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Daily News

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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Industry officials are renewing their lobbying effort for CMS to require "written mutual agreements" as part of the agency's national coverage determination process, according to sources. Proponents of this policy say that written mutual agreements would enable CMS and coverage petitioners to set parameters around the data that would be required by CMS to determine if services are reasonable and necessary in the Medicare program.

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January 28, 2002

A consumer interest group says it is worried that bioterrorism legislation introduced by Sen. Joseph Lieberman (D-CT) would offer patent, purchase, liability and tax incentives for the development of drugs and vaccines that treat nonbioterrorism-related diseases such as AIDS. Lieberman's office says the list is not binding and that it is up to the Office of Homeland Security to decide what drug and biologic countermeasures it wants to include for potential incentives.

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At a time when FDA is trying to implement a new protocol requiring the agency's general counsel to authorize warning letters before they are issued, a conservative legal foundation is urging the agency to seek input from industries regulated by FDA.

In a legal opinion to be unveiled by WLF today (Jan. 25), Washington Legal Foundation (WLF) member Larry Pilot writes, "The opportunity for public comment through a notice in the Federal Register is one possibility to encourage the broadest level of input."

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The public interest group most involved in patrolling FDA regulatory policies is pushing for Congress to hold hearings on the nine drugs that have been approved and subsequently recalled under the Prescription Drug Fee User Act (PDUFA). Public Citizen's biggest concern is whether FDA's standard of review for drugs under PDUFA meets a high enough bar to ensure public safety, according to a Public Citizen source.

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House and Senate staffers are saying legislation reauthorizing FDA's drug user-fee program will likely turn into a "Christmas tree" bill despite lobbying efforts by the drug and biologics industries for a simple five-year extension of the Prescription Drug User Fee Act (PDUFA). Sources say lawmakers may try to attach provisions covering such controversial items as Hatch-Waxman drug patent reforms, compulsory licensing, direct-to-consumer advertising regulation, import controls and changes to the ways medical devices are approved and regulated by FDA.

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A state judge has set a date for oral arguments on an industry coalition's lawsuit challenging Washington's pending ergonomics standard.

A Washington state judge has set a May 10 date for oral arguments on the case. The court also set a March 10 deadline for the industry coalition, the Washington Employers Concerned About Regulating Ergonomics (WE CARE), brief. The state's brief is due on April 10, and WE CARE has a April 25 deadline for its response brief.

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January 25, 2002

Despite strong rumors that the Bush administration's support for Alastair Wood to become the next FDA commissioner is fast waning, a spokesperson for Wood says that as of press time the White House has not informed Wood that he is out of the running.

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In response to a letter from the Washington Legal Foundation (WLF) spelling out concerns that federal agencies are not acting quickly enough to implement court decisions that strike regulations or policies, the Office of Management and Budget (OMB) has sent a memorandum to agency general counsels and solicitors calling on agencies to review their practices and procedures for expeditiously responding to adverse court decisions.

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In a major development, the Small Business Administration (SBA) is voicing concerns over the Bush Administration's latest, yet-to-be-released Medicare prescription drug discount card plan. SBA's involvement with the rule is a significant development given it was rarely allowed input on Clinton administration draft policy.

SBA's Office of Advocacy last month reviewed the administration's new draft card proposal and submitted comments to the Office of Management and Budget (OMB).

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The Pharmaceutical Research and Manufacturers of America (PhRMA) continues to oppose extending the use of prescription drug user fees to FDA postmarket safety activities despite a new FDA report that suggests otherwise, according to a PhRMA spokesperson. The spokesperson says the trade association and FDA are still negotiating what Prescription Drug User Fee Act (PDUFA) III should look like, and PhRMA maintains user fees should not be used to support the agency's postmarket activities.

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January 24, 2002

The leading Senate Democrat Medicare prescription drug benefit bill is likely to cost nearly one-third more in 2002, according to a leading health aide for Sen. Bob Graham (D-FL).

Speaking at the Sixth Annual Congress on Medicaid and Medicare, Graham senior policy analyst Lisa Layman predicted that under the new, yet-to-be-released Congressional Budget Office (CBO) baseline the senator's benefit bill would be "at least $400 billion."

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European Commissioners last week backed off from a plan to force a decision from member state leaders this spring on how to handle the European Union's approval of new varieties of genetically modified organisms. It will no longer push at the March Barcelona summit for member state leaders to lift an existing moratorium, but will raise the issue of EU competitiveness in the field of biotechnology.

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