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Daily News

January 24, 2003

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FDA issued a draft guidance Thursday (Jan. 23) standardizing the way the agency collects race and ethnicity data during clinical trials to make it easier for industry and FDA to identify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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January 22, 2003

The fate of the Medicare drug discount card -- a cornerstone of the Bush administration's prescription drug agenda to date -- will be played out in a federal district courtroom Jan. 29.

In what could be the defining hearing on the case, pharmacy groups contesting the administration's latest card plan and the Department of Justice (DOJ) will both present arguments calling on the U.S. District Court for the District of Columbia to make a ruling on the case.

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The veterinary drug industry is asking FDA and the U.S. Trade Representative (USTR) to urge Japan to reconsider its possible plans to prohibit the use of certain antibiotics in animal feed, according to industry and FDA sources. FDA has sent Japan information from its risk assessments on antibiotic resistance, and industry hopes the data will encourage the Japanese to use a similar "good science" approach, and not the precautionary principle.

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The Biotechnology Industry Organization (BIO) has launched a bid to join the Product Quality Research Institute (PQRI), hoping to play a role in the FDA/drug industry group's work on good manufacturing practices (GMPs), according to sources. If successful, BIO would be the first group on the steering committee to solely represent the biotechnology industry.

PQRI is a non-profit group designed to provide a neutral environment where FDA and industry can collaborate on pharmaceutical product quality research and develop information supporting drug regulatory policies.

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The recently crafted Senate omnibus appropriations bill includes a funding provision for an ergonomics standard and would reinstate worker safety and health training grant funding the Bush administration sought to eliminate, according to congressional documents.

Congress left last year without having voted on a series of spending bills, instead passing a continuing resolution to keep the government running. Lawmakers are now trying to consolidate the unfinished appropriations bills into an omnibus spending bill.

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Greece's Ambassador to the United States says the European Union could review a moratorium on approval of new genetically modified crops during Greece's six-month tenure in the EU presidency, but would not likely agree on a package of mid-term reforms to the EU's Common Agriculture Policy. However, neither of these issues is among the Greek Presidency's priorities, which focus on the pending entry of 10 new members into the EU, Ambassador George Savvaides told the National Press Club Jan. 14.

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Sen. Bob Graham (D-FL) and other lawmakers will seek to attach language to the Senate spending bill that would overturn a Dec. 20, 2002, CMS letter that they say reverses agency policy by limiting coverage of emergency care by states and managed care plans. Hospital groups strongly support the measure and are criticizing CMS for failing to consult them on the new policy.

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