December 27, 2010

BUDGET

Congress Passes Continuing Resolution Funding Government Programs at FY2010 Levels

This week, the House and Senate passed a temporary spending measure for FY2011, called a continuing resolution (CR), funding government agencies and programs at FY2010 funding levels. Passage of the CR, which will fund government programs until March 4, 2011, defers final FY2011 spending levels to the new 112th Congress. The President is expected to sign the legislation into law. Under the CR, the NIH, CDC and other health research and services programs are funded at FY2010 levels.

The enactment of a short--term CR spells trouble for the prospects of federal support for health research and services funding over at least the next year. The 112th Congress opens on January 5, and the new incoming members of House leadership have stated their intention to cut non-defense discretionary spending back to FY2008 funding levels, beginning with the FY11 funding bills. Some agencies and programs, such as the NIH, which enjoys bipartisan support, will fare better than others in terms of funding. However, for the foreseeable future, flat funding may be viewed as a relative funding victory for health research and services programs. The ATS is particularly concerned about how federal support for domestic and international health programs---like TB control---will fair in the new budget environment. The ATS will alert members when their action is need to preserve funding for health research and services programs.

CLEAN AIR

Diesel Emissions Reductions Act

In the waning days of the session, Congress passed legislation to encourage companies with diesel vehicle fleets to install upgraded engines to reduce diesel pollution emissions. The legislation authorizes up to $100 million to assist in the conversion to more modern diesel engines.

PUBLIC HEALTH

Senate Passes Year of the Lung Resolution

On the last day of legislative business, the Senate passed Senate Resolution 432---a resolution to declare 2010 to by the Year of the Lung. The resolution, introduced by Senators Lincoln (D-AR) and Crapo (R-ID), brings attention to burden of respiratory illness in the United States and around the world. The ATS thanks Senator Lincoln and Senator Crapo for their leadership in bringing attention to the causes, costs and cures of respiratory illness.

TOBACCO

FDA Asks for New Hearing to Review Appeal on E-Cigarettes.

Last week, the U.S. Food and Drug Administration (FDA) has formally appealed the recent U.S. District of Columbia Court decision that found electronic cigarettes should be regulated as tobacco products and not as drug delivery devices.  Earlier this month, the court had ruled that because the nicotine in electronic cigarettes is derived from tobacco plants, the electronic cigarette should be regulated as a tobacco product.

E-cigarettes are devices made to look like cigarettes, but use a small battery to heat and vaporize the nicotine held in a small cartridge. Users then inhale the vaporized nicotine product.

The ATS, and many tobacco control advocates, had supported the FDA's authority to regulate e-cigarettes as drug delivery devices. The ATS disagrees with the court's ruling and the precedent it sets for the e-cigarette industry.  The majority of e-cigarette manufacturers are marketing their products as being a healthy alternative traditional cigarettes and a smoking cessation tool.  By making these unsubstantiated health claims, e-cigarette manufacturers are effectively marketing these devices as health products and therefore should be regulated as drug delivery devices.

Products that are regulated as drug delivery devices are subject to a higher level of FDA scrutiny and must conduct safety and efficiency testing to support health claims.  Products that fail to conduct or meet safety and efficacy testing can be removed from the market. 

Tobacco products, because they have no known health benefit, fall into a separate regulatory category.  While the FDA now has the power to regulate tobacco labeling, marketing and advertising, the agency does not have the power to remove tobacco products from the market.