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Daily News

January 27, 2003

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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FDA issued a draft guidance Thursday (Jan. 23) standardizing the way the agency collects race and ethnicity data during clinical trials to make it easier for industry and FDA to identify differences in how trial subjects react to drugs and devices. The agency is recommending that industry use the criteria for defining race and ethnicity developed by the Office of Management and Budget (OMB).

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The Biotechnology Industry Organization (BIO) has hired Gillian Woollett --a former biotech expert for the U.S. drug trade group. Woollett's experience with both FDA's drug and biologics centers could come in handy as the biotech industry is increasingly regulated by the Center for Drug Evaluation and Research (CDER) under the agency's new consolidation plan.

Historically, biotech companies have dealt with the biologics center, but with FDA shifting the review of many therapeutic biologics out of the biologics center, the biotech industry will be dealing a lot more with CDER.

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Sen. Mike Enzi (R-WY) will likely take the gavel in the Senate subcommittee with OSHA jurisdiction, according to a source close to the lawmaker. Enzi's likely reappointment as chairman of this panel significantly increases the chances that significant OSHA reform discussions will take place in the new Congress.

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CMS Administrator Tom Scully this week extended his deadline for Congress to revamp the agency's average wholesale price (AWP) system until May. At a National Health Policy Conference in Washington, DC this week, Scully said CMS "could put out a rule tomorrow" on AWP but has decided to give lawmakers until May to legislatively repair the beleaguered payment system before the agency considers acting on its own.

Last year, Scully vowed to issue an AWP standard if Congress did not pass legislation on the controversial issue by the end of 2002.

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The administration's $13 million requested increase for FDA's generic drug program in fiscal year 2004, if passed by Congress, would allow the agency to hire 40 new experts in FDA's generic drugs and related programs. The proposed increase would also reduce the average generic drug review time by two months and fund research needed to establish standards of therapeutic equivalence.

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CMS Administrator Tom Scully said he hopes the agency never has to use its inherent reasonableness (IR) power, asserting that just having the authority to significantly lower Medicare payments will force suppliers to voluntarily lower their prices.

Scully's Jan. 22 statement is likely to ease the concerns of device groups but could attract criticism from Capitol Hill. Over the last several years, CMS' IR policies have been closely monitored by health care groups in Washington, DC and investors on Wall Street.

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In a move that could significantly increase the Senate's chances of passing a Medicare drug benefit this year, a key Democrat is indicating he will support a private, risk-basked insurance model. Former Senate Finance Committee Chairman Max Baucus (D-MT) plans to introduce legislation outlining a private, risk-based insurance approach as a potential compromise between Democrat and tripartisan drug benefit bills.

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January 23, 2003

The National Security Council is in the process of scheduling a cabinet-level meeting in the next two weeks to decide whether or not to pursue a biotechnology case in the World Trade Organization against the European Union's moratorium, according to informed sources. The options are to have the meeting next week or in the first week of February, according to an informed source.

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Supreme Court justices yesterday (Jan. 22) suggested that further guidance might be needed from HHS on a Maine prescription drug law that is vehemently opposed by the drug industry. Yesterday's oral arguments over Maine Rx -- eyed by many states as a blueprint for curbing escalating drug costs -- mark the first time the drug industry's legal battle over state initiatives to lower drug costs have been taken up by the high court.

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In a rare move, OSHA has rejected a cooperative agreement with a company that had offered to work with the agency to improve occupational safety and health. OSHA cites the company's lack of commitment to protecting its workers as the reason for denying the offer. However, the company, McWane, Inc., says it does have a voluntary agreement with the agency to improve the safety and health of its employees and the statement was confirmed by an OSHA spokesperson.

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Manufacturers of the dietary supplement "Siberian Ginseng" have reached a wall in their efforts to get legislative relief from a provision in the farm bill that stipulates that only supplements made from plants of the genus panax can use the term ginseng. "Siberian Ginseng" manufacturers are concerned that the provision does not grant them any time to make changes to their labeling so as to be compliant with the law.

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FDA Commissioner Mark McClellan said this week that lawmakers are interested in a broad range of topics facing the agency, including legislation on animal-drug user fees, food-security, and food-allergen labeling. McClellan also pointed to "legislative interest" in FDA-oversight of tobacco and Internet pharmacies but did not state the agency's position on these topics, adding that neither are the agency's purview.

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FDA's top official this week said the agency backs legislation to require food producers to "appropriately" label food for allergens. Last month FDA Commissioner Mark McClellan said the administration was taking risk-based allergen legislation into consideration, but was unclear on whether it would back it.

Speaking at a Health Policy Conference in Washington, DC on Wednesday (Jan. 22), McClellan said such legislation fits into his approach of ensuring that consumers get more complete, trustworthy information on the products the agency regulates.

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