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Congress

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.

January 08, 2007 | Daily News

Rep. Edward Markey (D-MA) is calling on FDA to keep better track of unapproved drugs on the market and make it easier for consumers to know whether the drugs they are taking are FDA-approved, despite FDA pledges it is cracking down on the unapproved drug market. A source in Markey's office says it is a strong possibility the congressman will consider legislative action due to his dissatisfaction with an FDA response to a letter he sent to the agency Oct. 11 asking for more information on unapproved drugs, patient safety and regulatory actions.

January 05, 2007 | Daily News

The House Republican Steering Committee this week appointed two new members to the Ways and Means Committee -- Reps. Pat Tiberi (R-OH) and Jon Porter (R-NV), both of whom sat on the Education and the Work Force Committee in the last Congress, according to a Jan. 3 announcement by Ways and Means Ranking Member Jim McCrery (R-LA).

January 05, 2007 | Daily News

FDA has sent to the Office of Management and Budget a proposed rule implementing food irradiation requirements from the farm bill Congress passed in 2002. The food irradiation requirements were pushed by Sen. Tom Harkin (D-IA), who this week took the helm of the Appropriations HHS subcommittee. Consumer advocates already are gearing up to challenge a possible move by FDA to allow companies to substitute the word "pasteurized" for "irradiated" on food labels, pointing to technical requirements included in the law.

January 05, 2007 | Daily News

The Senate Finance Committee will hold a hearing Jan. 11 to examine the contentious topic of having the government negotiate drug prices under Medicare Part D, the chairman's office announced yesterday (Jan. 4). The move comes in the midst of a whirlwind of activity surrounding Part D negotiations, as Senate Democratic leaders introduced a "sense of the Senate" negotiation bill (S. 3) Thursday, and House Democratic leaders are expected to introduce a more specific negotiation bill (H.R. 4) Friday (Jan.

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