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Congress

September 19, 2007 | Daily News

House and Senate Democrats have reached a deal on SCHIP that closely mirrors the Senate's $35 billion expansion proposal but also includes a few dental and mental health-related Medicare and Medicaid provisions pushed under the House proposal, House Speaker Nancy Pelosi's (D-CA) health advisor told health advocates Wednesday.

Wendell Primus, Pelosi's health advisor, told hundreds of health care advocates in a Capitol briefing that GOP Sens. Charles Grassley (IA) and Orrin Hatch (UT) have signed off on the compromise.

September 19, 2007 | Daily News

The House on Wednesday (Sept. 19) passed FDA legislation by a vote of 405-7 after House and Senate staff reached a compromise earlier in the morning. The Senate is expected to vote on the compromise user fee/drug safety legislation by Thursday.

The staff agreement allows the two chambers to sidestep formal congressional conference deliberations in a bid to get a user fee reauthorization bill to the president's desk in time to avoid 2,000 FDA layoff warning notices (see related story).

September 19, 2007 | Daily News

The nation's most powerful seniors and physician lobbies, upset that physician payment relief is not part of Congress' expected deal on the children's health care program, is stepping up efforts to get lawmakers to address the issue. The groups on Tuesday (Sept. 18) offered tempered praise for Congress' expected SCHIP deal, but also urged lawmakers to act quickly to protect physicians from the Medicare payment reductions that will hit on Jan. 1 without a legislative fix.

September 19, 2007 | Daily News
The compromise FDA legislation passed by the House Wednesday (Sept. 19) has big wins and losses for both Republicans and Democrats.

Republicans fought off attempts to cut pediatric exclusivity in half for blockbuster drugs while making permanent a law that lets FDA force pediatric research when the market exclusivity is not enough of an incentive to get companies to study their products on children.

September 19, 2007 | Daily News

House investigators who analyzed the government's handling of the tuberculosis scare in May are urging the Centers for Disease Control and Prevention to shift some of its bioterrorism agent testing technology to state labs that regularly test for TB.

September 18, 2007 | Daily News

Using the tax code to deter direct-to-consumer drug advertising would be unconstitutional several times over, a former FDA lawyer said in response to legislation by Rep. Pete Stark (D-CA) to tax certain DTC ads.

Arnold Friede, a former FDA assistant chief counsel, and John Kamp, an attorney at Wiley Rein, wrote in a Sept. 7 opinion that Stark's proposal runs afoul of both free speech and due process protections in the Constitution. Stark has previously defended the bill against First Amendment criticisms.

September 18, 2007 | Daily News

Panelists at a Senate Judiciary Committee hearing last week pressed Congress to require that FDA and other federal agencies consult state and local governments when they think regulations preempt state rules. Democratic and Republican lawmakers did not say they would propose legislation, but said they are keeping tabs on two important preemption lawsuits, one of which the U.S. Supreme Court has taken up, the other that the court is expected to take up.

September 18, 2007 | Daily News

Patient advocates and manufacturers are urging lawmakers to tweak House-passed comparative effectiveness language so that a planned research center does not take into account cost-effectiveness, maximizes stakeholder input and prevents Medicare and other payers from using findings to deny coverage. The stakeholders are concerned that boosting comparative effectiveness research, which is widely touted as key to improving clinical care and reducing spending, will come back to haunt beneficiaries who depend on treatments found to be less effective than others for the general public.

September 17, 2007 | Daily News

Senate Health Committee Chair Edward Kennedy (MA) and employment and workplace safety subcommittee Chair Patty Murray (WA) on Sept. 7 called on OSHA, FDA and the Centers for Disease Control and Prevention to examine immediately the risks of consumer and worker exposure to diacetyl, and the safety of proposed substitutes for this flavoring. The lawmakers warn, "If the Bush Administration won't act, then Congress must."

Senate legislation calling on OSHA to regulate diacetyl is expected to surface in the coming weeks. House diacetyl legislation has already cleared the committee.

September 17, 2007 | Daily News

The House Appropriations agriculture subcommittee is asking top FDA officials and former agency officials to testify on FDA's ability to keep domestic and imported food safe, sources say. The House Energy and Commerce also plans to hold a food safety hearing next week, possibly Sept. 26.

FDA Commissioner Andrew von Eschenbach and Assistant Commission for Food Protection David Acheson may testify at the Appropriations hearing. Two former officials from FDA's Office or Regulatory Affairs, Ben England and Carl Nielsen, are also expected to testify.

September 17, 2007 | Daily News

Senate Budget Committee leaders will unveil bipartisan legislation Tuesday (Sept. 18) that would force congressional action on proposals to rein in federal deficits and entitlement spending. Although the proposal targets much more than the entitlement programs, it would almost certainly focus lawmaker attention on the long-term fiscal health of Medicare, which faces insolvency in just over a decade.

September 17, 2007 | Daily News

FDA has historically had a hard time bouncing back when Congress has dragged its feet reauthorizing user fees, Commissioner Andrew von Eschenbach warned in a letter to Sen. Mike Enzi (R-WY). If Congress does not pass reauthorization bills this week, the letter states, FDA will have to send layoff notices to some 2,000 employees.

September 14, 2007 | Daily News

Former FDA Commissioners David Kessler and Mark McClellan said this week that FDA legislation now pending in Congress will help move the agency's drug centers forward, but also cautioned that Congress' emphasis on food safety and meager FDA funding stand in the way of fully realizing the bills' benefits.

September 14, 2007 | Daily News

The generic drug industry has fought hard for legislation that would allow FDA to approve generic biological medicines as "interchangeable" with the brand-name products they copy, but FDA's chief medical officer said last week that industry might be exaggerating the agency's ability to make that determination, as well as the value of the term itself.

September 14, 2007 | Daily News

Sen. Charles Grassley (IA) said in a Senate floor speech Wednesday (Sept. 12) he has two internal e-mails from GlaxoSmithKline showing the company tried to silence a medical researcher who suggested Avandia may have health risks beyond those stated on the label.

John Buse, a medical researcher at the University of North Carolina, is the subject of the e-mails.

September 14, 2007 | Daily News

With an Oct. 1 implementation date fast approaching, the pharmacy lobby has ramped up pressure on Congress to delay a CMS rule that requires physicians use "tamper-resistant" prescription pads for Medicaid patients. In a press release, the National Association of Chain Drug Stores (NACDS) suggested lawmakers insert a moratorium on the rule into its expected continuing resolution or "any other legislation" Congress takes up prior to the drop dead date.

September 14, 2007 | Daily News

Four months after the president enacted a one-year moratorium on a CMS rule meant to stop states from "recycling" Medicaid payments, two prominent lawmakers introduced legislation that would ensure the regulation is never implemented.

Sen. Jeff Bingaman (D-NM), a member of the Senate Finance Committee, and Rep. Henry Waxman (D-CA), chair of the House oversight committee, dropped joint resolutions on Tuesday (Sept. 11) that, if passed, would provide "congressional disapproval" of the CMS rule that bans intergovernmental transfers (IGTs).

September 13, 2007 | Daily News

House Democrats are considering extending FDA user fee programs three months, according to a release from Sen. Michael Enzi (R-WY), who opposes the idea. The move would ward off the need for FDA to send layoff warning notices to agency employees if Congress does not pass a bill renewing drug and medical device user fee programs by Sept. 21.

September 13, 2007 | Daily News

A bipartisan group of well-placed senators struck back at the Bush administration this week, introducing legislation that would prohibit CMS from implementing its controversial new directive that limits SCHIP eligibility to families earning 250 percent of the federal poverty level (FPL).

September 12, 2007 | Daily News

To cheers and applause from stakeholders, the Senate Finance Committee on Wednesday unanimously approved legislation to expand Medicare, Medicaid and SCHIP services to Native Americans. The bill would provide about $52 million over the next five years for improved services and outreach, as well as the elimination of cost sharing, for patients eligible for care through CMS programs.

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