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Daily News

June 16, 2003

Sen. Jon Corzine (D-NJ) plans to introduce tomorrow (June 17) legislation that would significantly strengthen OSHA's enforcement capabilities even though no Republicans have yet agreed to sign on as cosponsors, an aide to the senator said. The bill's introduction comes at a time when Republican legislation is pending in the House that some claim would weaken the agency's enforcement capabilities.

Corzine had hoped to gain bipartisan support before introducing the bill, according to the aide.

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The brand-name drug industry is urging HHS not to adopt a draft guidance on financial conflicts of interest in research involving human subjects on the grounds that sufficient safeguards already exist. The Pharmaceutical Research and Manufacturers of America (PhRMA) also argues that setting up a separate conflict of interest committee (COIC) to review studies would only complicate the review of research studies.

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A group of senior Democrats says the Department of Homeland Security is "broken" to the point where it cannot ensure adequate protection against biological terrorism.

Of top concern is the status of DHS' Office of Information Analysis, which is tasked with using intelligence information and applying it to threats and vulnerabilities at home. According to critics, this office is not ready to do its work in guarding against biological terrorism, an assessment lawmakers from both sides of the aisle find disturbing.

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Drug and medical device companies may have a better chance of getting product liability protections now that the House is considering attaching its medical malpractice bill to Medicare legislation, and the Congressional Budget Office (CBO) is saying the Republican's medical malpractice proposal would save the Medicare program $15 billion over 10 years, according to a congressional source.

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African, Pacific and Caribbean countries view the impasse over a declaration giving developing countries greater access to cheap copies of generic drugs with "grave concern" in light of the outbreak of severe acute respiratory syndrome (SARS). In a May 28 paper circulated to WTO members, ACP countries said SARS demonstrated the urgency of finding a "straightforward and easy to implement" solution to the fight over the Agreement on Trade Related Aspects of Intellectual Property Rights and public health.

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U.S. trade officials have taken a new approach to limit the scope of any World Trade Organization agreement on the so-called TRIPS and public health issue by telling some developing countries with pharmaceutical manufacturing capacity that in the U.S. view they would be ineligible for new flexibilities as a result of the negotiations, according to delegation and industry sources.

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June 13, 2003

Medicare reform legislation appears set for Senate passage following broad approval by the Senate Finance Committee last night, with six Democrats, including the caucus' top member, voting for the package.

The Finance Committee reported out the Prescription Drug and Medicare Improvement Act of 2003 virtually unaltered from the amended version presented earlier June 12 by Chairman Chuck Grassley (R-IA). The bill passed 16-5.

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When it marked up drug patent reform legislation this week, the Senate health committee failed to take up an unexpected FDA recommendation that lawmakers change current law to state that a court decision would no longer start the 180-day generic drug exclusivity clock. The proposal is one of many "technical corrections" that FDA has suggested senators include in the drug patent reform bill.

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FDA's final generic drug reform rule includes a provision opposed by the Federal Trade Commission and the generic drug industry that would allow patents claiming a polymorph (different crystal form) of the drug substance used in the approved drug product to be listed in the Orange Book. But the final version of the rule, issued June 12, adds a requirement that brand-name drugmakers listing such patents have test data demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the new drug application.

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House Ways and Means Committee Chairman Bill Thomas (R-CA) and the largest Medicare beneficiary advocacy group disagree on whether the catastrophic benefit of the House GOP Medicare reform bill constitutes "means testing."

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A consumer group is petitioning FDA to switch a nicotine replacement therapy drug from prescription to behind-the-counter status. The group says FDA could regulate this product under a third category of drugs such as injectable needles, syringes, insulin, and pseudoephedrine that are sold only through a licensed pharmacist.

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Senate Democrats are planning to attach drug reimportation legislation to the Senate Medicare bill, according to Debbie Stabenow (D-MI), who tried the same thing last year. The reimportation legislation will mirror last year's bill.

In the House, Rep. Gil Gutknecht (R-MN) this week also introduced a bill to allow individuals, pharmacists and wholesalers in America buy FDA-approved drugs from FDA-approved facilities in industrialized nations. Gutknecht emphasized the importance of controlling the price of pharmaceuticals before taking up Medicare prescription drug benefit.

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OSHA officials attending a June 10 roundtable discussion involving unions, industry, academia and federal agencies offered contradictory opinions whether regulatory action is needed to reduce workplace accidents resulting from chemical explosions. The meeting came a day after organized labor petitioned OSHA to issue a more-stringent process safety management (PSM) standard, the main standard to prevent hazards resulting from chemical explosions.

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Generic drug company Andrx says an FDA advisory committee's decision that the over-the-counter (OTC) version of a popular heartburn drug is "approvable" does not mean the panel had no reservations about switching the product. During the last round of the battle between Andrx and innovator Procter and Gamble over Prilosec 1 (omeprazole), P&G said FDA should dismiss Andrx's arguments because the advisory committee already dealt with those issues.

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June 12, 2003

A tightly held Ways and Means Committee summary of the main GOP Medicare reform bill shows that House Republican leaders plan to craft a front-loaded prescription drug benefit to ensure that most seniors will benefit from the plan. The bill also attempts to address concerns pharmacies raised to last year's bill, includes Medicare modernizations, and would revamp the drug reimbursement system.

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A Bush administration proposal to reorganize the trade advisory committee system may prompt a number of pharmaceutical industry representatives and organizations to leave a chemical trade committee for other newly formed panels, a key industry source says. The reorganization appears to confirm the fears of some chemical industry officials, who have said that the removal of pharmaceutical representatives from the committee could dilute the panel's overall influence on U.S. trade policy.

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Sen. Edward Kennedy (D-MA) is in negotiations with Senate health committee chair Judd Gregg (R-NH) to garner bipartisan support for a bill that would give FDA regulatory authority over tobacco, a congressional source says. The source would not say what provisions are sticking points in the discussion. The Senate bill differs in several aspects from a House bill, which would fund FDA regulation of tobacco through industry user fees.

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A press by tobacco industry giant Philip Morris for the government to allow smokeless tobacco makers to market their products as safer than regular cigarettes is sparking a partisan debate on Capitol Hill, with the U.S. Surgeon General appearing to side with Democrats opposed to such claims. FDA is also being drawn into the debate, with Philip Morris trying to drum up support for legislation giving the agency authority to ratify reduced-risk tobacco claims.

Meanwhile, the Federal Trade Commission says it could use outside help to verify the science behind reduced risk claims.

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Two months after the public comment period ended, OSHA today announced plans to set up a crane and derrick rulemaking committee to help the agency revise safety standards in the construction industry. According to the June 12 Federal Register, "virtually all commentators agreed with the need to establish this committee." The committee's charter will be issued June 27.

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Bipartisan Medicare legislation looks set to pass the Finance Committee at the end of today's long and contentious markup, as senators from both sides of the aisle voiced support for the bill, which cobbles together a prescription drug benefit, a new privately run Medicare option and a host of measures designed to meet specific demands from committee members.

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