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Another example of domestic manufacturing policy trumping the public health?
It took only two months after patent expiry in China for two generic versions of Novartis AG’s blockbuster chronic myeloid leukemia drug Glivec (imatinib) (marketed as Gleevec in the U.S.) to gain China FDA approval, and many more are expected to follow suit. But Novartis plans to fight back by highlighting the quality and efficacy of its brand and its long-running patient assistance program.
Two companies received CFDA approval June 26, Jiangsu Hansoh Pharmaceutical Co. Ltd. and Jiangsu Chia-tai Tianqing Pharmaceutical Co. Ltd., or CTTQ, 60% of which is held by Hong Kong-listed Sino Biopharmaceutical Ltd. CTTQ holds the first capsule generic approval, while Hansoh received CFDA approval for a tablet formulation of imatinib. Generic imatinib for chronic myeloid leukemia will launch in August, Sino Biopharmaceutical said during a July 4 event.
Although the Glivec compound patent expired in China in April, Novartis still holds a beta crystalline patent in the country until 2018 and a patent for a gastrointestinal stromal tumors indication until 2021, Novartis China said. According to Novartis, the two China generics are likely alpha crystalline forms of imatinib.
“The generic has a different crystal type, so the product quality and treatment result will be totally different,” said Wendy Wang, head of communications for Novartis Oncology China.
The imatinib generics race is just warming up. According to CFDA’s database, as of July 16, there were 16 new applications for imatinib generics in 2013, including an imported drug application.Read More & Comment...
For those of you following the recent CMS decision to deny coverage for contrast-enhanced PET scans ("Taking CMS to the Wood CED"), BioCentury’s Steve Usdin offers a timely and granular peek into the related world of laboratory-developed molecular diagnostics, detailing the cost, time and risk required to get these basic tools of personalized medicine onto the market -- and the decreasing the certainty that they will be covered.
The cost of demonstrating clinical utility, along with the lack of clear or consistent standards, is killing a business model that had made it possible for small companies to commercialize molecular diagnostics quickly and cheaply.
The fate of these laboratory-developed molecular diagnostics companies, and especially the conclusions investors draw about the viability of the space, could shape the future of personalized medicine.
Labs have been sparring with FDA for at least a decade over the agency’s attempts to regulate LDTs, and so far they’ve kept the regulators at bay. FDA Commissioner Margaret Hamburg opened the latest front at the American
Society of Clinical Oncology meeting in June, when she announced the agency plans to eliminate the regulatory distinction between LDTs and in vitro diagnostics marketed to multiple labs or physicians that have long been subject to premarket review.
The agency has developed a draft guidance that would “regulate all in vitro diagnostic tests in the same risk-based framework the agency currently uses, whether or not they are performed by a single laboratory.”
While FDA will find it difficult to use guidance documents or rules to impose clinical utility requirements on LDTs, payers have found a more prosaic tool for achieving the same goal: billing codes.
The full BioCentury article, “Coding for Utility,” can be found here.
Read More & Comment...
Why is it that, when the pharma industry does things right, the story goes unreported in the mainstream media?
That’s a rhetorical question.
Here’s the good news:
Per a new study by Johns Hopkins University (and supported by AHRQ), FDA requirements for postmarket data on new prescription drug approvals have raised the number of postmarket studies completed and reduced the number of uninitiated studies by manufacturers.
Following the passage of the Food and Drug Administration Amendments Act (FDAAA) in 2007, the number of completed studies that fulfilled postmarket obligations nearly doubled from 6.6% in 2007 to 12.6% in 2011.
Among studies not yet initiated by the manufacturer, there was an opposite trend over the study time period, with 56.7% studies not started in 2007 and 43.5% not yet started in 2011, they wrote in a research letter online in the Journal of the American Medical Association.
"Our analysis found the number of studies not yet started declined during this 5-year period, and the number of studies fulfilling obligations nearly doubled," the authors pointed out.
Prior to 2007, drug manufacturers completed postmarket safety trials on a voluntary basis. The passage of the FDAAA authorized the agency to require manufacturers to submit postmarket data as part of the prescription drug approvals process, as well as holding manufacturers to deadlines.
Many rare, but potentially serious adverse events are only found after a drug receives FDA approval, the authors noted.
The study reviewed changes in fulfillment of postmarket studies following the passage of the FDAAA from 2007 to 2011 through a review of all postmarket study status data for both biological and new drug applications.
Studies were categorized as pending, ongoing, delayed, terminated, submitted, released, and fulfilled.
The total number of postmarketing studies in each year in the study period was greater than the number required under the act:
- 1,841 versus 0 required in 2007
- 1,901 versus 46 in 2008
- 2,227 versus 153 in 2009
- 1,774 versus 279 in 2010
- 1,781 versus 387 in 2011
The authors noted three trends over that time: the number of studies not yet started decreased, completed studies that met postmarket requirements increased, and delayed studies also increased. The number of studies not yet started fell from 1,044 (56.7% of all studies) in 2007 to 775 (43.5%) in 2011. Completed studies rose from 122 (6.6%) in 2007 to 224 (12.6%) in 2011. Delayed studies rose from 125 (6.8%) in 2007 to 241 (13.5%) in 2011.
Over the study period, the number of ongoing studies, studies submitted for FDA evaluation, and terminated studies remained relatively constant.
"These trends help address concerns expressed by the Institute of Medicine that many postmarketing studies before the FDAAA were not implemented or fulfilled," they wrote, cautioning that in spite of improvements, "more than 40% of studies had not yet been started in 2011," while the number of studies that were delayed doubled over the study period to "approximately one in eight."
The authors also noted that their research was limited by a design that did not statistically isolate the legislation's effect on fulfillment rates, and a lack of examination of content and outcomes of postmarketing studies.Read More & Comment...
From the pages of Drug Industry Daily …
China Investigating Drug Pricing At Domestic, Multinational Firms
The Chinese government is conducting a review of drug pricing and manufacturing costs at selected domestic and international companies, with an eye on making healthcare more accessible to its people.
The review, by the National Development and Reform Commission (NDRC), will look at drugmakers’ data from 2010 through 2012, including corporate audit reports, sales agreements and shipping records. Importers will also be asked to provide information about border control costs such as customs clearance, quarantine fees and storage fees, a July 2 NDRC notice says.
According to Citi Investment Research analyst Richard Yeh, the inquiry will target about 60 drugmakers — including GlaxoSmithKline, Boehringer Ingelheim, Fresenius Kabi and Sandoz — and focus on prices of drugs recently added to the 2013 essential medicines list and preferentially priced branded generics from multinationals.
“Our checks also suggest that the survey may not necessarily lead to price cuts on the surveyed drugs or imply another round of price cuts, but likely reflects the NDRC’s intention to build a more optimized drug pricing regulation system and to provide a basis for future price cuts” on exorbitantly priced drugs, Yeh writes in a research note.
Helen Chen, head of L.E.K. Consulting’s China life sciences practice, said the exercise could be useful if the NDRC’s aim is to educate itself about the cost of providing quality drugs.
“The key issue here, though, is whether they understand the cost of drug quality goes beyond the simple manufacturing [cost of goods sold],” Chen said. “I hope NDRC’s intention is not just tallying ex-factory price and mandate [sic] a small allowable markup as they had proposed for device manufacturers.”
Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, also sounded a note of skepticism. “It’s important for Beijing to understand and appreciate that lower cost does not necessarily lead to broader patient access,” he told DID Wednesday. “For example, the 100 top drugs on the World Health Organization’s essential drug list are all off-patent and yet there is still little or no access to them in China.”
Also of concern, Pitts added, is that the national government’s control over manufacturing issues in the provinces has proven to be spotty, despite recent regulatory advances at the ministry level.
The survey comes amid an ongoing effort by China to “establish a healthcare system covering urban and rural residents, and to provide safe, effective, convenient and affordable medical service,” as explained by then-President Hu Jintao in 2007.
Chen noted that, in the early 2000s, the government had to force 10 large drugmakers to produce a list of basic medicines that companies had stopped making because the prices were too low to be profitable. According to Yeh, the NDRC released a guideline for drug ex-factory price surveys in November 2011 and began creating a mandatory ex-factory drug price reporting system in September of last year.
Pfizer has received European approval to expand the use of its pneumococcal conjugate vaccine Prevenar 13 to adults aged 18 to 49 years for the prevention of invasive pneumococcal disease, according to a company statement.
The vaccine, which protects against 13 strains of Streptococcus pneumoniae, is approved in the European Union (EU), the United States, and elsewhere for use in infants, young children, and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older.
"Prevenar 13 is now the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood." the company said in the statement.
The European Commission's decision to expand use of the vaccine to 18- to 49-year-olds followed the submission and review of data from an open-label phase 3 trial of the vaccine in healthy adults in this age group, the company said.
The study, which met all primary and secondary objectives, showed that the vaccine is at least as immunogenic in this age group as it is in adults aged 60 to 64 years, as measured 1 month after vaccination. Prevenar 13 showed a favorable safety profile and was generally well-tolerated.
"Adults aged 18 to 49 years with certain underlying medical conditions may benefit in particular from vaccination with Prevenar 13 because of an increased risk of pneumococcal disease," said Luis Jodar, PhD, vice president of the Vaccines Global Medicines Development Group at Pfizer.
Prevenar 13 (known as Prevnar 13 in the United States, Canada, and Taiwan) is now approved in more than 120 countries worldwide for use in infants and young children, as well as in more than 80 countries for use in adults 50 years of age and older.
But not approved for scheduling in the United States (beyond patients who are immunocompromised or over age 65). What’s wrong with this picture?
On the last working day of the year (December 30, 2011), the FDA approved Prevnar 13 (a pneumococcal 13-valent conjugate vaccine) for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. In fact, the new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.
(The Centers for Disease Control and Prevention reports that 5,000 adults die from pneumonia every year.)
And to drive home the importance of this action, the FDA issued a press statement on the approval before heading home for the long weekend:
“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Not so fast.
Although it’s quite a high hurdle to have a vaccine approved by the FDA (and appropriately so), it’s not the final hurdle in getting it to patients. That final hurdle resides with the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).
ACIP’s charge is to “provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population.”
The ACIP meets three times a year, and during these meetings newly licensed vaccines are discussed and a vote is taken to include (or not include) the new vaccine on the adult immunization schedule. ACIP’s recommendations become a basis for reimbursement by public and private payers who will pay for vaccinations that are part of the committee’s recommendation -- but generally not otherwise. The CDC schedule plays an important gatekeeper role for vaccines that goes well beyond the scope of FDA approval. Vaccines approved by the FDA but not appearing on the CDC routine vaccination schedule are likely to gain little traction because of a lack of guidance to providers on how to use the vaccine -- and lack of payer coverage.
In other words, minus a positive ACIP recommendation, a disease that is responsible for approximately 200,000 emergency room visits a year will continue to harass patients and haunt our healthcare system. Minus a positive ACIP vote, new and potentially life-saving vaccines are redlined and another nail is hammered into the coffin of innovation.
The need for this patient population exists. The vaccine is safe and effective. Without a recommendation the vaccine will not be available to a large swath of Americans. It’s time for ACIP to call the question.
The battle against the “dangerous idiots” of vaccine denial is dangerous enough, we must avoid the equally daunting danger of … inertia Read More & Comment...
"It is not from the benevolence of the butcher, the brewer, or the baker that we expect our dinner, but from their regard to their own interest." - Adam Smith
Good reporting from MedPage Today – demonstrating once again that, when it comes to lowering healthcare costs and improving healthcare outcomes, the free market trumps Big Government.
More Choice More Common in Medicaid Plans
States are increasingly moving to privatized managed care programs for their Medicaid recipients as state lawmakers look to change the safety-net system despite objections from naysayers, members of Congress were told Monday.
Kansas, Louisiana, and, most recently, Florida have received federal OKs to offer expanded managed care programs that allow patients to choose from a list of plans with varying benefits.
"The states set the floor of the benefits on those plans, but then the plans can add additional benefits on top of that using the savings they create by better coordinating care," Tarren Bragdon, chief executive of Foundation for Government Accountability, a conservative think tank in Naples, Fla, said after .
Privatized plans include traditional Medicaid managed care programs and provider-driven plans. Florida, which had its federal waiver approved last month, offered 13 plans and 31 benefit packages in its five-county pilot program, Bragdon said.
"Patients like this choice, with 70% to 80% of Medicaid patients proactively choosing the plan rather than being automatically assigned to one," .
States spend between a quarter and a third of their budgets on Medicaid, surpassing the amount spent on education, and they can expect that amount to grow under the Affordable Care Act's expansion program, which opens the program up to all those making up to 138% of the federal poverty level.
States like Florida, Louisiana, and Kansas can expect to save money, Bragdon said, making states like North Carolina, Texas, and Utah consider similar moves. The states believe they can generate greater savings through managed care for more expensive patient groups like the elderly and disabled.
The plans have risk-adjusted capitated rates so they earn more money to enroll sicker patients and have incentives to improve patients' health, Bragdon said. Competing for enrollment, plans are forced to improve benefit packages and improve access to specialists. Plans must publicly report outcomes and conduct consumer-satisfaction surveys annually.
In Louisiana, patients have the choice to opt back to traditional Medicaid. But of 900,000 Medicaid patients, only 3,000 took that option.
"The Florida reform pilot outperformed on health outcomes in 64% of the cases," Bragdon said.
But opponents of privatizing Medicaid cite a lack of accountability over the plans.
"The pilot program for Medicaid privatization [in Florida] was known as a real disaster," Rep. Kathy Castor (D-Fla.) said during Monday's hearing. "The state's own study condemned the results."
Several plans dropped out of the pilot citing an inability to make money, and patients complained of bouncing from plan to plan creating lapses in care.
She called the final waiver approved for the state-wide program "night and day" different from the pilot. The statewide program has new consumer protections, penalties for providers who back out, and medical loss ratios, Castor said.
"While these programs have been controversial in some instances, they reflect a desire by states to utilize care coordination and care management methods and move away from Medicaid's fee-for-service history," Alan Weil, .
All but three states have at least some Medicaid managed care in their state, and Weil said two-thirds of Medicaid patients receive most or all of their benefits through managed care.
"States are increasingly relying on mandatory managed care programs in Medicaid for more complex populations such as children with special healthcare needs and people of all ages with a variety of healthcare needs," Weil said.Read More & Comment...
The lack of clinically useful diagnostics is hindering the growth of personalized medicine.
According to research by the Tufts Center for the Study of Drug Development, without clinically useful diagnostics, personalized medicine growth will occur at a relatively slow pace.
And personalized medicine represents the future of healthcare around the world.
That’s why the recent CMS decision to deny coverage for contrast-enhanced PET scans is a disturbing harbinger of the continued battle between short-term cost concerns on the one side and long-term patient care and medical innovation on the other.
CMS released a draft decision memo indicating that Medicare would pay for contrast-enhanced PET scans aimed at visualizing beta-amyloid protein plaques in patients brains only in the context of rigorous clinical trials, under the agency's "coverage with evidence development" (CED) policy.
The Alzheimer's Association said it was "disappointed" by the government's tentative decision last week not to allow broad Medicare coverage for brain amyloid imaging.
"With 5 million Americans living with Alzheimer's and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical," the group said in a statement.
The Alzheimer's Association noted that, in the past, it has taken as long as 7 years for CMS to move from a CED designation for new medical technologies to full coverage.
"The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer's field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer's epidemic," the group's statement said.
Eli Lilly & Co., which sells the only currently approved PET contrast agent (AmyVid), said it was disappointed in the CMS's draft decision memo, as did the Medical Imaging and Technology Alliance.
All three organizations pointed to "appropriate use criteria" published earlier this year by an expert panel that backed clinical use of the technology in select patient groups.
The panel, convened by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging, said PET amyloid scans would be appropriate for patients with unexplained cognitive impairments, those with tentative Alzheimer's disease diagnoses who show unusual clinical presentations, and those with progressive dementia occurring before age 65.
The Alzheimer Association and Lilly noted that the memo is currently open for public comment (through August 2) and that CMS could still decide to allow broader coverage.
Let’s cut to the chase, if we are going to take meaningful strides both in addressing Alzheimer’s Disease specifically and in personalized medicine more broadly, we should not rely on Coverage with Evidence Development (CED) criteria in cases where the FDA’s approval process has expressly evaluated and endorsed the use of a drug or biologic in a specific patient population.
Fact: The evidence on amyloid imaging supports coverage for the population as identified by the Amyloid Imaging Task Force through Appropriate Use Criteria (AUC). A task force, convened by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, recommends coverage in this population based on a comprehensive review of the literature and expert consensus.
Fact: CMS currently covers similar PET technologies to aid in the diagnosis of Alzheimer’s Disease and other forms of cognitive decline. The agency has not previously required evidence of health outcome improvement as a condition of such coverage.
Fact: Using CED alone will deny Medicare beneficiaries adequate and rapid access to this technology, as the path to implementation is unclear. Such uncertainty in the reimbursement process strongly dis-incentivizes future investments in research and development. And without innovation there will not be advances in personalized medicine.
Wither “sustainable innovation?”
Why even bother with expedited review and similar FDA pathways? Clearly closer FDA/CMS coordination is required to address both the will of Congress – and the future of American healthcare.
What's on your list of FDA spending priorities? According to report in the Pink Sheet, the Wizards of White Oak are currently spending just south of $10,000,000 on 11 research projects -- including a $2 million study of online prescription drug promotion.
According to OPDP panjandrum Tom Abrams, “Our objective as an agency is to increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions.”
First let’s look at the record.
OPDP receives 6,000 to 8,000 advertising and promotional submissions each month, which are assigned to one of OPDP’s 32 reviewers. Per Tom Abrams, the office gets about 120 complaints about promotional materials each year from physicians, consumers and pharmaceutical companies, and of these about 45 concern DTC ads. In 2012, OPDP issued 10 untitled and warning letters for DTC promotions.
Are 10 letters worth $10,000,000 in sparse agency resources? Well, where you stand depends on where you sit.
In the view of Jeff Francer, PhRMA’s assistant general counsel, research activity is taking place “when many stakeholders are asking for regulatory guidance.” There is a “question as to how OPDP is spending its resources.”
As for the value of FDA’s DTC ad research, Francer said it is unclear to him what benefit it provides.
That’s a fair question. If, as Tom Abrams said, the objective of the studies (and hence the justification for the spending) is to “increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions,” then why isn’t the agency working with industry (where the expertise and experience resides) rather than going it alone? If the goal is to increase compliance, then why research rather than better guidance (per Francer)?
Tom Abrams equates “increased quality” with accurate, non-misleading information. And that’s important. But it’s the second part of his definition that should provide a pause for reflection. Consider, “ … instead provide patients with good information about prescription drugs and medical conditions.” Many (if not all) companies that advertise prescription drugs would (and should) argue that their advertisements do precisely that.
Can industry do better? Yes. Should they do better? Yes. Will these OPDP studies help them do better? That’s the question on the table – and it’s an open one.
At the end of the day, “in compliance” and “in the best interests of the public health” must not be mutually exclusive – indeed they should me mutually supportive.
Where will the FDA’s 10,000,000 take us? Will they be a turning point, resulting in pharmaceutical companies’ embracing an educational public health imperative and allotting more media dollars for help-seeking advertising? Or will they be a tipping point, with politicians and the public zeroing in on aggressively targeted DTC in print, on TV … and online?
Working together with industry, FDA can make a difference. Together, industry and FDA can evolve DTC communications into a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality—because “an educated consumer is our best customer.”
FDA DTC Advertising Research Projects Underway
Quantitative Effectiveness Information in Television and Print Advertisements
Examine whether adding placebo information and whether changing the framing of the information helps consumers understand risk information. Also examine how physicians use the prescribing information documents and assess efficacy information.
Determine whether consumers understand composite scores (overall score of drug’s affect on multiple symptoms) as currently communicated and how best to communicate these scores to lay audiences.
Disease Information in Branded Promotional Material
Investigate the effects of adding disease information to promotional materials on consumer perceptions and understanding.
Effect of Promotional Offers in Print Advertisements on Consumer Product Perceptions
Examine what impact, if any, the presence of coupons in DTC ads may have on consumers’ recall and perceptions of product risks and benefits, and the overall impression of the product in full-product and reminder ads.
Determine how consumers interpret and react to DTC comparative drug ads.
Corrective Television Advertising
Evaluate how corrective DTC Rx drug advertisements impact consumer perceptions
Test different ways of presenting Rx drug risk and benefit information on branded drug websites.
Brief Summary Format Variations in Print Advertisements
Determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary.
Healthcare Professional Survey
Follow-up to 2002 physician survey, it is designed to explore the opinions and perceptions of physicians, physician assistants and nurse practitioners regarding promotion of Rx drugs to consumers and health care providers.
Patient Information Prototypes
Test two different formats for presenting patient medication information to patients when they retrieve their prescriptions.
Risk and Benefit Perception Scale Development Focus Groups
Develop and validate risk and benefit perception scales and explore various methods for measuring recall and comprehension.
ObamaCare's 'Liar' Subsidies
The White House says you can sign up 'without further verification.'
The White House seems to regard laws as mere suggestions, including the laws it helped to write. On the heels of last week's one-year suspension of the Affordable Care Act's employer mandate to offer insurance to workers, the Administration is now waiving a new batch of its own ObamaCare prescriptions.
These disclosures arrived inside a 606-page catch-all final rule that the Health and Human Services Department published on July 5—a classic Friday news dump, with extra credit for the holiday weekend. HHS now says it will no longer attempt to verify individual eligibility for insurance subsidies and instead will rely on self-reporting, with minimal efforts to verify if the information consumers provide is accurate.
Remember "liar loans," the low- or no-documentation mortgages that took borrowers at their word without checking pay stubs or W-2s? ObamaCare is now on the same honor system, with taxpayers in tow.
People are supposed to receive subsidies only if their employer does not provide federally approved health benefits. Since HHS now won't require business to report those benefits or enforce the standards until 2015, it says it can't ask ObamaCare's "exchange" bureaucracies to certify who qualifies either.
HHS calls this "a slight technical correction" though it is much more than that. The exchanges will not only start dispensing benefits "based on an applicant's attestation" about his employment insurance status. HHS is also handing the exchanges "temporarily expanded discretion to accept an attestation of projected annual household income without further verification."
In other words, anyone can receive subsidies tied to income without judging the income they declare against the income data the Internal Revenue Service collects. This change has nothing to do with the employer mandate, even tangentially. HHS is disowning eligibility quality control because pre-clearance is "not feasible" as a result of "operational barriers" and "a large amount of systems development on both the state and federal side, which cannot occur in time for October 1, 2013."
You've got to love that passive voice. It's true that coordinating and managing vast amounts of information from hundreds of millions of Americans and corporations, and monitoring compliance with more than 10,000 pages of fine-print Federal Register regulations so far, is hard to do. Yet that is the system Democrats installed when they passed the law, which is not supposed to be optional due to administrative incompetence.
HHS promises to develop "a more robust verification process," some day, but the result starting in October may be millions of people getting subsidies who don't legally qualify. This would mean huge increases in ObamaCare spending. Some of these folks could be fraudsters, much as 21% to 25% of Earned Income Tax Credits flow to people who aren't eligible, according to the Treasury inspector general. The same error rate for ObamaCare would amount to as much as $250 billion in improper payments in its first decade.
The irony in the case of ObamaCare is that liberal health policy is predicated on the notion that if Congress commands something on paper, it will happen in the real world. Architects Peter Orszag and Ezekiel Emanuel are still claiming against all evidence that their policy experiments in human behavior modification will yield huge cost savings.
Yet now we are discovering that Democrats passed a bill that is so large and convoluted that even they can't implement it in practice. So don't be surprised if millions of individuals decide they're eligible for the subsidies, or should be, and wait for someone eventually to say they aren't.
Liberals are also now claiming that the employer mandate and these eligibility rules were never important parts of ObamaCare. This is revisionist history, not least because the mandate and eligibility limits helped reduce the cost as measured by the Congressional Budget Office.
The revisionism is also false because every provision of ObamaCare is supposed to "solve" a problem created by some other provision of the bill. Kick out one of the struts like the business mandate and the whole apparatus becomes even more unstable. In the case of the lawless decision to shelve any income or employer insurance scrutiny, HHS's logistical challenges are real. But our bet is that the Administration is also using them as a pretense in a deliberate bid to make it much easier to join the exchanges.
That's because the health planners are terrified that enough healthy, low-cost people won't sign up and therefore the Affordable Care Act's strict regulations on underwriting and risk-pooling will blow up insurance markets. As more and more of ObamaCare tumbles, the Administration is resorting to anything that can salvage the goal of permanently expanding the U.S. entitlement state.
All of this fits with ObamaCare's entire bloody-minded history. Democrats were determined to make their rendezvous with the liberal destiny of government-run health care, so they imposed this debacle on the country on a partisan vote and despite public opposition. Now that they are discovering how difficult it is to remake one-sixth of the U.S. economy, they are rewriting the law as they go and telling Americans they have no choice but to live with the consequences.Read More & Comment...
Since the Supreme Court’s recent 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett established that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the question on the lips of safety cognoscenti has been, “wither generic drug safety?”
The Supreme Court’s decision pushed to the head of the line concerns over bioequivalence, Narrow Therapeutic Index and – as biosimilars become a part of the conversation -- therapeutic interchangeability.
Well on Wednesday (yes, the very day before the Fourth of July holiday), the FDA posted a notice on the OMB website that it plans to published a proposed rule to “create parity” between generic and innovator drugs relative to how they update their labels. Buried treasure.
(Under current FDA regulations, generic manufacturers cannot update their products’ labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions before getting FDA approval.)
The FDA’s new proposal would also address requirements that all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug.
According to a report in the New York Times, the Generic Pharmaceutical Association had “no comment.”
And that’s a shame – because this presents the manufacturers of generic medicines with a timely opportunity to step up to the plate and become a player (rather than a problem) when it comes to both cGMPs, quality, and safety.
Hopefully, upon return from the long weekend, generic drug manufacturers will embrace the FDA’s proposals.
We shall see.
You cannot escape the responsibility of tomorrow by evading it today.
-- Abraham LincolnRead More & Comment...
BioCentury reports that the European Commission published an interim set of rules that would establish a permanent, voluntary network of EU member states to facilitate cooperation and sharing of information for health technology assessments (HTAs). Member states must send written notice to the EC to participate in the network, which will comprise the national authorities responsible for HTAs in each participating state. The EC will manage the network, which also will support the European Network for Health Technology Assessment (EUnetHTA) consortium. EUnetHTA is a group of government-appointed organizations, regional agencies and not-for-profits that produce or contribute to HTAs in 29 European countries, including 26 EU member states.
Last May in Moscow, I heard Hans Severens (Erasmus University) speak about “the possibilities and the impossibilities of HTA.” His main point (which became a mantra of all of the day’s presentations) is that, when it comes to HTA, “all decision-making must be made in a local context.” He also firmly stated that economic concerns are only one of many petals on the HTA flower – another point reinforced throughout the course of the program. Countries “shouldn’t just adopt NICE findings” but should assemble all available information and put all data into a local context.
If all politics is local – so to must HTA designs and decisions.
Hello PCORI!Read More & Comment...
Solid directional guidance fom Bob Hugin, CEO of Celgene and the new Chairman of PhRMA.
Supporting the ecosystem of medical innovation is the most important thing we can do to improve health care for patients with unmet medical needs in the United States.
Medical innovation is a crown jewel of America and its economy. It has been the greatest source of longer life and economic prosperity in our country and around the world. In the course of just one decade, from 1999 to 2008, medical innovation brought about a 45 percent reduction in deaths from cardiovascular disease. Biopharmaceutical therapy for a devastating disease like Alzheimer’s can reduce nursing home admissions by 50 percent. HIV has gone from an untreatable, fatal disease to a serious but manageable condition. And in cancer, nearly 50 million life-years have been saved for patients since 1990 because of innovative approaches to cancer prevention and treatment.
How did we accomplish this? By working together – large and small companies, academic researchers, government agencies, and patient organizations alike. By taking risks and investing in innovation. And those investments have paid off in scientific advancement and economic growth. For example, the US government spent $3.8 billion over thirteen years investing in the Human Genome Project, generating enormous private sector activity. Every $1 invested in the Human Genome Project created $140 in economic value, repaying the government for its investment via tax revenue many times over, and producing transformative scientific and medical advances for patients.
We cannot take this ecosystem for granted. In fact, it is very much at risk. Short-sighted policies that limit scientific and medical innovation today could negatively affect patients for decades in the future. Consider Alzheimer’s Disease. The Alzheimer’s Association reports that without new disease-modifying treatments, by 2050, at least 13.5 million Americans will have developed Alzheimer’s disease, costing this country $1 trillion per year – a crushing expense. A new therapy that delays the onset of Alzheimer’s by five years would reduce by nearly 45% the number of people with the disease by 2050, and save $447 billion per year. We cannot afford NOT to invest in the discovery and development of such a potential treatment today.
So how do we protect the ecosystem of medical innovation? Fortunately, while the challenges are greater than ever, so too are the opportunities. We are only at the early stages of being able to capitalize on the revolution in molecular biology and information technology. With more than 5,000 new treatments in development, the promise and potential of recent scientific and technological advances is enormous. We must be bold and courageous and stay focused on developing innovations that meet patients’ most pressing unmet needs. And to do this, we must have a policy environment that supports innovation, values the entire ecosystem of medical progress – academic medical centers, voluntary health associations, government agencies like the FDA, CMS and NIH, and, crucially, the biopharmaceutical company scientists, entrepreneurs and investors responsible for discovering, developing and bringing to patients the vast majority of new treatments.
Part of a supportive environment for innovation is ensuring that patients have access to the most innovative treatments. New therapies that reduce hospitalizations, promote productivity and improve quality of life have the potential to make real reductions in the overall cost of health care, but access to these treatments is critical. Medicare Part D is an example of how the public and private sectors can work together to maximize benefit to patients and value to society. This government supported, privately delivered program based on competition and choice has expanded access for good prescription coverage to 30 million seniors, with 90 percent satisfaction among participants, at a cost more than 40 percent lower than projections, and substantial demonstrated savings in other parts of the medical system. We must work to protect this model and also ensure patient access to therapeutics in Medicare Part B, other government-funded health programs, and in plans offered through health exchanges.
We can improve health care in the United States by fostering a policy environment that strengthens the ecosystem of innovation, so that working together, we can pursue bold innovations that create longer life and better health for patients.Read More & Comment...
"Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public."
You see, his renown comes froms digging up old data and proving that Steve Nissen and Andrew Wakefield were right all along!!
"He met Dr. Jefferson, a prominent skeptic of the flu vaccine, after researching whether the Centers for Disease Control was exaggerating the deadliness of the disease.
“We were both lone wolves in the field of influenza,” Dr. Doshi recalled.
Just great. Wakefield redux and the NYT believes that undermining the support for immunization is a important as curing cancer!
Transparency is a tool for people who hate the drug industry to make challenges based on statistical manipulation of data sets... Avandia and Paxil are great drugs for the right people and have saved lives. The second guessing has lead to both medicines being underused while treatments that have even clearer adverse events have been overprescribed. I have seen what researchers have done with the data.. Tamiflu works brilliantly for a subset of patients. The problems it now has is that the viral strains it was designed to block are mutating.
Moreover, what is submitted to the FDA and peer -reviewed publications has nothing to do with financial ties and everything to do with the exclusion criteria and the way studies are conducted. What do these guys contribute to improving or moving the ball forward towards personalized medicine...nothing. Anyone who claims that these drugs DONT work are liars and building their reputations on the bodies of people who are dead because they bought the bullshit. That goes for Ben Goldacre in particular who seems to get off on making TED speeches.
Datasharing that re-examines hypothesis or established science should be encouraged. But it has to be conducted as if people's lives are at stake. I hate to say it, but this is the kind of ass kissing 'stick it to the man' bias that allowed Wakefield to spread fear about vaccines.. Do you think the NYT would have ran the story if it was about giving a medicine a second life for dying patients? And would these 'whistleblowers' have gone after a company that pulled a drug working in a sub-group.
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It seems that lately, when it comes to healthcare policy, we are living in the land of unintended consequences.
Per the Supreme Court’s recent 5-4 decision that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the one-eyed man is measuring the throne room.
Writing for the majority, Mr. Justice Alito opines that state law cannot trump federal laws regarding prescription medicines whose design has been approved by the Food and Drug Administration. So, the obvious first question is, why doesn’t Federal Preemption hold for innovator products. Will the Court revisit Wyeth v. Levine? Not likely.
And then there’s the more important question – that of patient safety. While there is no language in the Supreme Court decision on either bioequivalence or therapeutic interchangeability, the unintended consequence of their decision is that many payers and physicians, now that the burden of potential legal entanglements has been lifted, will now consider generics as “the same” as their innovator forefathers and prescribe accordingly.
And since the Supremes’ made no special mention of Narrow Therapeutic Index, well, Katie un-bar the door for anti-seizure meds, anti-depressants, etc.
The Court’s decision also undermines the urgency of educating payers, physicians, and patients on the subject of generic drug quality – and this goes further than just excipient changes.
It’s one of our nation’s most important and yet invisible problems. How to educate the various relevant publics on “bioequivalence?” Not that we were trying very hard before – but as we approach the reality of both small molecule patent expiry and biosimilars, the issue becomes less and less academic and more and more practical.
For example, how will the Court’s decision impact the INN debate?
The Court’s decision has thrown yet another cloak of invisibility over the urgent need for quality maximization.
William Gladstone famously said that, “Justice delayed is justice denied.” Well, getting the right medicine to the right patient at the right time (as good a definition as any of “personalized medicine”) is healthcare justice – and the Supreme Court’s decision is going to be a barrier to achieving justice for all.Read More & Comment...
The battle over ObamaCare will reignite soon, and the next front will be the war for public opinion. The American public remains deeply skeptical of the new law. Many Americans say they will not sign up for insurance in the new “exchanges” scheduled to open October 1, 2013. As a result, the Obama administration is preparing a high-profile public relations blitz to again sell the law to the public.
Here are 4 talking points ObamaCare advocates will attempt to promote — and 4 questions Americans should ask in response.
1) “Free” benefits
One of the supposed selling points of the new law will be “free” benefits, such as “free” birth control, well-woman visits, STD (sexually transmitted disease) prevention counseling, and a variety of preventive services.
Of course, nothing is “free.” Others will have to pay for these services in the form of increased insurance premiums or higher taxes. If anyone touts “free” benefits, we should ask, “Who is really paying for them? And what else could they be doing with their own money if they weren’t compelled to do so?”
One of the goals of ObamaCare is near-universal “coverage.” But “coverage” is not the same as actual medical care. The American Medical Association predicts a “silent exodus” of physicians as ObamaCare is phased in, worsening the already existing physician shortage.
The New York Times notes the already growing disconnect between theoretical “coverage” and actual medical care in parts of California: “Patients still get care, but the process is often slow and difficult. In Riverside, it has left residents driving long distances to doctors, languishing on waiting lists, overusing emergency rooms and even forgoing care.” These problems will worsen under ObamaCare.
Read the full piece here.
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It’s rare that I find myself in agreement with Public Citizen. This is one of those times.
In a 5 to 4 vote the Supreme Court has ruled that makers of generic drugs cannot be sued under state law for adverse reactions to their products, a decision that consumer advocates called a blow to patient safety.
The majority opinion, written by Justice Samuel A. Alito Jr., said the state’s law could not run against federal laws regarding prescription medicines whose design has been approved by the Food and Drug Administration.
The consumer watchdog group Public Citizen said the Supreme Court decision Monday undermines patient safety at a time when about 80 percent of U.S. prescriptions are filled with generic medicines.
“Today’s court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen’s Health Research Group, said in an interview.
Wither innovator preemption?
Medicine was once considered a place where patients could confide in their doctors about their most intimate concerns and doctors had time to listen. Notes were one- or two-line jots in a chart. We’d spend the extra time because we were valued for our skills and for our knowledge and there was more to it than just pay. We had skin in the game. We got paid in chickens. We knew our patients. Back then, seven-minute appointments didn’t exist.
Now, doctors are cultivated as shift workers. Patients have Google. Everyone has information at their fingertips. Our new story line has become there are no limits to what patients can have in health care. Perfect data. Perfect health care access. Error-free health care with perfect delivery. Perfect communicating doctors. Always. We’re building our medical Utopia.
But this effort to school doctors on our path to Nirvana has a serious downside for health care workers on the front lines.
As I’ve said before, there’s a growing culture of hostile dependency that continues to grow toward doctors these days. The theme is like an adolescent who realizes his parents have feet of clay. He comes out of his childhood bubble and realizes his parents have failures and limitations because they are human beings. This results in the adolescent feeling unsafe, unprotected and vulnerable. Since this is not a pleasant feeling, narcissistic rage is triggered toward the people he needs and depends on the most. None of this occurs at a conscious level. Most of us understand this behavior simply as “adolescent rebellion,” not understanding the powerful issues at play. So when we spotlight one side of what doctors should do for patients, be it improve communication or empathy (or whatever) without acknowledging the realities health care workers face like looming staffing shortages and pay cuts, we risk fanning the flames of narcissistic rage against the very caregivers whom we depend on the most - the very caregivers who are striving to communicate, do more with less, check boxes while still looking in the patient’s eyes, meet productivity ratios, all while working in a highly litigious environment.
Read the full piece here.
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Actually Padzur personifies the problems inherent in what Eric Topol has called the "contrived clinical trial environment." Here's Padzur's punchline:
“I am extremely disappointed in the sponsor’s proposed labeling for this drug,” Pazdur said during a long aside quoted in The Cancer Letter. “There is no survival curve in the proposed labeling. There is no hazard ratio— there’s difference in the means and the explanation in one or two sentences confounding by crossover.
“But if this drug is approved, one would have to have a very careful conversation with the patient about this potential negative impact on overall survival. And how would you do this? I’ve been playing this in my mind in several scenarios, and any logical patient that I could think of would say, ‘Doc, if you are so uncertain about this most important endpoint, don’t we have any other drug to use here?’”
If my doctor used terms like survival curves, endpoints and hazard ratios in discussing my cancer treatment, I wouldn't stick around for an explanation. Why waste months debating such crap when my life is at stake?
The fact that Richard Padzur or any regulator is doing the thinking on behalf of patients underscores just how dysfunctional FDA review has become. It’s how drugs work in the real world that matters. Yet the most recent data shows that it actually takes cancer drugs more time to get to patients than any other area of medicine. And orphan designation is simply a way to get more patent life, not speed treatments to patients. An orphan designation is associated with more time in development, not less. Why are we still using phase 2 and 3 randomized trials to test medicines where a driver mutation is known? Why are we allowing insurance companies to force advanced stage patients to ‘fail first’ on cookbook treatments when we have can match mutation to treatment? The call for ‘more evidence’ is a deceitful dodge because the ‘evidence’ people like Padzur and others call for is randomized trials where survival curves mean more than real survival.
Padzur is not the problem. He is obviously a well-intentioned -- and caring -- public servant. Rather he is part of broken system where most patients die in less time than it takes to organize and conduct clinical trials. Read More & Comment...
Washington, D.C. – In advance of the upcoming U.S.-India Strategic Dialogue, U.S. Senators Rob Portman (R-Ohio), former U.S. Trade Representative, and Bob Menendez (D-NJ), Chairman of the Senate Foreign Relations Committee, today led a bipartisan letter signed by 40 total Senators to U.S. Secretary of State John Kerry urging him to work with the Government of India to improve the business operating environment in India and end its trade and economic practices that discriminate against American companies.
While calling India a “crucial ally” and “an important export market for American-made goods and services,” the Senators wrote: “…we are very concerned that India's recent actions to force the local production of certain information technology and clean energy equipment and to deny, break or revoke patents for nearly a dozen lifesaving medications risk undermining our broader partnership. This is particularly troubling against the backdrop of a generally deteriorating environment for intellectual property protection in India.”
“If India is to truly embrace its ‘Decade of Innovation,’ India’s policymakers must begin to recognize the value of intellectual property. The stakes are too high for India to ignore. India’s deteriorating IP environment is bad for investment, bad for innovation, and bad for international trade,” said Mark Elliot, executive vice president of the U.S. Chamber of Commerce’s Global Intellectual Property Center, co-chair of the Alliance for Fair Trade with India.
“India’s unfair and discriminatory trade practices are hurting manufacturers in the United States. It’s important that this issue is raised at the highest levels to ensure India abides by global trade rules to protect America's competitiveness. Manufacturers look forward to working with Congress and the Administration to ensure a level playing field,” said National Association of Manufacturers (NAM) President and CEO Jay Timmons. The NAM is co-chair of the Alliance for Fair Trade with India.
The Senators urged the State Department “to press for swift action,” adding: “A level playing field for American businesses, farmers and workers in India and other overseas markets is an essential U.S. diplomatic objective.”
Portman and Menendez were joined by U.S. Senators Kelly Ayotte (R-NH), Tammy Baldwin (D-WI), John Barrasso (R-WY), Roy Blunt (R-MO), Richard Burr (R-NC), Maria Cantwell (D-WA), Tom Carper (D-DE), Saxby Chambliss (R-GA), Jeff Chiesa (R-NJ), Dan Coats (R-IN), Susan Collins (R-ME), Chris Coons (D-DE), Bob Corker (R-TN), William “Mo” Cowan (D-MA), Mike Crapo (R-ID), Joe Donnelly (D-IN), Mike Enzi (R-WY), Dianne Feinstein (D-CA), Kay Hagan (D-NC), Martin Heinrich (D-NM), Johnny Isakson (R-GA), Mike Johanns (R-NE), Amy Klobuchar (D-MN), Mary Landrieu (D-LA), Carl Levin (D-MI), Claire McCaskill (D-MO), Patty Murray (D-WA), Bill Nelson (D-FL), Mark Pryor (D-AR), James Risch (R-ID), Pat Roberts (R-KS), Marco Rubio (R-FL), Brian Schatz (D-HI), Debbie Stabenow (D-MI), John Thune (R-SD), Pat Toomey (R-PA), Mark Udall (D-CO), and David Vitter (R-LA).Read More & Comment...
What's next? CMS commenting on PDUFA implementation?
BioCentury reports that Republicans on the U.S. Senate Committee on Health, Education, Labor and Pensions sent a letter to FDA Commissioner Margaret Hamburg asking "why and under what authority" the agency is publicizing new health insurance exchanges under the Affordable Care Act. According to the letter, FDA sent an email earlier this month to "families, individuals, small businesses and clinicians" promoting open enrollment in the new exchanges. The senators expressed concern that the email was an attempt by HHS to "avoid congressional limitations on implementation expenditures" for ACA, noting that the exchanges are outside of FDA's mission.
The senators are seeking information on FDA's legal authority to promote the implementation of ACA and the new health insurance exchanges and how the activities further the agency's mission, as well as details on the total costs FDA has spent during FY13 on promoting ACA implementation. The senators are seeking a response by June 26Read More & Comment...