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Daily News

March 04, 2002

A federal court of appeals recently heard oral arguments in a case that could have a significant impact on OSHA's jurisdiction as the agency and an industry group clashed over whether OSHA has the right to mandate how products should be designed.

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DOL Secretary Elaine Chao has lashed out at a powerful labor organization in response to criticism of OSHA's regulatory agenda. Chao says workers are better served with a streamlined agenda that accurately reflects which regulatory actions the agency can undertake in a one-year period than with an agenda that misrepresents OSHA's activities.

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Industry sources are claiming that recent guidance letters on ergonomics, which Washington State's Department of Labor and Industries (L&I) has sent to selected employers, contradict the state's ergonomics regulation. These officials allege that in order to attract a major company to the state, L&I has agreed to relax its ergonomics standard for this firm. A top L&I official strongly refutes these allegations.

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With the pharmaceutical industry already promising a fight, Sen. Byron Dorgan (D-ND), chair of a Senate Commerce and Transportation subcommittee, is planning to introduce a bill that would allow pharmacists and wholesalers to reimport drugs from Canada. The bill is likely to reignite controversy over reimportation, as the Pharmaceutical Research and Manufacturers of America (PhRMA) has promised to fight the impending bill, and an FDA source says the agency has safety concerns regarding the approach.

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A close relationship that is developing between the biotechnology industry and the Department of Defense (DOD) post-Sept. 11 could create new dynamics between FDA's review function and DOD's need for cutting-edge biotech products such as vaccines and wound therapies, according to a top official at the Biotechnology Industry Organization (BIO).

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The state of Maine has won round one against a pharmaceutical industry bid to quash the state's prescription drug discount program for low-income residents.

In a Feb. 25 decision, the U.S. District Court for the District of Columbia has ruled in favor of the Healthy Maine Prescription Program (HMP), authorized by HHS to reduce prescription drug costs for needy residents ineligible for Medicaid.

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Montana is taking several drug manufacturers to court over what the state believes is an abuse of the average wholesale price (AWP) system that it claims has cost Montana millions of dollars.

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Congress' first hearing this year on reauthorization of the Prescription Drug User Fee Act (PDUFA) will feature both FDA's newly tapped Deputy Commissioner and a former front-runner candidate for the FDA commissioner slot. Both Deputy Commissioner Lester Crawford and former FDA chief candidate Alastair Wood, currently assistant vice chancellor for research at Vanderbilt University School of Medicine, will testify Wednesday (March 6) before a House Energy and Commerce subcommittee.

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March 01, 2002

The head of FDA's vaccine office would like to begin laying the groundwork for stronger international cooperation when it comes to vaccines by opening up discussions on harmonization, mutual recognition agreements and even cooperative licensing arrangements. In an interview with FDA Week, Bill Egan, director of the Office of Vaccines Research and Review, says entering into arrangements with other countries whereby governments recognize the validity of each other's vaccine approval process would conserve resources and get vaccines to a much broader market faster.

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Newly named FDA Deputy Commissioner Lester Crawford is being put in the line of fire, as he will face the reauthorization of the Prescription Drug User Fee Act (PDUFA) and budget issues almost immediately after his arrival at the agency. Secretary Tommy Thompson tapped former FDA veterinary center chief Lester Crawford to be FDA deputy commissioner early this week.

The House plans to start hearings on PDUFA reauthorization next week and FDA will be called before a House Appropriations subcommittee on March 21 to defend its fiscal year 2003 budget proposal.

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Several Supreme Court justices expressed serious concerns this week that the FDA Modernization Act (FDAMA) inappropriately uses speech restrictions to regulate pharmacy compounding -- or to draw a line between drug compounding and drug manufacturing -- when other tools could accomplish the same goal. In light of these voiced concerns, according to a First Amendment advocate, the Supreme Court is likely to rule that the advertising restrictions are unconstitutional.

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Key House Democrats launched a legislative effort this week to force the withdrawal of eight antibiotics used in healthy animals due to concerns that they may cause antibiotic resistance in humans. This action comes at a time when FDA is struggling to ban a fluoroquinolone antibiotic used to treat sick chickens.

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Top House lawmakers are reconsidering their stance on Medicare reform funding and may call for more resources to pay for prescription drug coverage, Medicare+Choice improvements, and provider payment adjustments, according to sources.

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Pharmacy groups are "very likely" to resume their legal challenge over President Bush's prescription drug discount card following today's (March 1) release of the administration's revised initiative, according to an industry source.

Members of the two key pharmacy groups that successfully halted the administration's original card plan are meeting today to discuss continuing their court action. A source with one of the groups says the revised card plan is almost identical to the first proposal and therefore, violates the federal court injunction.

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February 28, 2002

Determined to rein in prescription drug prices, a coalition of governors, labor leaders and employers are throwing their weight behind congressional efforts to close legal loopholes, which they claim enable drug manufacturers to slow the release of generic equivalents. The move has drawn immediate fire from pharmaceutical groups vowing to vigorously oppose the legal clampdown.

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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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