Latest Drugwonks' Blog
Meanwhile, Sanofi is pursuing Genzyme, maybe, instead of or in addition to making an 'authorized' generic version of their product...
To underscore a point Peter made, analysts who think that the approval of generic Lovenox will unleash a flood of follow-on biologics had better readjust their sights and projections. Or at least read the FDA's approvable letter to Novartis and Momenta:
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220023.htm
Note to analysts: sameness is not interchangeability with all products. It requires testing. And post market monitoring. Reproducing is NOT copying and it is NOT bioavailability. It is equivalence of functionality based on activity. It has to work the same way and be designed in ways that produce such functional equivalence.
There are lots of IP landmines in making a "bio-same-ilar", which explains the Sanofi suit. Meanwhile, the Genzyme play, moving towards targeted, even fractional market, based on narrow therapeutic pathways and complex manufacturing is consistent with what other companies are doing.
The blockbuster model is dead and the era of equivalence is over.
"Many in the industry have felt that if FDA ultimately approves generic versions of Lovenox and it makes those generics fully 'substitutable' - which it just has - then this might signal what FDA may also ultimately do when it comes to 'true' biologics that generic companies are also pursuing," Tim Anderson, an analyst with Bernstein Research, wrote in a research note on the recent agency action.
Not necessarily.
Remember, the FDA has the authority to use its discretion in asking for new clinical trials for biosimilars and – here’s the sticky question – is Lovenox really a biologic? Sticky question? Not really -- because the answer is, "no."
When it comes to bioequivalence and biosimilars, the FDA will do the right thing.
After all (and with apologies to Senator Kerry), you can’t be for enhanced safety and against it at the same time.
Do not trust all men, but trust men of worth; the former course is silly, the latter a mark of prudence.
-- Democritus
That Britain’s NHS will undergo an historic change (“Britain Plans to Decentralize National Health Care”) is significant, sobering but not surprising. It’s an experience with valuable lessons for us over here on the other side of the pond.
Lessons about the inefficiencies of centralized government healthcare. There’s no value in calling it “socialist” when you can just say, “see, it doesn’t work.” As the man said, “attention must be paid.”
Lessons about what happens when your system is based on a cost-centric rather than a patient-focused philosophy of healthcare. Yes – we really need to put the 800-pound gorilla on the operating room table. Who needs “death panels” when you have “deny panels.”
And, finally, lessons about money. It really isn’t all about the amount of money you spend – if you don’t spend it in the right places. And that’s Lesson #1.
Britain Plans to Decentralize National Health Care
By SARAH LYALL
LONDON — Perhaps the only consistent thing about Britain’s socialized health care system is that it is in a perpetual state of flux, its structure constantly changing as governments search for the elusive formula that will deliver the best care for the cheapest price while costs and demand escalate.
Even as the new coalition government said it would make enormous cuts in the public sector, it initially promised to leave health care alone. But in one of its most surprising moves so far, it has done the opposite, proposing what would be the most radical reorganization of the National Health Service, as the system is called, since its inception in 1948.
Practical details of the plan are still sketchy. But its aim is clear: to shift control of England’s $160 billion annual health budget from a centralized bureaucracy to doctors at the local level. Under the plan, $100 billion to $125 billion a year would be meted out to general practitioners, who would use the money to buy services from hospitals and other health care providers.
The plan would also shrink the bureaucratic apparatus, in keeping with the government’s goal to effect $30 billion in “efficiency savings” in the health budget by 2014 and to reduce administrative costs by 45 percent. Tens of thousands of jobs would be lost because layers of bureaucracy would be abolished.
In a document, or white paper, outlining the plan, the government admitted that the changes would “cause significant disruption and loss of jobs.” But it said: “The current architecture of the health system has developed piecemeal, involves duplication and is unwieldy. Liberating the N.H.S., and putting power in the hands of patients and clinicians, means we will be able to effect a radical simplification, and remove layers of management.”
The health secretary, Andrew Lansley, also promised to put more power in the hands of patients. Currently, how and where patients are treated, and by whom, is largely determined by decisions made by 150 entities known as primary care trusts — all of which would be abolished under the plan, with some of those choices going to patients. It would also abolish many current government-set targets, like limits on how long patients have to wait for treatment.
The plan, with many elements that need legislative approval to be enacted, applies only to England; other parts of Britain have separate systems.
The government announced the proposals this month. Reactions to them range from pleased to highly skeptical.
Many critics say that the plans are far too ambitious, particularly in the short period of time allotted, and they doubt that general practitioners are the right people to decide how the health care budget should be spent. Currently, the 150 primary care trusts make most of those decisions. Under the proposals, general practitioners would band together in regional consortia to buy services from hospitals and other providers.
It is likely that many such groups would have to spend money to hire outside managers to manage their budgets and negotiate with the providers, thus canceling out some of the savings.
David Furness, head of strategic development at the Social Market Foundation, a study group, said that under the plan, every general practitioner in London would, in effect, be responsible for a $3.4 million budget.
“It’s like getting your waiter to manage a restaurant,” Mr. Furness said. “The government is saying that G.P.’s know what the patient wants, just the way a waiter knows what you want to eat. But a waiter isn’t necessarily any good at ordering stock, managing the premises, talking to the chef — why would they be? They’re waiters.”
But advocacy groups for general practitioners welcomed the proposals.
“One of the great attractions of this is that it will be able to focus on what local people need,” said Prof. Steve Field, chairman of the Royal College of General Practitioners, which represents about 40,000 of the 50,000 general practitioners in the country. “This is about clinicians taking responsibility for making these decisions.”
Dr. Richard Vautrey, deputy chairman of the general practitioner committee at the British Medical Association, said general practitioners had long felt there were “far too many bureaucratic hurdles to leap” in the system, impeding communication. “In many places, the communication between G.P.’s and consultants in hospitals has become fragmented and distant,” he said.
The plan would also require all National Health Service hospitals to become “foundation trusts,” enterprises that are independent of health service control and accountable to an independent regulator (some hospitals currently operate in this fashion). This would result in a further loss of jobs, health care unions say, and also open the door to further privatization of the service.
The government has promised that the new plan will not affect patient care and that the health care budget will not be cut. But some experts say those assertions are misleading. The previous government, controlled by the Labour Party, poured money into the health service — the budget is now about three times what it was when Labour took over, in 1997 — but the increases have stopped. The government has said the budget will continue to rise in real terms for the next five years, but it is unlikely that the increases will keep up with the rising costs of care and the demands of an aging population.
“The real mistake that is being made by the health secretary is to drive through an ideologically determined program of reorganization which is motivated by the principle of efficiency savings,” said Robin Durie, a senior lecturer in politics at the University of Exeter. “History shows clearly that quality will suffer as a consequence.”
Dr. Durie added, “The gulf between the rhetoric of the white paper and the technicalities of what is involved in the various elements of the overall reorganization being proposed is just extraordinary.”
For example, he asked, how will the government make good on its promise to give patients more choice — a promise that seems to require a degree of administrative oversight — while cutting so many managers from the system?
“How will the delivery of all this choice be funded?” Dr. Durie asked. “And how will the management of the delivery of choice be funded?”
Dr. Vautrey said the country needed to have a “mature debate about what the N.H.S. can and cannot afford.”
He said: “It is a sign of the mixed messages that government sends out. They talk about choice and competition and increased patient expectations at the same time as they tell the service they need to cut costs and refer less and prescribe less. People need to understand that while the needs of everyone may be met, their wants will be limited.”
As they prepare for the change, many doctors are wondering whether it will be permanent this time around.
“Many of our colleagues have seen this cycle of change repeatedly,” Dr. Vautrey said. “Many would look at previous reorganizations and compare it to this one and wonder how long the current change will last before the next one comes along.”
WASHINGTON—The Food and Drug Administration approved the first generic version of the big-selling blood thinner Lovenox, in a victory for a unit of Novartis AG.
The Novartis unit, Sandoz, and partner Momenta Pharmaceuticals Inc. have been in a tug of war for years with a California-based company, Amphastar Pharmaceuticals Inc., to win FDA approval for generic versions of Lovenox.
Amphastar has accused the FDA and its drug-division leaders of favoritism in the past year, noting that Momenta worked closely with the FDA on safety issues and investigations in recent years. Momenta has said its relationship with the FDA is appropriate.
Sanofi has fought to protect Lovenox from generic competition, saying that the drug is too complex to be completely copied safely. Researchers with ties to Sanofi recently filed citizens' petitions to the FDA asking the agency not to approve any company's enoxaparin.
The good news: FDA Social Media Guidance. The bad news: FDA Social Media Guidance.
Here’s how my interview with emarketer begins:
eMarketer: The FDA is expected to issue guidance on the use of social media this year. What do you think it will look like?
Peter Pitts:
There are a lot of ifs. The first if is, is this really a good thing? A lot of times when you ask for regulation and you get it, you may not be happy with it. If marketers are waiting for FDA guidance with the assumption that it’s going to make their jobs easier, that’s very much open to question.
And here’s how it ends:
Peter Pitts:
The concept of being incomplaunce vs. doing the right thig for the
For everything in the middle, see here.
Congressman John Boozman (R,AR) from CMPI on Vimeo.
Drafters had hoped the provision would generate $17 billion to help pay for reform. But James Gelfand, director of health policy at the U.S. Chamber of Commerce, says he's rarely seen an issue on which members are so strongly united in opposition, calling them "apoplectic" over the provision. An administration source tells Pulse that the comments from the business community are "obviously something we take seriously" and that there's been significant outreach to them. Treasury has already made one change: Transactions on credit and debit cards won't have to reported on a 1099.
James Gelfand Director of Health Policy, US Chamber of Commerce from CMPI on Vimeo.
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.
