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Daily News

February 04, 2003

Several industry groups and companies are appealing the American National Standards Institute (ANSI) ergonomics standard, arguing the procedures for the consensus rulemaking have not been followed.

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FDA's new medical device user fee program could need up to $65 million in direct appropriations in fiscal year 2005 to stay afloat if Congress were to pass the president's FY 04 budget request for the device center. The president's FY 04 request would leave the device center $20 million short of baseline funding, and under the user fee law Congress must give the device center on average $15 million annually above baseline-funding between FY 03 and FY 05.

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FDA plans to "proactively seek candidates" to switch from prescription drug (Rx) to over-the-counter (OTC) status if Congress approves an extra million dollars requested in the president's fiscal year 2004 budget for FDA's OTC drug review program. The agency's goal is to increase Rx-to-OTC switches by 50 percent.

FDA also plans to use the money to add and train new reviewers to speed OTC drug reviews.

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The day before he gave his State of the Union address President Bush sent a letter to the Generic Pharmaceutical Association (GPhA) praising the group for its efforts to provide affordable medicines, maintaining that generic drugs save consumers billions of dollars in prescription drug costs.

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February 03, 2003

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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The European Union told World Trade Organization members last week that its proposal to break a deadlock in negotiations on access to generic medicines would not limit the scope of diseases covered by a solution, but was designed to use input from the World Health Organization to allay U.S. fears about an overly broad application of the more flexible patent rules under discussion.

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A pharmacy group is asking the state attorneys general of Nebraska and Illinois to look into what the groups says are illegal sales of Canadian drugs by Sav-Rx, a firm operating in the two states. Kiwanis, a community-service club, has severed links with the discounted mail-order prescription drug company after the National Community Pharmacists Association alerted Kiwanis to the allegedly illegal actions.

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OSHA Administrator John Henshaw recently reiterated that OSHA's new advisory committee should not discuss ergonomics enforcement or debate whether the agency should pursue an ergonomics regulation, claiming that both issues are "beyond the scope of the committee."

The move is a clear indication that the Bush administration is seeking to firmly control the new ergonomic advisory panel by clearly stipulating what issues it can -- and cannot -- tackle.

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French Agriculture Minister Herve Gaymard said Jan. 30 it would be a mistake for the United States to launch a challenge in the World Trade Organization against the European Union's moratorium on genetically modified crops because it would increase the resistance of European consumers to such products.

If EU consumers feel that they would be forced to accept genetically modified foods, "I think it would only increase the distrust they already feel," Gaymard said in a Jan. 30 Washington press briefing.

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Ninety five percent of President Bush's $400 billion Medicare reform proposal will be devoted for prescription drug coverage and other preventive measures, an HHS budget official said Feb. 3. The official also suggested that the $400 billion plan calls for funding to be shifted from other providers to pay for physician payment increases.

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January 31, 2003

Senate Republicans may use a Democratic push for a smallpox vaccination injury compensation plan as a bargaining chip for liability indemnification of other biodefense measures, according to a congressional source. Staffers for Sen. Edward Kennedy (D-MA) are scheduled to meet Tuesday (Feb. 4) with staffers for key Republicans, the congressional source adds.

Kennedy told his staff he does not like the idea of indemnifying a broad range of biodefense measures at once.

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The Bush Administration is preparing to hold a cabinet-level meeting to decide whether to launch dispute settlement action against the European Union's moratorium on approval of new genetically engineered crops, at a time when Senate Finance Committee Chairman Charles Grassley (R-IA) is lashing out at the administration for its continued indecision on the dispute.

The meeting is to be held either Feb. 3 or Feb. 4 after a decision-meeting originally scheduled for the week of Jan. 27 was postponed, informed sources said.

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PUERTO RICO -- Defending the Bush administration's generic drug plan, FDA Chief Counsel Daniel Troy says the generic drug industry did an about-face in opposing FDA's proposal to only allow one 30-month stay per generic drug application. The industry is "playing high-risk poker," Troy says, by backing away from its own regulatory proposal and banking on a more aggressive legislative fix.

The candid remarks by the agency's top lawyer prompted a lively debate during the Generic Pharmaceutical Association's (GPhA) annual meeting this week.

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The drug center's Office of Compliance (OC) has shifted its oversight of pharmacy compounding from its former Division of Prescription Drug Compliance and Surveillance to its newly formed Division of New Drugs and Labeling Compliance, according to an FDA document. Relieved of the regulatory quagmire of pharmacy compounding, the compliance risk management division now will have more time to focus on the center's risk management activities, according to a source familiar with the OC.

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A key Senate appropriator earlier this month called CMS' coverage advisory committee "a colossal waste of taxpayer's money" and criticized the agency for its policy on positron emission tomography (PET) scans.

John McLaughlin's One On One television show, which was taped Jan. 16, focused on Medicare's looming coverage decision on PET scans for Alzheimer's disease. Senate Appropriations Committee Chairman Ted Stevens (R-AK), who has pressed CMS on PET issues for years, told McLaughlin that CMS' advisory committee is to blame for Medicare's skepticism on PET.

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In the wake of new numbers showing an increase in approval times for breakthrough drugs, FDA has unveiled an initiative comprising both new and old agency activities aimed at decreasing approval and development times. As a part of this effort the agency will develop regulatory pathways for pharmacogenomics, gene therapy and novel delivery systems; draft guidances on treatments of specific diseases such as diabetes and cancer; and finish a good review management practices guidance for drug reviewers.

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FDA took longer to approve breakthrough drugs last year than the year before, according to an FDA report summarizing the agency's product review performance for 2002. The agency cites fewer product applications as the main reason for the increase in average and median review times. The numbers have prompted FDA to announce a broad-based review initiative aimed at speeding up approvals.

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A key food industry group charges FDA has overstepped its mandate under the bioterrorism act by requiring extensive detail from food importers in the prior notice regulation it proposed Jan. 29. The information requirements in the proposed rule are very prescriptive and specific and have far more data elements than specified by the act, a source from the National Food Processors Association (NFPA) says.

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January 30, 2003

PUERTO RICO -- Rep. Henry Waxman (D-CA) has announced plans to craft legislation that would reform the drug patent law he authored with Sen. Orrin Hatch (R-UT) by eliminating the 30-month stay period during which FDA cannot approve a generic drug application. Waxman is adopting a different approach from the one in a bill he introduced last year that would have allowed only one 30-month stay per generic drug application.

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OSHA and a leading chemical manufacturer have agreed to work together to advance occupational safety and health with a focus on process safety management (PSM) and ergonomics.

The agency and Dow Chemical Company announced the formation of an alliance Jan. 13. In a statement, OSHA said the cooperation between the agency and the Fortune 500 company will focus on PSM, aim to reduce musculoskeletal disorders in the workplace and improve safety and health programs.

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