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Daily News

January 25, 2002

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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Senators are expected to raise serious questions about the federal government's protocol for overseeing the cleanup of Capitol Hill office buildings contaminated by anthrax, raising the specter of a possible standard for a safe level of exposure to bioterrorism agents.

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Chemical industry officials are drafting an alternative to a Senate bill that proposes new federal regulations for the handling of hazardous chemicals, and could subject companies to criminal liability in the event of a terrorist attack. Rather than adopt a single regulatory scheme for all facilities, industry officials are considering recommending a "general duty clause" that would require chemical plants to conduct a vulnerability assessment and implement security measures based on site-specific conditions, sources say.

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Regulations released by China two weeks ago for the approval and labeling of genetically engineered farm products are scheduled to take effect March 20, a date that could mark a halt to U.S. shipments of genetically modified soybeans unless China pushes back this date or pre-approves this product. In addition, U.S. government and industry sources noted, the regulations are drafted in a vague manner that leaves open the possibility of an onerous regulatory process for U.S. exporters.

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Environmental and consumer groups are pushing the Office of the U.S. Trade Representative to back off from its threats to challenge the European Union's biotechnology labeling requirements as unjustified trade barriers for fear it could backfire on U.S. food labels, such as dolphin-safe tuna. The EU's biotechnology labeling requirements clash with the U.S. FDA's view that mandatory labeling is unnecessary.

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January 23, 2002

FDA is refusing to grant a Washington Legal Foundation (WLF) request that the agency notify the Office of Management and Budget (OMB) within seven days of court rulings striking down agency regulations. The agency also will not post a notice on FDA's website with a link to rules, regulations or guidances struck down by the courts. But FDA promises to review on its own court decisions that have ruled against FDA regulations with an eye to revoking them.

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A Medicare advocacy group is calling for a congressional probe of drug pricing policies following the launch of a new drug discount card for Medicare beneficiaries by a leading pharmaceutical manufacturer.

The Pfizer Inc. initiative should be a "wake-up call" for Congress and the administration to explore why pharmaceutical companies are not offering discounts to all Americans, says Medicare Rights Center (MRC) President Robert Hayes.

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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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OSHA will soon release guidelines to help employers develop and implement emergency evacuation plans, OSHA Administrator John Henshaw revealed in a speech at a lecture series on bioterrorism in the workplace.

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January 22, 2002

FDA's food center is rethinking what countries it will target for food import inspections and what federal agencies it needs to foster relationships with in the new climate of bioterrorism preparedness. At a National Academies of Sciences Jan. 15 meeting on food and livestock security, an FDA official said the center is now pursuing a relationship with the intelligence community.

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The recess appointment of Eugene Scalia as Department of Labor (DOL) solicitor has drawn strong criticism from organized labor and resulted in applause from Senate Republicans.

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The Bush administration recently issued data-quality guidelines that are expected to prolong the time needed for FDA and other federal agencies to develop regulations and non-regulatory policy documents, possibly including warning letters. However, sources say they will have a better idea of the guidelines' full impact by April 1, FDA's deadline for sending a draft implementation plan to the Office of Management and Budget (OMB).

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Four years after its secretive Medicare coverage advisory panel was found to be in violation of federal committee rules, CMS is now planning an invitation-only stakeholder meeting to discuss the workings of the panel's successor, the Medicare Coverage Advisory Committee (MCAC). Some experts say the upcoming meeting could violate the very same rules that led to the disbandment of the earlier panel.

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After OSHA had already set a time on Jan. 11 to announce its comprehensive approach on ergonomics, the agency scrapped the plan and it is now unclear of when the announcement will be made.

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CMS is considering scaling back Medicare coverage of clinical trial costs and may unveil a rule this year that would rescind some of the policies issued by the Clinton administration, according to sources. Such a move would be highly controversial and trigger strong opposition from key lawmakers, patient advocates, and medical device groups.

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The Office of Management and Budget's (OMB) department-wide management initiative to consolidate all HHS public affairs, communications and legislative affairs could run into a stumbling block when it is time for Congress to appropriate funds for FDA, according to an FDA source. In order to designate FDA employees as HHS employees, the source says, the administration would have to get Congress' OK to pull responsibility from the Appropriations agriculture subcommittee and give that responsibility to the Appropriations HHS/Labor subcommittee.

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