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Daily News

March 04, 2003

House Democrats have reacted to the Bush administration's announcement of a Medicare reform plan by introducing a comprehensive drug benefit that mirrors their initiative from last year.

High-ranking House Democrats unveiled the legislation today (March 4). It includes a $25 premium, a $100 annual deductible, 20 percent copay and catastrophic coverage of costs exceeding $2,000, all features of last year's bill. At the time, the Congressional Budget Office (CBO) scored the 2002 legislation at nearly $1 trillion over ten years. However, this year's version has not been scored.

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President Bush this week unveiled a Medicare modernization plan that promises comprehensive prescription drug coverage for those willing to enroll in a private health plan but limited assistance for those electing to stay in traditional Medicare.

While Democrats decried the plan, as expected, key Republicans offered a lukewarm response. Although the plan does retreat from the Bush administration's recent and sharply criticized proposal not to offer drug coverage under traditional Medicare, some GOP lawmakers are signaling that it does not go far enough.

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March 03, 2003

Lawyers representing the Association of American Physicians and Surgeons (AAPS), the Competitive Enterprise Institute (CEI) and Consumer Alert are asking a federal appeals court to dismiss two pediatric groups' appeal of a decision striking FDA's pediatric rule. Now that the government has decided not to appeal the case, according to AAPS, the pediatric groups do not have a "justiciable" case or controversy and do not have standing to appeal.

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OSHA is moving forward with a negotiated rulemaking on its cranes and derricks standard and is accepting comments on a proposed negotiated rulemaking committee.

The agency floated its nominees for the panel in a Feb. 27 Federal Register notice, saying it has received "broad industry support" for revising the current standard through a negotiated rulemaking.

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NEW YORK--Key industry lawyers are urging the biotechnology industry to take an active role in shaping an abbreviated approval pathway for generic versions of biologics, arguing the advent of generic biologics are inevitable. Panelists at a Biotechnology Industry Organization (BIO) CEO and Investor Conference in New York last week discussed potential scenarios, emphasizing that the law will eventually follow the science.

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A key advisory committee is recommending that FDA remove the blanket hold on 27 gene therapy trials using retroviral vectors. The panel is asking FDA to examine individual trials before deciding if they should continue.

Further, in the three trials involving patients suffering from X-linked Severe Combined Immunodeficiency (X-SCID), the panel is recommending that researchers use gene therapy only when all other treatments have failed.

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FDA's Food Advisory Committee is urging the agency to give consumers more information about the possible risks of acrylamide than they are currently being given, a consumer source says. The panel asked the agency to contact consumer groups and explain that they are investigating acrylamide's carcinogenic effects but need more information before they can advise consumers about its safety.

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In a move that may add to the generic biologics debate, Aventis Pharmaceuticals is petitioning FDA not to approve any applications for a generic version of its biopharmaceutical Lovenox (enoxaparin sodium injection) unless the generic firms use the same or equivalent manufacturing process as Aventis. Or as an alternative, the generics should have to submit safety and clinical data, according to the brand-name drug company.

Lovenox is indicated for the prevention of deep vein thrombosis, which may lead to pulmonary embolism, following hip or knee replacement surgery.

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President Bush is this week expected to outline a framework for reforming Medicare and adding prescription drug coverage to the program, but will leave Congress to fill out the finer legislative details, according to a top administration official.

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February 28, 2003

FDA is setting a new precedent that would give Drug Efficacy Study Implementation (DESI) drugs a grace period to stay on the market for a limited period after a competitor gets a new drug application (NDA) approved. This stems from a new agency compromise regarding extended-release guaifenesin where drug makers who have not obtained NDA approvals are now being told they can stay on the market until November.

FDA will soon issue a Federal Register notice unveiling additional details about its new enforcement policy for unapproved drugs.

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A move by FDA to evaluate potential health hazards relating to a narcotic analgesic drug called Palladone has prompted the House Energy and Commerce Committee to step up its ongoing probe of pharmaceutical abuse and diversion of both Palladone and another Schedule II narcotic analgesic called Oxycontin.

On Wednesday (Feb. 27), the lawmakers demanded that Purdue Pharma L.P., which produces both drugs, hand over all records relating to its discussions with FDA on risk management, as well as internal company data on abuse and conversion and marketing plans.

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The Senate Judiciary antitrust subcommittee plans to investigate whether additional group purchasing organization (GPO) reforms are needed, examine drug competition and propose anti-trust law reforms to foster competition among its priorities for 2003.

Senate Judiciary subcommittee on antitrust, competition policy and consumer rights chair Mike DeWine (R-OH) and ranking member Herb Kohl (D-WI) unveiled the subcommittee's 2003 agenda in a Feb. 25 press release.

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Bobby Jindal, formerly one of the Bush administration's leading health care advisors, has privately announced he is entering the race to become the next Governor of Louisiana. In a Feb. 28 e-mail to friends, Jindal confirms his intention to run for governor, stating that he will "first tour the state" after which "an official declaration and a detailed platform will follow."

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A prominent industry attorney has detailed his case on why the American National Standards Institute (ANSI) consensus draft ergonomics standard should be withdrawn, claiming the committee tasked with developing the standard violated procedures and arguing that there is no consensus on the issue.

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The new chairman of the Senate subcommittee with OSHA jurisdiction will tackle OSHA reform and seek to update permissible exposure limits (PELs), according to a GOP source.

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February 27, 2003

The Defense Department will not be part of the Project BioShield initiative intended to protect U.S. citizens from the threat of a terrorist attack with biological agents, according to Navy Lt. Cmdr Don Sewell, a spokesman for Anna Johnson-Winegar, deputy assistant to the secretary of defense for chemical and biological defense.

Since the Sept. 11 terrorist attacks, the Bush administration has considered bioterrorism one of the most likely threats facing the nation.

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Trade advisory officials are expecting the Bush administration to remove pharmaceutical industry representatives from a chemical and allied products trade advisory group, saying the move could undercut the group's effectiveness. The anticipated proposal is part of a broader Bush administration plan to overhaul the industrial sector advisory committees (ISACs) to better reflect the nation's economy.

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A key coverage policymaker has decided to leave CMS to take a top position at FDA, sources told Inside CMS. Jeff Shuren, who is in charge of Medicare coverage issues affecting items and devices, will be the fourth physician to leave CMS' coverage shop within the last year, these sources say.

It is unclear what position Shuren will assume at FDA but sources indicate he will be a top policy advisor. It is also unclear when he will start at FDA. Shuren, who was hired in the fall of 2001, did not return a phone call at press time.

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The White House has delivered to Congress its legislative plan for the BioShield Project, which promises big-money contracts for biodefense products. Although some have said that BioShield would be a tough sell to Congress, FDA Commissioner Mark McClellan said Sen. Edward Kennedy (D-MA) supports passing the legislation quickly.

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FDA says there is no evidence to date that unusual particulate matter found in some blood components, mainly red blood cells, pose a threat to blood safety. But while investigations are ongoing, the agency is recommending that blood banks continue to inspect all blood and blood components using the enhanced procedures that have been in place for the last several weeks and to quarantine suspect products, the agency states in a Feb. 27 press release.

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