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The same members introduced similar bills in 2005 and 2007. Bad idea then. Bad idea today. At least they didn’t try to bury it in the stimulus package.
In addition to gutting the Non-Interference Clause (originally authored, it should be remembered – by Senators Kennedy and … Daschle) HR. 684 would create a federal drug plan option to compete with privately offered Part D plans.
"We have many reasons to be optimistic about the passage of this legislation," Schakowsky said. "It is very much in line with [President Barack Obama's] overall plan in that it gives people an option of a public plan or sticking with a private plan."
When combined with the "Federal Coordinating Council for Comparative Effectiveness Research" (a $1.1 billion earmark in the stimulus package that won’t create a single job on “Main Street”), there's the real potential for Uncle Sam to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price and a big step towards overall price controls.
And price controls = choice controls.
This new “Federal Council” (under the Agency for Healthcare Research and Quality and with zero patient group, industry or academic representation – it’s 100% government) would be responsible for "assessing the clinical benefit of covered Part D drugs and making recommendations to the secretary on which drugs should be included in the formulary."
In addition, an advisory committee can request AHRQ conduct clinical effectiveness and comparative effectiveness studies on drugs.
That means bureaucrats in Washington will be able to tell doctors how to practice medicine by dictating formulary options.
Wither competition? The Bill sponsors expect that if the bill becomes law, it would ultimately limit the number of plans participating in Part D, as private plans would drop out from competing with a publicly run plan.
And to that point, a few things worthy of consideration:
"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
Stanford Business School's Alain Enthoven and Kyna Fong
"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause. Consider:
* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition.
* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
We shouldn’t interfere with success.
According to Senator Ben Nelson (D-NE), it's unclear whether President Obama's $819 billion economic stimulus bill will win enough support to pass in the Senate. "I don't even know how many Democrats will vote for it, as it stands today," he told FOX News.
Seems like the upper house is unhappy that the bill, passed by the other house on Wednesday, contains billions of dollars for programs that arguably won't spark much job growth. Senator Nelson wants to pluck out what he says are extraneous projects in the stimulus bill to pay for the amendment.
How about plucking out the “sneaking socialism of healthcare.” Specifically the $1.1 billion for a "Federal Coordinating Council for Comparative Effectiveness Research." Not only is this expense a slippery slope towards a NICE-like body for the U.S. – it wouldn’t create a single job for "Main Street."
Here’s a suggestion – give that money to the FDA to hire more scientists, reviewers, and inspectors, update their woeful IT infrastructure, and fund the agency’s Critical Path program.
That’s what I’d call a real stimulus package!
Well that’s what “consensus” gets you.
The current definition of WHO says counterfeit drugs are 'medicines which are deliberately and fraudulently mislabeled with respect to identity or source.
The proposed definition proposed removes the clause “deliberately and fraudulently” and replaces it with “a medical product is counterfeit when there is a false representation in relation to its identity, history, or source.” It also says that ‘this applies to the product, its container, packaging or other labeling information.”
As
Here's her bio:
Margaret A. Hamburg, MD, Senior Scientist, Global Health and Security Initiative, NTI
One of the youngest people ever elected to the Institute of Medicine of the National Academy of Sciences, Dr. Margaret “Peggy” Hamburg is a highly regarded expert in community health and bio-defense, including preparedness for nuclear, biological, and chemical threats. She currently serves as Senior Scientist for the Global Health and Security Initiative of the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. A graduate of Radcliffe College, she earned her M.D. from Harvard Medical School, and completed her training at the New York Hospital/Cornell University Medical Center.
From 1997 to 2001, Hamburg held the position of Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services (HHS), serving as principal policy advisor to Secretary of Health and Human Services Donna Shalala. From 1991 to 1997, she served as New York City Health Commissioner, a position in which she designed and implemented an internationally recognized tuberculosis control program that produced dramatic declines in tuberculosis cases, and created the first public health bio-terrorism preparedness program in the nation. Between 1986 and 1990, she held a variety of positions within HHS, including Special Assistant to the Director, Office of Disease Prevention and Health Promotion; and Special Assistant to the Director, and later Assistant Director, of the National Institute of Allergy & Infectious Diseases at the National Institutes of Health.
A member of the Harvard College Board of Overseers and the Boards of Trustees of Rockefeller University and the Rockefeller Foundation, Hamburg is also a distinguished senior fellow with the Center for Strategic and International Studies, and a fellow of the American Association of the Advancement of Science. She holds membership in the New York Academy of Medicine, and the Council on Foreign Relations and serves on the board of Henry Schein Company. She has served on the boards of other organizations, including the New York City Health and Hospitals Corporation, the Nathan Cummings Foundation, the Primary Care Development Corporation, and the Board of Scientific Counselors for the National Center for Infectious Diseases of the Centers for Disease Control and Prevention.
According to a new Harris poll, 81% of Americans say they prefer generics to brand-name drugs.
Earlier this month, the GPhA applauded the introduction of HR 573, a bill that would prohibit the marketing of authorized generics during the 180-day generic exclusivity period. Kathleen Jaeger, chief executive of the GPhA, sees the proposed legislation as a way to close a “loophole” in the 1984 Hatch-Waxman Act that allows innovator life science companies “to delay generic competition by discouraging generic companies from challenging weak and potentially unenforceable patents." She praised the bill’s sponsor, Republican Jo Ann Emerson, and colleagues for “working to close this loophole for the benefit of consumers struggling with health care costs during these difficult economic times."
Historical pricing data shows that brand companies launch their generics at a 50 percent discount off retail price compared to a 30 percent discount experienced when a generic drug has no competition. If HR 573 passes, consumers and taxpayers over the next two years would realize about $8 billion instead of $13 billion in savings. Cui bono? The missing $5 billion will line the pockets of a handful of generics companies. That’s quite a cui bonus. This end-run around Hatch-Waxman is an extended index finger to the FDA, the FTC and judicial precedent. (A Federal Appeals Court made it clear that Hatch-Waxman allows for authorized generics.)
Over the next few years about $60 billion in brand drugs will become generic; $30 billion of that will be sold without competition for 180 days if Ms. Jaeger and Representative Emerson get their way.
No wonder this “modest proposal” is being greedily embraced by the generics industry and Big Pharma bashers. And greedy is hardly hyperbole since profits on generic medicines exceed 45% -- even when there is a competitive branded generic on the market.
We all call the existing legislation by its inside-the-Beltway designation, “Hatch-Waxman” – but let’s not forget that the full name of the law that brought the generic industry into being is the Drug Price Competition & Patent Term Restoration Act -- not the Generic Drug Company Guaranteed Profit Act. When the media and generic drug lobbyists conflate suspicious stalling tactics with legal and consumer-friendly market actions, neither the truth nor the public health are served.
You mean the ends doesn’t justify the means?
According to a Reuter’s report, “The healthcare spending watchdog NICE said it was reviewing how it values new technologies, a week after an industry report called for such a move.” NICE's announcement followed an industry report published last week calling for an enquiry to assess the long-term impact of NICE on the cost and the uptake of drugs, along with a series of tax breaks and other measures to support the crisis-hit biotechnology industry
The study (due this July) will be led by Ian Kennedy, Emeritus Professor of Health Law, Ethics and Policy at University College London. He’s an academic lawyer who, for the past few decades, has lectured on the ethics of medicine. A long-standing member of the General Medical Council, he is a former president of the Centre of Medical Laws and Ethics, which he founded in 1978.
On a releated note, the Pink Sheet reports that, “Third-party payer policies appear to have an effect on clinical trial participation, but the impact "is difficult" to quantify, according to a draft report by Duke Evidence-Based Practice Center researchers prepared for the Agency for Healthcare Research and Quality.”
The draft report, "Horizon Scan: To What Extent Do Changes In Third-Party Payment Affect Clinical Trials and the Evidence Base?" was posted on AHRQ's technology assessment Web site. Comments on the draft are due Jan. 23. The topic is of interest because there is no consensus on financial responsibility for clinical trial-related health care costs, resulting in uneven reimbursement policies. A lack of adequate coverage for those costs may discourage patients from participating in trials, reducing the body of available clinical evidence.
A 2000 survey of nearly 6,000 cancer patients who were aware of clinical trial availability revealed that about 75 percent chose not to participate, with 20 percent of that group citing uncertainty about insurance coverage as the reason for declining participation. The top responses given for not entering into a clinical trial were: standard treatment was believed to be better (37 percent) and fear of receiving a placebo (31 percent).
Yet another unintended consequence of cost-based versus patient-centric reimbursement policies.
What’s better than 1 FDA? How about 50.
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.
