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The President is inviting Republicans to a televised health care summit to restart health care talks. Why is he doing it? The history of the 2008 campaign may offer a clue.
FDA is planning a spring meeting to discuss next steps in a class-wide Risk Evaluation & Mitigation Strategy for opioids. The outcome will redefine the rules of commercial success in the pain class—and provide a critical case study for how FDA’s new regulatory tools may reshape other sectors over time. The good news: there appear to be new opportunities amid the change. The bad: industry is definitely not driving the process.
King Pharmaceuticals is pursuing an interesting business model for pain therapy: driving abuse-resistance via continual innovation in formulation technology. It might be a home run in the current regulatory climate—provide King can stay on the right side of the regulators itself. The RPM Report sat down with King CEO Brian Markison and Chief Scientist Eric Carter during the JP Morgan health care conference in January.
The Massachusetts special election changed the entire health reform landscape, leavingthe Democrats a vote short in the Senate to pass a merged House-Senate bill. The broad opportunities for biopharma tied to interdependent provisions in sweeping legislation may vanish with the possible death of the bill. Where does the drug industry go from here?
Several of the highest profile new drug applications pending or expected to be submitted as 2010 begins involve potential blockbuster market opportunities. They also lack Big Pharma partners. Is Big Pharma really that picky? Or are the applications out of step with the regulatory and commercial climate? Either way, intense investor interest will keep FDA in the spotlight.
The US prescription drug market remains anemic, but don’t blame the federal government. The Medicare Prescription Drug Benefit that began in 2006 is the only reason there has been any growth in the retail sector. No wonder industry has been pushing so hard for health care reform.
FDA’s transparency initiative is starting to take shape. While many industry executives see the value in making more information available to the public, one idea makes them nervous: publicizing the letters FDA sends when it declines to approve a new drug or biologic. Top FDA officials already support making “complete response” letters public, and the Commissioner’s office is open to the idea. How should industry prepare?
The Food & Drug Administration faces a difficult, legislatively-mandated requirement in the anti-infective area. It is charged with updating antibiotic susceptibility charts in labeling for approved drugs. That is a huge task – almost equivalent to re-reviewing the large cadre of existing antibiotic drugs. To try to achieve that task without disrupting other new antibiotic review activities, the agency has proposed trusting an outside standards group for help. That sounds like a practical solution; but Capitol Hill is raising political questions about agency autonomy.
An HHS departmental appeals board decision finds Purdue executives at fault despite plea and convictions based solely on the Dotterweich and Park doctrines.
Conflict of interest remains a thorny topic in the conduct, analysis and dissemination of clinical trials. Four panelists on a recent Windhover Webinar offer their perspectives on how private companies can best align with the public interest goals of medical research.
