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FDA Commissioner Andrew von Eschenbach made his second appearance in two days before Congress to support the agency’s proposed 2008 budget, but he also had to defend the agency’s handling of Ketek and other controversial topics.
The Centers for Medicare & Medicaid Services (CMS) is guilty of fostering a monopoly in the treatment of anemia and may also be placing the public in jeopardy through its policies, lawmakers say.
FDA Commissioner Andrew von Eschenbach defended the agency’s budget proposal for 2008 to a Senate subcommittee, saying funding increases and new user fees would help accelerate drug approvals and improve product safety reviews.
Days before the start of a hearing challenging India’s drug patent laws, House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) called for an end to the challenge by Novartis, saying that a victory for the company could limit access to low-cost generic drugs.
A newly published survey suggests that orthopedists want to see a shorter FDA drug approval process and a return to the market of Vioxx, despite the agency’s concerns with the drug.
With the rapid evolution of gene-based diagnostics and targeted drug therapies, a movement to protect the confidentiality of genetic information is picking up steam. Concerned that fear of genetic discrimination is undermining R&D and market traction for gene-based products, lawmakers last week reintroduced a bill addressing the issue.
An FDA program that encourages eligible device firms to pay accredited organizations to conduct their inspections rather than having the FDA conduct inspections for free may work better for larger firms than smaller ones, according to a new report.
Outgoing Senate Majority Leader Bill Frist’s (R-Tenn.) last-minute effort to push through the Bush administration’s choice to be FDA commissioner was successful as the Senate voted overwhelmingly late Dec. 7 to approve the nomination.
Andrew von Eschenbach’s nomination to be the next FDA commissioner remains stalled as the agency’s efforts to reach a compromise with a prominent lawmaker over access to an ongoing clinical trial investigation have failed. Read More