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FDA plans to implement during FY14-FY15 a new structured benefit-risk assessment framework to review new molecular entity (NME) NDAs and original BLAs, according to a five-year draft plan released by the agency. The new framework was one of FDA's commitments under PDUFA V. FDA said it plans to implement the framework when reviewing efficacy supplements for new/expanded indications by FY16, and for all NDAs by FY17. FDA said it will publish completed frameworks for newly approved products on its website.
PDUFA V is part of the FDA Safety and Innovation Act, which was enacted in June 2012 and took effect with the start of the fiscal year in October. The law's new set of rules on the review of applications to market NMEs provide for a longer, more interactive review process between FDA and sponsors.
The draft plan is worthwhile reading – but will it gather dust during sequestration?
“The fact that FDA did not require you to conduct a tQT for exenatide to support the safety of Bydureon did not relieve you of your obligation to submit those data once they became available.”
So wrote FDA’s John Jenkins (Director, CDER’s Office of New Drugs) in May of 2011.
FDA documents detailing its review of the diabetes drug Bydureon exenatide indicate the agency delayed approval by a year and a half after concluding the drug’s sponsor, Amylin Pharmaceuticals Inc., had intentionally and deceptively withheld data from a QT study that agency officials believed raised serious concerns about the product’s safety.
In fairness to Amylin, they have a different perspective on the situation. (A solid review of the story is in BioCentury and is worth a read.)
Many issues arise from this situation. One is clearly related to the current imbroglio over the call from Ben Goldacre, et al. for complete clinical trial transparency. A key take-away from the Amylin story is – you can run but you can’t hide. Or, perhaps more precisely, you can’t hide for long.
More importantly, the Amylin situation points out yet another reason why the FDA needs more funding – vigilance counts.
And costs.
Congressman John Conyers just introduced a bill that, if passed, would create government-run health care here in the United States. This same proposal for a "single-payer" system has been put forth in every Congress since 2003, and like all of those previous bills, Conyers’ legislation is destined to die an unceremonious death.
Almost simultaneously, Senator Richard Durbin (D-Ill.) and Rep. Jan Schakowsky (D-Ill.) introduced into the U.S. Senate and House of Representatives versions of a bill that would require the HHS secretary to negotiate Medicare Part D drug prices with pharmaceutical manufacturers. The Medicare Prescription Drug Savings and Choice Act of 2013 would offer one or more Medicare-administered prescription drug plans to compete with the privately administered prescription drug plans currently offered under Medicare Part D. Durbin and Schakowsky have introduced versions of the bill in Congress at least three times since Part D came into effect in 2006.
But just because such brazen attempts at socialized medicine are doomed to fail doesn’t mean the threat of government-run healthcare isn’t real. In fact, the current push to allow federal price controls in the Medicare drug benefit, Part D, is a first step towards a single-payer system.
While Medicare as a whole is a fiscal basket case -- due to run out of money in 2024 -- Part D has been the very model of a well functioning federal program since its implementation in 2006.
The Congressional Budget Office (CBO) found that, between 2004 and 2013, Part D will cost an extraordinary 45 percent below what was initially estimated. Premiums for the program, meanwhile, are roughly half of the government’s original projections. Part D enrollees pay, on average, $30 a month -- a rate that has remained essentially unchanged for years.
It’s no wonder that beneficiaries are so pleased with the program. In fact, 96 percent of those enrolled in Part D say that their coverage works well.
These unprecedented results are largely due to Part D’s market-based structure. Beneficiaries are free to choose from a slate of private drug coverage plans, forcing insurers to compete to offer the best options to American seniors. It’s hardly surprising that the program has led to low prices and satisfied customers.
Of course, anywhere there are market principles at work creating value for consumers, there are liberals eager to meddle -- and Part D is no exception. First, President Obama promised to dismantle Part D in the State of the Union with his proposal to “reduce taxpayer subsidies to prescription drug companies.” This was his coded way of saying that he intends to ruin one of the best market-based government programs in history.
And now, Minnesota Senator Amy Klobuchar has introduced a bill that makes good on the president’s promise. The legislation would allow the Department of Health and Human Services to negotiate directly with drug companies in order to set prices under Part D. The bill would repeal Part D's “non-interference clause” that was included in the law specifically to stop HHS from distorting the market by strong-arming drug companies.
It’s hard to see Klobuchar’s bill as anything but a federal power grab. Unhappy that a single-payer system is a political loser, the president and his fellow liberals are content to takeover the health sector one reform at a time. After all, despite the Democrats’ false promises of cost-savings, there’s no reason to revoke the non-interference clause.
Through their own negotiations with drugmakers, private insurance plans that operate under Part D have already had great success in keeping pharmaceutical prices down. In fact, the CBO has observed that Part D plans have “secured rebates somewhat larger than the average rebates observed in commercial health plans.”
What’s more, the CBO has said time and again that doing away with the non-interference clause “would have a negligible effect on federal spending.” In a report from 2009, they reiterated this view, explaining that such a reform would “have little, if any, effect on [drug] prices.”
In fact, allowing the feds to negotiate drug prices under Part D would likely have a negative effect on the program. The CBO predicts that, when HHS forces pharmaceutical firms to lower the cost of a particular drug, this tactic brings with it “the threat of not allowing that drug to be prescribed.”
In other words, Democrats want to take a program that provides affordable medicine for millions of seniors, and reform it in a way that limits drug access without saving money or addressing any of the systemic problems that afflict Medicare.
As Mr. Conyers’ bill demonstrates, Democrats will never succeed in creating a single-payer system by passing one, all-encompassing bill. Instead, liberals in Washington will have to take over the health sector bit by bit. The push to impose Part D price controls is the latest attempt to grab a little more power for the federal government. Those who support a healthcare system that benefits from choice and competition have a lot to be concerned about.
Read More & Comment...You’re more likely to get a doctor’s appointment in Canada if you’re rich than if you’re poor, even though the government pays the bills, according to a new study.
In the spring and summer of 2011, a team of Canadian researchers posing as prospective patients cold-called 375 doctors offices in Ontario to schedule a check-up.
The researchers posed in each call as one of four types: a wealthy banker in good health, a wealthy banker with diabetes and back problems, a welfare recipient in good health, or a welfare recipient with diabetes and back problems.
Overall, the callers were 50% more likely to be offered an appointment when they posed as bankers than when they posed as welfare recipients.
Canada has universal healthcare, and the researchers said they studied Ontario in particular because it has a single public insurer, and patient pay no copayments or deductibles for visiting a physician. In theory, therefore, general physicians in Ontario and their staffs would have no financial incentive to choose a rich patient over a poor one, according to the study, conducted by doctors at the Keenan Research Centre at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital in Toronto.
Read the full piece here.
Read More & Comment...
But I think in general states are going to have to accept the federal dollars to expand Medicaid. It is the law of the land for better or worse and to say no to tax dollars that already being collected and not use them is a waste at any level.
Is this how entitlements are created? You bet. Will Medicaid be faced with cost overruns and shortages of care and other bad stuff? No doubt. I could write the articles now and just add the numbers in later. It will be up to those of us who would rather see a more rational market for medicine to change how dollars are spent. To tell governors NOT to use Medicaid money to expand healthcare is like telling students not to get student loans for college. Few of us have the income to match the courage of that conviction. And any politician who does not take money to cover a new benefit is probably a politician that will not be re-elected. People forget that Reagan expanded Medicaid coverage in California.
From here on in -- or until there is one party Republican government -- Obamacare will be the law of the land. The binary decision has been made. The issues are no longer a matter of yes or no as much as they are "how much?" and "how?"
That's governing. As James Madison wrote in the Federalist Papers: "in framing a government which is to be administered by men over men, the great difficulty lies in this: you must first enable the government to control the governed; and in the next place oblige it to control itself."
Somethings never change.
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This quote from an unnamed administrtation source in the New York Times says it all: “There is no general mandate under Medicaid to reimburse providers for all or substantially all of their costs,” the administration said. Substantially. As in ten cents on the dollar. Maybe. Anyone out there willing to increase their business by charging 75-90 percent less?
States Can Cut Back on Medicaid Payments, Administration Says
By ROBERT PEAR
Published: February 25, 2013
WASHINGTON — The Obama administration said Monday that states could cut Medicaid payments to many doctors and other health care providers to hold down costs in the program, which insures 60 million low-income people and will soon cover many more under the new health care law.
Enlarge This Image
Manuel Balce Ceneta/Associated Press
Gov. Jerry Brown of California, center, on Monday during a National Governors Association meeting in Washington.
The administration’s position, set forth in a federal appeals court in California, has broad national implications as it comes as the White House is trying to persuade states to expand Medicaid as part of the new law.
The statement of federal policy infuriated health care providers and advocates for low-income people. But it may encourage wavering Republican governors to go along with the expansion because it gives them a tool to help control costs.
Byron J. Gross, a lawyer at the National Health Law Program, an advocacy group for low-income people, said: “The federal government is trying to bend over backward to show flexibility and accommodate states as much as it can. California is an example of that.”
In a brief filed with the United States Court of Appeals for the Ninth Circuit, in San Francisco, federal officials defended a decision by California to cut Medicaid payments to many providers by 10 percent.
Kathleen Sebelius, the secretary of health and human services, approved the cuts in October 2011 after finding that beneficiaries would still have “adequate access” to the wide range of services covered by Medicaid.
The Obama administration urged judges to uphold those cuts, which are being challenged by patients, doctors, dentists, hospitals, pharmacists and other health care providers in California.
AARP, the lobby for older Americans, joined the health law advocacy group and more than a dozen consumer groups in opposing the cuts, which they said would reduce access to care for millions of current and future beneficiaries.
In an interview, Gov. Jerry Brown of California, a Democrat, said the Medicaid cuts were essential to his efforts to dig the state out of a budget hole.
“California has a great record of providing more benefits, expanding to more people, doing more of everything,” said Mr. Brown, who was here for the winter meeting of the National Governors Association. “But I believe in balancing our budget, living within our means.”
“We like the president’s commitment to extend health care to as many Americans as possible, and we can be powerful partners,” Mr. Brown said. “But we need more authority than we now have. I want to emphasize that — more authority than we have now to manage the Affordable Care Act and the expansion of Medicaid.”
Medicaid is one of the fastest-growing items in state budgets. Cutting payment rates saves money for states and for the federal government, which will pay most of the costs for people who become eligible for Medicaid under the new law.
Health care providers said California’s payment rates were inadequate even before the cuts. They pointed to a federal study that said, “California stands out because of its very low Medicaid payment levels.”
In an interview, Dr. Paul R. Phinney, president of the California Medical Association, a plaintiff in one of the court cases, said: “Two-thirds of doctors in California cannot afford to participate in Medicaid because the rates are so low. The problem will only get worse if rates are cut as we move more and more people into Medicaid.”
The cuts were supposed to take effect in 2011 but have been held up, pending the outcome of litigation.
Health care providers said California was cutting Medicaid payment rates for “purely budgetary reasons.”
In court papers, the Obama administration said, “It is entirely appropriate for a state to review its Medicaid plan to determine whether it can continue to satisfy its statutory obligations at lower payment rates.” Indeed, the administration said, states should conduct such reviews “to avoid the perpetuation of payment rates that are unnecessarily high.”
Federal law says Medicaid rates must be “sufficient to enlist enough providers” so that Medicaid beneficiaries have access to care at least to the same extent as the general population in the same geographic area.
The Obama administration said California officials had agreed to monitor beneficiaries’ access to care and to “take prompt action if any problems are indicated.”
Moreover, the administration said, Congress gave states “wide discretion” to set Medicaid rates, and courts should not second-guess decisions by Secretary Sebelius on the adequacy of rates.
“There is no general mandate under Medicaid to reimburse providers for all or substantially all of their costs,” the administration said. Read More & Comment...
Is the concept of “limited use” approvals falling victim to concerns that the could become a tool for the agency to narrow approved indications and to bar off-label prescribing.”
Janet Woodcock calls it like she sees it, “Given that there is skepticism and controversy, to pick an area where there is a compelling need might be a reasonable thing to do.”
It seems likely that limited use will be limited (at least initially) to anti-infective drugs.
As BioCentury points out, “Restricting the pathway to anti-infectives would allow FDA to address a public health crisis and test drive the concept, but would disappoint patient advocacy organizations and emerging biotech companies that hope the regulatory tool could speed development and approval of new drugs for a variety of conditions.”
And the pathway would be voluntary. Woodcock, “The pathway would be voluntary,” said Woodcock, and would be used to help companies tailor highly streamlined development programs to meet urgent public health needs.
The basic concept is for FDA to allow extremely streamlined development programs for drugs for well-defined subpopulations for which benefits clearly outweigh risks, and to couple expedited approvals with measures intended to discourage inappropriate off-label prescribing.
What measures? And through what authority? BioCentury opines that, “The lack of specifics and distrust of the agency’s intentions have led some critics to assume FDA is seeking a broad expansion of its power over the practice of medicine, and others to accuse the agency of plotting to allow dangerous under-tested drugs on the market.”
There is little controversy about approving drugs based on relatively small studies that demonstrate high levels of efficacy in tightly targeted populations. But FDA’s suggestion that it could work with physicians and payers to limit use of a marketed drug in the absence of documented safety concerns is controversial.
Since the FDA is being attacked from almost every side -- it’s likely they are doing something right.
And anti-infectives are a good place to start.
Read More & Comment...The Washington Post reports that David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, "said he will support legislation requiring pharmacies that operate like drug manufacturers to register with the Food and Drug Administration and be subject to stricter standards enforced by the agency." The Post notes, "Miller and his 2,700-member group have traditionally argued that all pharmacies should fall under the purview of state pharmacy boards, not the FDA, and fought efforts in 2007 to shift primary oversight from the states to the federal government. On Thursday, Miller said he now wants to see FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms."
Read More & Comment...HHS issued a final rule on Wednesday that includes language that will increase the number of drugs eligible for reimbursement by insurers under the Affordable Care Act's essential health benefits requirements. Under the final rule, insurers must cover at least one drug per therapeutic area or the same number of drugs in each category and class as specified in the state benchmark plan, whichever is greater. The rule also states that a health plan "must have procedures in place that allow an enrollee to request and gain access to clinically appropriate drugs not covered by the health plan." The language on coverage requirements for drugs is virtually identical to that included in the proposed rule in November.
In response to comments expressing concerns about the cost of the requirement, HHS said it believes the policy "reflects drug coverage in a typical employer plan and will have a negligible effect on premiums." The agency added that the policy will be a "transition" for the first two plan or policy years starting in 2014 -- when ACA is slated to come into effect -- and that it "will study and take into considerations the effects this policy, if any, have on changing typical drug coverage in the market."
Read More & Comment...
If we want to change our national healthcare paradigm we must also change the way people learn, discuss and address healthcare issues. And that means social media.
Attention Pharmaceutical Industry: If you’re not at the table, you’re on the menu.
If you can't measure it, then it doesn't count.
The FDA plans to draft guidances on how companies should create goals for a REMS and on the other metrics needed to determine if those goals are successfully met and a guidance on methodologies for assessing REMS. (FDA agreed in the PDUFA V commitment letter to issue a draft assessment guidance by the end of September 2014.)
An OIG review of 49 REMS, and the FDA’s reviews of those assessments states the obvious, “If FDA does not have comprehensive data to monitor the performance of REMS, it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks.”
But sometimes the obvious is important to state.
According to the Pink Sheet, “FDA currently possesses no way to force sponsors to provide the needed assessment data, so OIG recommends the agency seek enforcement authority from Congress. FDA agreed that this recommendation should be pursued if an opportunity arises. That opportunity could be the reauthorization of the Animal Drug User Fee Act, which is eyed as a means to gain approval of a track and trace system.”
We’ll see if that dog hunts.
Read More & Comment...When it comes to social media, the FDA wants companies to do what’s in the best interest of the physician and the patient (really!). But there’s an unfortunate disconnect – the regulatory go-forward proposition of many companies is to avoid any regulatory ambiguity. The result is a vast regulated healthcare speech wasteland. Alas, when it comes to social media, “in compliance” and “in the best interest of the public health” are often viewed as mutually exclusive.
Read More & Comment...Personal epigenetic 'signatures' found consistent in prostate cancer patients' metastases
Discovery may help distinguish indolent from lethal cancers
In a genome-wide analysis of 13 metastatic prostate cancers, scientists at the Johns Hopkins Kimmel Cancer Center found consistent epigenetic "signatures" across all metastatic tumors in each patient. The discovery of the stable, epigenetic "marks" that sit on the nuclear DNA of cancer cells and alter gene expression, defies a prevailing belief that the marks vary so much within each individual's widespread cancers that they have little or no value as targets for therapy or as biomarkers for treatment response and predicting disease severity.
A report of the discovery, published in the Jan. 23 issue of Science Translational Medicine, describes a genomic analysis of 13 men who died of metastatic prostate cancer and whose tissue samples were collected after a rapid autopsy.
Samples from three to six metastatic sites in each of the patients and one to three samples of their normal tissue were analyzed to determine the amount of molecular marks made up of methyl groups that attach to sites along the genome in a process known as DNA methylation. The process is part of an expanding target of scientific study called epigenetics, known to help drive cell processes by regulating when and how genes are activated. Mistakes in epigenetic processes also are known to trigger or fuel cancers.
"Knowing both the genetic and epigenetic changes that happen in lethal prostate cancers can eventually help us identify the most aggressive cancers earlier and develop new therapies that target those changes," says Srinivasan Yegnasubramanian, M.D., Ph.D., assistant professor of oncology at The Johns Hopkins University School of Medicine. "But there has been an open question of whether epigenetic changes are consistently maintained across all metastatic sites of an individual's cancer."
The research team found that while methylation patterns vary from one patient to another, many methylation patterns occur "very consistently" within different metastatic sites in an individual patient. They identified more than 1,000 regions of the genome where various types of DNA methylation were consistently maintained within their 13 subjects' genomes.
"As they evolve and grow, cancer cells acquire and maintain changes that enable them to continue thriving," says Yegnasubramanian. "We know that cancer cells maintain and pass along genetic changes in the nucleus of cells across metastatic sites, and our research now shows that epigenetic changes also are maintained to nearly the same degree."
The scientists say that the consistent methylation changes they found appear to represent so-called driver changes critical to the cancer's development and could be targets for treatment. By contrast, other methylation changes found only sporadically in the metastatic sites are more likely what are called passenger changes that occur by chance and are less promising as treatment targets or biomarkers than driver changes.
"Our study shows that for prostate cancer, at least, each person develops his own path to cancer and metastasis, and we can find a signature of that path in the epigenetic marks within their tumors," says Yegnasubramanian, who envisions that certain epigenetic changes can be grouped into clusters to be used as biomarkers signaling a lethal cancer.
Yegnasubramanian and his team also plan to study how each of the driver changes work and how they influence cancer metastasis.
Read More & Comment...
http://www.economics21.org/commentary/incredible-lowering-medicare-drug-benefit-baseline
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June 2003, "I happen to be a proponent of a single-payer universal health care program." -- Barack Obama
Calling for the revocation of the Kennedy/Daschle Non-Interference Clause is the Drug Importation canard of the Obama Administration. – a faux policy that pretends to offer an easy solution to a complex problem. Populism may "sell" but it doesn't solve – and it may be a stalking horse for something more ominous.
During Tuesday’s State of the Union the President said, “We’ll reduce taxpayer subsidies to prescription drug companies.”
And on Thursday (and right on cue), a “coalition of liberal groups” (according to an article in Politico), launched a campaign to allow Uncle Sam to negotiate Medicare drug prices, claiming it will “save billions of federal dollars every year.”
Senator Amy Klobuchar (D/MN) recently introduced a bill (S. 117) to empower the Health and Human Services Department to negotiate for lower drug prices. "This is a matter of fairness for our seniors, who deserve affordable prices for their prescription drugs, and it is a matter of fairness for America's taxpayers, who deserve less waste in our system," she said.
Senator Klobuchar should pay closer attention to the numbers.
The non-partisan Congressional Budget Office (CBO) has found that Part D plans “have secured rebates somewhat larger than the average rebates observed in commercial health plans.”
And the Medicare Trustees report that “many brand-name prescription drugs carry substantial rebates, often as much as 20-30 percent and that on average, across all program spending, rebate levels have increased in each year of the program.
Is the argument that Uncle Sam could do better?
According to the CBO (in 2004), revoking the Kennedy/Dascle Non-Interference Clause, “would have a negligible effect on federal spending because CBO estimates that substantial savings will be obtained by the private plans and that the Secretary would not be able to negotiate prices that further reduce federal spending to a significant degree. Because they will be at substantial financial risk, private plans will have strong incentives to negotiate price discounts, both to control their own costs in providing the drug benefit and to attract enrollees with low premiums and cost-sharing requirements.”
In 2007 after two years of experience with bids in the program, the CBO found that striking noninterference “would have a negligible effect on federal spending because … the Secretary would be unable to negotiate prices across the broad range of covered Part D drugs that are more favorable than those obtained by PDPs under current law.”
In 2009 after even further program experience, the CBO reiterated its previous views, stating that they, “still believe that granting the Secretary of HHS additional authority to negotiate for lower drug prices would have little, if any, effect on prices for the same reason that my predecessors have explained, which is that…private drug plans are already negotiating drug prices.”
Importantly, the CBO says that no further savings are possible unless the government restricts beneficiary access to medicines or establishes market-distorting price interventions.
In the words of USA Today (America’s vox populi) “Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan … 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."
Is revoking the Kennedy/Daschle Non-Interference Clause the President’s next move towards what he has previously said is his preferred policy solution – a single payer system? It’s a question worth asking.
Read More & Comment...Just in time for Valentine’s Day comes the Institute of Medicine’s new report, Countering the Problem of Falsified and Substandard Drugs.
Some relevant findings include:
· Congress should fund the FDA to do a national track and trace system, possibly using California as a model.
· The 50 states should adopt NABP's standards for wholesaler licensing (and revocation of license).
· The FDA should publish a list of wholesalers who have lost their licenses from states to, in effect, create a de facto national wholesaler blacklist.
· NIST should setup a repository of counterfeit detection technologies.
Lots of good information.
More good information (and insights) will be at hand at the February 28th conference, The Danger of False Profits: The Threat of Counterfeits to the Public Health. Jointly presented by the Center for Medicine in the Public Interest and the Institute for Policy Innovation, this event will feature speakers iSenior Counselor to the FDA Commissioner John Taylor, Jeff Gren, Director, Office of Health and Consumer Goods, U.S. Department of Commerce, John Clark, Vice President & Chief Security Officer, Pfizer, Michael Maves of Project Hope, Former Executive Vice President and CEO, American Medical Association, Gaurvika Nayyar Research Fellow and Analyst, National Institute of Health, among others.
Event Details:
Thursday, February 28, 2013
9:00 am - 2:00 pm
Reserve Officers Association Headquarters, 5th Floor
One Constitution Ave NE, Washington DC
*Complimentary lunch will be provided
Questions? Please contact Erin Humiston at (972) 874-5139, or erin@ipi.org
Read More & Comment...President Obama on Medicare,
“We’ll reduce taxpayer subsidies to prescription drug companies and ask more from the wealthiest seniors.”
Does that mean another ill-considered assault on the Kennedy/Daschle Non-Interference Clause and a call for Medicare means-testing? Stay tuned.
“Our government shouldn’t make promises we cannot keep.”
Like "If you like your health care plan, you can keep your health care plan.”
Hm.
“But we must keep the promises we’ve already made.”
Like 12 years of data exclusivity for biologics?
Just asking.
He that promises most will perform least.
-- Gaelic Proverb
Read More & Comment...I am pleased to announce that Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., a nationally recognized expert in clinical research and development, has been selected as deputy center director for science operations.
With CDER now over 4,000 employees, Dr. Moscicki, in his newly established role, will join Bob Temple, deputy director for clinical science, and Doug Throckmorton, deputy director for regulatory programs, in providing leadership and overall direction to Center activities to ensure that we accomplish our mission most effectively.
Dr. Moscicki currently serves as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation. He joined Genzyme in 1992 as medical director and became the chief medical officer and SVP of biomedical and regulatory affairs in 1996 -- holding that post until 2011.
Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He is known to be inclusive in his management style and is credited with implementing solid business practices to sustain the company’s long-term operations.
As deputy director for science operations, Dr. Moscicki will share in executive direction of Center operations and provide leadership in overseeing the development, implementation, and direction of our programs.
Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency with a focus on immunology, followed by a four-year fellowship at Massachusetts General Hospital (MGH) in immunology and immunopathology. He remains on staff at MGH and on the faculty of Harvard Medical School.
His medical, academic, clinical, and regulatory knowledge and expertise – coupled with his strong leadership and organizational management qualifications – make him the ideal candidate for this important position.
Please join me in welcoming Dr. Moscicki. He respects the work that we do and is looking forward to bringing his skills and experience to our Center to assist us in advancing the Agency’s mission.
Janet Woodcock Read More & Comment...
Less is more.
The CBO report outlining its 2013-2023 projections is not pretty reading -- but there is one exception:
“The largest downward revision in the current baseline is for spending for Medicare’s Part D.” (This citation appears on page 57 of the report.)
The actual data table can be found here.
The ever-accumulating evidence shows that Part D is succeeding beyond all expectations, delivering needed prescription drugs to Medicare beneficiaries for less money than anyone expected—driven by strong competition among plans.
Note to President Obama, if it ain’t broke, don’t fix it.
Smart partnership between government and the free market works.
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3D bioprinter and “virus traps” take top startup honors at FutureMed pitch contest
As you’d expect at an event called FutureMed, disruption ruled this week’s event, and Saturday’s startup pitch contest was no exception.
Of the 27 companies that participated, the two that wowed the panel of investor judges the most were seriously outside-of-the-box ideas.
For their “startup to watch” award, the judges chose a company that made a splash in the tech world last fall when Peter Thiel’s foundation put $350,000 behind its novel idea to make more sustainable meat by 3D printing it. That company is ModernMeadow, co-founded and pitched by Andras Forgacs, who’s also one of the co-founders behind the human tissue-focused 3D bioprinting company Organovo.
It was a compelling presentation with some mind-blowing statistics and visuals depicting theresources required to produce a quarter-pound burger. ModernMeadow’s business model also includes a cultured leather product.
The overall startup winner, Vecoy Nanomedicines (Vecoy standing for virus + decoy), is focused on creating a new way to address one of the biggest unmet needs in medicine by outwitting viruses that cause infection.
The Israeli-based company is working on a therapy that uses tailor-made “virus traps” that mimic human cells and cause viruses to attack them. When they attack, the viruses get locked into the decoys and annihilate themselves before they can reach the real human cells, CEO Erez Livneh said. He noted that this new approach to fighting viruses may have the potential to lower the viral load in patients with HIV/AIDS, hepatitis B and C and other infections.
[Disrupt image from BigStock Photos]
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