WASHINGTON — The budget crunch in Washington is on the minds of policymakers everywhere, which holds for the FDA budget as much as other agencies. FDA commissioner Margaret Hamburg, MD, addressed the annual conference hosted by the Food and Drug Law Institute (FDLI; Washington) and said that despite the doubling of user fees under the latest device user fee agreement, she "remain[s] enormously troubled that FDA's responsibilities continue to outstrip resources."

WASHINGTON — Device makers concerned about the effect of healthcare reform on coverage and reimbursement for their devices have closely eyed the goings-on at the Centers for Medicare & Medicaid Services, but Jonathan Blum, CMS's deputy administrator, tried to reassure attendees that the agency is taking a longer-term view of the cost dilemma. Responding to a question from the audience, Blum said CMS's view is that the cost question is "more about the total cost of care" rather than "cost per click."

April is not yet complete, but two items of interest already bear noting. One of these is perhaps the most important patent case to be heard by the Supreme Court in a long time, at least where life sciences are concerned. The other is of broader but no less intense interest to device makers. Myriad at SCOTUS Leading off is the April 15 hearing of the Myriad case at the Supreme Court, a hearing during which Justice Elena Kagan remarked that the Patent and Trademark Office is "very patent-happy." Of all the comments signaling a jurist's likely vote, this was...