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January 23, 2007 | Daily News

Facing a Democratically controlled Congress for the first time in his White House tenure, President Bush in his State of the Union speech Tuesday told a well-behaved ocean of lawmakers that he wants to win a war in Iraq, tackle climate change, reduce gasoline consumption, and alter the tax code to make health insurance affordable for more Americans. But on the last point -- like the first -- the Democrats are already lining up in opposition.

January 22, 2007 | Daily News

HHS Secretary Michael Leavitt said the president will propose Tuesday (Jan. 23) a broad plan aimed at helping states begin to cover many of the nation's 47 million uninsured beginning in 2009 using a combination of federal and state funds, tax credits and premiums.

Performing what he calls a balancing act on the "three-legged chair of cost, quality and access," Leavitt said the plan -- dubbed the President's Affordable Choices Initiative -- would allow states the ability to design coverage plans and subsidize needy patients, with help from HHS.

January 19, 2007 | Daily News

The chair of the House Appropriations subcommittee with jurisdiction over FDA's budget said Friday (Jan. 19) she wants to exert more oversight on the issue of drug safety, particularly post-market safety, and how the agency spends taxpayer money.

January 19, 2007 | Daily News

Troubled by recent foodborne illnesses and a dramatic decline in FDA food facility inspectors, Sen. Herb Kohl (D-WI), chair of the Appropriations subcommittee with authority over FDA's budget, plans to make the case for increasing the agency's budget for inspectors, a spokesperson for the senator said.

Kohl met Jan. 10 with FDA Commissioner Andrew von Eschenbach and food center Director Robert Brackett to talk extensively about how the agency is addressing two recent E. coli outbreaks, one which resulted in three deaths.

January 19, 2007 | Daily News

Federal Reserve Chairman Ben Bernanke told lawmakers this week what most know but few will discuss: Entitlement spending threatens to consume the federal budget in the not-too-distant future, and Medicare, not Social Security, is the primary cause.

January 19, 2007 | Daily News

House Speaker Nancy Pelosi (D-CA) said Friday (Jan. 19) that she personally supports the adoption of a Medicare-sponsored prescription drug plan that would compete with private plans under Part D, but she will allow the relevant committees to crunch the concept before it moves further.

January 19, 2007 | Daily News

The House Ways & Means Committee Wednesday announced an oversight agenda that targets virtually every aspect of the Medicare program -- Parts A, B, C and D -- as well as the idea of creating a stand-alone Medicare-administered prescription drug plan. Highlights include a detailed review of Medicare Part D implementation, as well as oversight of the Bush administration's transparency and quality initiatives, patient access to care and Medicare Advantage, among many other items.

January 18, 2007 | Daily News

FDA opposes using Congress' reauthorization of drug user fee law as a vehicle to pass biogenerics legislation, FDA drug center chief Steven Galson said Thursday (Jan. 18). Galson also criticized Congress for postponing action of FDA's appropriations bill, leaving the agency strapped for cash.

"Every time [the Prescription Drug Fee User Act] is up for reauthorization, people try to attach other drug legislation," Galson said at a health care conference sponsored by Stanford Policy Research. "We don't want it to turn into a Christmas tree."

January 17, 2007 | Daily News

Medical device manufacturers and venture capitalists plan to lobby senators to loosen a patient population limit on "humanitarian device exemptions," which lets FDA approve devices used in small populations without costly efficacy data. Sen. Christopher Dodd (D-CT) last year introduced legislation aiming to encourage development of pediatric devices, and he expects to introduce it again this year as Congress considers reauthorizing FDA's device user fee program.

January 17, 2007 | Daily News

GOP lawmakers introduced legislation in both the House and Senate Tuesday (Jan. 16) that would force Congress to address the unsustainable incongruence between projected federal revenues and long-term spending on federal entitlement programs -- including Medicare, Medicaid and Social Security. The move, which has White House support, is aimed at overhauling all of those entitlements, which, at current rates of spending, face bankruptcy in the coming decades.

January 17, 2007 | Daily News

Senators who want to stop brand drug companies from paying generics to stay off the market and introduced legislation Wednesday (Jan. 17) to ban the practice already are working on a compromise to head off a potential unintended consequence of the bill, a congressional source told FDA Week. The bill as it was introduced has the potential to halt all settlements between brand and generic companies because it would prohibit them from accepting anything of value.

January 12, 2007 | Daily News

Legislation that would require the government to haggle directly with drug makers for lower prices under the Medicare drug benefit passed the House Friday (Jan. 12) by a count of 255 to 170 with two dozen Republicans crossing party lines to support the measure. There were no Democratic defections. House leaders suggested their next goal is to create a stand-alone Medicare-administered drug plan.

January 12, 2007 | Daily News

As the 110th Congress moves forward with an ambitious health agenda, a handful of staff maneuvers have altered the face of several of the congressional committees overseeing Medicare.

January 12, 2007 | Daily News

Lawmakers seeking to establish a single food-safety agency need to ensure their efforts do not backfire, leading to fewer inspections of facilities regulated by the U.S. Agriculture Department instead of boosting inspections at FDA-regulated facilities, according to sources following the matter. Much of the debate in the past has been over the difficulty of meshing different cultures at FDA and USDA, but some say the biggest challenge would be ensuring there is enough money and authority to beef up inspections.

January 12, 2007 | Daily News

Past congressional proposals to create a single food safety agency did not include any "on-farm" regulations, and the House lawmaker drafting this year's version of the bill does not intend to include such regulations in the new version either. A key consumer advocacy group is petitioning FDA to start regulating growers, but growers say they are already regulated and the marketing agreement they're working on with the federal government suffices.

January 12, 2007 | Daily News

The first several days Congress was back in town, members reintroduced, or made their intentions known to reintroduce, bills regarding generic drugs and RU-486.

Sen. Herb Kohl (D-WI) plans to reintroduce two bills from last year meant to stop tactics used by brand-name drug companies to delay generic competition, according to a statement from his office. This month, Kohl gained control of the Senate Appropriations subcommittee with jurisdiction over FDA's budget.

January 11, 2007 | Daily News

Senate Finance Chair Max Baucus (D-MT) vowed Thursday (Jan. 11) to support legislation that would repeal the controversial non-interference clause of the Medicare drug benefit -- an about-face that could pave the way for congressional passage of a measure allowing direct government negotiations for drug prices under Part D. Baucus offered few details of his plans, however, declining to disclose if he would push to require the administration to pursue such negotiations -- as a much-hyped House bill would -- or merely authorize it to do so.

January 11, 2007 | Daily News

Rep. Jo Ann Emerson (R-MO) Thursday (Jan. 11) said "a good dozen" GOP members support H.R. 4, the House bill that would require HHS to negotiate Medicare Part D prices directly with manufacturers, just hours before the White House formally announced it would veto the bill if it passed Congress.

Medicare already negotiates prices for oxygen, devices and other products, Emerson noted Thursday at a joint press conference with Democratic House leaders and health care advocates.

January 09, 2007 | Daily News

Two members of the Senate Finance Committee -- a Democrat and a Republican -- plan to introduce legislation Wednesday (Jan. 10) that would require the administration to negotiate directly with pharmaceutical companies for lower prices on prescription drugs under Part D. The move will come just a day before Finance will hold a hearing on the issue, and two days before the House is expected to vote on a similar measure.

January 08, 2007 | Daily News

Consumer advocates think FDA is not doing enough to get trans fat out of processed food so they plan to lobby lawmakers such as Sen. Tom Harkin (D-IA) and Rep. Rosa DeLauro (D-CT) to lean on FDA to ban trans fat from commercial foods or tighten labeling requirements.

The American Public Health Association and the Center for Science in the Public Interest are also asking state and local governments to do more, pointing to New York City and Chicago as good examples of how municipalities can ban trans fat.