Tuesday, November 18, 2008
Kennedy Taps Clinton, Two Others For Health-Care Reform Roles
Senate health committee Chair Edward Kennedy (D-MA) on Tuesday announced Sen. Hillary Clinton (D-NY) will oversee a new working group on insurance coverage reforms, one of three new health reform panels to operate within his committee. Senate Finance Chair Max Baucus (D-MT), who plans to meet on Wednesday with Kennedy and the top GOP members of the Finance and health committees to hammer out jurisdictional issues, told reporters Tuesday that Finance still has authority over health care, although Kennedy’s health committee will play a large role in the upcoming reform debate.
CMS Anticipates Further Delays Of Part D Financial Audits
CMS doesn't expect final results until April 2009 for 81 financial audits of Part D plan sponsors, an agency spokesman tells Inside CMS, confirming yet another delay in the audit process for the 2006 program year that was slated for completion in October. The setback limits information available on accuracy of plan sponsors' payment reconciliation, including whether pharmacy benefit managers are keeping drug price rebates, as beneficiaries begin selecting plans for the 2009 program year during the open enrollment period that started Nov. 15.
Stakeholders Say OSHA RFI Meant To Improve Trade Relations With EU
In its final months, the Bush administration is offering the European Union and industry stakeholders yet another chance to make a case for getting around U.S. third-party safety inspection and approval of electrical products. OSHA, although a proponent of third-party certification, published a second request for information and comments Oct. 20 on whether the U.S. should consider a supplier’s declaration of conformity (SDoC) as an alternative to its nationally recognized testing laboratories (NRTLs) approval process.
FDA To Take Another Stab At Generic User Fees In 2009
FDA officials plan to meet with the Generic Pharmaceutical Association in coming weeks to discuss user fees for generic drug reviews, an agency official said. The last round of negotiations broke down in part because industry opposed FDA using the fees for foreign inspections, but since then problems at foreign drug making facilities have made headlines.
Court: Brands May Be Held Responsible In Some Suits Over Generics
Brand-name drug makers can be held liable for certain injuries caused by their generic competitors, a California court said this month. Although the California court sidestepped direct issues of FDA preemption, its decision is relevant to that debate, sources say.
Baucus, Kennedy To Meet Tuesday To Discuss Roles On Health Care Reform
Senate Finance Committee Chair Max Baucus (D-MT) said he plans to meet Tuesday morning with Senate health committee Chair Ted Kennedy (D-MA) and the top GOP members of both committees to hash out jurisdictional issues related to health care reform. Baucus indicated he still hopes to move health reform legislation in a bipartisan manner, but is willing to resort to partisanship if necessary.
FDA Device Center Scientists Allege Intimidation; House Dems Investigate
House Democrats are investigating allegations that scientists in FDA's device center were intimated and harassed into approving unsafe products. Several scientists sent a letter to Energy and Commerce Committee Democrats alleging a pattern of interference and retribution among senior center officials.
Drug Makers Expect Changes To FDA Safety Biomarkers Guides Soon
Drug makers believe the development of safety biomarkers will be stalled until FDA changes guidelines on data submissions from studies on biomarkers, sources say. FDA gave verbal assurance several weeks ago it has changed its policy, but FDA’s Web site still doesn’t reflect that, an industry source says.
Obama, Democratic Congress Could Change FDA Preemption Policy
President-elect Barack Obama said during the campaign that he intended to roll back the Bush administration’s push for FDA preemption, a doctrine the agency has advanced through both court briefs and regulations. Now, stakeholders are questioning whether preemption will be a high priority for Obama and the Democratic Congress, as well as the mechanics of a policy reversal.
