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Daily News

August 11, 2003

CMS is planning to again deny pass-through status for Amgen's drug Aranesp in 2004, the agency announced in its proposed Medicare outpatient hospital prospective payment system (PPS) rule.

In last year's final outpatient hospital rule, the agency deemed Aranesp and Ortho Biotech's Procrit "functionally equivalent" and decided to not reimburse Amgen's drug at a higher rate. The decision, which had not been included in last year's proposed rule, triggered a firestorm of controversy.

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August 08, 2003

FDA has met all but one of its deadlines under the medical device user fee law, according to an FDA status report. FDA has done a good job of meeting its deadlines, but the General Accounting Office has yet to issue a report that was due to Congress by July 1 on whether FDA is meeting its performance goals for this fiscal year and whether it will meet future performance goals.

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As part of an agency-wide strategic initiative, FDA is promising to cut medical device approval times. Measuring performance by approval times is a different way of measuring performance than the metrics negotiated in the Medical Device User Fee and Modernization Act (MDUFMA).

Device companies like that FDA is working to shorten approval times, according to an industry source, but they want FDA to stay focused on meeting the MDUFMA goals because that is what industry is paying for.

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A key food industry group is upset with California's proposal to apply Proposition 65 regulations to acrylamide in foods. California's environmental health hazard office is proposing to add acrylamide to the list of Prop. 65 items that require warning labels in light of recent research showing that acrylamide can form when cooking food at high temperatures. If California were to go ahead with its plan, foods containing acrylamide would need to carry a warning label.

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A key food industry group wants Codex to form a chairman's group to tackle controversial issues, such as process-based labeling, that have stymied efforts to craft an international standard for genetically engineered food labeling. The Grocery Manufacturers of America (GMA) says forming such a group would let the Codex Committee on Food Labeling (CCFL) move ahead on points where there is consensus, such as the need for labeling of genetically engineered foods that change the nutrient content of the food.

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Studies indicating a correlation between formaldehyde exposure and leukemia in workers are raising concern among White House officials and OSHA, Bush administration sources say. However, the administration is waiting for further analyses before discussing a change in exposure limits or revision of OSHA's formaldehyde standard.

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August 07, 2003

Jeff Flick, a top-ranking advisor to CMS Administrator Tom Scully, has been named the new regional administrator for CMS' San Francisco regional office. He will take up the new position next month.

Described by Scully as "my right arm," Flick has served as one of four special assistants to the CMS chief for the past two-and-a-half years. Prior to joining CMS, he spent more than 20 years working in the private healthcare sector.

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As an OSHA reform legislative package makes its way through the House, Rep. Charlie Norwood (R-GA), chairman of the House Education and the Workforce subcommittee on workforce protections and sponsor of the bills, tells Inside OSHA he will pursue additional reforms to the OSH Act to reduce workplace injuries and illnesses. Norwood says, "The days when Congress opted to just leave the OSH Act alone are long gone."

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The United States is requesting a special session of the World Trade Organization's Dispute Settlement Body to hear its first request for the establishment of a panel against the European Union's moratorium on approvals of biotechnology products, according to sources. A special session to consider the request is important because the United States wants the WTO to establish the panel prior to the Cancun ministerial, as the last scheduled DSB meeting prior to the ministerial is set for Aug. 29.

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A key food industry group says it will oppose FDA's move to withdraw certain Generally Recognized As Safe (GRAS) affirmation for food ingredient proposed rules unless FDA promises that food companies can continue using these ingredients. FDA had issued proposed rules for a number of ingredients and now that the agency is withdrawing those proposals the group is afraid that food companies may have to stop using those ingredients.

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CMS is planning to propose three alternatives to the embattled system it uses to pay for prescription drugs under Medicare and adopt one of them after evaluating stakeholder input, according to a draft notice of proposed rulemaking (NPRM) obtained by Inside CMS. As it seeks to change the system that has led to overpayments for drugs, CMS plans to simultaneously hike payments to oncologists and other specialty groups that have benefited from the flawed drug payment system.

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Concerns being raised by brand-name drug company Eli Lilly, and supported by Sen. Orrin Hatch (R-UT), with the 180-day generic drug exclusivity provisions in the Senate and House Medicare bills may slow efforts by congressional conferees to negotiate a drug patent reform compromise. Hatch reportedly supports Lilly's proposal to change the 180-day award provisions, which are essentially the same in both bills and therefore under normal circumstances would not be touched by conferees.

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August 06, 2003

Senate and House lawmakers recently introduced modified legislation that would phase out the non-therapeutic use of antibiotics in food-producing animals. The bills introduced in the last few weeks, unlike earlier versions, do not address the use of fluoroquinolones. The bills also include a provision that would require drug sponsors to provide data about the use of their antibiotics in animals.

Consumer groups praise the bill, while animal drug industry, animal feed industry and veterinarians oppose it.

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The Biotechnology Industry Organization (BIO) is urging Medicare conferees to adopt the Senate bill's more generous hospital reimbursement formula for new drugs and biologicals as well as its prohibition against denial of increased reimbursement for new drugs that are "functionally equivalent" to existing treatments.

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The Justice Department is asking a federal judge to pull a footnote critical of FDA's tactics from a ruling that the judge issued last month on CollaGenex's Periostat. The Justice Department, which is in part acting on FDA's behalf, takes issue with the memorandum opinion's statement that FDA's counsel engaged in "gamesmanship" and "hide-the-ball" activity in statements to the court about when it would approve a generic.

A lawyer says that it is rare, but not entirely unheard of, to ask a court to withdraw a footnote of a memorandum opinion.

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Facing union objections, OSHA is proposing to make it easier for companies to qualify for the voluntary protection programs' (VPP) star and merit categories in an apparent bid to dramatically increase industry participation in the voluntary compliance effort. An organized labor source says the proposal, which would adjust VPP benchmarks to counter dramatic fluctuations in injury and illness rates, will "water down" VPP by allowing substandard companies to enter the program. The proposal also differs from a Jan.

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The Congressional Budget Office (CBO) predicts the Senate Medicare bill will channel a third of Medicare beneficiaries into drug coverage from a government contractor that has less incentive to control drug costs, but says the Senate plan provides more tools for drug plans to control costs than the House counterpart.

The CBO projection of high participation rates in fallback plans is based on its view that pharmacy benefit managers (PBMs) will opt to provide the fallback drug benefit as long as that is an attractive option under the legislation.

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August 05, 2003

The Senate Environment and Public Works Committee unanimously approved legislation July 30 designed to boost the training and safety of first responders in the event of terrorist attack. But the bills fall short of providing direct, additional funding despite calls for increased federal assistance from industry manufactures.

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Senate Finance Committee Chairman Charles Grassley (R-IA) may draft new legislation to amend the tax provisions of an asbestos injury bill currently awaiting floor debate if his committee is not granted jurisdiction to revise these provisions.

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A Clinton appointee, Thomasina Rogers, received an additional six-year term as the Senate confirmed two Occupational Safety and Health Review Commission (OSHRC) members last week.

Scott Railton and Rogers were confirmed July 31. A source close to OSHRC said Rodgers' confirmation is indicative of her political clout. "She is a Democratic woman in a conservative administration, it's pretty outstanding that she got through."

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