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FDA NEWS RELEASE
For Immediate Release: August 3, 2009
Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA, European Medicines Agency Launch Good Clinical Practices Initiative
Collaborative effort aims to ensure appropriate conduct of clinical trials
The U.S. Food and Drug Administration and the European Medicines Agency (EMEA) today announced an agreement to launch a bilateral Good Clinical Practices (GCP) Initiative, designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted uniformly, appropriately and ethically. The initiative will begin with an 18-month pilot phase on September 1, 2009 and will focus on collaborative efforts to inspect clinical trial sites and studies. Products regulated by the FDA’s Center for Drug Evaluation and Research in the United States, and by the EMEA for the European Union will be the focus of the initiative.
“Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This important effort will help to strengthen safeguards for participants and others involved in clinical studies.”
Key objectives of the FDA-EMEA GCP initiative will be:
--To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
--To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
--To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.
“The clinical development of medicines is a global undertaking,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “With limited resources available to address the global nature of clinical research, this is an outstanding opportunity for the FDA and the EMEA to work together to carry out inspections and share information.”
At the conclusion of the pilot phase, a joint assessment will be made by the FDA and the EMEA, with the scope and process modified and amended as needed.
"This is another initiative that will further strengthen the very robust relationship between the FDA and the EMEA," said Murray M. Lumpkin, M.D, Deputy Commissioner for International Programs. "This will allow both the FDA and the EMEA to leverage each other's GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality."
According to Bloomberg, Novartis AG’s two-year effort to revive its Prexige pain pill after it was rejected by
Novartis may re-submit a marketing application for Prexige to the Food and Drug Administration this year along with a genetic test that can detect who may suffer the liver damage that arises in some patients, said Michael Nohaile, the head of Novartis’s new molecular diagnostics unit. The test would be obligatory for patients to obtain a prescription, a first for the drug industry, he said.
“This is a very real opportunity now,” Nohaile said in an interview at the company’s
While a growing number of treatments are marketed as personalized medicine, with genetic tests to allow doctors to determine which patients will benefit, Prexige would be the first with a test to ensure safety. Drugmakers see testing as a way to persuade regulators and insurers to approve and pay for the medicines by showing that they’re effective.
Novartis is counting on the test to reassure doctors and patients. With a test showing that a certain drug will be safe, Nohaile said, “We can go to doctors and say it moves it out of the realm of choice into the realm of malpractice if you don’t use this drug.”
Click here for the entire Bloomberg article.
What do you call a medical home without a physician? Well, for starters, you can call it HR 3200.
HOUSE HEALTH-CARE BILL WOULD ESTABLISH 'MEDICAL HOME' FOR THE ELDERLY AND DISABLED
By Marie Magleby
(CNSNews.com) - The House health-care reform bill proposes to decrease hospital visits by establishing a “medical home pilot program” for elderly and disabled Americans.
Such a medical home would not require a physician to be on the staff, and therefore could be run solely by nurse practitioners and physician assistants. Medical homes also would practice “evidence-based” medicine, which advocates only the use of medical treatments that are supported by effectiveness research.
But physicians’ groups say the legislation could lead to restrictions on which treatments may be used for certain conditions, despite the fact that some patients might require a unique or unconventional approach. It also may lead to dumping Medicare/Medicaid patients in facilities that are not required to have physicians on staff.
The Center for Medicine in the Public Interest (CMPI) expressed its concerns in a report that explains why statistical evidence does not always reflect reality of effective medicine.
“‘One size fits all’ rarely does,” the report said. “From clothes to shoes to hats, few people find that items carrying that label work with their individual bodies. So why do we entrust the health of our bodies -- one of the most important assets we have -- to a one-size-fits-all mentality?”
With so many articulate, high-powered brains talking about healthcare reform these days, it’s refreshing to debate someone like the former Boy Mayor from Cleveland. He’s so deeply entrenched in Kumbaya fantasyland that it’s really the next best thing to the Daily Show. Except that it’s not funny.
Mr. Kucinich tried to convey his message of a healthcare system that was paid and provided for by the federal government – but wasn’t run by the government. Um, right.
He also wanted to make it very clear that he wasn’t for “socialism,” but rather for a national healthcare system that ran like a “non-profit. Welcome to Kucinichcare via “non-profitism.”
It’s an interesting rhetorical finesse – but isn’t a system that’s run by the government minus any free-market incentives well, socialism?
Maybe Mr. Kucinich should introduce a bill called “the Non-Profitism Manifesto?”
Video shortly.
How to Encourage Biotech Innovation
There's no evidence to suggest that granting makers of biologic drugs 12 years of market monopoly "would drive costs even higher" for these drugs. In fact, shortening the monopoly period is likely to raise the price of biologics.
Academic research shows that a biologic producer needs more than 12 years of exclusive sales to break even on the development costs of a new drug. If a firm faces competition from biosimilars any earlier, it would probably raise prices for its innovator biologics, as it must recoup its initial investment within a much smaller monopoly window. As a result, cutting-edge medicines would become even less affordable.
Peter Pitts
President
Center for Medicine in the Public Interest
New York
Read more here.
Meanwhile, the increasingly anti-pharma fiercepharma can't say enough about how horrible it is that CER can't be used to deny people access to new drugs and devices... Because if people die in the pursuit of denying drug companies profits, that's just the cost of advancing one's ideology... My advice, to the fierce proponents of public options and government guided decisions... why not enroll in Medicaid and tell the rest of us lesser mortals what it's like? Put your lives where your mouthpieces are (or is??)
Read here
Meanwhile, I will move to Mr. Rogers' neighborhood.
The Wall Street Journal reports, “Declining popularity of the health-care overhaul reflects rising anxiety over the federal budget deficit and congressional debate over the most contentious aspects of the legislation, including how to pay for it. The poll also shows concern over the role of government in determining personal medical decisions.”
The New York Times reports, “President Obama’s ability to shape the debate on health care appears to be eroding as opponents aggressively portray his overhaul plan as a government takeover that could limit Americans’ ability to choose their doctors and course of treatment.”
Translation: Americans are really concerned that healthcare reform has moved from the “first principle” of providing insurance to the uninsured to a big power grab that would turn Uncle Sam into Uncle Sam, MD.
And concern is most definitely warranted.
Nowhere is this more important then when it comes to the issue of comparative effectiveness. Current legislative drafts generally refer to “clinical effectiveness” – a more appropriate term. But, when you peel back to onion what most pro-big government advocates mean is “cost effectiveness.” These terms are not (nor should they be) interchangeable.
For more on this issue, have a look at the Reuters “Great Debate page. The relevant article is, “In determining healthcare cost, one size doesn’t fit all.”
The editors dedication to doing so is evident even when their support of the "public option" doesn't square with the news the provide readers... as in this delicious morsel of cognitive dissonance from editor Anne Zieger...
Establishing a government-run public health plan to compete with private health plans may be a great idea, or the model may truly be rife with those nasty "unintended consequences" its opponents like to cite. I simply don't have enough data to tell you whether it's a good idea for the long term.
But what I can tell you is that as a blunt instrument, it seems that analysts are pretty much agreed that a public plan will have the immediate effect the Obama administration is hoping for, which is to drive down private health insurance costs. A new study by Lewin Group is only the most recent to project that a government-run plan would come in with much lower premiums than its private competitors--in its case 20 percent lower. And sure enough, private health plans will have to respond with big price cuts of their own.
True, if you're a financial manager reading this, one of those pesky "unintended consequences" is probably that you'll find that your reimbursements falling. Private health plans are going to pass those price cuts on to you, after all. Hopefully, you'll make up the difference by seeing far more insured patients walk in your doors, a deal that's pretty much on the table under any version of reform, but yes, for the short term you'll be in a scary place. Hopefully, though, the longer-term picture includes a more-stable system that works better for everybody.
Overall, the bottom line is that at present, giving way on a government-option plan is a pointless compromise that wastes not only an enormous amount of Congressional time and effort, but also a unique moment in history when the President, the Congress and the people are agreed that it's worth seeing everyone take some big bruises to fix some of health system's biggest problems.
Namby-pamby half-measures like a health co-op, which, let's face it, still has an incentive to keep its medical expense low so it can grow and attract new members, are feel-good nonsense which do nothing to take advantage of the government's powerful position in the industry. Create health co-ops and you've only added another player to basic capitalist cycle, not-for-profit though it may be.
So I say, come on now, Congressional leaders. Don't pussy-foot around--be honest and forceful about what the government option is intended to do. It's designed to hit the health insurance industry with a clue-by-four and let it know that the time of extreme profit-taking is on its way out. If you can't get that through, so be it, but at least you'll have fought the good fight. Don't let this once-in-a-lifetime chance to save countless Americans' lives and health go away because you refused to take a real stand. - Anne
Meanwhile there are these stories about the impact of government involvement on "profit taking"... (which will also affect Anne's job no doubt..)
According to a new analysis by The Lewin Group, under a health reform draft currently under consideration by Congress, the number of uninsured Americans would fall dramatically, by about 32. 6 million, and premiums for a "public option" plan would be an average of 20 percent less than private plans for families.
However, things don't look so rosy for providers, the report suggests. Hospitals that accept Medicare and other public plan reimbursements would see cuts that take them down to an average of 32 percent below what private health plans pay. Physicians would see their pay cut by an average of 14 percent below what private insurances pay out for a given treatment, Lewin's analysis concluded.
While Lewin doesn't make a big deal of it, apparently it does support the conclusion that a public plan would put considerable pressure on private plans to lower their premiums, something employers and consumers are likely to favor. However, clearly providers face a real threat here. This data is definitely something to chew on..
Yes indeed, especially since a lot of those private sector providers are in the non-profit sector, and accept a whole bunch of Medicaid and Medicare folks already. Meanwhile there is this, also in Fiercehealthfinance...
The next few months shouldn't be much better for non-profit hospital systems than the first half of 2009 was, according to a new report from financial ratings firm Standard & Poor's. S&P says that with the recession continuing to grind away at balance sheets and credit market troubles limiting access to cash, systems are continuing to struggle.
The agency reports that median operating margins fell or remained flat for the 134 systems it rates, regardless of their credit rating. Overall, the median operating margin for the group was 2.4 percent, compared with 2.8 percent the prior year.
Net margins, which take into account plunging investment income, fell from 6.3 percent in 2007 to 2.5 percent in 2008. Meanwhile, cash reserves were sapped as health systems used savings for capital investments and pension funds, and to post collateral on interest-rate hedges known as swaps.
As a result of these pressures, health system rating downgrades doubled in 2008, to 18, with S&P lowering the outlook for 27 systems, up from 14 such actions the previous year.
To learn more about the S&P report:
Read this American Medical News piece
I am sure all that public reimbursement will make the non-profit situation just namby-pamby....
Good thing Anne has that quality of care and impact on life expectancy and morbidity issue worked too... particularly among the chronically ill seniors, poor minorities and low birth weight neonates... but maybe that's just the namby-pamby in me...
At least Zieger is honest: a government takeover of health is a blunt instrument: price controls and rationing.
Now I am wondering if she was being sarcastic or serious?
Read more here
Permit me to share some personal information – my eldest son has epilepsy. The good news is that his condition is under control due to the wonders of modern medicine. For that reason, today’s Good Morning America segment on generic drug substitution (minus patient and physician knowledge or consent) hit a particularly resonant chord.
Here’s how GMA began its report:
"Imagine going to the pharmacy to fill your prescription only to learn later that the drug your doctor prescribed is not the one you received. The prescription was switched without your knowledge or permission. Pharmacies could be switching your drugs without your knowledge. Not just switched to a generic version of the prescribed drug, but to a different drug altogether. That is exactly what happened to Amy Detrick, who said her pharmacist switched her epilepsy medication without her permission.”
The report also interviews Sally Greenberg, executive director of the National Consumers League, "We believe that if a patient is switched from one drug to another, that it should not be legal unless the patient and the doctor have been informed and are on board with the switch."
(The complete Good Morning America segment can be found here.)
In October 2008, National Consumers League released a survey of 1,035 prescription drug users on therapeutic substitution issues this morning. The survey was conducted by Harris Interactive. Full results and additional materials are online at www.nclnet.org/health/switching/ and the press release is at http://www.nclnet.org/news/2008/therapeutic_substitution_10012008.htm.
Key data points include:
- Respondents very much oppose health insurance companies providing incentives to pharmacists (55%) or physicians (55%) for switching patients to lower cost alternatives to medications.
- Vast majorities of respondents (78%) very much favor an explicit requirement to consult the physician before any and all therapeutic substitution takes place.
- Vast majorities of respondents (85%) very much favor a requirement that patients always be notified if their prescription is changed.
- A large majority of the general population are not sure if there is a law in their state that regulates therapeutic substitution (90% of the Rx users), but 50% of Rx users somewhat or very much favor legislation.
Patient Awareness of Therapeutic Switching is Low, but Patients Believe it is Happening
- As expected, awareness of the concept of therapeutic substitution – and the difference with generic substitution – is low.
– 2 of 3 prescription users are unaware therapeutic substitution
– Only 1 in 4 prescription users are unaware that therapeutic substitution involves replacing the prescribed drug with a chemically different one
- The vast majority of Rx users think that therapeutic substitution occurs at least sometimes in the
Switching Doesn’t Always Result in Positive Outcomes
- 15% of general Rx users saying that they or a family member experienced therapeutic substitution
– Nearly half of Rx users (47%) were dissatisfied (or their family was) with how the process occurred and report that this substitution did not result in lower pocket costs.
– More than a third (40%) said that the new medication was not as effective as the original one, and nearly a third (30%) experienced more side-effects following the substitution.
– Large majorities of Rx users think that the potential side effects of the new medication, the patient’s medical history, how well the drug works and the prescribing physician's opinion are factors that are absolutely essential when decisions are made about therapeutic substitution.
Just as no two patients have the same biochemistry, no two medicines are exactly equivalent. But if your primary goal is to reduce short-term costs, that's an inconvenient truth.
I am a big believer in FDA-approved generic drugs. They are safe and effective and represent an enormous opportunity for health care savings. I applaud insurance company programs that seek to educate consumers about them. However, I am a bigger opponent of forced switching. Disempowering physicians and patients results in bad outcomes.
The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.
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.
