FDA to Regulate Tobacco?
It seemed like back to the future in Washington on Feb. 15, when Sen. Edward M. Kennedy (D-Mass.) presided at a press briefing announcing a proposal that would give the Food and Drug Administration the authority to regulate cigarettes as a drug delivery device. In the mid-1990s, Dr. David Kessler, then FDA commissioner, made a bid to do just that, but lost in a battle that ended at the Supreme Court. Since that time, congressional bids to extend FDA's purview have failed. Sen. Kennedy declared that 2007 is the lucky year. “The likelihood of passage is extremely high,” he said of his bill, which according to cosponsor Sen. John Cornyn (R-Tex.) already has 30 allies, 11 of them Republicans. Rep. Henry Waxman (D-Calif.), introducing the House companion bill, agreed that, “this is the year it will become law,” noting that 100 of his colleagues are ready to sign on. The bill would give FDA more power to restrict tobacco ads and sales to children in particular, require reduction of nicotine levels, and necessitate bigger and more informative warnings on tobacco products. FDA could not ban nicotine-containing products. President George W. Bush has not shown support, but Sen. Cornyn said he'd encourage him to sign it into law if the bill passes the House and Senate.
HEART for Women Reintroduced
The American Heart Association is throwing its weight behind the Heart Disease Education, Analysis and Research, and Treatment (HEART) for Women Act, which was reintroduced in both the House and Senate last month. Sponsored by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska), the legislation authorizes the Health and Human Services department to provide education to older women and health care professionals on the diagnosis and treatment of women with heart disease, requires gender-specific reporting of heart disease data to the federal government, and expands WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation), the free heart disease and stroke screening program, beyond its current 14 states. The legislation also is backed by the Society for Women's Health Research, WomenHeart: the National Coalition for Women with Heart Disease, and the Association of Black Cardiologists Inc.
Cardio Tops Drug, Hospital Costs
New data from the Agency for Healthcare Research and Quality show that drugs for cardiovascular disorders are the most costly and that heart disease, stroke, and other circulatory conditions account for one in six hospitalizations. Americans spent $32 billion on drugs for cardiovascular conditions in 2004. The two biggest categories were cardiovascular drugs ($17 billion) and cholesterol-lowering drugs ($10 billion). Although 44% of adults bought a central nervous system drug, compared with 38% buying a cardiovascular drug and 22% a cholesterol cutter, spending for CNS drugs was only $7 billion. Circulatory system diseases put 7 million people in the hospital in 2004. The most common reasons: atherosclerosis (1.2 million stays), congestive heart failure (1.1 million), nonspecific chest pain (846,000), heart attack (695,000), and irregular heart beat (694,000).
FDA's $2 Billion Budget
The Bush administration is requesting $2.1 billion for the FDA in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees “will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry.” The budget also includes $11 million for improving drug safety (this does not include user fee funds that also will go to that effort) and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA gradually has been moving its operations to the new facilities. The Washington-based consumer-, patient- and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.
Medicare Generic Drug Use Rises