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Rosa DeLauro came to an Institute of Medicine meeting on regulatory science to praise FDA’s new leadership and to take credit for increasing its resources. But she also trashed the agency’s handling of Avandia. It isn’t clear that science has anything to do with that debate, but resolving it looks like a critical test for the agency and its new leadership this summer.
Michael Loucks stepped down as acting US Attorney at the end of 2009, after a career that put him at the center of many of the largest health care fraud prosecutions in the pharmaceutical industry. We spoke to him about what happens next, for industry, for prosecutors—and for him.
Agriculture Appropriations Subcommittee Chair Rosa DeLauro is a critical figure in FDA’s quest to secure expanded resources to support regulatory science. The good news: she believes in the cause. The bad news: she has a lot of other changes she would like to see at FDA.
The Center for Drug Evaluation & Research approved one more new molecular entity in 2009 than it did in 2008. But dig a little deeper and there is promising evidence that the approval trend is on an upward trajectory. It is far too early to declare a turnaround, but at least there are signs that the FDAAA era is translating into more products making it to market.
Critics of Big Pharma’s deal with the Obama Administration reacted with glee to the sudden collapse of the final reform bill in January. But for investors betting against reform, there was no payoff. The only winner may be uncertainty.
Senate Finance Committee report and internal FDA analysis on cardiovascular risks associated with GSK’s Avandia may revive argument to split CDER into two groups of safety and efficacy reviewers.
The Institute of Medicine convened a two-day meeting in late February to review approaches for stimulating commercial interest in biodefense efforts and assuring adequate supplies of products. The speech below was prepared by a long-time legislative and industry expert in the area of biodefense, Chuck Ludlam, for a session at the IOM meeting on Blue Sky alternatives to the existing system. Ludlam says the model for a positive system already exists in an unenacted bill from 2005, BioShield II.
Kaiser recognizes that some sponsors are trying to use REMS to make an end-run around gatekeepers, and it is fighting back. The non-profit integrated care system wants FDA to help, filing a citizen petition that could profoundly affect commercialization of new products in the US. The recently approved MS drug Ampyra offers a case-in-point.
The long-awaited Risk Evaluation & Mitigation Strategy for Aranesp and Procrit is here. For the oncology indication, it requires provider training program enrollment. It may not seem like the best outcome for Amgen and J&J, but there are some upsides.
The lead story at HHS took a sharp turn with the unveiling of the President’s budget for 2011: From expanding health care coverage to collecting penalties from miscreants. HHS is setting high return standards for its fraud activities: $1.55 in net returns to the government for every dollar spent. That may drive HHS to continue to press big pharma for big settlements—and assures more publicity for settlements in the pipeline already.
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.
