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After perhaps the most intense week of legislative work on health care ever in the US, the sudden calm the week of June 26 is almost disconcerting. But the annual Fourth of July recess may be a key period for health care reform: it could be the last chance legislators have to touch base with their constituents before being forced to commit to a vote on reform.
The politics of health care reform are playing out in the White House and both chambers of Congress. Despite almost daily hurdles and challenges, are the administration’s plans still on course? The RPM Report reads the tea leaves to help you prepare for a busy summer in Washington.
The health care reform debate is entering the critical phase. Here are our predictions for where the legislation will end up.
New FDA Commissioner Hamburg lays out her priorities for the agency and believes she can restore FDA’s credibility much like she turned around the New York City Health Department.
The biopharma industry and its allies have gone about the comparative effectiveness debate in misguided fashion and given themselves a black eye in the process, despite stated support for the initiative. Now it’s time for companies to focus their resources and consensus-building strategies around standards of evidence to support reimbursement decisions.
FDA’s top management can’t be accused of overstating the importance of the agency’s new drug safety tools. But sponsors need to wake up to the reality: the REMS are a critical fact of drug development and marketing.
It’s not often than any industry group voluntarily agrees to give up $80 billion in future revenues, but that’s what the Pharmaceutical Research & Manufacturers of America is pledging to do to in the context of the health care reform debate. There are a lot of details to work out, but this is a case where what is important is not what PhRMA is giving—but what it gets.
The new FDA senior leadership duo of Hamburg and Sharfstein are sending signs that they are ready to identify some object lessons for high-visibility enforcement actions. A former FDA chief counsel and Justice Department chief of staff warn that the agency should pick its targets carefully. Enforcing regulatory priorities instead of regulatory law can get the agency into difficult situations.
