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Daily News

February 26, 2003

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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The Biotechnology Industry Organization (BIO) will resume its lobbying effort for legislation that would protect biotech companies from lawsuits over biodefense products, according to a list of priorities BIO recently sent to President Bush. This year the group also hopes to block bills that would prohibit therapeutic cloning, reform patent law to speed generic drugs to market, and allow drug reimportation.

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FDA will allow medical device firms to bundle most premarket submissions, called 510(k)s, for multiple devices within the same generic device type. The agency also will allow bundling of most 510(k)s for devices of different generic types that are to be used together for a single therapeutic or diagnostic purpose, according to an FDA draft guidance implementing the new device user fee law.

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OSHA is notifying 14,200 employers that their injury and illness rates are at least twice as high as the national average and for the first time has included the construction industry in this annual initiative. The agency is offering assistance to employers, especially small businesses, in order to reduce the injury rates.

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The Bush administration may include a "sheathed needle" provision in its smallpox vaccination compensation plan, but it likely will not include a liability indemnification provision for companies manufacturing biodefense products, according to a high-ranking federal health official. The administration may propose its legislative plan for compensating health care workers injured by the smallpox vaccine as early as this week.

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February 21, 2003

FDA's centers this March will begin reviewing all drug good manufacturing practices (GMP) warning letters, instead of allowing the field to send the letters directly to FDA's general counsel. On Feb. 28, the agency will rescind the field offices' "direct reference authority."

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Informal talks of World Trade Organization ministers aimed at brokering a deal on access to medicines failed to find a solution, even as the United States tried to show new flexibility by signaling it is willing to accept an open-ended scope of diseases if only African countries are eligible to import generic medicines.

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The omnibus appropriations bill signed by President Bush Feb. 20 provides FDA with its requested funding levels for countering terrorism and curbing medical errors, and gives the agency more than it had sought for generic drugs.

The bill provides FDA with $1.6 billion (including drug and device user fees) in FY 03, tracking the amount appropriated by the Senate. The House proposed giving FDA slightly less.

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FDA's device center will not be collecting user fees for modular premarket applications (PMAs) if companies submitted the first module before Oct. 1, 2002, according to a draft guidance explaining how FDA will collect device user fees. FDA had considered collecting partial fees for subsequent modules submitted after Oct. 1, even if the first module was submitted before the user fee law's start date, but the Advanced Medical Technology Association (AdvaMed) opposed the idea.

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February 20, 2003

Rep. Bernie Sanders (I-VT) announced on Tuesday (Feb. 18) he has introduced legislation that would slap fines on drug manufacturers who refuse to provide drugs to Canadian wholesalers that sell to U.S. citizens. The legislation is a response to GlaxoSmithKline's decision to no longer supply drugs to Canadian wholesalers and pharmacies that export medicines outside Canada.

Sanders also plans to soon reintroduce legislation that would allow pharmacists and wholesalers to reimport drugs, according to a Sanders' spokesperson.

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A bipartisan group of House lawmakers is mounting a campaign to delay implementation of a looming CMS standard designed to crack down on inappropriate Medicare hospital outlier payments. The move, however, has drawn immediate opposition from a key House health care fraud and abuse watchdog.

Ten House members have called on CMS to provide a transition period to give hospitals time to prepare for likely outlier payment cuts. They contend immediate implementation of CMS' interim final rule on hospital outlier payments will likely prompt cuts in essential health care services.

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