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Daily News

January 13, 2003

Two key lawmakers who had earlier indicated concern about the revamping of HHS advisory committees do not have immediate plans to protest the makeup of the newly-formed Secretary's Advisory Committee on Human Research Protection (SACHRP), according to congressional staffers. Senate health ranking member Edward Kennedy (D-MA) and Rep. Henry Waxman (D-CA) have been receiving numerous complaints on the issue from interested parties, sources say, but they have not sent letters or asked HHS for an explanation.

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The Biotechnology Industry Organization (BIO) is reorganizing its regulatory affairs department, according to industry sources. Under the reorganization, Steve Lawton, who currently shares the jobs of vice president of regulatory affairs and general counsel, will focus on legal issues such as corporate security and intellectual property. Wendy Taylor, who has worked closely with Lawton, will become acting vice president of regulatory affairs.

BIO hopes to hire a full-time vice president for regulatory affairs, a biotech industry source says.

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OSHA and other agencies hope to develop an "action plan" on personal protective equipment (PPE) interoperability and other issues affecting federal workers who would respond to incidents involving weapons of mass destruction (WMD). Initial discussions on the topic took place during a high-profile meeting sponsored by OSHA last month.

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The incoming chair of the Senate Finance health subcommittee is calling on HHS to take action by Wednesday (Jan. 15) to help reinstate a Maine prescription drug assistance program struck down by a federal appeals court late last year.

Sen. Olympia Snowe (R-ME) is asking HHS to either implement one of three options proposed by Maine to resurrect its Healthy Maine Prescriptions program, or clarify for the court HHS' approval of the quashed program.

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January 10, 2003

Confused by unclear signals from the Bush administration, staffers for a bipartisan group of Senate lawmakers who want to pass legislation codifying FDA's pediatric rule hope to meet with FDA soon to resolve the matter. When it decided not to appeal the court decision, the administration announced it would instead seek swift congressional movement on legislation giving FDA authority to mandate pediatric studies on drugs. FDA has since told stakeholders that there are differences between the defunct rule and the legislation that has been pushed on Capitol Hill.

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The Bush administration's smallpox vaccination plan could halt all biodefense preparations at local public health facilities and hurt their ability to offer routine public health services, according to Patrick Libbey, head of the National Association of County and City Health Officials. He said focusing almost all their time and federal biodefense money on the complex vaccination program could prevent them from improving the disease surveillance systems that are essential for identifying a smallpox outbreak.

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In a ruling that supports FDA on where the line falls between drugs and dietary supplements, a federal district court has validated the agency's decision that a supplement maker cannot claim that saw palmetto can curb enlarged prostate symptoms. The court backed the agency's stance that dietary supplement manufacturers can make claims about how their products can help prevent disease but they cannot claim their products can treat symptoms of a disease.

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Sens. John McCain (R-AZ) and Charles Schumer (D-NY) have reintroduced legislation passed by the Senate last year that would reform drug patent law in an effort to speed generic drugs to market. On the same day, Jan. 7, the Democratic leadership included the same generic drug access proposal in broad-sweeping pharmaceutical legislation that would also establish a Medicare drug benefit and ease reimportation restrictions.

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The European Union is trying to break a deadlock in World Trade Organization talks on providing access to generic copies of patented medicines by floating a compromise that uses the World Health Organization to determine the full scope of diseases covered by the new rules. But the United States has signaled that it does not see a need to go beyond the unilateral steps it has taken to address a limited set of grave infectious epidemics like HIV/AIDS after the WTO negotiations on the issue broke down late last year.

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Organized labor officials strongly criticized OSHA's decision not to renew the appointment of AFL-CIO Director of the Department of Safety and Health Peg Seminario to the National Advisory Committee on Occupational Safety and Health (NACOSH), accusing the agency of trying to silence its critics.

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Key Senate Republicans are urging Senate Majority Leader Bill Frist (R-TN) to add bipartisan, bicameral legislation on unspent State Children's Health Insurance Program (SCHIP) funding to an omnibus appropriations bill, sources indicate.

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CMS Deputy Administrator Ruben King-Shaw is to split his time between his agency duties and a new, temporary position at the Department of Treasury. From Monday, he will serve as the Treasury secretary's senior advisor for health insurance policy, sources indicate. The temporary position is expected to run until August.

King-Shaw will spend four days a week at the Treasury Department and one at CMS. He was asked to make the move to treasury by the White House, sources add.

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January 09, 2003

HHS has sent a letter to Congress defending its decision to allow herbal ephedra to stay on the market despite the agency's ban on synthetic ephedra and over-the-counter (OTC) phenylpropanolamine (PPA). Facing strong questions from key lawmakers about the agency's rationale, HHS it will not be able to determine the safety of herbal ephedra until a RAND study is completed next month.

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Asserting that CMS' rule would undermine the intention of Congress, a slew of consumer groups has called on the agency to withdraw its proposed implementation of a new Medicare coverage appeals system.

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Faced with a Centers for Disease Control and Prevention (CDC) study urging FDA to be more aggressive in curtailing high levels of salmonella in animal feed, FDA is revisiting how it enforces its "salmonella-negative" policy in feed, an FDA official says. But FDA has stopped short of endorsing CDC's call for a mandatory Hazard Analysis and Critical Control Points (HACCP) program, opting instead to support a variety of industry methods to reduce salmonella levels in feed.

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A key medical device manufacturer has crafted a list of data it says reprocessors should submit for FDA premarket review of cleaning, processing and sterilization of certain 510(k) reprocessed devices under the new device user-fee law. Absent from the list are design data, which the original equipment manufacturer (OEM) industry had sought to include before the law was enacted. FDA has resisted requiring submission of design data on the grounds that doing so would make it impossible for hospitals to reuse single-use devices.

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The Washington State Supreme Court is pushing back the due date for the state's Department of Labor and Industries (L&I) reply brief in the ongoing legal battle over Washington's ergonomics standard.

This past November, Washington Employers Concerned About Regulating Ergonomics (WE CARE) appealed a July Thurston County Superior Court ruling that upheld the L&I ergonomics rule. In the decision, the court found that the state had the authority to promulgate an ergonomics standard and used the best available science to do so.

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FDA Commissioner Mark McClellan has decided to shift roughly around one-third of the biologics center's review resources to the drug center this fiscal year to carry out his controversial plan to transfer most biologics therapeutic reviews to the that center. While the drug center will gain 208 full-time equivalents (FTEs) from the biologics center, it will not get all the supporting management resources.

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Although FDA's biologics center will technically retain overall responsibility for therapeutic vaccines, the drug center will play a joint role in regulating these products, according to an email by Commissioner Mark McClellan unveiling the second phase of agency's reorganization plan. McClellan directs the biologics center to fully coordinate its review of therapeutic vaccines with the drug center, and asks the two centers to craft a plan to conduct and pay for these consultations.

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A prominent women's health group is praising FDA's "prompt effort" in revising the labeling of estrogen and estrogen-containing products to provide new safety information to women. The group is particularly pleased with FDA's move to extend the labeling changes to other hormone therapy products, according to a representative of the group. However, the representative says it is unfortunate that the reproductive health advisory committee had not been formed in time to give input to the agency on this issue.

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