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Daily News

March 05, 2003

Citing personal reasons, HHS Inspector General Janet Rehnquist is resigning from her post effective June 1. However, stakeholders point out that Rehnquist was subject to several investigations into her handling of the agency and a key Senate Democrat planned to call for her resignation.

Rehnquist informed President Bush of her decision in a March 4 letter, saying, "At this time, I feel it is important to spend more time with my teenage daughters and pursue other professional opportunities."

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March 04, 2003

Following a major disagreement with the White House, CMS decided to seek public comments before implementing a looming standard designed to crack down on inappropriate Medicare hospital payments.

CMS had sought to issue the outlier regulation as an interim final rule. However, the Office of Management and Budget (OMB) would not clear the standard, instead requiring it to be issued as a notice of proposed rulemaking, Inside CMS has learned.

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Stakeholders and an agency source say OSHA is beginning the process of withdrawing either some parts or the entire employer payment for personal protective equipment (PPE) rulemaking. However, high-ranking agency officials did not confirm such plans and OSHA Administrator John Henshaw said he liked the size of the current regulatory agenda, which includes PPE.

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President Bush today (March 4) unveiled his framework for modernizing Medicare and adding prescription drug coverage to the program. The three-tier benefit plan would offer more extensive drug coverage to those beneficiaries opting to join private insurance plans, while providing those choosing to stay in traditional Medicare relief through a prescription drug card and catastrophic coverage.

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FDA has announced a major animal feed recall after dioxin was found in catfish and feed samples, sources say. The announcement Friday (Feb. 28) addresses contamination that found its way into fish from a mineral supplement added to feed.

As part of monitoring efforts, FDA scientists sampled both catfish and feed simultaneously and discovered that a zinc mineral supplement added to the feed to prevent clumping resulted in levels that exceed FDA's 1 part per trillion action level.

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A major medical device group is urging CMS to set up a tracking system on proposed inherent reasonableness (IR) actions that would resemble the agency's posting of pending national coverage determinations, claiming the move would allow more public input on planned payment changes.

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Maine's outgoing top health care official has criticized federal inaction on the Maine prescription drug assistance program struck down by a court last year and voiced opposition to President Bush's Medicaid reform plan.

"To me, it cannot be explained or defended that we have not had [Healthy Maine Prescriptions] restored," Kevin Concannon, Maine's human services department (DHS) commissioner, said at a Feb. 13 AARP meeting -- one day before leaving his DHS position.

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In a change of heart the U.S. delegation to a Codex Alimentarius task force is recommending that there be two separate safety assessments for foods derived from biotech microorganisms, a consumer advocate says.

Until now the U.S. delegation had opposed the idea of doing separate safety assessments for the recombinant-DNA microorganism (RDM) relative to its conventional counterpart and the food produced with the aid of the RDM relative to its conventional counterpart, the consumer representative says.

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Two key House Republicans are requesting that the General Accounting Office (GAO) conduct a study examining the impact professional liability expenses have on Medicare.

In a March 3 letter, Ways and Means Committee Chairman Bill Thomas (R-CA) and health subcommittee chair Nancy Johnson (R-CT) urge GAO Comptroller General David Walker to investigate the "total cost to the Medicare program of medical liability, including increased malpractice premiums, defensive medicine, and liability related production and warning costs of pharmaceuticals, biologics and medical devices."

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House Democrats have reacted to the Bush administration's announcement of a Medicare reform plan by introducing a comprehensive drug benefit that mirrors their initiative from last year.

High-ranking House Democrats unveiled the legislation today (March 4). It includes a $25 premium, a $100 annual deductible, 20 percent copay and catastrophic coverage of costs exceeding $2,000, all features of last year's bill. At the time, the Congressional Budget Office (CBO) scored the 2002 legislation at nearly $1 trillion over ten years. However, this year's version has not been scored.

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President Bush this week unveiled a Medicare modernization plan that promises comprehensive prescription drug coverage for those willing to enroll in a private health plan but limited assistance for those electing to stay in traditional Medicare.

While Democrats decried the plan, as expected, key Republicans offered a lukewarm response. Although the plan does retreat from the Bush administration's recent and sharply criticized proposal not to offer drug coverage under traditional Medicare, some GOP lawmakers are signaling that it does not go far enough.

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March 03, 2003

Lawyers representing the Association of American Physicians and Surgeons (AAPS), the Competitive Enterprise Institute (CEI) and Consumer Alert are asking a federal appeals court to dismiss two pediatric groups' appeal of a decision striking FDA's pediatric rule. Now that the government has decided not to appeal the case, according to AAPS, the pediatric groups do not have a "justiciable" case or controversy and do not have standing to appeal.

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OSHA is moving forward with a negotiated rulemaking on its cranes and derricks standard and is accepting comments on a proposed negotiated rulemaking committee.

The agency floated its nominees for the panel in a Feb. 27 Federal Register notice, saying it has received "broad industry support" for revising the current standard through a negotiated rulemaking.

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NEW YORK--Key industry lawyers are urging the biotechnology industry to take an active role in shaping an abbreviated approval pathway for generic versions of biologics, arguing the advent of generic biologics are inevitable. Panelists at a Biotechnology Industry Organization (BIO) CEO and Investor Conference in New York last week discussed potential scenarios, emphasizing that the law will eventually follow the science.

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A key advisory committee is recommending that FDA remove the blanket hold on 27 gene therapy trials using retroviral vectors. The panel is asking FDA to examine individual trials before deciding if they should continue.

Further, in the three trials involving patients suffering from X-linked Severe Combined Immunodeficiency (X-SCID), the panel is recommending that researchers use gene therapy only when all other treatments have failed.

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FDA's Food Advisory Committee is urging the agency to give consumers more information about the possible risks of acrylamide than they are currently being given, a consumer source says. The panel asked the agency to contact consumer groups and explain that they are investigating acrylamide's carcinogenic effects but need more information before they can advise consumers about its safety.

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In a move that may add to the generic biologics debate, Aventis Pharmaceuticals is petitioning FDA not to approve any applications for a generic version of its biopharmaceutical Lovenox (enoxaparin sodium injection) unless the generic firms use the same or equivalent manufacturing process as Aventis. Or as an alternative, the generics should have to submit safety and clinical data, according to the brand-name drug company.

Lovenox is indicated for the prevention of deep vein thrombosis, which may lead to pulmonary embolism, following hip or knee replacement surgery.

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President Bush is this week expected to outline a framework for reforming Medicare and adding prescription drug coverage to the program, but will leave Congress to fill out the finer legislative details, according to a top administration official.

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February 28, 2003

FDA is setting a new precedent that would give Drug Efficacy Study Implementation (DESI) drugs a grace period to stay on the market for a limited period after a competitor gets a new drug application (NDA) approved. This stems from a new agency compromise regarding extended-release guaifenesin where drug makers who have not obtained NDA approvals are now being told they can stay on the market until November.

FDA will soon issue a Federal Register notice unveiling additional details about its new enforcement policy for unapproved drugs.

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A move by FDA to evaluate potential health hazards relating to a narcotic analgesic drug called Palladone has prompted the House Energy and Commerce Committee to step up its ongoing probe of pharmaceutical abuse and diversion of both Palladone and another Schedule II narcotic analgesic called Oxycontin.

On Wednesday (Feb. 27), the lawmakers demanded that Purdue Pharma L.P., which produces both drugs, hand over all records relating to its discussions with FDA on risk management, as well as internal company data on abuse and conversion and marketing plans.

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