Medical Device Daily Washington Editor

The Senate passed legislation last Thursday giving FDA the authority to regulate tobacco, and the House of Representatives voted Friday to approve the Senate bill, putting the legislation on track for a signature from the White House. The Senate version of the the Family Smoking Prevention and Tobacco Control Act of 2009 (S. 982) would ban the use of the word "light" on cigarette packaging and would increase the size of warning labels.

The House had passed its own version of the bill earlier in the year by a hefty margin of 298-112 (Medical Device Daily, April 8, 2009), but the latest House vote provided an even larger margin of 307-97 (Thursday's vote in the Senate was 79-17). The Obama administration has indicated it will sign the bill, giving FDA yet another unwieldy task, although FDA commissioner Margaret Hamburg, MD, had said in Senate testimony in May that the agency is the appropriate entity for tobacco regulation (Medical Device Daily, May 12, 2009).

The final version of the bill would give FDA authority to set the levels of nicotine and other chemicals in cigarettes, although it is unclear how a public safety agency will determine "safe" levels of chemicals that exhibit no health benefit. Cigarette makers will also be forbidden from making flavored cigarette products, a ban that presumably affects menthol, because of a perception that such flavorings induce first-time smoking. Tobacco advertising will also have to be presented only in black and white and will be banned within 1,000 feet of schools.

In a June 11 statement, Secretary of Health and Human Services Kathleen Sebelius said the vote was "a victory in the fight to protect public health, and reduce the death and suffering tobacco products cause every year." Sebelius also asserted that the bill "is a key part of our plans to cut healthcare costs" and that "our department looks forward to implementing this critical legislation."

Nancy Nielsen, MD, President of the American Medical Association (Chicago), said in a June 11 statement that the association "cheers Senate passage of legislation that will for the first time allow the FDA to strongly regulate cigarettes and other tobacco products," a development she characterized as "a victory for public health over Big Tobacco."

Nielsen also said, "more than 400,000 Americans die needlessly every year as a direct result of tobacco use" and that because of the law, many people will "think twice before picking up a cigarette."

AMA, NYT tangle on healthcare

Strange bedfellows abound where the politics of healthcare is concerned, but crossed wires are interesting, too. This was the case as a recent statement by the American Medical Association (Chicago) makes clear. AMA's June 11 statement takes on a story dated the previous day appearing in the New York Times which alleged that the association opposes a public health plan option.

According to the AMA statement, the NYT article "creates a false impression about the AMA's position" where a public option is concerned. AMA President Nancy Nielsen, MD stated that the association "opposes any public plan that forces physicians to participate, expands the fiscally-challenged Medicare program or pays Medicare rates," but that AMA "is willing to consider other variations of a public plan that are currently under discussion in Congress."

The June 10 article alleges that AMA "is letting Congress know it will oppose creation of a government-sponsored insurance plan," citing congressional testimony during which the AMA is purported to have take the position of opposing "a public health insurance option for non-disabled individuals under the age of 65." The article's author, Robert Pear, does not name the AMA representative and does not give the date or the committee which held the hearing.

In the June 11 AMA statement, Nielsen remarked "health reform that covers the uninsured is AMA's top priority this year" and that "every American deserves affordable, high-quality health care coverage." AMA, she said, favors "a federally chartered co-op health plan or a level playing field option for all plans" as opposed to a straightforward expansion of Medicare and Medicaid to expand coverage. AMA, Nielsen said, "is ready to stand behind legislation that includes coverage options that work for patients and physicians."