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Daily News

February 06, 2002

The top Democrat on the House Energy and Commerce health subcommittee says prescription drug user fees should go toward FDA postmarket safety activities. Rep. Sherrod Brown (D-OH) plans to use both this issue and the possibility of generic drug reforms as leverage in upcoming talks with the prescription drug industry over how to craft a Prescription Drug User Fee (PDUFA) reauthorization bill.

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In a major development, a powerful House GOP lawmaker is demanding that the Bush administration quickly provide Congress with many more details on the Medicare policies outlined in the president's fiscal year 2003 budget request. HHS Secretary Tommy Thompson has agreed to comply with the request, signaling that the White House will unveil new plans on the government's policy regarding reimbursements to providers.

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In a move that will likely shelve debate on the nation's economic recovery package, a Senate attempt to force a vote on the Democrat's slimmed-down stimulus proposal failed today [Feb. 6]. As expected, a move by Senate Majority Leader Thomas Daschle (D-SD) to end ongoing debate on the proposal fell shy of the required 60 votes. Daschle called for the debate halt in an effort to bring discussion and amendments on the package to a close and move the measure to a vote. The attempt failed by four votes, drawing 56 votes to 39.

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DOL Secretary Elaine Chao is eyeing major changes to OSHA's enforcement system. Citing a lack of consistency, Chao suggested this week that she wants federal policymakers to have a larger role in the OSHA enforcement process.

The details of how Chao will change OSHA's enforcement system are unclear. The Bush administration did not propose changes to enforcement in its fiscal year 2003 budget proposal. However, it is clear that top policymakers within DOL are considering changes to the enforcement of the OSH Act.

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February 05, 2002

Six nongovernmental organizations (NGOs) are asking the World Trade Organization (WTO) to recognize a limited exception to patent rights under Article 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The groups argue that patents should not prevent the export of technology for health purposes, and that compulsory licenses may be granted under this section of TRIPS without certain conditions having to be met by the exporting country.

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FDA's food center has pegged as its top priority ensuring the safety and security of the nation's food supply following recent bioterrorism scares. The new emphasis on security is in part due to FDA's increased funding for security, which is resulting in more food inspectors in the field and development of new methods for inspections at laboratories.

Food center chief Joseph Levitt has carved out several "A-list" priorities for increasing food security. The food center expects to complete nine out of 10 of the 92 items put on the A-list so far.

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The Bush administration is again relying on an unpopular user-fee proposal to help fund CMS' program management budget. HHS Secretary Tommy Thompson is driving the initiative -- outlined in President Bush's fiscal year (FY) 2003 budget -- and hopes to convince Congress to authorize the plan that is opposed by physicians and hospitals.

At a Feb. 4 briefing, Thompson revealed he is again spearheading plans to charge Medicare providers user fees for paper-filed or duplicate claims -- a proposal that critics call a "hidden tax."

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A slew of consumer and industry groups are urging President Bush to repeal the $1,500 therapy caps on Part B services, claiming the limits would force some seniors to pay high out-of-pocket costs or forgo necessary care.

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The future of the politically charged economic stimulus debate is on the line -- and with it states' hopes for increased Medicaid federal funding. The Senate is scheduled to vote Feb. 6 to continue debating the Democrat's slimmed-down stimulus proposal, which includes federal medical assistance percentage (FMAP) hikes for states battling budget woes.

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February 04, 2002

In a preview of the political roadblocks ahead, top House Republican and Democrat health care aides are divided over the coupling of a Medicare prescription drug benefit with wider Medicare reform measures in 2002. The policy rift, compounded by budget constraints and election-year politics, puts passage of a drug benefit on shaky ground just days into the new congressional session.

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After failing to convince Congress to pass legislation on its prescription drug discount card plan, the Bush administration has shifted its political strategy on the issue by halting all lobbying efforts until the courts have ruled on a pending legal challenge by pharmacy groups.

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In what could be a promising sign for the Bush administration, a powerful Senate Democrat has not closed the door on President Bush's controversial Medicare prescription drug discount card plan.

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House Democrats see generic drugs as a key issue in both upcoming legislation on pharmaceutical drug user-fee reauthorization and Medicare. Rep. Sherrod Brown (D-OH), the top Democrat on the House Energy and Commerce, health subcommittee, said Democrats will consider attaching Hatch-Waxman drug patent reforms to the reauthorization of the Prescription Drug User Fee Act (PDUFA), but the party may also decide to tackle the reforms through other legislation such as the Greater Access for Affordable Pharmaceuticals (GAPP) Act or compulsory licensing.

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Despite widespread skepticism on Capitol Hill, HHS Secretary Tommy Thompson said today he is optimistic Medicare reform will be enacted this year. In a Feb. 4 budget briefing, Thompson said Medicare reform is HHS' top priority and stressed that the Bush administration wants to tackle prescription drug coverage and Medicare reforms simultaneously.

"I understand people have written the obituary for Medicare reform," Thompson said. "But I haven't. I happen to be optimistic. I think it's entirely possible... Medicare reform is our number one priority."

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President Bush's requested $123 million hike to FDA spending levels in fiscal year (FY) 2003, if approved by Congress, would be used to improve the new drug review process, accelerate generic drug reviews, bolster counter-bioterrorism work and increase patient safety efforts.

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President Bush's $5.9 billion homeland security budget request for fiscal year (FY) 2003 includes $2.4 billion to help update the current medical "toolkit" of diagnostics, vaccines and therapeutics in order to adequately respond to bioterrorism attacks. The budget request, a whopping $4.5 billion increase from the enacted 2002 level, also would set aside $49 million for FDA to expedite drug approvals and research, according to a background budget document on homeland security.

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The Bush administration is proposing a 2 percent cut to OSHA's budget and is seeking to significantly reduce funding for a training grant program that has recently attracted congressional attention. DOL Secretary Elaine Chao said during a Feb. 4 budget briefing that the "wartime budget" is responsible for the funding decreases.

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February 01, 2002

Consumer-interest group Public Citizen is pressuring HHS Secretary Tommy Thompson to seize 10 products containing synthetic ephedra that are being marketed over the Internet.

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FDA's long-awaited proposed rule for dietary supplement good manufacturing practices (GMP) remains in limbo after being internally withdrawn by FDA. After reviewing the proposal for nearly a year, the Office of Management and Budget (OMB) finished its review in mid December, then FDA promptly "withdrew" it from the formal agency review process, according to OMB's website. The move may indicate that OMB raised significant enough concerns to force FDA to go back to the drawing board on the proposal.

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FDA is sending signals to the drug industry that the mere act of reprinting off-label information would likely not prompt agency enforcement action, but the agency may still refer to reprints and continuing medical education (CME) activities as evidence in broader enforcement cases. The agency's emerging off-label enforcement policy can be gleaned from FDA's denial this week of a citizen petition filed by the Washington Legal Foundation (WLF) asking the agency to alter its policy on dissemination of off-label information.

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