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Congress

June 22, 2007 | Daily News

House Ways and Means health subcommittee Chair Pete Stark (D-CA) introduced legislation Thursday (June 20) that would regulate direct-to-consumer drug ads using the tax code. The bill also revives an attempt to restrict ads within the first few years a drug is on the market, a plan scrapped by the House Energy and Commerce Committee earlier this week. The media lobby, which helped kill that measure, appears ready to go to the mat again to block Stark's legislation.

June 22, 2007 | Daily News

House Ways & Means health subcommittee Chair Pete Stark (D-CA) is interested in streamlining Medicare Advantage (MA) and Part D enrollment periods and simplifying the process beneficiaries use to contest their plan's coverage determinations. The powerful lawmaker highlighted these and several other potential reforms at a June 21 hearing.

Stark wants beneficiaries to have easy access to data on the sanctions CMS has imposed on plans in the case of marketing fraud or other concerns.

June 21, 2007 | Daily News

House investigators are reviewing documents showing FDA officials have received bonuses of up to $50,000 and some agency lawyers have received "Title 42" salaries that were supposed to be reserved for scientists, fueling concerns over FDA's payment policies, a congressional source says.

The House Energy and Commerce Committee requested the documents on salaries and bonuses. The committee has received about half of what it has asked for, the source says.

June 20, 2007 | Daily News

FDA is posting on its Web site many more meetings between agency officials and outside groups after House Energy and Commerce Committee Republicans challenged the near absence of public calendar listings for top drug officials. However, the lawmakers still want FDA to write criteria for determining what gets posted, a congressional source says.

Committee Republicans wanted to know why the agency's two top drug officials were not listing meetings with the drug industry at a time when FDA, Congress and the public were advocating openness on drug reviews and post-market monitoring.

June 20, 2007 | Daily News

The Bush administration is stonewalling efforts by House Democrats to scrutinize elements of the Medicare program by twice this week refusing invitations to testify before the House Oversight and Government Reform Committee.

June 20, 2007 | Daily News

House Energy and Commerce lawmakers plan to offer amendments to FDA legislation on subjects as diverse as clinical trial registries, advisory panel member financial conflicts and antibiotic resistance during full committee markup Thursday. The health subcommittee marked up the legislation Tuesday (see related story).

June 20, 2007 | Daily News

Patient advocates and a spectrum of health industry interests are renewing pressure on lawmakers to raise the tobacco tax to fund renewal of the State Children's Health Insurance Program (SCHIP). Although the strongest congressional push has been for a 61-cent hike per pack of cigarettes, outside proponents of the tax are now using figures ranging from 75 cents to $1.

June 19, 2007 | Daily News

The House Energy and Commerce health subcommittee late Tuesday (June 19) passed FDA legislation after striking measures that would have let FDA ban advertising up to three years for new drugs and require labels and advertisements to bear a symbol indicating when drugs are new. The subcommittee also removed earlier language that would have limited incentives companies get for researching drugs on kids.

The legislation also was amended to include a toll-free number on drug labels for reporting side effects to FDA's MedWatch.

June 19, 2007 | Daily News

Senate Finance Committee leadership joined a long list of congressional colleagues Tuesday (June 19) by urging CMS Acting Administrator Leslie Norwalk to withdraw the proposed 2.4 percent payment reduction included in the hospital inpatient prospective payment schedule (IPPS) proposed in April. They say CMS' plan unfairly cuts funding for rural hospitals based on an untested assumption there will be future coding problems.

June 18, 2007 | Daily News

Biogenerics bills friendly to the generic industry have gained the support of AARP. The group wants lawmakers to pass legislation introduced in the House by Rep. Henry Waxman (D-CA) and in the Senate by New York Democrats Hillary Clinton and Charles Schumer. The bills create an approval pathway for follow-on and generic biologics and do not give market protections to brand-name manufacturers.

AARP is circulating a fact sheet that says biologics now cost up to 20 times more than non-biologic medications and are gaining popularity.

June 18, 2007 | Daily News

A new study about the number of uninsured children and enrollment in the State Children's Health Insurance Program is drawing sharp criticism from top Senate Democrats, children's advocates and academics who claim it was designed in a way that "low balls" enrollment in the program and was timed to influence the ongoing political debate about the amount of funding necessary to reauthorize the program for the next five years.

June 18, 2007 | Daily News

A powerful Senate Republican is renewing his call for a major overhaul of CMS' quality improvement organizations, saying a new Inspector General report indicates a cozy relationship between providers and QIOs, which handle beneficiary complaints and help improve quality of care. But CMS' top official defends the close ties, saying the agency has shifted away from a punitive approach and is instead pushing for "collaborative relationships" between QIOs and providers as a better way to improve care.

June 15, 2007 | Daily News

CMS late Friday (June 15) announced a temporary halt to the marketing of a vast majority of private-fee-for-service (PFFS) plans under the Medicare Advantage (MA) program-- a move voluntarily agreed to by insurance companies affected, according to CMS officials and industry representatives. The government/industry pact allows PFFS plans to resume marketing if they meet conditions prescribed by CMS.

June 15, 2007 | Daily News

Key House Democrats are "shocked" FDA wants to cut 196 employees as part of planned lab closures, and the lawmakers are asking how FDA will test imports that these lab analysts would have conducted. The 37 percent staff reduction would come after the agency already lost 24 percent of its lab employees between 2003 and 2007.

House Energy and Commerce Committee Democrats obtained details of what FDA calls its lab consolidation plan. The lawmakers say they are worried about a "drastic cut" of lab employees when the volume of food imports has been doubling every five years.

June 14, 2007 | Daily News

Business interests, consumer advocates and federal officials this week unanimously urged a House panel to get moving on the expansion of comparative effectiveness research (CER) for health care products and services, but the chair of the panel questioned the feasibility of comprehensive legislative action this year in the absence of scored savings from the Congressional Budget Office (CBO).

Instead, Ways & Means health subcommittee chair Pete Stark (D-CA) suggested Congress would move "to lay the groundwork" for a CER system.

June 13, 2007 | Daily News

The tobacco and convenience store lobbies this month launched a push to deter Congress from hiking the federal tobacco tax to fund the reauthorization of the State Children's Health Insurance Program (SCHIP).

June 13, 2007 | Daily News

Senate Democrats hoping to use a tobacco tax to offset much of the $50 billion they aim to put toward SCHIP reauthorization seem destined to meet a House challenge from Blue Dog Democrats as well as the powerful chair of the Energy & Commerce Committee.

The Blue Dog Coalition--a group of conservative-leaning House Democrats--was successful already in removing a tobacco-tax provision from the Senate's version of the Democrats' 2008 budget resolution, sources say.

June 13, 2007 | Daily News

House Democratic leaders met Wednesday (June 13) to hash out a strategy to pay for the renewal of the State Children's Health Insurance Program (SCHIP), according to health lobbyist sources. Ways & Means health subcommittee chair Pete Stark (D-CA) had forecast the meeting a day earlier, indicating that participants would include leaders of the Ways & Means and Energy & Commerce committees, as well as House Speaker Nancy Pelosi (D-CA).

June 12, 2007 | Daily News

The Senate health committee postponed its mark up of biogeneric legislation until June 27, a source following the issue says. Many had expected the mark up to occur June 20, in which case the bill would have to have been introduced by 10 a.m. Wednesday (June13).

Lobbyists hope to get some sense this week of where Senate negotiators are on the legislation, a source says, though the big items on an approval path and intellectual property issues are still in the air.-- John Wilkerson

June 12, 2007 | Daily News

House Democrats agreed Tuesday (June 12) to limit the scope of controversial state preemption language in their FDA reform package to clinical trials and risk management requirements after FDA, Republican lawmakers and industry blasted its earlier inclusion in all the bills. FDA's policy chief spoke out against the language Tuesday, and GOP and industry members called it a "deal breaker" that could derail the entire FDA reform and user fee package.

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