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Congress

June 04, 2007 | Daily News

America's Health Insurance Plans' (AHIP) campaign to persuade lawmakers that low-income and minority beneficiaries would be disproportionately hurt if Congress cuts funding to Medicare Advantage (MA) seems to be proceeding with mixed results as the chair of the House Ways & Means Committee, a founding member of the Congressional Black Caucus, said he has seen no evidence that minorities are more interested in MA than they are in other health care programs.

June 04, 2007 | Daily News

Sources tell Inside OSHA that lawmakers are considering introducing legislation that would set a deadline for OSHA to produce diacetyl standards for the food flavoring industry. The move comes as OSHA remains tight-lipped about the status of its newly announced national emphasis program (NEP) prioritizing inspections of microwave popcorn facilities.

June 04, 2007 | Daily News

Senate Finance Committee Chair Max Baucus (D-MT) and ranking GOP member Charles Grassley (R-IA) are continuing efforts to hash out a compromise on the much-anticipated SCHIP reauthorization bill and have pushed markup until next Wednesday (June 13) or Thursday (June 14), sources indicated Monday (June 4). Sources had previously signaled the markup might occur this week.

A Baucus aide confirmed that Finance staffers on both sides of the aisle are working together to craft a bill, and Baucus' five principles he had previously outlined "remain our stated goals."

June 04, 2007 | Daily News

FDA is forming a panel of outside experts to advise it on how to tell the public about potential dangers and benefits of medical products such as drugs. FDA announced the Risk Communication Advisory Committee Monday (June 4), weeks after scientists outside the agency reported the diabetes drug Avandia may pose previously unknown risks. The data prompted some lawmakers to criticize FDA anew for not alerting the public soon enough and to weigh additional drug safety reforms.

June 04, 2007 | Daily News

House Energy and Commerce Committee Chairman John Dingell (D-MI) are urging House appropriators to deny FDA the funds it would need to follow through with a plan to close seven of its field laboratories.

May 31, 2007 | Daily News

Two measures in the Senate-passed FDA Revitalization Act require tracking technology on drugs, but one excludes radiofrequency identification, which means the net effect of the two provisions would be to discourage RFID for pharmaceuticals, an industry source says.

Both measures are in section 514 of S. 1082, which the Senate passed earlier this month.

May 31, 2007 | Daily News

Food industry groups will likely push the House to modify a food safety provision included in the Senate's FDA reform bill that lays out requirements for notifying FDA of possible "adulterations" in the manufacturing process -- standards the groups feel are overly vague and would leave FDA swimming in extraneous reports at the expense of legitimate causes for concern.

May 31, 2007 | Daily News

Washington insiders are circulating a "hit list" of up to $65 billion in Medicare provider payment cuts eyed by lawmakers to pay for reauthorization of the State Children's Health Insurance Program (SCHIP) and provide doctors with short-term stability in Medicare payments, with the bulk of the savings coming from Medicare Advantage (MA) cuts.

May 30, 2007 | Daily News

CMS Tuesday (May 29) released the final version of the controversial rule that limits Medicaid reimbursement to providers and bans intergovernmental transfers (IGTs), just days after the president signed a war spending bill that delays the rule by one year. A CMS spokesman confirmed the agency will delay implementing the requirements, and said CMS released the final version in the interest of "transparency" and to inform the public CMS will continue to take public comments regarding the definition of a "unit of government" until July 13.

May 30, 2007 | Daily News

A new Institute of Medicine report touts tobacco legislation by Sens. Edward Kennedy (D-MA) and John Cornyn (R-TX) that would give FDA broad regulatory authority over the manufacture, distribution, marketing and use of tobacco products, but also recommends the bill be beefed up. IOM says lawmakers should also remove federal limits that restrict states' ability to pass more stringent anti-smoking measures, and strengthen the bill's advertising restrictions, among other changes.

IOM specifically urges lawmakers to add provisions that would do the following:

May 30, 2007 | Daily News

Some U.S. companies have been making fish and livestock feed laced with melamine, a contaminant that originally was found in Chinese pet food imports and has led Congress to look anew at how FDA polices the nation's ports. The contaminated U.S. feed may also contain a urea formaldehyde resin-type ingredient, FDA unveiled Wednesday (May 30). A House appropriations panel is expected to call FDA's food safety czar to testify next Tuesday (June 5) on the quickly unfolding food safety problem.

May 30, 2007 | Daily News

A powerful Senate watchdog is asking drug giant Johnson & Johnson to cooperate in an "ongoing inquiry" into the pricing, marketing and safety of anti-anemia drugs prescribed to treat Medicare cancer and end-stage renal disease (ESRD) patients.

May 25, 2007 | Daily News

A CMS press briefing on the Medicare Advantage (MA) program held in advance of a congressional hearing on the topic was "inappropriate" and not befitting the agency's role "as a regulator and steward of the Medicare program," Senate Finance Chair Max Baucus (D-MT) charged Thursday.

May 25, 2007 | Daily News

The House Wednesday (May 23) passed a bipartition bill that would temporarily relax a provision of Medicare law by allowing physicians serving in military active duty to stay away from their offices and still bill the government longer than the current 60-day maximum.

The bill, HR 2429, was sponsored by Reps. Mike Thomson (D-CA) and Rep. Sam Johnson (R-TX), a Vietnam veteran and former prisoner of war.

May 25, 2007 | Daily News

The war supplemental spending bill approved by Congress and sent to President Bush late Thursday provides as much as $650 million to cover shortfalls in federal funding for the State Children's Health Insurance Program, and delays controversial CMS rules that would cut Medicaid payments for public hospitals, nursing homes and graduate medical education. The rule slashing graduate medical education payments was proposed by CMS just days ago.

May 25, 2007 | Daily News

House Energy & Commerce Chair John Dingell (D-MI) Thursday (May 24) threatened to subpoena FDA if the agency doesn't turn over by June 1 documents sought by the committee on issues ranging from the antibiotic Ketek to pet food and lab closures.

Dingell and oversight subcommittee Chair Bart Stupak (D-MI) complain FDA has not handed over documents the panel wanted one to three months ago and in other cases has provided shoddy responses.

May 25, 2007 | Daily News

FDA drug safety officials wanted to change the label on the diabetes drug Avandia in 2002, but higher-ups did not, according to an internal agency memo obtained by the consumer group Public Citizen. Sen Charles Grassley (R-IA), who has been trying to give drug safety officials equal footing with drug reviewers, said his investigators have confirmed there was tension between the staff members who review drug applications and those who monitor drugs on the market.

May 24, 2007 | Daily News

Fourteen Democratic senators have joined Sen. Dick Durbin (D-IL) in asking the Senate Appropriations agriculture subcommittee to increase funding for FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Office of Regulatory Affairs (ORA). Durbin circulated a letter May 16 that called for higher appropriations to FDA's food safety programs in light of the recent discovery of contaminated pet food.

May 23, 2007 | Daily News

The Medical Device User Fee Modernization Act (MDUFMA) is scheduled for mark up by the House Energy and Commerce Committee during the week of June 18, though the House has not yet decided whether to consider it independently or roll it in with other FDA bills. In either case, MDUFMA will likely include a provision on pediatric devices nearly identical to the Senate's.

May 23, 2007 | Daily News

Tucked in the massive FDA reform bill the Senate passed this month is a measure to make FDA review the use of carbon monoxide to keep meat looking fresh longer.

The measure, by Sen. Carl Levin (D-MI), was included in block of 17 amendments to S. 1082 accepted by unanimous consent.

The amendment does not mention carbon monoxide, but that is what it is aimed at.

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