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In a background briefing, an official with the White House Office of Management and Budget explained the funding will "begin to lay the basis for safe and effective reimportation at FDA. But we think we need to put some infrastructure and build some processes there to do that."
What’s “reimportation?” If it means bringing back into the US drugs manufactured within our borders and then sent abroad (which is what most people think it means) then there’s no there there.
If, on the other hand, the unnamed official means “importation,” then Katie bar the door on safety, intellectual property rights, and the importation of foreign price controls.
Did President Obama discuss this plan when he met with Canadian Prime Minister Stephen Harper?
Probably not.
Getting it right with modern drugs
Congress and President Barack Obama should be commended for expressing a strong commitment to modernize the Food and Drug Administration.
The FDA needs funding, resources, and the support of our leaders in Washington if the agency is to get it right in confronting our most urgent health challenges - especially if they want to ensure patients receive the safest, most effective generic medications.
As a top priority, the FDA must move to modernize its standards for approving generic versions of "controlled release" drugs. Controlled release drugs are a new generation of medication. They are engineered to deliver a precise amount of a medicine, at precise intervals, over a period of hours, without losing potency or effectiveness. This controlled release mechanism helps treat patients suffering from some of the most chronic and debilitating conditions - pain, depression, Parkinson's, Alzheimer's or hypertension.
The good news is that more than 20 generic controlled release drug formulations are poised to be released to the market, pending FDA approval. The bad news is that the FDA is using dated generic approval standards to evaluate these modern medications. This is critical considering any deviation from how a controlled release drug is delivered to the body can lead to unbearably painful, harmful or even fatal patient consequences.
For the FDA to approve a generic drug it must, in part, be identical in strength, dosage form, and route of administration to the original, branded drug. But the FDA's tests for controlled release generics are not measuring the very element that makes the original drugs so valuable to patients: the safe, controlled delivery of a specific amount of medication over an extended time. Measurements that don't include time variables simply cannot assure bioequivalence for this class of drugs.
One remedy to the bioequivalence testing shortfall will only require FDA to use multiple time-based measurements of active ingredient concentration. This will allow regulators to compare the complete performance and equivalence of a generic to the original controlled release medication. This is just a small alteration in the testing standards and only requires generic controlled release applicants to submit more data.
Those who would decry this tweak of the measurements miss the bigger picture. Controlled release drugs are only one class in a whole emerging generation of medications - follow-on biologics are another example - that the FDA will need to adapt to and address if it hopes to keep patients safe. There must be no public doubt that all new classes of generic drugs are exactly bioequivalent to branded versions that have been validated by clinical trials and years of use.
By no means is this a call for the FDA to scrap its standards for bioequivalence - not at all. Rather, this is a call to make them more robust and stringent in order to honestly assess a new generation of drugs. Evidence supporting that conclusion is mounting - a host of complaints and reports from patients losing effectiveness after switching from a branded, controlled release anti-depressant to a generic led the FDA to review whether the generic was bioequivalent and therapeutically equivalent to the brand. The review board gave the generic its vote of confidence, but noted its sensitivity to the bioequivalence issue, saying:
"The question is whether the reported lack of efficacy and/or new onset side effects in these patients who switched suggests a problem with the generic product, i.e., lack of bioequivalence to the branded product, or have some other explanation."
Simply put, the generics industry cannot flourish, innovate and compete if it does not inspire the confidence of American patients. For the FDA to continue to ignore the controlled release regulatory oversight is to invite disaster on two fronts: the complete erosion of the generic industry's reputation in the eyes of patients, and, unthinkable, widespread patient harm caused by ineffective controlled release generics.
Many of the health and food incidents over the last few years were hard for the FDA to predict or prevent, given its resources and funding. There will be no excuse, however, if the FDA ignores the potential for harm waiting in this regulatory gap. Pretending there is no risk in changing formulations is not science-based regulation. In the real world, there are no shortcuts to patient safety.
Peter Pitts is president and co-founder of the Center for Medicine in the Public Interest and was a Food and Drug Administration associate commissioner from 2002-04. Robert Goldberg is vice president and co-founder of the Center for Medicine in the Public Interest.
Uncertainty over new health safety net for jobless
AP – Cassandra Kelsey, 55, of Washington, has a variety of paperwork seen on Thursday, Feb. 26, 2009. Kelsey …
WASHINGTON – The Obama administration rushed to include a health care safety net for laid-off workers in the recently signed stimulus bill, but has not told employers exactly how to make it work.
As a result, tens of thousands of jobless people could wait months before getting help paying for health insurance that their employers previously had covered.
"Too many people are still trying to figure this out," said Heath Weems, director of human resources policy at the National Association of Manufacturers. "There is a lot of confusion."
At issue is the program called COBRA, the acronym for the law that allows workers to keep their company's health insurance plan for 18 months after they leave their job, if they pay the premiums.
The policies are so expensive that only a minority of eligible workers sign up, often those with medical conditions that demand attention. Costs for a family of four can top $1,000 per month."You betcha.
As Peter has noted, divide $700 billion by the real number of the uninsured -- 20 million -- over ten years or better, $70 billion a year by 20 million you get $3500 per person. So why not give people a tax credit and let insurers, health care agents, etc provide a product from scratch that offers insurance coverage that automatically enrolls people, is universal, portable guaranteed issue of some sort, incentives for healthy behavior, a rider that people would pay that would cover out of catatstrophic out of pocket expenses and encourage pre-funding of deductibles via HSAs through employers, direct deposit. etc. Compare that to the unworkable effort to extend COBRA and all it's complexities....and COBRA is so expensive precisely because the health plan it is "replacing" is unfairly subsidized by lower income Americans in favor of health care plans like those that are bankrupting GM and Chrysler.
How to pay for it? End the system that creates the COBRA like plans in the first place and give people a chance to design plans that they truly value with their own money. Encourage more personal responsibility for health. Provide doctors and patients with information on real comparative effectiveness information, information on what health technologies and treatments are best for them, not guidelines twisted by any one interest as Roy Poses of the www.hcrenewal.blogspot.com/ has noted. (Yes, I agree with Roy on this emphatically!) More on this in future post.
Last night Peter and I were surrounded by people who celebrated Dr. Sol Barer, CEO of Celgene for his leadership and vision in transformational medicine. They and we were graced by the warmth and wit of John Stossel, Rich Bagger, Mike Ferguson, myleoma survivor Elijah Alexander, and Dr. Jules Hirsch -- individuals who are leaders in their respective fields of journalism, the pharmaceutical industry, politics, professional football and academic research. Their charge to us, at the First Annual CMPI Odyssey Dinner, was to dare and endure as they have, on behalf of medical innovation. We were called upon to speak out, to make biomedical innovation a personal and passionate cause -- and to battle against those who vilify its capitalist origins.
I can't thank enough those who gathered with us to begin this new movement -- friends old and new -- for their support, generosity, warmth and participation. Above all, I am left with a memory of your kindness, the appreciation of which I look forward to repaying in the months and years ahead!
Thank you.
"The Budget supports the Food and Drug Administration’s (FDA’s) new efforts to allow Americans to buy safe and effective drugs from other countries ..."
Don't kid yourself by thinking this has anything to do with lowering costs for seniors (because even the AARP says Part D is a better deal) or "broadening access" for the uninsured (which is what pharmaceutical patient assistance programs are for). Importation is yet another stealth strategy towards a straight up price control regime for medicines. If importation goes forward, you don't need to revoke the Non-Interferene Clause. This has been Rahm Emanuel's strategy for the past few years and now he's an agent in place.
If you like "universal care" provided by Uncle Sam, MD -- you're going to love importation.
Here we go again.
Sing in me, Muse, and through me tell the story
of that man skilled in all ways of contending,
the wanderer, harried for years on end,
after he plundered the stronghold
on the proud height of
So begins Homer's Odyssey. And so began last night's first annual Center for Medicine in the Public Interest Odyssey Award gala dinner.
The dinner (held at the posh Short Hills Hilton) honored Sol Barer, PhD, CEO and Chairman of Celgene, for his lifetime of dedication to the cause of medical innovation. (Watch this space soon for his complete remarks.) Sol is a visionary and the evening was all about him -- but he is all about innovation in the service of patient care.
And while Dr. Barer got the trophy, the hero of the evening was Elijah Alexander, ex-NFL linebacker, husband, father of two -- and survivor of multiple myeloma. (For more on Alexander's fight against multiple myeloma, visit the "Tackle Multiple Myeloma Foundation" website here.)
Elijah talked about his cancer, about the impact it had on his family -- and how innovation saved his life (specifically via Revlimid). He cried. Everyone cried. Even John Stossel, Mr. "Give Me A Break" (and the evening's emcee), misted over.
The evening was all about the importance and urgency of innovation.
Yes -- even innovation via the resurrection of thalidomide.
President Obama says he want to "cure cancer." He should talk with Sol Barer.
But first he should listen to Elijah Alexander.
1. I don't like tax increases. However capping the deductibility of health care expenses at some point does make sense. So does taxing benefits beyond a certain dollar value or income level (inflation adjusted). Obama got that half right.
2. Requiring HMOs to bid using the Medicare actuary's estimate was something President Bush proposed in 2003. Most people don't remember that. Now Obama is proposing the same thing in lieu of the bonus. Will seniors pay more or less? Will they be better off? Hard to predict.
3. No price controls on part D which rewards use of market forces and preventive technologies. Cuts to medical imaging and home health which will likely not stand or will be adjusted.
4. The administration proposes a bundled hospital payment that includes 30 days for post discharge care. Can we say DRG-based capitation? Nothing new here...just another reimbursement code to exploit.
The Obama team did as little as prescriptively possible to come up with $700 billion for universal health care. More -- about a trillion more (at least) will be needed and even then not everyone will be enrolled. And of course enrollment does not equal better health or outcomes. Where will the rest of the money come from? A tax on employers in lieu of providing coverage.
So for the most part the health care reforms are nothing new and the cost is very high. Still, the down payment does little to move us towards "government run" health care. If free market types want to come up with a way to provide people with a choice of health plans that eliminates penalties for pre-existing conditions and a range of insurance products that are affordable that does not involve government control over medical decisions, now is the time. It can't be HSAs alone, which are still a confusing and difficult benefit to provide. It has to protect people from financial catastrophe, reward healthy behavior, reward better outcomes, encourage more personal responsibility. And the proposal has to be bold and big.
Nothing else will compete or do.
According to a story in today’s Washington Post, “President Obama is proposing to begin a vast expansion of the
(And this isn't counting the unemployment insurance-eligible Americans and their families who now qualify for government benefits as part of their unemployment benefits.)
Not surprisingly (in advance of the budget) light on details. No surprises.
Per healthcare reform, two words that may serve as tea leaves -- "down payment" and "affordable."
"Down Payment" = incremental.
"Affordable" = insurance reform.
Relative to "affordable," here's are a few paragraphs from the recent Robert Pear story in the New York Times:
Since last fall, many of the leading figures in the nation’s long-running health care debate have been meeting secretly in a Senate hearing room. Now, with the blessing of the Senate’s leading proponent of universal health insurance, Edward M. Kennedy, they appear to be inching toward a consensus that could reshape the debate.
Many of the parties, from big insurance companies to lobbyists for consumers, doctors, hospitals and pharmaceutical companies, are embracing the idea that comprehensive health care legislation should include a requirement that every American carry insurance.
While not all industry groups are in complete agreement, there is enough of a consensus, according to people who have attended the meetings, that they have begun to tackle the next steps: how to enforce the requirement for everyone to have health insurance; how to make insurance affordable to the uninsured; and whether to require employers to help buy coverage for their employees.
The ideas discussed include a proposal to penalize people who fail to comply with the “individual obligation” to have insurance.
“There seems to be a sense of the room that some form of tax penalty is an effective means to enforce such an obligation, though only on those for whom affordable coverage is available,” said the memorandum, prepared by David C. Bowen, a neurobiologist who is director of the health staff at the Senate Committee on Health, Education, Labor and Pensions.
The full New York Times story can be found here.
Another question worth pondering is wither Medicare Advantage?
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Court verdict could give generic drug makers an unfair advantage
Generic drug companies are pressuring Congress to pass a bill that would profoundly alter how drugs are developed and sold. Supporters claim the measure will expand choice and lower prices for consumers. The truth, however, is that it will limit competition and drive up prices.In recent years, the generic drug industry has been growing by leaps and bounds. Once seen as fringe players, generics now account for 65 percent of all U.S. prescriptions and post $59 billion in annual sales.
In fact, the generic market has been growing faster than the brand name drug market. This explosive growth has brought with it increased stature and influence. And the generic drug industry is not shy about flexing its newfound muscle in legal and legislative arenas.
Drug innovators can spend 15 years and more than $1 billion discovering, developing, testing, and bringing a successful drug to market. In return for this tremendous investment, pharmaceutical companies are given a patent, generally for 20 years, during which they alone can sell the drug.
This exclusivity period often includes the years spent in research and development, so drug companies don’t have very long to recoup their investment. And once a patent expires, generic drug makers are able to offer their version of popular drugs.
Not saddled with massive R&D expenses, generic companies can offer the drug at a fraction of the cost of the original, allowing them to quickly gobble up the market share.
Currently, the first generic manufacturer to win government approval can market their version of the drug without competition for six months. Often, the original drug innovator creates its own generic, called an “authorized generic,” and wins this brief exclusive marketing period.
The bill currently before Congress will outlaw authorized generics, paving the way for generic-only companies to move their version to market more quickly.
Proponents say this will lower prices for the generics, but the evidence suggests otherwise.
Historical data demonstrate that authorized generics are usually introduced to the market at a 50 percent discount. Straight generics, on the other hand, are introduced at a 30 percent discount.
In addition, once the six-month exclusivity period is up, the market is open to all generics, and the more there are, the lower the prices for consumers. Arbitrarily banning one of those generics is not only unfair to consumers, it also creates a disincentive for drug innovators to invent new cures.
The development of new drugs is a risky and expensive process, so anything the government does to obstruct companies from recouping their investment tends to have a chilling effect on drug innovation.
Which is why a recent decision by the California Supreme Court in the case of Conte v. Wyeth is so troubling.
The plaintiff, Ms. Conte, became quite ill after taking a generic heartburn medication prescribed by her physician. Conte not only sued the generic manufacturer, but also Wyeth, the company that made the original brand name drug, even though she never ingested any medicine made by Wyeth.
Because her physician admitted he had not read the warning labels for the generic drug he prescribed, but rather relied on the Wyeth warnings he had been exposed to decades earlier, Wyeth was found liable for Conte’s injuries.
Pushing the bounds of common sense even further, the generic manufacturer has been excused from the case entirely. Why? Because even though they made the actual product that harmed Conte, the physician hadn’t read their warning label.
This case sets a potentially disastrous precedent. In addition to doing all the research, development, testing, trials, and advertising for new drugs, innovators must also assume the legal liability for their competitors when they someday market a generic version of the drug.
In our already-litigious society, it is difficult to imagine a greater deterrent to developing new medications.
Generic drugs are widely trusted by Americans, as they should be. But however safe their products are, the policies the generic industry is pushing are anything but. They threaten to eliminate competition, drive up prices, and stifle innovation -- all prescriptions for catastrophe.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
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.
