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Daily News

April 23, 2003

A key FDA pediatrics official says brand-name drug companies may decide to do pediatric studies of their off-patent drugs -- even though they cannot receive exclusivity -- because they do not want their generic drug competitors to dictate what information goes on their drug labels. Under the pediatric exclusivity law, the company that studies a drug for use in children is the company that negotiates any changes to the drug label with FDA.

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CMS is resisting pressure from lawmakers on both sides of Capitol Hill to rescind language in the hospital outpatient prospective payment system (OPPS) rule that lays out a "functional equivalency" method for determining reimbursement levels of new drugs. A CMS spokesperson told Inside CMS the agency would not reopen the record or pull back parts of the rule.

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April 22, 2003

The American Academy of Pediatrics (AAP) objects to an FDA final rule allowing beverage companies to use vitamin D3 in calcium-fortified juice drinks. AAP argues that the rule could encourage parents to give their children too much juice, adding to the national epidemic of childhood obesity. The group is asking FDA to hold a hearing on the issue and conduct a risk assessment before implementing the rule.

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The Bush administration's long-awaited chemical security bill will require chemical companies to submit vulnerability assessments to the government, according to a key congressional aide, countering speculation from environmental groups that the bill would allow companies to keep these assessments on-site.

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Senators working on comprehensive vaccine legislation shoring up support for a compromise they reached three weeks ago that nearly fell apart at the last minute when Senate health committee chair Judd Gregg (R-NH) postponed a mark-up of the bill, according to a spokesperson for Senate Majority Leader Bill Frist (R-TN). Senators are still discussing the compromise over recess, which they are supposed to mark up soon after recess, but the spokesperson said they are not negotiating, rather "solidifying an understanding" of their previous agreement.

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FDA's suggestion in a recent concept paper that comparative safety data could be useful in certain circumstances signals a change in agency policy, a drug industry lawyer says. The agency's move suggests that requiring comparative trials could become a standard for initial product approvals, the source says.

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The European Commission has launched a two-pronged assault aimed at assuring the Bush administration that it is working to lift an informal member state moratorium on approvals of genetically modified organisms. Amid signs that the United States is at a minimum aggressively seeking international support for a potential challenge of the EU's moratorium at the World Trade Organization, the commission has written to almost 200 members of Congress contending that approvals could start as early as the middle of the year.

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House Energy and Commerce Committee leaders April 22 called on HealthSouth and its auditor, Ernst & Young, to turn over records related to financial irregularities at the company. The congressmen, in a letter to HealthSouth Acting Chairman Joel Gordon and Ernst & Young Chairman James Turley, requested the company provide internal documents related to federal fraud charges and Medicare and Medicaid abuses.

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April 21, 2003

FDA is asking blood banks to quarantine blood from donors suspected of having severe acute respiratory syndrome (SARS), according to an FDA release. Although there are no known cases of SARS being transmitted by blood, scientists have detected the genes of a possible causative virus in the blood of a SARS patient.

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A commercial speech association is calling on the Federal Trade Commission (FTC) to reform the way it conducts "nonpublic" investigations of food and supplement health-benefit advertisements the agency believes are deceptive. The group says FTC's practice violates the First Amendment and causes food firms to self-censor even non-misleading information.

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Correction: This article incorrectly reported that FDA Commissioner Mark McClellan plans to hire as many as 10 or more political appointees to push his agenda. He has hired three bureaucrats from outside the agency for key positions and will likely hire one more. However, none of these new hires are political appointees, which require a lenghty White House vetting process. FDA Week regrets the error.

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Right-to-know activists are sharply criticizing a rulemaking by the Department of Homeland Security (DHS) restricting public access to sensitive information, arguing the rule imposes burdens on other federal agencies beyond what was specified in legislation creating the new department.

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The General Accounting Office (GAO) has curtailed its investigation into the legality of a CMS ban on Medicare contractor-based outreach and education efforts following news that the agency has formally reinstated the program.

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As House GOP leaders prepare to unveil their Medicare reform plan, a group of five senior Energy and Commerce Republicans is independently crafting its own prescription drug legislation, according to a source close to the effort. That bill would create a drug benefit within Medicare but also provide incentives to direct seniors to a privately run, comprehensive benefit package dubbed "Enhanced Medicare."

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A coalition of dietary supplement trade groups has issued a release emphasizing that supplement companies should not promote their products as treating or preventing severe acute respiratory syndrome (SARS). Industry sources say they want to distance themselves early on from those who make such illegal claims, just as they did during the Anthrax attacks.

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April 18, 2003

Hospital emergency department staffing companies would be able to bill CMS directly under separate Medicare regulatory reform bills approved last week by the House Ways and Means Committee and last month by the House Energy and Commerce Committee.

The two bills, which are being reconciled for a floor vote, have slightly different language owing to the complicated nature of the statute that governs what types of provider entities can enroll under Medicare.

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Drug company Dr. Reddy's Laboratories is defending FDA's 505(b)(2) policy, arguing that FDA can use 505(b)(2) as a pathway for companies that rely on brand-name drug makers' private data to get their products approved. The company is responding to Pfizer's recent bid to block FDA from approving Reddy's amlodipine maleate tablets, one in a series of challenges Pfizer has mounted to the policy.

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Former high-ranking FDA official Bruce Burlington says FDA's application of science is discouraging drug development. Burlington says FDA requires the latest scientific techniques and advances to be used, even if they do not significantly provide value and burden industry. Burlington recommends that the agency institute peer review of field inspectors and provide industry a chance to provide input before the agency publishes draft drug guidances.

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The head of FDA's office in charge of reviewing new drugs is urging the drug industry to stop sending the agency incomplete or low-quality new drug applications (NDAs). The official said FDA often accepts applications that are incomplete or not up to standard, and rarely refuses to file new drug applications. If a company takes the time needed to prepare a quality application, instead of submitting a substandard application at an earlier date, it will help speed drug approval, the official added.

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OSHA has enlisted help from unions and trade groups to develop draft ergonomics guidelines for the shipyard industry by the end of the year, marking the fourth set of ergonomics guidelines planned by the agency.

Guidelines for the nursing home have recently been completed and OSHA plans to soon announce draft guidelines for the retail grocery and poultry processing industries.

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