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Daily News

July 10, 2003

Industry, consumer groups and the American Medical Association all welcomed FDA's final rule requiring that food labels include trans fat content by January 2006. Industry had strongly opposed FDA's previous proposal to require a footnote recommending that "intake of trans fat should be as low as possible," and FDA removed the requirement for the final rule.

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FDA has established a new premarket notification scheme for qualified food health claims under which stakeholders will have 60 days to comment and FDA has up to 270 days to make a decision. FDA has established a new ranking system that will classify the scientific evidence supporting health claims.

This ranking system will categorize the quality and strength of the scientific evidence for every proposed qualified health claims, FDA Commissioner Mark McClellan said.

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July 09, 2003

The ranking Democrat on the Senate Finance Committee says President Bush's involvement in the upcoming Medicare conference talks is key to ensuring a quick resolution. The lawmaker predicts there is a 90 percent chance that Medicare reform will be signed into law this year, despite his view that there are a half dozen controversial issues that may be difficult for conferees to resolve.

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House leaders tweaked language allowing commercial reimportation of cut-price Canadian pharmaceuticals in an effort to ease FDA's ability to enact safety regulations and gain votes for Medicare prescription drug legislation, but kept a provision from the Senate bill that allows reimportation to remain indefinitely on hold pending approval from the HHS secretary.

Drug reimportation is one of many issues that will be addressed in the upcoming Medicare reform conference where House and Senate lawmakers will meld their bills.

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FDA's associate commissioner for regulatory affairs sent a memo June 23 to field inspectors urging them to enforce the law and adding that if inspectors feel they need to depart from regular procedure they must first discuss the approach with management. John Taylor issued the reminder the day before House lawmakers lambasted him for releasing a large shipment of counterfeit generic Viagra that U.S. Customs had detained.

Here is the chronology of the events:

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The leading pharmaceutical industry group hopes to play a key role in reviewing a National Institute for Occupational Safety and Health (NIOSH) guidance on reducing health care workers' exposure to harmful pharmaceuticals. Among other concerns, the pharmaceutical group is upset that a draft version of the fact sheet lists specific pharmaceutical products which could be hazardous to workers -- a move the group argues could inadvertently give producers of products not on the list a competitive advantage.

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The report language accompanying a bill passed by the Senate health committee reinstating FDA's pediatric rule does not resolve concerns by pediatric groups that the bill could let hundreds of deferred studies slip through the cracks. However, Senate committee staffers are still working to address this issue plus a lingering enforcement issue, possibly in a manager's amendment, according to a Senate health committee spokesperson.

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Means testing will be hotly debated in the upcoming Medicare conference talks: While Senate Majority Leader Bill Frist (R-TN) has predicted the final bill will include some form of means testing, the top Democrat on the Senate Finance Committee July 9 said inclusion of income-relating provisions could derail Medicare reform.

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July 08, 2003

U.S. interest in negotiating a free-trade agreement with Egypt has cooled dramatically since that country decided it would not support a U.S. complaint in the World Trade Organization against the European Union's ban on genetically modified foods, according to a U.S. trade official.

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Organized labor strongly disagrees with OSHA's rationale for withdrawing the musculoskeletal disorder (MSD) provision in its recordkeeping rule, charging the move will proliferate the number of MSDs in the workplace. Industry groups, however, praise the decision to not record MSDs in a separate column.

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The House Energy and Commerce's oversight subcommittee is conducting a large investigation into dietary supplements and lawmakers plan to hold a hearing this month on the weight-loss supplement ephedra and possibly on children diet pills, according to a congressional source. Lawmakers also plan to hold an oversight hearing on steroid precursors this fall.

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FDA may exempt some botanical drugs from its drug combination policy, which requires proof of contribution for each component, according to an agency official. The official suggests "nature" mixtures using one part of a single plant will be exempt.

In February, FDA's Office of New Drugs established a Botanical Review Team in an effort to consolidate the office's scientific and regulatory expertise in botanical products. Shaw Chen was tapped to serve as the team's leader.

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Democratic and GOP Senate Finance Committee health staffers say they are open to considering the House Medicare bill's plan to cut physician reimbursement for outpatient drugs, even as compromises in the House bill failed to win the support of oncologists, the main physician group affected.

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Senate Democrats fired the opening salvo on the Medicare conference debate today (July 8) with a warning that they will not support a Medicare bill that deviates from key aspects of the Senate-passed plan. The stance -- issued on the eve of bicameral conference negotiations -- kick-starts what many predict will be lengthy and difficult Medicare negotiations.

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The conference to reconcile the House and Senate Medicare bills must take into account both the bipartisan support needed for Senate passage and the narrow margin of support in the House, according to Senate Finance Committee Chairman Chuck Grassley (R-IA), who is pushing to wrap up the conference by the end of September at the latest.

"I have to be cognizant of getting a bill through the House as well as getting one through the Senate," Grassley said.

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July 07, 2003

Negotiations between House leaders on Medicare legislation resulted in a compromise on parameters for how CMS can reduce reimbursement for new drugs it views as functionally equivalent to existing pharmaceuticals, but the House-Senate conference will test whether Ways and Means Committee Chairman Bill Thomas (R-CA) can again withstand industry pressure to bar use of the functional equivalence standard.

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A key industry group has sent a strongly worded letter to OSHA Administrator John Henshaw urging him to avoid letting political motives drive ergonomics policy and reasserting its view that the ergonomics guidelines should not be used as an enforcement tool under the general duty clause. The group warned Henshaw that OSHA would risk losing its credibility with industry unless he holds a tight rein on field inspectors and avoids following "potentially misguided information from compliance officers or internal legal counsel."

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House Democrats are planning to ask Speaker Dennis Hastert (R-IL) to support language in the Senate Medicare reform bill during the upcoming conference talks that would ensure members of Congress do not get a better drug benefit than Medicare beneficiaries. Reports are circulating that Senate Republicans may attempt to strip the provision during conference.

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Three members of the Senate health committee, including chair Judd Gregg (R-NH), have asked Congress' investigative arm to study the scope and regulation of pharmacy compounding. The members are asking the General Accounting Office to probe the issue to help the committee prepare for a September hearing on the topic.

Gregg, Kit Bond (R-MO) and Pat Roberts (R-KS) sent a June 26 letter to GAO's Janet Heinrich requesting the study. Among other things, the lawmakers want to know if current law provides FDA adequate enforcement authority to oversee compounding.

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Sens. Kit Bond (R-MO) and Pat Roberts (R-KS) attached to the Senate Medicare drug benefit a measure that would set up an FDA pharmacy compounding advisory committee. FDA disbanded a similar committee following the Supreme Court's decision to strike the FDA Modernization Act (FDAMA) pharmacy compounding provision.

Pharmacy compounding is the mixing of drugs to meet the needs of a patient who cannot take a ready-made drug. Removing a preservative a patient may be allergic to is an example of traditional pharmacy compounding.

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