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Daily News

May 22, 2003

In a major boost for rural providers, President Bush has given his blessing to the inclusion of a $25 billion rural Medicare payment increase as part of wider Medicare reform legislation. The White House endorsement strengthens the likelihood of a payment hike for rural providers should Congress enact Medicare reform this year.

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The House Government Reform Committee on Thursday (May 22) passed BioShield legislation by voice vote, keeping a contentious funding provision in the bill that the House Energy and Commerce Committee passed last Thursday (May 15). Government Reform chair Thomas Davis (R-VA) amended the bill to give HHS the broader "simplified acquisition" authority that the Defense Department uses in military contracts, while also requiring the HHS Secretary to declare that there is a "pressing" need to use the broader authority.

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May 21, 2003

Struck by what she claims are egregious health and safety violations which are followed with soft disciplinary action, Rep. Rosa DeLauro (D-CT) is discussing with Rep. Major Owens (D-NY) legislation to toughen OSHA penalties and make some safety and health violations felonies. DeLauro discussed her plans in a May 8 interview with Inside OSHA.

A similar effort is underway in the Senate, by Sen. Jon Corzine (D-NJ).

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CMS pushed ahead with July 1 implementation of a congressionally mandated cap on rehabilitation therapy despite demands from nursing homes and therapy providers that the $1,590 cap be delayed because providers and Medicare beneficiaries have not had sufficient notice and the CMS implementation plan violates the statute.

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Hospitals are backing House and Senate bills that would recoup their losses from this year's mandated hospital Medicare cuts, positioning themselves for a likely repeat of last year's bargaining in the House to gain support for prescription drug legislation from lawmakers backing the hospitals' request.

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A food industry representative suggests that the Nutrition, Labeling and Education Act's (NLEA) 540-day notice-and-comment rulemaking process for authorizing health claims is too slow and unresponsive to be used for qualified food health claims. The official recommends two possible approaches that FDA could adopt.

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The Biotechnology Industry Organization (BIO) and FDA agree that biotech companies should not recommend as independent consultants people who have financial conflicts, who helped design the trial, or who will help run the clinical trial, according to a BIO source.

The trade group was the driving force behind the provision in the Prescription Drug User Fee Amendments of 2002 that allows sponsors to ask the agency to call on independent consultants to help review the company's phase III clinical trial protocol.

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A key FDA veterinary center official says it is unclear if FDA has the authority to impose and enforce environmental controls on sponsors of applications for transgenic animals. The official said either Congress or the courts should determine if FDA has the authority, but he stopped short of calling for legislative reform.

John Matheson, senior regulatory scientist at FDA's Center for Veterinary Medicine (CVM), addressed the question of authority over environmental issues at the National Food Policy conference last week in response to a question.

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May 20, 2003

The U.S. Supreme Court has given the go-ahead to a controversial Maine law that seeks to lower residents' prescription drug costs but has been blocked by a long-running drug industry legal challenge. The ruling is a setback for the pharmaceutical industry, which launched its first ever high court appeal over a state drug plan in a bid to quash the Maine initiative.

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A firm producing allergenic extracts is asking FDA to exempt such products from the proposed bar coding regulation. These biological products are combinations of hundreds of different antigens extracted from plants and animals and are mostly sold directly to physicians, the firm says.

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In a position that may strike middle ground in the debate over FDA's implementation of the drug 505(b)(2) approval process, law firm Frommer Lawrence & Haug says 505(b)(2) applicants should only be able to rely on an innovator's proprietary data if FDA relied on that specific data to approve the original new drug application (NDA).

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An international food-labeling committee is trying to expand its purview to include advertising, a move the U.S. delegation opposes, according to food industry sources.

At a meeting two weeks ago in Ottawa, Canada, the Codex Committee on Food Labeling expanded the health and nutrition claims document to include claims related to advertising. A food industry source says the expansion was added during a working group meeting on the Saturday prior to the committee meeting, and it stuck. Sources say that previously the document only covered food labeling.

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The Pharmaceutical Research and Manufacturers of America (PhRMA) is concerned that the HHS Office of Inspector General (OIG) is raising a red flag on research grants that originate through company sales or marketing activities. The warning is included in the OIG's new compliance policy guidelines covering the pharmaceutical industry.

While PhRMA is still in the process of reviewing new parts of the guidance document, a PhRMA spokesperson said a section on educational grants is one "area of concern." PhRMA indicated that it might comment on the guidelines in the future.

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Two leading groups of occupational safety and health professionals are in the midst of a war of words ignited by Florida mold legislation. A group of safety engineers is charging that industrial hygienists tried to shut out competition for mold remediation in the state by helping get a provision tucked into the bill -- charges the industrial hygienists flatly reject.

As a result, American Industrial Hygiene Association (AIHA) President Gayla McCluskey is seeking a meeting with her American Society of Safety Engineers (ASSE) counterpart Mark Hansen to discuss the issue.

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In its bid to tighten government controls over plant-made drugs, the food industry says FDA should start withholding new drug applications (NDA) when drug companies violate the U.S. Department of Agriculture's (USDA) guidelines to prevent the release of plant-made pharmaceuticals (PMPs) into the food supply.

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May 19, 2003

The House Government Reform Committee does not plan to change a contentious funding provision in a BioShield bill that the House Energy and Commerce Committee passed last Thursday (May 15), according to a committee spokesperson. Government reform is scheduled to mark up the bill Thursday (May 22), and committee chair Thomas Davis (R-VA) likely will add a measure that would allow large drug companies to contract for procurement, and research and development in the same legal document, according to an industry source.

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FDA has extended the comment period for the three risk management concept papers in response to a request from the Pharmaceutical Research and Manufacturers of America (PhRMA). The three concept papers, which were discussed at an April 9-11 public workshop, will form the basis of three future guidances.

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A 10-state coalition seeking to lower state drug costs by establishing an alternative to the private-sector middlemen who manage prescription drug plans is calling for input from non-profit organizations.

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The advocacy groups Public Citizen and the Center for Science in the Public Interest (CSPI) plan to sue FDA within the next few months over the agency's stance that it does not need notice-and-comment rulemaking to allow qualified food and supplement health claims, an advocacy source says. The groups will sue FDA unless the agency addresses the groups' concerns, the source adds.

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OSHA Administrator John Henshaw recently told a House panel that a rulemaking requiring employers to pay for employees' personal protective equipment (PPE) would be included in the agency's upcoming regulatory agenda. Henshaw's statement contrasts with indications earlier this year that OSHA was planning to withdraw the rule. The issue gained greater visibility last month when the Congressional Hispanic Caucus and organized labor petitioned OSHA to finalize the rulemaking.

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