat e-cigarettes more aggressively, as it does traditional cigarettes—from banning flavors that appeal to children to lowering and eventually removing nicotine from e-cigarettes.

Sanginiti also pointed out that regulatory rollbacks of the FDA’s “deeming rule” to include ENDS products in its tobacco-regulating authority have exacerbated the situation. “The original deeming rule would have already required e-cigarette companies to file FDA applications for existing and new tobacco products. . . . However, after a comment period, the FDA pushed that requirement out to 2022. Had it not done so, it’s possible that the JUUL product and others would not have been approved without modifications.”

Advertisements

6/11 ballot

Town Clerk, Carol Mayer, posted this specimen ballot for the 6/11/18 over ride election –

20180611-specimen ballot

Globe vouchers for the MFi

mfi logo

Please consider submitting your Boston Globe voucher that was emailed to you this morning for the Medfield Foundation (www.MedfieldFoundation.org) (a copy of my email appears below).

The MFi has already raised over $2m. in private monies since 2001 for public purpose in the Town of Medfield, and is now creating an endowment for our town’s future (the Medfield Foundation Legacy Fund).

 

Use this $100 GRANT voucher to support your favorite non-profit.

 

The Boston Globe is proud to announce the return of GRANT (Globe Readers And Non-profits Together), a community initiative that allows subscribers like you to help deserving non-profits earn free advertising space in The Globe.

As a 7-Day subscriber, you have $100 in a GRANT voucher to allocate to the certified 501(c)(3) of your choice.

Submitting your GRANT voucher is easy — just click the button below and enter the name of the organization you’d like to support. The non-profit you select can later redeem the GRANT vouchers it has accumulated for free advertising space in the Globe. The more GRANT vouchers earned, the larger the advertising space provided. Submission deadline is July 31, 2018.

Submit your voucher »

Thousands of Globe subscribers participated in GRANT last year, and over 3,000 organizations were recognized. Altogether, more than $3 million in advertising space was donated at no cost to our subscribers or to the groups selected.

For more information and to stay up-to-date on subscriber contributions, go to BostonGlobe.com/GRANT.

Thank you for subscribing to The Boston Globe and joining us in supporting our remarkable community.

The Boston Globe

School Committee office hours 7PM tomorrow

From Anna Mae O’Shea Brooke –

library sign

Because of the upcoming override and the questions that the citizens of Medfield may have, we are offering another option for School Committee Office Hours this week:
 
– Newly added: Tuesday, April 24 from 7-8pm in the conference room at the Medfield Public Library
 
Wednesday, April 25 from 9-10am at Dale Street School

Conference room available

Medfield office

CONFERENCE ROOM (hourly, per diem)

Deb has a first floor conference room/reception area available on an hourly or per diem basis for those in need of a private meeting/work space in downtown Medfield.  Rates are negotiable. Second floor space suitable for an office/conference room may also be available.   Call Deb at 508 269 9364.

MMA on House budget

This alert came today from the Massachusetts Municipal Association about the areas needing protection by our legislators in the House budget negotiations this coming week.  I did email both our representatives to ask that they follow the Massachusetts Municipal Association recommendations.

MMA-2

House to Start FY19 State Budget Debate on Monday

 

Representatives to Decide on Many Municipal and School Amendments

Please Oppose Costly Health Insurance Amendments

 

Please Call Your Representatives Today

 

April 20, 2018

 

Dear Osler Peterson,

 

This coming Monday, April 23, the House is scheduled to start debate on the fiscal 2019 state budget. House members will take up the 1,400 amendments that were filed by the deadline last Friday, including dozens related to municipal and school aid accounts, and many on important policy issues that affect local government. Debate is expected to wrap up by the end of the week.

 

The MMA has sent a detailed letter to all House members, taking a position on the major local government amendments. The House Ways and Means budget (H. 4400) and the proposed amendments can be found on the Legislature’s website.

 

Please Click Here for a Copy of MMA’s Budget Letter on House Amendments

 

Please review the MMA’s House budget letter, and call your Representatives to let them know how these amendments would impact you. This is the best time to influence their support for the issues and amendments that matter most. Please call on them to support amendments that would fully fund state obligations, such as the special education “circuit breaker” and charter school reimbursements, and oppose amendments that would pre-empt local decision-making in the area of health insurance.

 

This is a quick reference to amendments covered in the MMA letter.

 

Municipal Aid

Support for: Payment-in-Lieu-of-Taxes (#830), Shannon Anti-Gang Grants (#40), Planning Grants (#282 and #731), and Public Libraries (#1171)

 

School Aid

Support for: Charter School Impact Payments (#952), Special Education “Circuit Breaker” (#693), Chapter 70 Minimum Aid at $50 per Student (#1154), McKinney-Vento Student Transportation (#930), Regional School Student Transportation (#29, #785, #823 and #974), Out-of-District Vocational Student Transportation (#192 and #1278), Summer Learning (#888), and Sumer Jobs (#456)

 

Labor Relations and Health Insurance

Oppose: Undermining Municipal Retiree Health Insurance Authority (oppose #1048 and #13)

Support for: Mediation and Dispute Resolution (#1153, #248 and #1160) and, and Municipal Police Training Fund (#1235 and #1380)

 

Other Amendments

Support for: Community Benefit Districts (#1074), Municipal Impact Statements (#62), water Infrastructure Funding (#813), Community Preservation Act Revenues (#466), Conservation Tax Credit (#1248), Bulk Purchasing of Naloxone (#223, #226, #477 and #1209), and Firefighter Equipment Cleaning Grants (#1189).

 

If you have any questions about amendments, please contact MMA Legislative Director John Robertson at jrobertson@mma.org or (617) 427-7272.

 

Please Call Your Representatives Today and Ask them to Support Cities and Towns in the House Budget Debate

 

Thank You!!

 

DOR data

Massachusetts Department of Revenue maintains lots of data on the cities and towns, and put it out via a dashboard that makes interesting reading:

https://dlsgateway.dor.state.ma.us/reports/rdPage.aspx?rdReport=Dashboard.Category_4

https://screenshots.firefox.com/aBaT7jE7U768w4Y0/dlsgateway.dor.state.ma.us

When I checked our Total Budget per Capita figures against the other 351 cities and towns, we were solidly lined up amongst the other Metrowest communities.  We are not alone in being financially strapped and pressured by the declining state assistance, causing more of our town services to be paid for on the property tax.

Below is the DLS newsleter about the DOR dashboard, without the graphics:

==========================================================

Identifying Fiscal Stress Using the DLS Trend Dashboard
Tony Rassias – Bureau of Accounts Deputy Director

This article follows Deputy Commissioner Sean Cronin’s introduction of the Division of Local Services’ (DLS) Municipal Finance Trend Dashboard. As outlined in that article, the Dashboard “is comprised of key municipal fiscal health indicators based upon data that is part of required municipal submissions to DLS, annual financial statements, state agency databases, and the US Census. It graphically displays trends in revenues and expenditures, municipal operating positions, demographic information, unfunded liabilities, property taxes, Proposition 2½ data, and debt.”

It is our hope that this new resource will help local officials identify areas that may be trending in the wrong direction and negatively affecting fiscal health. Cities, towns, school and special purpose districts can utilize these metrics to both assess current conditions and track performance over time. To assist in these efforts, this piece will define and highlight indicators of fiscal stress as they relate to governmental financial operations. Utilizing the DLS Municipal Finance Trend Dashboard, local officials can identify and monitor these early warning signs. In future articles, we will outline approaches, practices, and procedures to address difficult circumstances and prevent their re-occurrence.

What is Fiscal Stress?

Fiscal stress doesn’t necessarily imply that the fiscal roof is about to collapse, but rather foretells that significant challenges may loom ahead should a community or district continue down a certain path. These challenges may then eventually affect taxpayers, creditors, vendors, employees, retirees, local officials and the local governmental entity itself.

According to a Pew Charitable Research Report of July 2013:

When budget gaps widen and a city cannot pay its bills, meet its payroll, balance its budget, or carry out essential services, the local government is viewed as distressed. Officials usually respond with some combination of service cuts, worker layoffs, tax and fee increases, reserve spending, and borrowing. If those measures do not work and the city no longer has the money to meet its obligations, the distress can escalate into a crisis or financial emergency, which may include defaulting on a bond payment or, in rare instances, filing for Chapter 9 bankruptcy protection.

A fiscal crisis can occur in any city, town, regional school or special purpose district. It causes public discontent with government, breeds low morale with its employees, prompts concerns by retirees about retiree benefits, and sends signals to the credit market of heightened credit risk.

Identifying Fiscal Stress Using the Dashboard

Monitoring fiscal activity within a fiscal year and trended over multiple fiscal years can determine whether a community is meeting its objectives. Our Municipal Trend Dashboard can be used to view indicators of fiscal stress including operating position, unfunded liabilities, property taxes, revenues and expenditures, demographics, and debt. Below please find some examples of Dashboard information revealing potentially problematic trends.

Operating Position


Combining the above metrics, we see a community that has no available reserves. Obviously, this is a very precarious situation to be in financially. DLS recommends that the local government establish a sound reserve policy as outlined here.

Unfunded Future Liabilities

Taking the above three metrics together, we see $250 million in unfunded liabilities. Such liabilities could put a strain on the community’s future ability to provide core services to the public.

Revenues and Expenditures

Property Taxes

In the above combination, there is excess levy capacity to tackle additional expenditures inside the Proposition 2½ levy limit, but this community’s average single family tax bill as a percent of income is one of the highest in the Commonwealth. As a result, policymakers must reconcile the need for revenue with the demands of the overall tax burden on residents and businesses. Such challenges are faced every day by local officials across Massachusetts.

The above are just a few examples of how city, town, regional school or special purpose district officials can use the DLS Municipal Trend Dashboard to identify fiscal stress indicators. In coming issues, we will delve further into other areas of concern and establish a road map back to fiscal health for distressed communities.