Latest Drugwonks' Blog
According to President, Hugo Chavez, “we consider that patents cannot be a restriction or a trap ... An invention or a scientific discovery should be knowledge for the world, especially medicine,” said Chavez, adding: “that a laboratory does not allow us to make a medicine because they have the patent - no, no, no.”
The proposals were announced on national television by the Minister of Trade, Eduardo Saman, who told the nation that “patents have become a barrier to production, and we cannot allow barriers to the access of medicine or transnational medicine companies to impose their rights on the Venezuelan people."
“We are revising all the doctrines and laws related to patents, which should be compatible with the international treaties that we have signed and respect and honor,” he added.
But, there’s always enough money to invest in a vast military. So much for “respect and honor.
Last time the prescription drug plan for senior citizens was in the news it was being vilified by many members of the majority party. Some even saw it as an election wedge issue. And then there was the whole Non-Interference Clause thing.
And then the politios and pundits saw that Part D was a huge success with America's seniors and coming in well under budget projections. And that was the last we heard of it.
Until yesterday.
Yesterday's announcement of the $80 million deal not only put Part D back on Page One -- but also introduced a new fan -- President Barack Obama. Now, it seems, we have a President who embraces the program designed to maximize free-market public/private partnerships and provide maximum healthcare choices for program participants.
Who'd a thunk it?
This plan will also do away with the silly Catch 22 of not being able to include medicines provided via patient assistance programs (PAPs) towards spanning the infamous donut hole -- something that the Bush Administration was not able to do. It's kind of a Nixion-going-to-China thing, although I'm sure the President would wince at such a comparison.
Maybe it would be more palatable to say that, when it comes to healthcare reform ... it takes a village.
Sorry. And I know how excited everyone is and everything.
FDA regulation of tobacco? Bad idea. Really.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. With FDA as the nation's tobacco Tsarcoe Selo it will be difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs. After all, now it’s the FDA’s responsibility.
Can you say “FEMA?
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program will be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself -- is that really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
Sorry about that. Really sorry.
I recently participated in the 9th France/USA AGIPHARM Conference. This year’s event was held in
* Edouard Croufer (Director, Healthcare & Chemical Practice, Arthur D. Little), declared that the pharmaceutical industry needed a new model – that Pharma needs to move from “find a molecule and market it” to “identify a need and find a solution.” When I pointed out to him that the latter was precisely what the industry is currently doing, he … agreed! Nothing like having the strength of yor convictions. As Henri Poincaré said, “To doubt everything, or, to believe everything, are two equally convenient solutions; both dispense with the necessity of reflection." Croufer also pointed out that 21st success for medicines would be realized through “speed and intensity.” Amen.
* Francois Meyer (Director, Haute Autorité De Santé) made a rather revolutionary statement for the head of a national reimbursement authority when he stated that “we must move beyond clinical trials” to make true 21st century healthcare technology assessments. He also spoke to the need to include outcomes data in reimbursement decisions – or rather in the revisiting of already-decided reimbursement decisions. Or as he put it, “comparative efficacy in real life.” Heady stuff.
* Relative to the development of public/private partnerships, Patrice Jaillon (President of GIP CENGEPS – the
* All well and good until Noel Renaudin (President of the CEM – the comité économique du medicament), the Grand Fromage of healthcare reimbursement in
Particle accelerators are, after all, about high-speed collisions.
Officials said Saturday that the White House, lawmakers and the pharmaceutical industry had struck a deal to have drug companies pay $80 billion to help narrow a gap in coverage in the prescription drug program for Medicare. The officials said that the agreement would have drug companies pay part of the cost of brand name drugs for lower and middle-income older people in the "doughnut hole." That term refers to a feature of the current drug program that requires beneficiaries to pay the entire cost of prescriptions after initial coverage is exhausted but before catastrophic coverage begins.
Obama seized on the deal as evidence that his efforts are gaining momentum.
"Key sectors of the health care industry acknowledge what American families and businesses already know — that the status quo is no longer sustainable," the president said, and noted: "We are at a turning point in America's journey toward health care reform."
So drug and biotech companies are finally being permitted what they wanted to do all along but were banned from doing -- giving seniors a discount to give them a seamless drug benefit. That makes sense since the decision about what drug to take should be what works, not the price or cost. At least that is what the evidence says. And making that decision on clinical evidence leads to value based benefit designs which focus on overall health outcomes...
All to the good. And the rationale, in part, to Medicare Advantage pay more for prescription drugs.
But what is Obama proposing to fill the nearly $2 trillion gap to shove 25 million people into public health plans.
"Obama has proposed cuts in Medicare spending on hospitals, prescription drugs and other services, but a political consensus is far from certain."
He has proposed eliminating Medicare advantage, which has primarliy benefited the chronically ill and minorities... Leaving them with what?
So just as the private sector provides seniors with a solution that moves us towards a preventive approach to health care Obama is pillaging the one part of Medicare that provides just that to prop up a health plan that cannot even support paying for preventive care....
The cynicism is breathtaking and the mainstream media is too busy fawning to take note. Real health care reform is within reach but not the way the President wants to take us...
Read article here.
Here's the story, courtesy of Politico:
Drug firms reach $80 billion deal

By: Carrie Budoff Brown and Mike Allen 

Giving a boost to health legislation after a bruising week, pharmaceutical companies have offered Congress and the White House an $80 billion commitment over 10 years to help pay for comprehensive reform, negotiators told POLITICO on Saturday. 

The promised savings from the industry are to be written into the new law, making them binding. The deal is to be announced soon by President Barack Obama or the Senate Finance Committee. 

Obama was relying on drug-makers to help finance his $1 trillion health care overhaul. The deal provides a lift to the administration’s efforts to regain momentum in the debate after a tough week in which congressional budget analysts returned eye-popping cost estimates on proposed bills, and even some Democrats dug in their heels against the high costs. 

“You’ve got your first passengers on the train and now you can start moving forward down the track,” said an industry source close to the negotiations. 

The offer was approved on a conference call Friday afternoon by the governance committee of the Pharmaceutical Research and Manufacturers of America, which represents top drug and biotechnology companies. 


Afterward, PhRMA President and CEO Billy Tauzin called Senate Finance Committee Chairman Max Baucus (D-Mont.). The White House was then notified. PhRMA’s board had discussed the parameters of the deal during a board meeting in Washington on Thursday. 

House and Senate Democrats have increasingly raised the idea of using the health-care bill as a vehicle to begin narrowing the so-called "doughnut hole" — a coverage gap in the Medicare Part D plan that forces seniors to pay out of pocket for some of their drugs, above a certain cost. 

Three senators called on Baucus this week to address this gap in the Senate reform package, and House committee chairmen agreed Friday to deal with it in their legislation. 

Under the deal, a senior who makes $80,000 to $85,000 will effectively have their out-of-pocket costs cut in half, an industry official said.


The two main prongs of the agreement among PhRMA, congressional leaders and the White House: 

— Drug companies will provide a 50 percent discount to most beneficiaries on brand-name medicines covered by a patient’s Part D plan when purchased in the coverage gap. 

—The entire negotiated price of the Part D covered medicine purchased in the coverage gap would count toward the beneficiary’s out-of-pocket costs. That would lower the beneficiary’s total out-of-pocket spending. The proposal would not require any additional paperwork on the part of the beneficiary nor would an asset test be used for eligibility. 

Most plans in the Medicare drug program, which began in 2006, included a gap in coverage. The cost of drugs are covered until the beneficiary and the government had spent $2,250. At that point, individuals have to pay 100 percent of the costs until reaching $5,100 for the year, and then the government coverage kicks in again. That gap between $2,250 and $5,100 is often referred to as "the doughnut hole." 


The agreement couldn’t come at a better time for Obama and Baucus. It blunts charges that Democrats aren't concerned about the cost of the overhaul. And with this deal, they are showing that the industry remains at the table, and willing to deal. This could put pressure on other industries to deal as well. 

PhRMA has been negotiating the deal for months with Baucus and his staff, and with Nancy-Ann DeParle, director of the White House Office of Health Reform.
“This is a huge amount of money,” said an industry official. “Our CEOs tossed and turned in their beds for a long time before signing off on this. It’s going to provide a significant amount of money toward achieving health-care reform.” 

The official added: “We recognize that there has to be a shared sacrifice if we’re going to extend health-care coverage to everybody in America.” 

Obama hinted at the negotiations in his radio and Web address last week, when he outlined about $75 billion in savings that could come from lower payments for prescription drugs – money that could be used to pay for his $1 trillion health care overhaul. White House budget director Peter Orszag told reporters at the time that the administration was “in discussions with stakeholders over the best way of achieving that $75 billion.” 


But even the $80 billion is just one part of a massive health-reform tab that the Congressional Budget Office said this week is likely to cost more than $1 trillion – a number that many Republicans and even some Democrats say is too much. Obama has announced a package of tax increases, cuts in hospital and other reimbursements and other savings that he says add up to $950 billion to pay for a health overhaul, but Congress has balked at some of his proposals and it’s not yet clear if others would achieve all the savings he hopes.
Read more here
"What was originally offered up as a down payment on healthcare reform simply can't be accurately estimated by the CBO and will result in far less savings than the originally promised $2 trillion," said Republican senator Mike Enzi of Wyoming, the ranking member of the Senate health committee. "The administration will need to come up with far greater savings proposals – savings that Congress can take to the bank – to achieve the massive healthcare bill Democrats are proposing."
(In May, President Obama announced that six groups– had pledged to reduce healthcare spending growth by 1.5 percentage points annually over 10 years, saving an estimated $2 trillion. Within days of the announcement, reports surfaced that the groups had planned to ramp up to the 1.5 percentage point level over time, rather than committing to such savings annually.)
According to the CBO, extending prescription drug coverage to the entire population "would probably increase the deficit significantly", the CBO said. It also cited its December 2008 estimate that establishing a biosilimar approval pathway would yield federal savings of about $10 billion over the next decade. The December report estimated that an FOB measure with 12 years of innovator exclusivity would generate federal healthcare savings of $9.1-11.7 billion, with the larger figure contingent upon placement of FOBs in the same billing code as their branded counterparts for payments under the Medicare Part B program.
According to a story in SCRIP World Pharmaceutical News, “The budget office's brief analysis was released as healthcare reform activity in Washington reached a fevered pitch, much of it focused on the costs of a massive overhaul. Among the activity of note, the CBO released higher-than-expected cost estimates for reform legislation being considered by the Senate health committee, and the Obama Administration said it was working with Congress to extract $22 billion in savings over 10 years from the Part D drug programme, including lowering reimbursement of medicines for "dually eligible" individuals who qualify for both Medicare and Medicaid.”
Relative to the Affordable Health Choices Act, the CBO estimated the measure would cost the federal government $1 trillion over 10 years and result in a net decrease in the number of uninsured people by only 16 million.
Yeah – reality bites.
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.
