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Daily News

January 29, 2003

A key Senate Democrat said after President Bush's State of the Union address that "at least as much money" as the administration is proposing for its $672 billion tax plan is needed to reform Medicare.

Following the State of the Union address last night (Jan. 28), Sen. John Breaux (D-LA) told Inside CMS the $400 billion set aside for Medicare reform under the president's proposal "is the very minimum [to get a discussion] started."

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In response to a key Democrat's questions, FDA says it "has not developed a legislative position" on whether it would back legislation requiring dietary supplement companies to submit adverse event reports (AERs) to the agency. FDA downplays the value of AERs in assessing product safety and says it will not formulate a regulatory policy on the controversial dietary supplement ephedra until a high-profile study by the RAND Corp. is completed.

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A Senate Democrat is planning to introduce legislation that would change OSHA enforcement and the agency's penalty structure, allowing for stricter penalties for bad actors in the employer community, according to an informed source.

The issue has taken on renewed prominence after The New York Times, the PBS program Frontline and the Canadian Broadcasting Corporation conducted an investigation of McWane, Inc., which concluded that the company is routinely violating OSHA regulations and has an "egregious" health and safety record.

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Health care experts and congressional officials are highly skeptical that President Bush's Medicare reform plan will be embraced by GOP congressional leaders, claiming the plan looks extremely similar to proposals that the administration has pursued previously.

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A federal district court Wednesday (Jan. 29) struck down the Bush administration's latest Medicare-endorsed prescription drug discount card proposal, stating once again that HHS lacks the statutory authority to implement the program. The decision means the future of the discount program -- which has been a key part of the administration's prescription drug plans -- now hinges on congressional action to give HHS the authority to proceed or a court of appeals.

At press time, it was unclear if the administration would appeal the ruling.

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January 28, 2003

AARP is likely to once again file an application to take part in President Bush's Medicare-endorsed prescription drug discount card program, according to a source with the organization. The move is a significant boost for the much-criticized Bush administration plan and could help White House officials nullify some of the opposition to the proposal.

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CMS Administrator Tom Scully says he is "on a mission" to get the agency's regional administrators (RAs) more actively involved in policymaking.

In a Jan. 16 e-mail to agency staffers, Scully states that he is taking over Ruben King-Shaw's responsibility of working with the RAs. At the request of the White House, King-Shaw was recently transferred to the Treasury Department (Inside CMS, Jan. 16, p3).

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Claiming CMS' proposal would trample patients' rights, consumer advocates are strongly urging the agency to scrap its plan to merge beneficiary and provider appeals into one system.

Several consumer groups, including the Center for Medicare Advocacy, Inc. and the National Senior Citizens Law Center, assert that CMS' proposed rule to implement Section 521 of the Benefits Improvement and Protection Act of 2000 (BIPA) is not consistent with congressional intent.

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The International Conference on Harmonization (ICH) steering committee and expert working groups will discuss a broad array of topics at an upcoming Feb. 3-6 meeting in Tokyo, Japan, including the electronic Common Technical Document (eCTD), gene therapy, post-marketing and clinical evaluation of QT prolongation.

ICH is an international forum charged with harmonizing the drug registration requirements of the United States, Japan and European Union.

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The chairman of the Senate Finance Committee says the United States should launch a case in the World Trade Organization against the European Union's moratorium on approving new genetically engineered crops even if officials in the State Department object.

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Senate Majority Leader Bill Frist (R-TN) says he will work to quickly get legislation providing "appropriate funding" to those injured by the smallpox vaccine. Frist promised to work on a smallpox vaccine injury compensation plan during last Friday's (Jan. 23) floor session, and Senate health committee chair Judd Gregg (R-NH) is holding a hearing Thursday (Jan. 30) to start looking into such legislation.

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January 27, 2003

Trade associations representing food importers say an FDA draft guidance laying out when the U.S. Customs Service should seize and destroy imported food oversteps the law, suggesting that FDA may find itself in court if it does not change course.

The groups say the guidance is a back-door attempt to ease the statutory criteria FDA must meet to invoke seizure and destruction. Adoption of the guidance, according to the groups, would make it so FDA would never again have to go to court to seek seizure and destruction of an imported food.

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The agency is delaying transferring dura matter and heart valves from the device center to the biologics center until the biologics center has finalized its tissue regulations to avoid a situation where these products would be unregulated.

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FDA has denied a petition that sought approval of the brand-name "Carbolite" as an implied nutrient content claim in foods qualifying for "zero sugar" or "reduced sugar" claims. A key food industry trade association and several food companies said Carbolite Foods Inc., which filed the petition, tried to use a back-door route to establish a new nutrient content claim for "light carbohydrate" instead of going through the rulemaking process.

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The California Standards Board has pushed back its decision on the future of the state's ergonomics regulation by one month, according to an informed source.

The Occupational Safety and Health Standards Board, the standard-setting entity for Cal OSHA, was scheduled to make a decision on a union petition to amend the state's ergonomics rule on Jan. 16.

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Rep. John Dingell (D-MI) may call for the resignation of Attorney General John Ashcroft if the Department of Justice (DOJ) fails to comply with a legal requirement to publish a study on the vulnerability of chemical plants to terrorist attacks, a congressional source says. Dingell wrote to President Bush on Jan. 23 demanding that DOJ complete the study, which is a high priority for environmentalists concerned about the vulnerabilities of facilities that store dangerous chemicals.

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The Senate health committee plans to mark up compromise legislation requiring plain English labels for food allergens Feb. 12, according to a spokesperson for Sen. Edward Kennedy (D-MA). Committee chair Judd Gregg (R-NH) and former committee chair Kennedy are set to introduce the bill -- which likely will resemble the compromise version they worked out last Congress with Sen. Bill Frist (R-TN), now Senate majority leader. The congressional movement comes at a time when FDA says legislative action on food-allergen labeling is needed.

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January 24, 2003

The National Community Pharmacists Association (NCPA), a long-time supporter of legislation that would enable pharmacies and wholesalers to import and reimport drugs, has launched a multi-pronged campaign to curb the sale and promotion of illegally imported drugs. As a part of the effort, the group has written FDA asking it to target advertisements, and has started drafting legislation that would make it difficult to pay for these drugs with a credit card.

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The chairman of the dietary supplement working group of a key state-regulators association says Congress should revise the law governing dietary supplements to require pre-market notification to FDA for all supplements. The working group chair also wants lawmakers to mandate supplement adverse event reports.

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The Advanced Medical Technology Association (AdvaMed) is urging FDA to expand its approach to bundling medical device submissions to ensure that manufacturers are not charged multiple times for single reviews, according to comments the group sent to FDA on implementation of the medical device user fee law. FDA currently allows bundling for new device applications and changes to existing applications.

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