Latest Drugwonks' Blog
Pursuant to yesterday's discussion of the HHS IG's report on FDA's oversight of non-US based clinical trials, some commentary from Leslie Ball, director, division of scientific investigations, Office of Compliance, FDA Center for Drug Evaluation and Research:
"As a consequence of that report, I think we will be looking, internally, at the quality of data a little bit more critically that's conducted outside the U.S. ...That might result in some additional analysis and soul-searching about whether or not requirements need to be put in place."
A new site-selection model already is under development that will move the agency to a more risk-based approach to determine which sponsors will be inspected, Ball said.
The factors that could trigger an inspection include the drug application and trial design, or site-specific risk attributes like enrollment and drop-out rate. FDA Principal Deputy Commissioner Joshua Sharfstein said in his response to the report geography also is a risk parameter in the formula.
"We are expecting that to be a little more complex," she said. "We also want to say that just when the regulated community figures out what our risk algorithm is, we will change it. So don't get too comfortable."
FDA also already is looking to expand its partnerships with other regulators, as was recommended in the report to maximize its resources. A pilot program with the European Medicines Agency to conduct joint inspections and share other information, if successful, could lead to more collaborations with other foreign regulators.
When it's a medguide ... maybe.
FDA is searching for a way out of imposing a REMS when only a medication guide is required.
According to John Jenikns, director of the Office of New Drugs (and the best dressed man at the FDA), having to develop and then assess the impact of medication guides as part of the REMS program is a burdensome administrative task for the agency, as well as for sponsors and pharmacies and society at large.
"We are looking to try and be creative in how we interpret that part of the statute, so stay tuned to see if we're able to find some creative ways around this," he said.
In the meantime, medguides remain a component of a REMS and "until we work through this further, there are a lot of medication guide-only REMS - a lot of burden on us, a lot of burden on you - that we'd like to try to get out of."
As of June 3, FDA had listed 123 REMS on its website. Eighty-four consist only of a MedGuide, while another 25 involve a medguide and communication plan. The other 14 REMS require sponsors to adopt elements to ensure safe use. Five of those also involve a MedGuide; three also have a communication plan; and the other six also require both a MedGuide and a communication plan.
If FDA does not find a solution it can implement itself, the next reauthorization of the Prescription Drug User Fee Act in 2012 offers an opportunity for legislative change. Industry and other stakeholders already have cited REMS as an area for focus during PDUFA V.
(And, hopefully, that's "V" like in "victory.")
The NY Times rejoinder to Elliot Fisher is devastating and could have been even more complete if Reed Abelson and Gardiner Harris had not pulled their punches on such aspects of the Dartmouth empire as it's deep involvement in and financial dependency on Health Dialog...
It also raises the stakes on the Berwick nomination since Berwick's love and faith in Dartmouth is well known and has been reciprocated. From an earlier NPR report"
ROVNER: So at first glance, the person President Obama has chosen, Donald Berwick, seems an unlikely candidate. He's a mild-mannered pediatrician and Harvard Medical School professor. But Dartmouth health policy researcher Elliot Fisher, who's worked with Berwick for years, says he's the perfect choice to implement some of the most sweeping changes to the nation's health care system in generations.
Dr. ELLIOT FISHER (Researcher, Dartmouth Health Policy): Don Berwick is a visionary leader who not only understands health care, but also understands and has shown that he can help physicians, nurses and hospital leaders work together to improve the care that patients receive.
www.npr.org/templates/story/story.php
I smell hypocrisy and an unwillingess to respond to this important question.
Congressman Todd Tiahrt (R,KS) from CMPI on Vimeo.
Senator John Barrasso (R,WY) on Health Care Reform from CMPI on Vimeo.
Senator John Barrasso (R,WY) on Health Care Reform from CMPI on Vimeo.
Once you get past the wonk talk about Markov estimates and parametric projection models the key considerations were the following:
"no data for the stable disease subgroup were provided to allow separate consideration of the use of erlotinib in squamous and non-squamous disease. Furthermore, no evidence was provided comparing erlotinib with pemetrexed in patients with non-squamous disease who have stable disease after first-line treatment."
And,
"The Committee discussed whether the SATURN study could be generalised to UK clinical practice and noted that there were few UK patients and a high proportion of patients from Southeast Asia in the study. The Committee noted a comment from the ERG that Asian people are known to respond better to lung cancer treatments than other races. The Committee heard from the clinical specialists that there are no significant reasons why the relative benefit of erlotinib in the SATURN trial would not also be seen in the UK population."
And
"It also heard from clinical specialists that patients with EGFR mutations have a longer natural history of disease and a better prognosis than other patients with non-small-cell lung cancer. The clinical specialists also commented that the small proportion of patients with EGFR mutations in the SATURN trial would be similar to the UK population. The Committee noted that no one in the SATURN trial had received first-line treatment with pemetrexed and cisplatin, which is now becoming a commonly used combination chemotherapy regimen for patients with non-squamous disease. It therefore concluded that there was uncertainty about the clinical benefit of erlotinib in patients who had previously received pemetrexed and cisplatin."
Do I think Tarceva should not have been approved. No. Because it would make more sense to allow reimbursement, encourage biomarker development and contribute to personalized medicine.
But the NICE consultation process reveals a deeper appreciation of the role of biomarkers in evaluating treatment effectiveness than the current bone headed approach being funded by AHRQ.
www.nice.org.uk/guidance/index.jsp
effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
