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Congress

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.

May 23, 2007 | Daily News

An agreement worked out between congressional Democrats and the White House on the war supplemental spending bill retains earlier language pushed by Majority Whip Sen. Richard Durbin (D-IL) slapping a moratorium on two CMS Medicaid rules, congressional insiders indicated Wednesday (May 23).

May 23, 2007 | Daily News

The House is gearing up to cut Medicare payments to Medicare Advantage plans, specifically targeting private fee-for-service plans, according to a key House lawmaker who is armed with ready-made endorsements from organized medicine and hospital groups who support the move. Rep. Pete Stark (D-CA), the Ways & Means health subcommittee chair, said Tuesday (May 21) these MA plans are at the "top of the list" of stakeholders who are slated for Medicare payment reductions, set to be handed down sometime next month.

May 23, 2007 | Daily News

FDA would not have identified heart problems associated with Avandia earlier had the drug safety measures in the Senate FDA Revitalization Act been in place, according to a New England Journal of Medicine (NEJM) editorial published this week -- an assertion one of the bill's authors refutes.

May 22, 2007 | Daily News

An aide to Finance Committee Chair Max Baucus (D-MT) said Tuesday (May 22) the lawmaker is working to keep in the Senate's evolving rewrite of the war supplemental bill a provision allocating $650 million in funding to cover a projected shortfall in the State Children's Health Insurance Program (SCHIP). Capitulating to White House objections, Democrats had dropped a number of domestic provisions from the supplemental, and earlier reports indicated SCHIP might be among them.

May 21, 2007 | Daily News

The Infectious Diseases Society of America is lobbying the House to strengthen a measure on antibiotic resistance included in the FDA bill passed by the Senate, an IDSA source says. IDSA wants a section on "single enantiomers" to apply to antimicrobials so such products can get five years of market exclusivity, and wants to reauthorize a defunct antimicrobial task force.

May 21, 2007 | Daily News

Gearing up for a Tuesday showdown with congressional critics of Medicare Advantage (MA) plans, CMS officials defended the controversial program Monday (May 21), citing the additional benefits offered to vulnerable populations and the coordination of care available for patients with multiple chronic illnesses.

Critics of the program contend the highly subsidized program does more to benefit insurers than patients, and a number of key Democrats are eyeing an end to the federal subsidies as a method to pay for other Medicare-related legislation this year.

May 21, 2007 | Daily News

As Congress weighs changes at FDA, the agency is in hot water again for taking its time to warn the public about the safety of a drug -- this time for not more quickly warning that Avandia may cause heart attacks in diabetes patients. Congressional investigators were after FDA to do more to alert patients about the popular diabetes drug well before the New England Journal of Medicine Monday (May 21) published a study on Avandia's risks.

May 18, 2007 | Daily News

Some industry lobbyists are worried a provision in the Senate FDA bill that uses sales figures to cut the market protection incentive afforded drug makers that do pediatric research could set a precedent for other types of "exclusivities."

The lobbyists hope the House will revisit the provision when it drafts its version of the bill passed by the Senate last week. S. 1082 includes provisions authorizing the collection of user fees and pediatric research laws, as well as other provisions on drug safety, food safety, clinical trial registries and drug patent reforms.

May 17, 2007 | Daily News

Senate drug safety maverick Charles Grassley (R-IA) is pointing to FDA's alleged slowness in getting safety data on widely prescribed anti-anemia drugs in his latest bid to get FDA the power to demand drug companies hand over certain study data. Grassley says time is of the essence, as the Senate has already passed its FDA reform bill but the House has yet to act on what may be Congress' only attempt at reforming the agency for years.

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