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Daily News

February 04, 2002

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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In a precedent-setting move, two over-the-counter (OTC) drug companies are attempting to take advantage of little-used type of new drug application called a "505(b)(2)" to market an OTC version of a competitor's prescription product. Drug industry sources say that this is the first time that drug companies have attempted to use FDA's controversial interpretation of 505(b)(2) for such a use. Some see FDA's 505(b)(2) policy as a back door route to getting generic products approved.

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In a major new development, the House Ways and Means Committee is expected to put the drug industry's multi-billion dollar advertising and marketing practices under the microscope this year as part of its efforts to pass a Medicare prescription drug benefit and reform package.

The committee is likely to focus on the direct-to-consumer (DTC) advertising of drug companies, and examine how pharmaceuticals are bought to the market. The scrutiny of the drug industry's advertising habits is a significant new focus in the Medicare reform debate, according to health care experts.

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The Washington Legal Foundation (WLF), a conservative legal think tank, is considering taking FDA back to court to further challenge agency policies aimed at stopping company dissemination of off-label use information, a WLF source says. WLF is upset by FDA's denial this week of a citizen petition filed by the group calling for the agency to issue new policies that would strictly bind FDA to protect companies' First Amendment rights.

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Billions of dollars could be shaved off the cost of a Medicare prescription drug benefit through greater use of generics, according to a groundbreaking new study released Jan. 31. Hailed as the first systematic study to measure potential savings through increased generic use, the study has drawn immediate praise from political health care heavyweight, AARP, which plans to lobby Capitol Hill and Congress' official budget calculator with the study findings.

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Two key Senate appropriators are asking OSHA Administrator John Henshaw to adhere to recent appropriations report language by reversing a 25 percent cut to training grants. OSHA's decision to cut back on training grant funding attracted intense criticism from union officials, who said the move was grounded in politics.

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In his farewell speech, a key occupational safety and health official urged OSHA's career staff to play a more dominant role in the politics of regulation, arguing that the agency's staff has the "strongest and most comprehensive commitment to protecting workers' safety and health." The departing DOL official also criticized the administration for its opposition to regulation as a tool for worker protection.

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January 31, 2002

In an attempt to significantly enhance patient access to prescription drugs, HHS has approved a "radical" Illinois waiver request and crafted a Medicaid model program that administration officials say will provide states with a roadmap for delivering more cost-effective drug coverage.

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A joint government/blood industry task force is presenting a plan to an HHS panel today (Jan. 31) on steps the government and the blood banking community should take to ensure optimal blood collection in the event of a future domestic disaster or terrorist attack. The group is calling for the American Association of Blood Banks (AABB) to coordinate the blood communities' response during future disasters and suggests that FDA take the lead government role in spreading the word about the task force's activities.

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A key beneficiary group will push harder this year for the inclusion of generics as part of a Medicare prescription drug benefit and also plans to educate its members on the benefits of generics. But the lobbying effort is expected to be fiercely opposed by brand-name manufacturers, who have already floated a document that criticizes the widespread use of generic drugs.

This showdown between AARP and certain drug manufacturers could play a key role in this year's debate on adding a prescription drug benefit to Medicare.

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January 30, 2002

A federal governmental organization charged with protecting the nation's infrastructure is expanding its list of responsibilities to include chemical storage, production and delivery. The National Infrastructure Protection Center (NIPC), which works law enforcement officials to coordinate efforts between local and state governments and the private sector, is expanding its "critical infrastructure" list to include chemical operations. The move will establish a streamlined and improved communications link between national security agencies and the chemical industry, according to sources.

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Public health advocates and environmentalists say a recent dramatic increase in federal funding to detect and combat bioterrorism will be a major boost for tracking and monitoring health problems, such as asthma and cancer clusters, that have been linked to chemical and other industry pollutants.

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FDA plans to require that the label on the Anthrax vaccine be rewritten to warn of higher incidences of systemic reactions, especially among women. But the new label will also include a statement about the limitations of the studies used to show the increased frequency of systemic reactions such as malaise, chills, headaches and low-grade fever.

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