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Daily News

February 24, 2003

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for modular premarket applications (PMAs) if companies submitted the first module before Oct. 1, 2002, according to a draft guidance explaining how FDA will collect device user fees.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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Congress has stripped a provision from the homeland security law that protects thimerosal producers -- most notably Eli Lilly -- from class-action lawsuits involving the vaccine preservative, while promising to enact a similar provision later this session as part of broader vaccine legislation. Congress is expected to take up a bill originally introduced last Congress by Senate Majority Leader Bill Frist (R-TN) that would indemnify manufacturers of thimerosal as well as give more federal money to families with vaccine-injured children.

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FDA Feb. 20 unveiled several initial steps it is taking to implement a broad-sweeping plan to reform the pharmaceutical good manufacturing practices (GMP) program.

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In another attack on the state's ergonomics standard, the Washington Senate this week passed with bipartisan support a measure that would make the regulation voluntary.

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FDA will not enforce key elements of its electronic submission and recordkeeping rule as it weighs whether to revise the so-called "Part 11" regulations to facilitate innovation for modern manufacturing, electronic record keeping, and regulatory submissions. The agency unveiled the plan in a draft guidance "Part 11, Electronic Records, Electronic Signature -- Scope and Application" released yesterday (Feb. 20).

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FDA's drug center, veterinary drug center and Office of Regulatory Affairs (ORA) are setting up a centralized pharmaceutical inspectorate comprised of a specialized team of experts in drug product manufacturing that will conduct inspections of high-risk firms. The move is in line with an agency working group's call for FDA to consider using product specialists on inspection teams.

Yesterday (Feb. 20) FDA announced a series of steps it has taken to implement its broad-sweeping initiative to overhaul its current good manufacturing practices (GMP) program (see related stories).

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February 19, 2003

The recent introduction of a compromise cloning bill by key senators has significantly decreased the possibility the Senate will pass Sen. Sam Brownback's (R-KS) anti-cloning bill. Neither bill has enough votes to pass through the Senate, a congressional source says.

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OSHA says the closing of a Maine agency office is only temporary after state lawmakers and members of the Maine's congressional delegation strongly objected to a potential move to consolidate the state's local offices.

An OSHA spokesperson stated that the agency "will temporarily close its Bangor, Maine office space on Feb. 14 due to the General Service Administration's mandate that OSHA give up its current space...to make way for another tenant. Planning and research for another location for OSHA's Bangor office continues."

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The Small Business Administration's (SBA) regulatory watchdog branch has prioritized CMS' one-hour restriction on the use of patient restraints in hospitals for regulatory reform in a bid to reduce the burden on small businesses.

The one-hour provision, which is currently under CMS review, is one of three CMS rules identified by SBA's Office of Advocacy (Advocacy) in a Feb. 6 letter to the Office of Management and Budget (OMB) as high priorities for reform. The agency's certificates of medical necessity and Medicare physician fee schedule were also highlighted.

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Two key Senate Democrats are attacking an American Bar Association (ABA) plan that is backed by industry and would establish medical criteria for asbestos plaintiffs, a proposal that is the crux of a new Republican bill to curb the spread of asbestos lawsuits. The criticism may signal growing opposition among Senate Democrats against industry-backed efforts to limit asbestos claims, which are also opposed by such key Democratic constituencies as organized labor and the trial lawyers.

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Pediatric groups have failed to convince a federal appeals court to expedite a review of whether a district court erred in striking a controversial FDA rule that required biologics and drug firms to test their drugs on children.

Earlier this month, the federal appeals court denied the pediatric groups' "motion to expedite" the appeal, which would have allowed the parties to skip the dispositive motion stage and start filing the opening briefs.

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The Senate health committee hopes to hold either a hearing or a markup later this month on legislation to reinstate FDA's pediatric rule that required manufacturers to conduct studies of drugs and biologics on children, according to a congressional and health advocacy group sources. Meanwhile, pediatrics groups are fighting an idea that has been circulating on Capitol Hill to use the pediatric rule legislation as a vehicle to also make the pediatric exclusivity incentive permanent.

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February 18, 2003

A biotechnology industry group is voicing its concerns with CMS' interim final rule on inherent reasonableness (IR), urging the agency to keep the IR process transparent and to use its authority to increase unjust payments rates, not just to reduce those that may be too high.

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The U.S. government and its pharmaceutical industry are assessing a proposed WTO statement limiting the use of more flexible patent rules to see if it establishes legally binding limits that could inform a future dispute settlement panel, according to delegation and industry sources.

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