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Daily News

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proposed rule for dietary supplement good manufacturing practices (GMP) remains in limbo after being internally withdrawn by FDA.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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FDA plans to draft a proposed rule that would amend the over-the-counter (OTC) drug labeling rule now on the books by defining "convenience size" drug packages and addressing "drug facts" labeling requirements for such packages. In the meantime, FDA plans to publish a notice in the Federal Register delaying the compliance date for complying with the "convenience size" packages section of the current drug facts rule.

The agency unveils its new plans in a response to citizen petition filed by Lil' Drug Store Products, Inc.

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In a flurry of new proposals, the White House this week announced proposals to enhance prescription drug coverage for Medicaid beneficiaries, to increase Medicare+Choice funding, and to create two Medigap plans. The initiatives are aimed at providing immediate benefits to seniors as policymakers continue to seek a consensus approach on Medicare reform.

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Two Senate Finance Committee Democrats are strongly objecting to speculation recently floated by a powerful pharmaceutical trade group that they are close to endorsing the "tripartisan" Medicare reform proposal that is favored by the Bush administration.

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January 29, 2002

FDA is considering bringing back to market, under a special risk management program, a voluntarily withdrawn drug after being pressured to do so by patients. FDA notes in a Jan. 23 letter to patients that it has received numerous adverse event reports associated with the use of the Irritable Bowel Syndrome (IBS) drug Lotronex, including death, but it will attempt to meet the desire by IBS patients to obtain the drug. FDA has decided to seek advice from one of its advisory committees, possibly on April 23, on the matter.

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President Bush plans to ask Congress next month for a five-fold increase in bioterrorism research funding for the National Institutes of Health (NIH). NIH would use the extra funds to accelerate development of next-generation anthrax vaccines, expand basic research on genome sequencing of potential bioterrorism agents, and improve diagnostic tools.

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