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Daily News

July 31, 2003

An analysis by Joint Economic Committee Democrats claims changes to Medicare deductibles and premiums under the House GOP Medicare bill will more than eat up seniors' cost-of-living increases under Social Security.

The July 30 paper paints the premium increases under the House bill's premium support provision in a bad light in part by comparing multiple years of projected increases in seniors' Medicare payments against one year's Social Security cost of living increase (COLA).

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House lawmakers did not include liability protections for biodefense products in BioShield legislation because they believe an act included in the Homeland Security law provides enough protection, according to BioShield report language. The Support Anti-terrorism by Fostering Effective Technology (SAFETY) Act allows the Department of Homeland Security (DHS) Secretary to waive liability for products it deems "qualified anti-terrorism technology," which includes products "limiting the harm such acts [terrorism] might otherwise cause."

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FDA is increasing medical device user fees 35 percent for fiscal year 2004 after receiving fewer applications for the two most expensive kinds of applications. An FDA source says the practice of bundling applications also was part of the reason for the shortfall, but the source did not know how many of the various kinds of applications were bundled or how much bundling cost the program overall.

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Senate health committee chair Judd Gregg (R-NH) announced July 31 his committee would mark up legislation in September giving FDA authority to regulate tobacco. The bill, sponsored by Sen. Mike DeWine (R-OH), would impose FDA restrictions over the marketing and distribution of tobacco products, but would prevent FDA from regulating tobacco farmers.

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Senate Judiciary Committee chair Orrin Hatch (R-UT) plans to bring key administration officials before his committeee today (Aug. 1) to discuss the generic drug reform provisions in the House and Senate Medicare bills as conferees prepare to negotiate a compromise. Hatch, who coauthored the original drug patent law, may quiz FDA, Justice Department, Patent Trademark Office and Federal Trade Commission officials about the declaratory judgment scheme in the Senate bill. Hatch has suggested the provision may be unconstitutional.

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July 30, 2003

The Environmental Working Group released a report today (July 30) showing that most farm-raised salmon sold in this country have what the group considers to be unhealthy levels of polychlorinated biphenyls. PCB standards set by the Environmental Protection Agency for wild salmon are 500 times stricter than FDA's limits for fish sold in grocery stores, according to EWG, and the group is asking FDA to adopt EPA's standards for the cancer-causing chemical.

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A federal district court is blocking FDA from approving a generic version of CollaGenex's Periostat until the agency provides the administrative record on why it decided that the periodontal drug is an antibiotic, and the court rules on that decision. As an antibiotic, Periostat was not granted the exclusivity protections under the Hatch-Waxman drug patent law, and generics can come to market.

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FDA is participating in a White House-sponsored interagency food working group, with representatives in subgroups. The agency also is working with the states and food industry to craft a "National Interagency Food Response Plan," a government-wide plan on food security rules and responsibilities.

The agency referred to the White House Homeland Security Council's Interagency Food Working Group (IFWG) in its recently unveiled progress food security report.

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California legislative aides are looking to a draft proposal by the European Union as a model for overhauling the state's chemical regulatory system that could be proposed in a bill next year, according to a senior staffer in the legislature. The legislation would be the first of its kind in the U.S.

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Congressional investigators warn that hospitals would face a shortage of essential equipment and health care workers in the case of a large-scale Severe Acute Respiratory Syndrome attack in the United States. Federal, state and local health officials are preparing for another possible SARS outbreak but these plans face hurdles because of lack of resources in hospitals, a General Accounting Office official says.

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Sens. Olympia Snowe (R-ME) and Jeff Bingaman (D-NM) are spearheading a campaign for CMS to lower the fiscal year 2004 Medicare inpatient outlier threshold so that more hospitals qualify for the additional federal payments designed to help reimburse high-cost cases.

The senators have called on CMS Administrator Tom Scully to reduce the agency's proposed $50,645 threshold to between $25,000 and $30,000. Key hospital groups are also strongly lobbying for a threshold reduction.

CMS is expected to announce the new outlier level Aug. 1 in its final inpatient rule.

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Members of both the House and Senate are orchestrating campaigns to substantially boost Medicare payments for teaching hospitals through increased indirect medical education (IME) payments in Congress' final Medicare bill. Having secured a modest IME increase in the Senate-passed plan, lawmakers are now working to replace the placeholder language with a larger increase and return IME payments to Medicare's fiscal year 2002 rate.

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July 29, 2003

In line with a recent court settlement, an expert coverage advisory panel is to soon review whether Medicare should expand coverage of a blindness therapy that last year sparked a lawsuit over CMS' failure to implement a new Medicare appeals system.

The Medicare Coverage Advisory Committee (MCAC) will hold a public meeting Sept. 9 to examine coverage of ocular photodynamic therapy (OPT) with verteporfin for age-related macular degeneration (AMD) and occult with no classic choroidal neovascularization. AMD is the leading cause of blindness in people aged over 50.

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Conservative think-tank the Washington Legal Foundation (WLF) and a patient group sued FDA July 28 over the agency's investigational new drug (IND) policies, which the groups claim keep dying patients from accessing potentially life-saving drugs that have been shown to be safe and effective during preliminary clinical trials. The groups charge FDA's policies violate the U.S. Constitution.

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Although poised for Senate consideration this week, a long-running campaign to return $2.7 billion of unspent State Children's Health Insurance Program (SCHIP) funding to the states instead of the federal coffers has, for the moment, stalled in the Senate.

The Senate was this week expected to follow in the House's footsteps and take up a bicameral plan to redistribute the leftover SCHIP funding, however, a hold by Sen. Jeff Bingaman (D-NM) has put the legislation's progress in limbo. The House unanimously passed H.R. 2854 July 25.

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A Washington state industry group says it has gathered enough signatures to place an initiative on the ballot in the next election that would allow the state's voters to decide the fate of Washington's ergonomics standard. The announcement comes in the wake of considerable controversy surrounding the group's lobbying tactics.

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FDA may scale back some of the requirements in its controversial proposal to implement the bioterrorism law's mandate that importers provide the agency with prior notice before food shipments enter the country, according to an FDA official.

The food industry strongly criticized the proposed rule, complaining that it is exacting and gives a rigid timeframe for compliance. Firms recommended the agency adopt a rolling notification period for products arriving at the port of entry. Industry also asked FDA to allow multiple amendments to the prior notice.

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July 28, 2003

FDA's new internal task force to curb counterfeit drug imports likely will make many of its recommendations based on a report due out this September from another anti-counterfeiting task force formed about a year ago between FDA and the drug industry, called the Product Surety Working Groups Initiative, according to a source familiar with the group.

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Two years after FDA gave HHS a proposal creating a straightforward system for managing drugs imported through the mail, the department has yet to take action, despite the increasing number of counterfeit drugs imported into the country, according to industry and congressional sources. FDA's plan calls for Customs to simply deny entry of all drug packages that are not affixed with a special notice signaling the drugs were prescribed by a licensed U.S. physician.

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From weight loss management to money for Hawaii's Medicaid program, a slew of Medicare odds and ends that gained last-minute passage in the Senate Medicare plan must now be addressed by conferees hammering out a final Medicare reform bill.

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