Latest Drugwonks' Blog
Isn’t it about time that CDRH is renamed the Center for Medical Technology?
The U.S. Food and Drug Administration has proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.
For the complete FDA announcement, see here.
"We do what we must, and call it by the best names."
-- Ralph Waldo Emerson
I've got a little list, I've got a little list
Of healthcare regulators who PDUFA doth confound
With deadlines often dissed, they never would be missed.
I believe it was former US Senator, Everett Dirkson who first said, “When I feel the heat I see the light.”
Now it’s time for folks at the FDA to repeat it. Repeat it, in fact, as a mantra.
As you’ve surely heard, House Approps has FDA on its little list of cuts to 70 accounts that will be included in the CR. And included on that list is a $220 million cut to FDA. (The list does not specify how those cuts are to be allocated but, if enacted, would be implemented over the final seven months of the current fiscal year - -which ends on March 4th.)
The general sense is that the Appropriations Committee will not hold a markup, rather the bill is expected to be brought to the floor next week under an open rule. That means the number of amendments to be filed could reach into the thousands, so where things end up is anybody’s guess.
What is pretty clear is that FDA is, indeed and as predicted, in the Congressional crosshairs.
Repeat after me, “When I feel the heat I see the light. Om.”
Remember, that $220 million won’t come from PDUFA fees but rather from that piece of the FDA budget largely allocated for staff and school supplies. And there’s no fat there. None. (Note: Despite the dearth of new obesity medications, this is most certainly NOT a good thing. Indeed – it is a dangerous thing. Very.)
But this proposed cut is, in many ways, tied to the PDUFA debate. The current deliberation surrounding PDUFA reauthorization, at its core, is a discussion of first principles – of predictability, consistency, transparency, and cooperation.
When I feel the heat, I see the light.
Perhaps the best way for the FDA to counter the very unfair and perilous call for bone-deep budget cuts is for FDA Commissioner Hamburg to raise go in front of the committee, raise her right hand and say, “I want a more accountable FDA.”
But shouldn't more money be tied to what my colleague Peter Pitts calls for: "responsible and predictable behavior on the FDA's part?"
We have heard the complaint that FDA is under-funded for decades. But all bureaucracies say that if they had more money, they could do more. The question is, what is FDA doing with the money they have. Or as Lincoln once observed: "Be what you are. But be a good one."
The FDA is spending way too much time and money on regulatory science that does nothing to encourage the use of biomarkers in clinical trials.
Instead of following the critical path, it is more inclined to apply the precautionary principle to product approvals.
By framing its decisions on relative risk it has raised the bar for product approval in ways that make even helpful products unavailable. And by shifting standards for post market review of drugs like Avastin it demonstrates that it cannot always be trusted with the money it has...
The FDA should show how it will get back on the track it was taking before Vioxx before it asks for money. It should show it will be something different, not a smaller version of what it currently is.
Or as Steve Martin put it: A day without sunshine is like, you know, night.
Virginia Heffernan’s article (Prescription for Fear www.nytimes.com/2011/02/06/magazine/06FOB-Medium-t.html) claims WebMD is a less trustworthy health info than Mayo because it (in her words) shills for drug companies.
She should be less concerned about drug advertising and more about how online health sites are used to shape public perception. If she did, she would have focused on all the sites that spread anti-vaccine fear. Most of them are not in it for the money. Those that are hawking their own products.
Moreover, she ignored how mainstream coverage, relying on such sources, spread panic and misinformation. The media perpetuated the anti-vaccine ideology, overstated the risks of anti-depressants and recently called a 1 in 3 million occurrence of a rare lymphoma in women with breast implants a “link.”
Ms. Heffernan is right to be wary about many online health sites. But her concern with WebMD is misplaced. WebMD’s medical reporting copies other news outlets. She should have focused on her own industry’s mangling of medical information.
Peggy Hamburg’s letter to the editor (Washington Post, February 4, 2011)
Drug approval isn't a race between the U.S. and the E.U.
In his Jan. 24 op-ed, "Finding a strategy for growth," Fareed Zakaria missed the mark regarding the speed of drug approvals in the United States and Europe. The facts show that the Food and Drug Administration's review times are somewhat shorter and that approval of new drugs generally occurs sooner in the United States, compared with Europe.The FDA compared marketing approval of 57 novel drugs approved by both FDA and European Union regulators between 2006 and 2010. Of these, 43 were approved first in the United States and 14 were approved first by the E.U. Twenty-seven of these 57 drugs were FDA-designated priority review drugs that provide a therapeutic advance, and all but three of the 27 were approved first by FDA. The median time from marketing submission to FDA approval was 183 days for priority review products, and 396 days for standard review products. In the E.U., those times were 403 days and 449 days, respectively.
The review and approval of new drugs is not a race between FDA and EU regulators, with whom we collaborate and whom we see as colleagues. But we do operate under different laws and procedures. Finally, we note that apart from the FDA's regulatory climate, there are many reasons why industry chooses to work overseas, including reduced labor and production costs.
To get a sense of how divorced from real experience most healthcare policy experts are let me share with you some recent examples..
Here's Jonathan Cohn:
"The idea behind the Affordable Care Act is to strengthen health insurance and give it to more people, which will cost the government money. At the same time, though, it will make the health care system as a whole more efficient, which will save the government money. Over the course of a decade, the costs and savings should be about equal, which means the net cost to the government would be roughly zero -- even as we'd made insurance both more reliable and much more available. That would be a pretty good deal...
Now, if you're worried about the government's long-term fiscal future -- and you should be! -- the key question is what happens after those 10 years. The big worry is that the budgetary burden of health care will become staggeringly heavy in 2030, 2040 and beyond. The only way to avoid that scenario is to slow down the growth of federal health care spending -- that is, to make sure it doesn't keep going up as fast as it's been for the last few decades."
But it begs the question: haven't we been making health care more efficient over the past 20 years? Following Cohn's argument, doing so would have prevented federal health care spending and spending overall not to go up as fast as it's been for the last few decades.
www.kaiserhealthnews.org/Columns/2011/February/020311cohn.aspx
Applying that timeline what do we see?
The rate of increase in healthcare spending is three times slower in the last few years compared to what it in 1970.
Assuming government wasn't doing anything to help, what was? I have some ideas but the point is, health care debates that don't start with accepting the facts as they are instead of some narrative we "feel" is right will go nowhere fast.
In the interest of fairness, here's an example of empty expertise from the conservative perspective:
Here's John McCain on Rx drug costs:
"Americans salaries are being cut, household budgets are slim and millions of Americans are struggling to make their monthly mortgage payment. For these reasons and so many more, Americans should not be forced to wait another day to purchase safe and affordable prescription drugs from outside the United States. But, while Americans all over the country and having to choose between their next meal and their necessary prescriptions, the large pharmaceutical companies continue to pressure Congress to delay consideration of any legislation to allow the importation of safe and lower priced prescription drugs."
The reality?
"Canadians (on average) spent 2.5% of their per capita PDI on prescription drugs in 2007, compared to 2.6% in 2009. Americans spent less of their per capita after-tax income (2.3%) on prescription drugs than Canadians in both 2007 and 2009. Comparable results were found when prescription drug spending as a share of per capita GDP was ana- lyzed. Canadians (on average) spent roughly 1.5% of their per capita GDP on prescription drugs in 2007, compared to 1.7% in 2009 (figure 1). Americans spent the same percentage of their per capita GDP on prescription drugs in 2007 as they did in 2009—roughly 1.7%."
tinyurl.com/4f7x94y
www.fraserinstitute.org/.../fraser.../prescription-drug-spending-Canada-and-US.pdf - Canada
People can have their own opinions, but not their own facts....
Getting the biggest bang for the regulatory buck doesn't mean that the FDA needs fewer bucks.
According to a story on today’s AP wire:
“House Republicans are seeking to keep their campaign promise to cut $100 billion from domestic programs … The hardest hit agencies would include the Food and Drug Administration …”
This is a crucial debate at a time when the agency needs more, not less funding and PDUFA is up for reauthorization. Both the Congressional determination to spend more wisely and the pharmaceutical industry’s desire that PDUFA V returns to first principles are not mutually exclusive. What both groups want is a properly funded FDA that spends its money in a responsible and predictable manner.
For more on the urgent need for smart and timely PDUFA reauthorization, see here, here, here, and here.
“Money is better than poverty, if only for financial reasons”
-- Woody Allen
Here’s the headline:
WASHINGTON — The Obama administration is examining whether the new health care law can be used to require insurance plans to offer contraceptives and other family planning services to women free of charge.
The article by Robert Pear is more about the continuing and hypersensitive debate over contraception than anything else – but there’s another issue.
According to the Patient Protection and Affordable Care Act, insurers must cover “preventive health services” and cannot charge for them. Without getting into the myriad and highly political issues surrounding contraception, an obscured, undiscussed but highly important question relative to the PPACA is – just what is “preventive medicine?”
With dynamic advances in diagnostics, we can now determine (with ever-greater degrees of accuracy and certainty) if someone, say, is prone to develop Alzheimer’s Disease. A recent article in the New York Times, “Two Tests Could Aid in Risk Assessment and Early Diagnosis of Alzheimer’s,” discusses a diagnostic scan that can help physicians determine whether a patient’s dementia is actually Alzheimer’s – allowing earlier and more aggressive treatment. The article also points out that, “… a large study sponsored in part by the National Institute on Aging is scanning healthy people and following them to see if the scans predict the risk of developing Alzheimer’s disease.”
If such a predictive test does become available, would this fall under the codicils of the PPACA’s call for “no-cost preventive screenings?” The impact on payers would be significant. Such a diagnostic would cost significantly more than a prescription for the Pill. And if Alzheimer’s was indeed the diagnosis – treating it is expensive.
The question then arises, is it cheaper to identify and aggressively treat a patient in the early stages of Alzheimer’s (even before there is a significant manifestation of symptoms) or to wait until the late stages – where the real costs lie not only in therapeutics, but in the related expenses of care-giving?
As the Center for Medicine in the Public Interest demonstrated in the paper, “Alzheimer’s Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money or Indirect Price Controls”, early intervention saves significant dollars over the course of the disease – even by delaying disease progression. This is a crucial point as there is, at present, no “cure” for Alzheimer’s Disease.
Where you stand often depends on where you sit. Will the PPACA demand that insurance providers provide free “preventive care” for a drug that doesn’t lead to prevention of a disease (like Alzheimer's) but delays its progression (like Aricept)? What about diagnostic screenings that can significantly lower the long-term costs of a non-preventable disease? If you are a payer, it’s a question of short-term costs versus long-term savings. And then, of course, whether the disease state is Alzheimer's Disease or breast cancer -- there’s what’s best for the patient.
And that’s a consideration particularly germane for our nation’s largest payer – Uncle Sam.
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.
