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Daily News

February 28, 2002

Neither the Senate nor House have plans at this point to schedule hearings on drug patent law reforms despite a call this week by the National Governor's Association (NGA) for congressional hearings on the issue, sources say.

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A key Democratic senator announced yesterday (Feb. 27) that his revamped prescription drug legislation would cut premiums in half, compared to last year's bill.

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Citing possible financial disparities between fee-for-service and Medicare+Choice (M+C), the Senate Finance Committee is calling for an examination of how the M+C program's only private fee-for-service (PFFS) plan is operating, according to a congressional document obtained by Inside CMS.

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Public Citizen Touts PDUFA Bill As Vehicle For Drug Law Reform

A leading consumer group is weighing into the Prescription Drug User Fee Act (PDUFA) debate with an aggressive proposal to revamp food and drug law to significantly increase FDA's enforcement powers, give the agency more leverage in drug reviews, and enhance postmarket drug safety oversight. Public Citizen's blueprint, likely to be strongly opposed by the pharmaceutical industry, says among other things that FDA approval deadlines should be stayed when companies procrastinate in giving FDA requested information.

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Members of the House Agriculture and Judiciary Committees have succeeded in their bid to have a direct role in shaping the future of the broad-sweeping bioterrorism bill. The House has tapped members responsible for hammering out an agreement with the Senate, and several members from the Agriculture and Judiciary Committees have made the long-awaited list.

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February 27, 2002

AARP's call this week for Congress to spend more than $700 billion on Medicare reforms centered on a prescription drug benefit has put a new spark in the prescription drug debate on Capitol Hill. The press by the nation's largest senior group for more than double what the congressional budget committees have set aside in the past for Medicare reform may bolster Democratic efforts to enact a comprehensive Medicare drug benefit reform bill prior to the fall elections, sources say.

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Congressional sources say House lawmakers hope to promptly pass a "clean" bill reauthorizing the Prescription Drug User Fee Act (PDUFA) by this spring for two reasons: Lawmakers want to move on to higher-profile campaign issues such as Medicare and also want to avert forcing FDA to write a plan for drug reviewer layoffs, which could occur if the act's reauthorization slips close to its September expiration date.

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The research arm of Congress says that FDA and the U.S. Department of Agriculture (USDA) have not taken sufficient actions to ensure that all animals infected with mad cow disease are kept out of the United States and the American food supply. The General Accounting Office (GAO) says FDA is lax in its oversight of animal feed and its enforcement against companies who do not comply with bovine spongiform encephalopathy (BSE) regulations.

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FDA is crafting a new bovine spongiform encephalopathy (BSE) enforcement strategy as part of a broader effort to improve BSE compliance that will detail the agency's inspection, reporting and enforcement plans. The strategy, slated to be released sometime this fiscal year, is being drafted at a time when the agency is facing strong criticism from the investigative arm of Congress for its lax enforcement of BSE restrictions.

FDA is also reviewing whether proteins from horses and pigs should be allowed in animal feed.

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A House Democrat and organized labor are questioning DOL Secretary Elaine Chao's claims that the administration is increasing OSHA's enforcement budget, noting that Bush administration budget documents show that DOL is calling on Congress to cut the agency's enforcement funds.

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Congress' research arm, the General Accounting Office (GAO), warns that items contaminated with mad cow disease may be slipping across U.S. borders in personal packages. "A small but steady stream of BSE-risk material may still be entering the United States though international bulk mail," says GAO.

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A Democratic congressman is criticizing the Bush administration for its lack of a comprehensive ergonomics plan, saying that it is "ironic" that workers are not protected in a time when protecting Americans is a priority.

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February 26, 2002

The National Institutes of Health (NIH) is signaling that it is willing to spend research dollars earmarked for bioterrorism on a vast spectrum of diseases that potentially could be weaponized for terrorist purposes, such as malaria, lyme disease and salmonella.

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The Bush administration has denied a petition from Mexican workers demanding that DOL, under an international agreement, press the Mexican government to enforce safety standards in its factories. The decision resulted in a strong response from a group of occupational health and safety experts that called it "unacceptable."

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The Office of the U.S. Trade Representative (USTR) is gearing up its legal preparations for a possible World Trade Organization challenge to the European Union's continued moratorium on the marketing approval of new genetically modified organisms, but has not yet decided if or when it will pull the trigger on a case, officials recently told industry representatives, according to industry sources.

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State food and drug officials are discussing a possible compromise with the food industry on national uniformity legislation, key sources say. The state regulators, whose prior opposition to industry-backed national uniformity legislation blocked its passage, are suggesting alternative language that essentially would allow state laws to stand so long as they have goals "equivalent" to national laws. The food industry has sought legislation that would preempt any state food laws that are not "identical" to federal food and drug law.

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A GOP senator is urging the White House to boost its funding commitment for programs aimed at reducing the number of uninsured. In a Feb. 13 letter to President Bush, Sen. Gordon Smith (R-OR) says he is encouraged that the White House has set aside $89 billion in the form of health credits but he insists that more can be done.

Smith states he wants to work with the White House to find funding for the 34 million uninsured that would not benefit from the tax credits.

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The Blue Cross Blue Shield Association (BCBSA) is lobbying the Bush administration and Congress to significantly increase the availability of preferred provider organizations (PPOs), claiming these plans could help solve some of the major problems facing Medicare+Choice (M+C).

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February 25, 2002

In an unprecedented move, AARP will soon ask Congress to dip into the Medicare Trust Fund to finance a $700 billion Medicare reform bill that would mostly pay for a comprehensive prescription drug benefit, according to an AARP source.

AARP is preparing a letter to both the House and Senate budget committees that will propose taking $350 billion from general revenue and $350 billion from the Medicare Trust Fund, according to the source. The letters will likely be sent this week.

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With the help of the device industry, Sen. Joseph Lieberman (D-CT) is revising his bioterrorism bill, introduced last December, to ensure that diagnostic manufacturers have adequate incentives to develop counterbioterrorism diagnostics, according to a Lieberman staff member.

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