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Daily News

November 03, 2003

FDA has stalled an industry proposal to create a new 510(k) category, called In Vitro Analytic Test (IVAT), which would rely on analytical data instead of clinical data for clearing diagnostic tests, according to an industry source. Industry proponents hope to meet soon with FDA lawyers, and if they can't prod the agency to revive the plan they may eventually push for legislation to harmonize FDA's 510(k) scheme with Europe's IVD Directive, which is slated to go into effect Dec. 7.

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The American Society of Clinical Oncology (ASCO) charges that CMS' proposal to cut physicians' Medicare drug reimbursements is premature and potentially illegal, jumping the gun on a congressional moratorium on changes to the average wholesale price (AWP) system and proposing new payment systems that are unreasonable and unjustified.

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Academics are proposing a new approach to drug development that they claim will allow companies to ethically and efficiently detect sex differences that affect how a drug works early in the development process. The approach takes information obtained sequentially from earlier studies to guide later development.

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The Department of Homeland Security has made several changes favorable to the drug and biologics industries in an interim final rule implementing a law designed to shield makers of counterterrorism technologies from lawsuits. Among the changes, homeland security officials are now clearly stating that no one distributing a qualified product is liable, that the protection covers products involved in terrorist attacks against Americans outside the country, and that the new law does not preclude a 1950s liability indemnification executive order.

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The European Commission is poised to seek approval from EU member states for a genetically modified variety of corn this month for import into the EU, partly as a means of showing that it is moving forward on lifting an informal moratorium on biotechnology that has sparked a U.S. challenge in the World Trade Organization. But this approval would avoid a fight with member states over whether to allow genetically modified crops to be planted alongside non-GM crops.

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Industry officials are arguing that regulations being considered by California that would require manufacturers to produce biodegradable plastics would do little to meet its intended goal of reducing plastic waste. Officials also argue the questionable environmental benefits of a biodegradable production mandate do not justify the economic harm that would be inflicted on the state's competitiveness in the plastics industry by any new restrictions.

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Senate Republican leaders are trying to make room in a crowded Senate floor schedule for debate and a vote on chemical security legislation before Congress adjourns for the year, according to a key Senate Republican aide. Industry officials and environmentalists have doubted whether the legislation, which recently passed the environment committee, would be taken up by the full Senate before the end of this session, given the controversy surrounding the proposal and the pressure on Senate leadership to pass several other high profile bills before the year's end.

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HHS is giving the FBI more time to review applications from researchers who handle select dangerous biological agents because many researchers have submitted incomplete forms. Even if immediately completed, the FBI could not process the outstanding applications by the Nov. 12 deadline, according to HHS.

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October 31, 2003

After final congressional passage of BioShield legislation had seemed like a sure thing weeks ago, Sen. Carl Levin (D-MI) opposed the plan for not requiring enough competition among contractors, according to industry sources. However, Congress is still expected to pass BioShield by Nov. 7 after industry lobbyists worked out changes to the "simple-acquisition threshold" provision of the legislation, one industry source says.

A spokesperson for Levin says the senator has not yet taken a position on the legislation.

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A key lawmaker is asking the supplement industry to clarify its position on the regulation of steroids at a time when FDA is weighing whether to regulate steroids as dietary supplements or drugs. Sen. John McCain (R-AZ) also wants industry to clarify if it favors any legislative remedies to boost FDA's authority to regulate dietary supplements and what companies intend to do about misleading labeling on dietary supplement packaging.

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The Bush administration has issued its planned changes for the medical device user fee law to let Congress get out of paying for the first two years of the user fee program. The Advanced Medical Technology Association (AdvaMed) supports the plan. But in addition to supporting changes to the law to let Congress off the hook, AdvaMed plans to "review" the compensating-adjustment factor that was responsible for steep user fee increases for fiscal year 2004.

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FDA has decided that a "designer" steroid used by athletes to enhance performance is an unapproved drug and not a dietary supplement, but says the decision should not be read as setting a precedent for other steroids.

An FDA spokesperson says the agency will be looking at other steroids and precursor steroids on a case-by-case basis to determine if they are unapproved drugs, the spokesperson says.

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The final hospital outpatient payment rule, issued by CMS today (Oct. 31), says the agency will not have to trim pass-through payments for new drugs, estimating these payments will total less than the statutory ceiling. The rule also proposes to limit any decrease in drug reimbursement payments, if hospital data show those payments should decrease by 15 percent or more.

CMS will not pay hospitals separately for drugs costing less than $50 per day, a lower threshold than originally proposed.

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FDA says food products from cloned animals are likely as safe to eat as products from non-cloned animals. The agency is basing its conclusions on data from peer-reviewed studies of cloned animals. FDA's draft summary of the qualitative report concludes that risks to animal health from cloning are no greater than risks from assisted reproductive technologies. An FDA official said regulatory action is an option if the final report finds risks associated with cloned animals.

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House lawmakers who favor drug reimportation have asked Attorney General John Ashcroft to investigate if drug companies are violating anti-trust laws by blocking sales of prescription drugs to Canadian pharmacies. The letter to Ashcroft adds to the recent clamor over moves by some high-profile drug companies to restrict drug sales to Canada in a bid to cut-off the potential for reimportation. Some state attorneys general already have investigations underway.

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October 30, 2003

FDA plans to keep Serzone (nefazadone) on the market despite a press by the consumer advocacy group Public Citizen for the agency to follow Canada's example and yank the antidepressant. Canada has decided to take Serzone off the market less than a year after Bristol-Myers Squibb stopped selling the product in Europe and Scandinavia. An agency official says FDA has no plans to follow suit because Serzone may be the only drug that works for some patients.

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Washington state's most senior business group threatened to take legal action against the consultant it hired to estimate the cost of the state's embattled ergonomics standard, charging a recent article by the consultant suggesting hired experts often shade the truth casts a "dark shadow" over the ergonomics data. The often-quoted ergonomics cost study by the independent California consultant claims the yet-to-be-enforced ergonomics rule would cost state businesses $725 million to implement.

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The nation's leading industry coalition on ergonomics has decided to enter the financial fray between the state of Washington's business and organized labor interests by contributing to the state industry campaign to repeal Washington's yet-to-be-enforced ergonomics standard. The recently made decision is consistent with the group's past efforts to curb the regulation of ergonomics nationwide, an informed source says.

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FDA is working on a guidance to clarify its 1996 regulation allowing an exception from informed consent requirements for emergency research, according to a top FDA official. The agency and HHS' Office of Human Research Programs soon will publish a joint regulation requiring investigational review boards (IRBs) to register either with OHRP, FDA, or both.

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The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has announced that investigators working with scientists from Pfizer Global Research and Development and Stanford have discovered a new immunosuppressant drug that may be beneficial in treating autoimmune diseases and organ transplant infections.

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