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Daily News

January 30, 2002

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FDA is considering bringing back to market, under a special risk management program, a voluntarily withdrawn drug after being pressured to do so by patients.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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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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