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Daily News

April 04, 2003

FDA drug center deputy Steven Galson vigorously defended the agency's drug review efforts at a conference this week, claiming that the increase in the total approval times does not mean the agency is taking longer to review drug applications. Instead, there have been fewer applications, which skews the median approval time because the approvals during the time period include older applications.

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FDA drug center deputy Steven Galson says the agency hopes to publish three new draft guidances by the end of September that will break new ground on managing drug risks, and urges stakeholders to get actively involved early on. The guidances will be based heavily on the concept papers issued recently by FDA on risk assessment, risk management and good pharmacovigilance practices.

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FDA has yet to decide how it will manage the biologics center and the drug center's staff in charge of overseeing advertising and promotional activities under the agency's plan to shift therapeutic biologics to the drug center, according to CDER Deputy Director Steven Galson.

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April 03, 2003

The Bush administration is laying the foundation for an appeal to its latest Medicare prescription drug discount card court loss. The move signals the administration's continued pursuit of its beleaguered drug card initiative, which to date has been a cornerstone of the White House's plans to curb Medicare beneficiary's pharmaceutical costs.

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A federal appeals court April 2 ordered OSHA to finalize a new permissible exposure limit (PEL) for hexavalent chromium by Jan. 18, 2006. The court adopted the timetable proposed by a mediator after OSHA and the petitioners in the lawsuit could not reach agreement. OSHA had asked the court for more time to issue the rule and the consumer group Public Citizen wanted OSHA to move more quickly than recommended by the court mediator.

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A coalition of cancer groups is calling on CMS to abandon the national coverage analysis process for an FDA-approved colorectal cancer drug, reiterating its stance that the agency should cover anticancer drugs approved by FDA. The cancer groups view CMS' latest move as an indication the agency is moving forward with a controversial plan announced last November to review whether Medicare should cover certain FDA-approved drugs.

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Senate Majority Leader Bill Frist (R-TN) is offering to amend measures that deal indirectly with a controversial provision that would drop lawsuits against manufacturers of the mercury-based preservative thimerosal, but the Senate health committee again had to put off marking up Frist's vaccine legislation because ranking Democrat Sen. Edward Kennedy (MA) refuses to budge until the thimerosal provision is scrapped or significantly changed.

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Following stakeholder lobbying, CMS has back-tracked on a draft proposal requiring Medicare+Choice (M+C) plans to give enrollees four days written notice before terminating coverage of certain medical services and is instead calling for two days advance notification.

The requirement is part of final M+C beneficiary appeal protections slated for release in the Federal Register April 4. CMS says the final rule provides beneficiaries with new appeal rights and financial protections when their M+C plan decides to terminate coverage of certain services.

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April 02, 2003

State feed control officials are urging FDA to move forward on a plan to broaden the existing ruminant feed ban by banning the feeding of poultry litter to ruminants and requiring a statement on pet food labeling cautioning buyers from feeding pet food to ruminants or cattle. The group says these two actions would further safeguard against the risk of bovine spongiform encephalopathy (BSE).

Last November FDA published an advanced notice of proposed rulemaking (ANPR) seeking input from stakeholders on whether these and some other changes should be made.

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FDA's decision earlier this month to issue a "Talk Paper" instead of sending a warning or untitled letter to SuperGen complaining about its promotional practices involving a cancer drug may signal a new enforcement stance by the agency, a key food and drug law firm says. This is the first time in over a decade that the agency used a Talk Paper instead of a warning or untitled letter to address an allegedly false or misleading press release, according to Arnold & Porter.

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A new report by the General Accounting Office (GAO) finds that HHS and other key agencies have failed to take adequate steps to identify critical agency assets and assess their vulnerabilities. The report examined HHS, the Departments of Energy and Commerce and the Environmental Protection Agency.

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The American Hospital Association (AHA) is calling on CMS to implement at least a 30-month transition period to protect hospitals "adversely impacted" by the agency's proposal to crack down on inappropriate Medicare hospital inpatient outlier payments. The request is one of several changes being sought by the group, which says it is "deeply troubled" by aspects of CMS' proposed outlier revisions.

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Closing the door on litigation, FDA will allow dietary supplement manufacturers to make a qualified claim that antioxidants can help reduce the risk of certain kinds of cancer if the claim is accompanied by one of three agency-approved disclaimers and meets other agency conditions.

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Two GOP amendments offered during the April 2 House Ways and Means Committee markup of Medicare regulatory reform legislation ignited a partisan battle over the bill, which had previously enjoyed broad bipartisan consensus. A key committee Democrat said Republicans "sold out to the lobbyists," and accused GOP lawmakers of breaking a deal on the legislation.

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Senate Democrats are vowing to fight the administration's version of smallpox vaccine compensation legislation on the floor after the Senate health committee voted April 2 along party lines to defeat four Democrat amendments, then passed the bill out of committee. Senate health committee chair Judd Gregg (R-NH) and ranking Democrat Edward Kennedy (MA) failed to even come close to negotiating a plan that both sides could agree to, according to Kennedy.

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April 01, 2003

Medicare regulatory reform legislation that was recently passed out of the House Energy and Commerce Committee with broad bipartisan support includes a provision that would require even those hospitals outside of OSHA's jurisdiction to comply with the bloodborne pathogens standard.

The bill states that failing to comply with the requirement would result in a civil monetary penalty in an amount "similar to the amount of civil penalties under [the OSH Act]." Similar language had been included in previous Medicare regulatory reform bills, which never passed the Senate.

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HHS Inspector General Janet Rehnquist has issued a "special fraud alert" aimed at stopping durable medical equipment (DME) suppliers from making unsolicited phone calls to Medicare beneficiaries. The Office of Inspector General (OIG) is upset that some DME firms are hiring independent marketing firms to conduct improper telemarketing.

"Suppliers cannot do indirectly that which they are prohibited from doing directly," the OIG's new fraud alert warns.

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Responding to a Public Citizen request that a proposed rule on hexavalent chromium be issued as an interim final rule, OSHA says it lacks the authority to do so.

In a March 25 submission to the United States Court of Appeals for the Third Circuit, which is calling for OSHA to finalize a hexavalent chromium standard and is working on the schedule for when the regulation should be completed, the agency says it "lacks statutory authority" to issue a proposed rule as interim final regulation.

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The medical device industry hopes to use a "corrections" bill to fix unworkable third-party-inspection provisions in the new device user-fee/reform law, according to an industry source. Staffers for Senate health committee chair Judd Gregg (R-NH) drafted a corrections bill months after the law was signed, but they postponed work on the bill to deal with more pressing legislation such as Project BioShield and the smallpox vaccine compensation plan, industry sources say.

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Canadian Internet pharmacies are trying to lure small U.S. pharmacies into illegally importing drugs from Canada by offering them lucrative contracts, according to a community pharmacy source. In most cases, the pharmacies are enticed with profits several times what they make off their average prescription orders.

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