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Daily News

February 27, 2003

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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A key House Democrat says the first reported case of a health care worker's "moderate to severe" adverse reaction to the smallpox vaccine is a call to take action to establish a compensation program for those injured through the vaccination program.

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The House Ways and Means Committee has marked up a new version of the patient safety and medical error reporting bill which drops explicit references to agencies that fall within the jurisdiction of the House Energy and Commerce Committee. The new Ways and Means Committee bill limits the application of the bill to Part A providers like hospitals, skilled nursing facilities, home health and hospice and to doctors that practice in these institutions.

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February 26, 2003

The House Republican leadership is calling for Medicare reform legislation to reach the House floor by the end of May, according to House GOP aides. The request mirrors the Medicare deadline GOP leaders set last year.

Aides indicate GOP leaders have asked for the bill be bought to the floor by late May, with one staffer adding that House Speaker Dennis Hastert (R-IL) requested a Memorial Day deadline.

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A top legislative priority of the Advanced Medical Device Association (AdvaMed) is passage of legislation that would exempt FDA-cleared devices from having to pay punitive damages.

AdvaMed-backed liability reform legislation was passed by the House last year, but the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2002 (H.R. 4600) did not make it through the Senate.

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The Grocery Manufacturers of America (GMA) is urging FDA to regulate drug crops as it would any other drug manufacturer or bulk supplier. GMA envisions FDA sending inspectors to fields as it would with brick-and-mortar plants.

GMA and the National Food Processors Association (NFPA) focus on containing drug crops and lay out their argument for stringent regulation in comments to the agency's plant-made pharmaceutical (PMP) draft guidance.

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An FDA warning letter adds a new element to an ongoing trade debate over whether a highly concentrated form of milk protein should continue to be imported into the United States. Some have charged that milk protein concentrate is inappropriately being brought into the country through a tariff loophole. FDA's letter to a prominent cheese manufacturer objects to the use of ultra filtered milk as a raw ingredient to manufacture cheese.

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A court-appointed mediator is proposing that OSHA finalize its hexavalent chromium standard by January of 2006 after OSHA and the consumer advocacy group that brought a lawsuit seeking to force the agency to finalize a standard could not come to agreement over a timeline for the rulemaking.

In its Dec. 24, 2002, decision on the lawsuit, the U.S. Court of Appeals for the Third Circuit gave the parties 60 days to agree on a timeline, stating that in case no consensus would be reached, a mediator would propose a rulemaking schedule.

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After working closely with the medical device industry, a bipartisan group of House lawmakers Feb. 26 introduced legislation that they claim would give Medicare patients faster access to new technologies by reducing delays in CMS' coverage, coding and payment processes.

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February 25, 2003

FDA has sent the two remaining food regulations mandated by the recently enacted bioterrorism act to the Office of Management and Budget (OMB) for approval. The agency is expected to hold another satellite meeting in March to discuss these two regulations with stakeholders, Deputy Commissioner Lester Crawford said earlier this month.

The two rules sent to OMB are key components of recently enacted bioterrorism legislation. FDA has already published proposed rules on prior notice and registration.

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In a move that could eventually lead to a stronger state ergonomics rule, the California Occupational Safety and Health Standards Board has given the green light for a panel to determine whether the state's ergonomics regulation should be amended.

At its Feb. 21 meeting, the standards board approved to convene a committee to examine the issue by a 3-2 vote. The labor, safety and public representatives voted for the proposal while the management and health representatives opposed the measure.

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If the United States goes to war with Iraq, states could get more money to beef up homeland security, according to Senate Majority Leader Bill Frist (R-TN). Biodefense measures, such as preparing hospitals and first responders for bioterrorism, are a major component of homeland security on the state and local levels.

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HHS Secretary Tommy Thompson strongly defended the Bush administration's new Medicaid reform plan Feb. 24 as governors and lawmakers repeatedly questioned the merit of the proposal that seeks to give states the flexibility to alter coverage for their optional benefits without approval from the federal government.

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The fiscally conservative House Democrat Blue Dog Coalition is again attempting to craft a Medicare prescription drug benefit, according to a House aide. The move is of note as House Republicans have in the past relied in part on Blue Dog support to pass their Medicare reform legislation.

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Generic drug company TorPharm is suing FDA over the agency's decision that competitor Purepac, not TorPharm, is entitled 180-day exclusivity for generic gabapentin. The firm says FDA's decision that TorPharm does not deserve exclusivity for challenging the brand-name drugmaker's method-of-use patent could discourage generic drug firms from challenging some method-of-use patents.

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FDA has decided to allow dietary supplement makers to make claims about the possible benefits of phosphatidylserine and selenium if FDA-cleared disclaimers accompany the claims.

This marks the first time the agency has allowed a health claim about reducing the risk of mental illness, according to the press release issued by Emord and Associates, which filed the phosphatidylserine health claim petition on behalf of Kyl Smith.

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February 24, 2003

A key House policymaker is formulating legislative strategies to encourage middle-aged Americans to purchase some form of private long-term care insurance before they retire, according to a House GOP aide.

Although discussions on possible legislative options are just beginning, House Ways and Means health subcommittee chair Nancy Johnson (R-CT) plans to pursue the issue strongly this year. In doing so, the lawmaker hopes to elevate attention to the need for long-term care insurance, the official adds.

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An FDA dispute-resolution working group has issued a progress report that recommends the agency set up a three-stage dispute resolution process for current good manufacturing practices (cGMP). Over the next 90 days, the public may submit comments on the issues and processes discussed in the report, which FDA will use as the basis of a dispute-resolution draft guidance.

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