Latest Drugwonks' Blog
Today the House Energy & Commerce Committee’s 21st Century Cures Initiative tackles the FDA and “communications.”
According to the committee’s own white paper:
Communication about how certain treatments are working in certain patients is happening through a multitude of media around the globe. These conversations between and among doctors, patients, researchers, and scientists in academia and industry should be facilitated. This includes the free flow of data, research, and results related to what a therapy or combination of therapies does or does not do well and in what types of patients. We need to harness the power of the Internet and social networks.
That’s a big topic – but perhaps the most important issue within that big tent is that of off-label communications.
Perhaps the first thing to note is that there is distinction between off-label communications and off-label marketing. And is a distinction with a difference. Off-label marketing means sharing information with the intent to impact sales. Off-label communications means sharing information to improve and advance the public health. One well-known moniker for off-label communications is “the free and fair dissemination of scientific data.”
Let’s start here: Facts do not cease to exist because they are ignored.
According to a 2011 notice in the Federal Register:
The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange. FDA is interested in obtaining comments and information regarding scientific exchange about both unapproved new uses of products already legally marketed (“off-label” use) and use of products not yet legally marketed for any use.
And the issue of “scientific exchange” comes front and center. According to the FR notice, To assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange.
The FR notice puts this request into perspective:
On July 5, 2011, a citizen petition was submitted by Ropes & Gray and Sidley Austin LLP on behalf of seven product manufacturers (Petitioners): Allergan, Inc.; Eli Lilly and Co.; Johnson & Johnson; Novartis Pharmaceuticals Corp.; Novo Nordisk, Inc.; Pfizer, Inc.; and sanofi-aventis U.S. LLC under 21 CFR 10.30. The citizen petition requested that FDA clarify its policies for drug products and devices governing certain communications and activities related to off-label uses of marketed products and use of products that are not yet legally marketed for any use. Specifically, the petition requests clarification in the following areas:
1. Manufacturer responses to unsolicited requests;
2. Scientific exchange;
3. Interactions with formulary committees, payers, and similar entities; and
4. Dissemination of third-party clinical practice guidelines.
For some time, FDA has been considering these issues and is currently evaluating our policies on sponsor or investigator communications and activities related to off-label uses of marketed products and use of products that are not yet legally marketed for any use. We have been considering what actions to take in the areas specified by the petitioners with respect to manufacturer responses to unsolicited requests; interactions with formulary committees, payors, and similar entities; and the dissemination of third-party clinical practice guidelines.
Specifically, the FDA asks:
• How should FDA define scientific exchange?
• What types of activities fall under scientific exchange?
• What types of activities do not fall under scientific exchange?
• Are there particular types and quality of data that may indicate that an activity is, or is not, scientific exchange?
• In what types of forums does scientific exchange typically occur? Should the use of certain forums be given particular significance in determining whether an activity is scientific exchange or an activity that promotes the drug or device? If so, which forums?
• What are the distinctions between scientific exchange and promotion? What are the boundaries between scientific exchange and promotion?
• Generally, who are the speakers involved in scientific exchange, and who is the audience for their communications?
• Should the identity of the participants (either speakers or audience) be given particular significance in determining whether an activity is scientific exchange or an activity that promotes the drug or device? If so, which participants would be indicative of scientific exchange and which would be indicative of promotion?
• How do companies generally separate scientific roles and promotional roles within their corporate structures?
• How should the Agency treat scientific exchange concerning off-label uses of already approved drugs and new uses of legally marketed devices? Please address whether there should be any distinctions between communications regarding uses under FDA-regulated investigation (to support potential approval) and communications regarding uses that are not under express FDA-regulated investigation.
• How should the Agency treat scientific exchange concerning use of products that are not yet legally marketed (that is, products that cannot be legally distributed for any use outside of an FDA- or institutional review board (IRB)-approved clinical trial)?
• Should investigational new drugs and investigational devices be treated the same with respect to scientific exchange? Why or why not?
• Under 21 CFR 812.7(b), an investigational device is considered to be “commercialized” if the price charged for it is more than is necessary to recover the costs of manufacture, research, development, and handling. Similarly, FDA considers charging a price for an investigational drug that exceeds that permitted under its regulations (generally limited to cost recovery) to constitute “commercialization” of the drug (see 74 FR 40872 at 40890, August 13, 2009; 52 FR 19466 at 19467). What other actions indicate the commercialization of drug and/or device products? If there are differences in the steps taken to commercialize drug products and the steps taken to commercialize device products, either before or after approval, please explain these differences.
As PhRMA wrote in a June 2014 statement:
To get the best possible health outcome for patients, FDA should revise its regulations to allow companies to share truthful, scientifically accurate, and data-driven information with healthcare professionals to inform treatment decisions. Some examples of this kind of information include:
Observational data and “real world evidence” – Information on the safety and effectiveness of medicines taken from medical records based on actual use of approved medicines.
Sub-population data – Information on the safety and effectiveness of medicines in sub-populations including gender and race. Such information can help healthcare professionals tailor their treatment to meet the needs of individual patients.
Observational and comparative data – Information from the use of a medicine outside of randomized clinical trials, especially comparisons between two or more therapies.
Pharmacoeconomic information – Healthcare economic data and information on the economic value of medicines can improve the efficiency of patient care.
Information on medically accepted alternative uses of medicines – Information on new uses of approved medicines that are listed in major compendia and/or routinely reimbursed by the federal government and major payers. As the National Cancer Institute states, “Often, usual care for a specific type or stage of cancer includes the off-label use of one or more drugs.”[1] Healthcare professionals help patients by applying new uses of approved drugs in “every specialty of medicine.”[2] When patients are being prescribed medicines off-label, they deserve to know that their healthcare professionals have the latest information on these uses.
[1] See National Cancer Institute, Off-Label Drug Use in Cancer Treatment, available at http://www.cancer.gov/cancertopics/druginfo/offlabeldrug.
[2] Christopher M. Wittich, et; al., Ten Common Questions (and Their Answers) About Off-label Drug Use, Mayo Clinic Proceedings, available at http://www.mayoclinicproceedings.org/article/S0025-6196(12)00683-0/fulltext#sec3.
And it’s not just PhRMA – patient groups are keen to weigh in. Some examples:
NORD:
At the same time, the government severely restricts what drug companies can say about new research and about off-label uses, thus cutting off information from the most knowledgeable sources. The Congress should seek new policies that permit drug companies to share appropriate information without fear of enforcement action.
Ovarian Cancer National Alliance
In ovarian cancer, as in many oncology settings, patients receive “off-label” therapies, which are legal and often part of practice guidelines. Access to these therapies is critical to providing patients with the best possible care...
The Alliance is deeply concerned that these revisions will chill off-label use of drugs and the dissemination of scientific information about non-approved uses. We strongly urge FDA to reconsider these changes and remove any language that may curb patient access to medically-accepted and life-saving medications.
And from BIO:
Current law deals with the important question of providing payers and others with meaningful information regarding the pharmacoeconomic benefits of medicines. However, implementation of Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) has undermined innovators’ ability to meet requests for such information. The committee could evaluate how this important provision could be implemented in a less restrictive way to allow manufacturers to discuss more fully the value to the healthcare system of their innovations.
More broadly, provision of other truthful and non-misleading information to providers, payers, and patients also should not be impeded by unnecessary and cumbersome regulatory restrictions or requirements. Such approaches hinder users of medicines from accessing information that can help them use the medicines most effectively.
A lot of questions and, it seems, a lot of potential regulatory mission creep. All the more reason for both Congressional input .. and oversight.Why ‘pricey’ drugs save money — and lives
Expensive new drugs often get fingered as the culprit to rising US health-care costs. The truth is closer to the reverse.
First off, it’s hard to see how pharmaceuticals can be a major driver of costs when they’re just over 11 percent of the total US health-care budget.
But more important is that even extremely pricey drugs still save money if used right.
Consider Sovaldi, which has a 90 percent cure rate for Hepatitis C, a disease affecting over 3 million Americans. A three-month treatment cycle of the new drug costs upward of $84,000. On the market for just a few months, Sovaldi has already clocked in a record-shattering $2.3 billion in sales.
Some are calling foul, accusing the drug’s developer — Gilead Sciences Inc. — of exploitative pricing. “The company in this case is asking for a blank check,” says Karen Ignagni, president of America’s Health Insurance Plans. “It will blow up family budgets, state Medicaid budgets, employer costs and wreak havoc on the federal debt.”
That’s 100 percent wrong — the exact opposite of reality. New, better medications are actually the best and swiftest way for this country to cut down on our health-care expenses. By more effectively combating disease and improving patients’ lives, drugs reduce long-term medical costs and bolster the overall economy.
Consider one pre-Sovaldi “best practice” treatment for Hepatitis C, the drug Pegasys. This requires one injection a week for 48 weeks — and very few patients see the treatment through to completion, so much of that treatment, both physician time and drug cost, is wasted. Nor is it that much cheaper: At about $7,000/month, the full course of treatment is over $70,000 — barely less than cost of the three months needed for Sovaldi to work a cure.
And the price of not using Sovaldi is very high. One in three patients with the Hepatitis C virus eventually develops liver cirrhosis, and managing these patients is costly. A “routine” liver transplant (where the liver is from a cadaver) costs close to $300,000; a “living donor” transplant is even more expensive.
Thanks to Sovaldi, a pill that cures the disease when taken once a day over 12 weeks will eradicate the need, the risks and the costs of liver transplantation. Such radical innovation deserves to be both lauded and rewarded.
And Sovaldi’s costs will come down. The initial price of such breakthrough medications reflects the huge R&D costs required to bring the drug to market, not avarice.
As Food and Drug Administration official Dr. Janet Woodcock noted of the Sovaldi controversy: “We may have to put a big down payment down now to get something really good.”
It’s remarkable that some large insurers have the chutzpah to complain that curing 3 million Americans of hepatitis C will bankrupt health-care systems. Data recently published by the PwC Health Research Institute suggests the reverse. The study shows that the use of Sovaldi will actually drive down overall spending within a decade. According to the authors, “The challenge may lie in targeting the patient most in need of the more expensive course of therapy.”
In short, drugs aren’t the cause of rising health-care costs — they’re the solution. Demonizing new treatments distracts from the real problem in the US biopharmaceutical industry: top-down cost-centric policies that focus on the near-term, short-changing long-term patient outcomes, and so endanger “sustainable innovation” by denying fair reimbursement for high-risk investment in R&D. (Research and development costs big even if a drug never makes it to market — and most don’t.)
New treatments are a bargain. Disease is always much more costly.
Unfortunately, under ObamaCare health plans are sticking more people with a bigger share of drug costs — a strategy designed to discourage use by the people in greatest need and direct outrage away from insurers to drug companies.
Breakthrough drugs could generate huge new savings in the US economy — but only if federal regulators don’t smother them in the womb with expensive and unnecessary legal hurdles. Left unencumbered, domestic medical innovation will generate the new treatments to improve lives, stave off disease and cut down on long-term health-care costs.
If we don’t reward risk-taking on behalf of human health, both will shrink.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely. The FDA’s September 2011 draft guidance provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. It's fair to say that support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.
Can a patient self-diagnose and self-dose? Do symptoms hide another, potentially more serious, underlying condition? And what of safety concerns? In considering an Rx-to-OTC switch, the FDA looks to see whether patients can use the product safely without the oversight of a physician or pharmacist. This includes ensuring that the right patients use the drug in the appropriate way ("safe use"). The agency is not evaluating the risk-benefit of the product, since that was done earlier when it was approved as a prescription drug.
The journal SelfCare has published "an essential blueprint for designing and implementing any Rx-to-OTC drug development program," says lead author Bill Soller, professor and executive director of the Center for Consumer Self Care at the University of California, San Francisco, School of Pharmacy. Well, maybe not essential -- but certainly intriguing.
Soller and his colleagues list questions - "OTC Considerations" - based on switch principles FDA set in 1990 and 1998 and questions to post-2002 advisory committees that evaluated first-in-class switches.
The analysis recommends 11 primary questions about the Rx fundamentals of a drug, its "OTCness" and overall risk vs. benefit.
1- Has the Rx product been on the market for a sufficient time and extent to enable full characterization of the drug's safety profile?
2- Can the condition be adequately self-diagnosed or is there a need for physician diagnosis?
3- Is the minimally effective dose known?
4- Are there efficacy studies needed to support the intended OTC use of the switch candidate?
5- What are the patterns of diagnosing, prescribing and patient use in the Rx setting related to OTC intended use?
6- Are the studies supporting OTCness generalizable to the intended OTC target population?
7-Do consumers understand key communication objectives of the label, relating to directions for use, contraindications, in-use warnings and precautions?
8- Do consumers show they would be likely to be able to assess and take action on the treatment effect (e.g., take appropriate action if the drug is not working, serious side effects emerge, or self-monitoring is needed)?
9- Do consumers demonstrate successful self-selection and de-selection of the product under conditions (or simulated conditions) of actual use?
10- Does the pattern of actual use support that the label can be successfully used in practice?
11- Do the benefits of OTC availability outweigh the risks?
The authors say FDA "uses its discretion to select areas of concentration for advisory committee discussions on switch." Factors influencing the agency's questions for advisory committees include the novelty and uniqueness of a proposed OTC indication or Rx active ingredient; intrinsic and extrinsic toxicity of a switch candidate; and robustness of published and NDA-derived data and worldwide post-marketing surveillance evaluations.
But there are other important factors at play that, while not entirely within the scope of FDA’s regulatory authority, need to be considered within the context of the broader Rx-to-OTC switch conversation. These factors fall under the general headline of “the consumer healthcare continuum.”
Today’s healthcare consumer has access to much more information than ever before. (Some of it is even accurate.) More importantly, they seek choice and empowerment. At the same time healthcare providers are under multiple pressures to further decrease the amount of time spent with their patients. Moving certain products from Rx to OTC would certainly decrease (in a safe and appropriate manner) a provider's patient load, while at the same time obviating the need for a patient (otherwise known as a “consumer”) to spend both the time and money (office co-pay as well as time off from work) required for an office visit -- allowing physicians to focus their limited time on high-risk patients or those with more complex conditions.
And what about the evolving role of pharmacists and the important question (among others) of pharmacy scope of practice (blood tests, etc.). The removal of the Rx designation doesn’t require the removal of a learned intermediary.
There is also good research showing that patients on OTC medications demonstrate higher rates of utilization. A 2013 study indicates that offering OTC forms of a prescription medication increased utilization per drug class by 30 percent, potentially closing treatment gaps. And, in contrast with many Rx treatments for chronic disease (such as high cholesterol), adherence rates are higher for OTC medications.
Patient, treat thyself. That’s one way of looking at it. Knowledge is power. But is a little knowledge a dangerous thing?
The consumer healthcare continuum continues.
Desperate too-clever-by-half efforts to derail biosimilar pharmacovigilance are contrary to the public health and require rebuttal.
Some generics manufacturers, payers, and national chain drug stores have interwoven half-truths, out of context comments and just plain misinformation to build a fatuous argument dressed up as support for patient safety. But the actual patient and safety communities are firmly on the polar opposite side – in favor of safety, choice, and transparency.
The insurance-industry driven effort claims that distinguishable names for biologics “could lead to patient and prescriber confusion, increasing the possibility of medication errors.” Unpacking that a bit, biologics are complex therapies that are made from living cells and prescribed for patients with difficult-to-target, debilitating and life-threatening health conditions such as cancer, diabetes, MS, lupus, Crohn’s disease and rheumatoid arthritis. There are no generics for them but it is expected that the closest thing – biosimilars – will soon enter the US marketplace. What the insurers are essentially saying is that, a biosimilar that relates to a biologic should have exactly the same name as that biologic.
In the case of biologics and biosimilars, even minute differences between products can cause individual patients to respond differently even though each product is considered safe and effective. Of greatest concern is immunogenicity, which carries a significant risk for all biologics. Because of the size and complexity of the biologic molecule, patients can experience unwanted immune reactions; these reactions can occur months after a patient begins taking the medicine and it is often difficult to know if it is due to the reaction to the medicine or simply the progression of the patient’s condition.
With all of these considerations, it stands to reason that the name of biologics and biosimilars should be similar, not the same. But rather than taking my word for it, consider these important viewpoints:
“Distinguishable names…will enable the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for minorities. This will lessen the inevitable confusion and assure optimum medical care in the use of biosimilars among minority populations.” – From a June 10th letter to FDA signed by 22 of the leading U.S. organizations focused on minority health, including the National Alliance for Hispanic Health, National Hispanic Medical Association and National Medical Association.
“…For millions of female patients, any potential increase or decrease in effectiveness of a biologic, along with side effects and adverse reactions, will only be discovered after the treatment is approved and under active use…As states across the country look to the FDA for guidance on issues surrounding biosimilarity, interchangeability, and therapeutic substitution, the agency’s views on sex and genomic-based differences will be crucial…Distinguishable names will enable the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for both men and women.” – From a May 20th letter to FDA spearheaded by the Society for Women’s Health Research and signed by 45 other leading U.S. organizations focused on women’s health.
“Distinguishable names for biologics support the medical community’s vital post-approval learning curve about which medicines are best for their rare disease patients. Health care providers need to know that a prescribed medicine was actually given to the patient and whether a substitution was made and to what alternative product. This can’t be achieved unless biologic products—especially ones with similar therapeutic purposes—cannot be distinguished, tracked and studied.” – From a June 3rd letter to FDA by the National Organization for Rare Disorders (NORD), the umbrella organization representing the interests of the many advocacy groups that serve 30 million patients impacted by nearly 7,000 rare diseases.
By my estimate, the patient-focused organizations that have come out in support of distinguishable naming cover just about every single American family. Fully addressing all of the inaccuracies and agenda-driven language in the insurance-industry driven letter requires an extensive point-by-point rebuttal [link to one], but the key take-away is this: if you’re for patient safety, you can’t be against distinguishable naming.
As acknowledged by WHO and regulatory bodies of every developed nation, biologics are not chemical compounds (e.g., statins) — they’re infinitely more complicated. When it comes to biosimilars, we need to be extremely thoughtful about how we set policy and strike a balance that promotes health and safety, rather than forcing a binary response that is driven by profits rather than patients.“After years of timid, low-scoring play, that one word has become the theme of Brazil's World Cup. When the history of this tournament is written, the sport's cognoscenti will likely point to it as an event that changed the game. The finalists, Germany and Argentina, have survived the most offense-oriented tournament of the modern era, a series of games where playing defensively almost guaranteed an early exit.”
Pharma could learn a lot from the World Cup champion German club. Stay on offense.
Last night I attended a dinner hosted by Poppy McDonald the publisher of The National Journal to discuss what “value” means to various health care interests. Attendees included Chris Jennings, who advised both the Clinton and Obama administrations on health care reform, John Rother, the former head of policy for AARP (and now CEO of the National Coalition on Health Care), Nancy Ennis-Davenport who is the CEO of National Patient Advocacy Foundation and Alex Wayne, who writes about health care for Bloomberg. Julie Rovner led the discussion.
It was a lively group and the discussions were spirited and friendly. The conversation quickly turned to and focused on the price of Solvadi and whether it was reasonable or not.
I was struck by how, for the most part, few at the table thought in terms of what Solvadi would replace, how much money it would save relative to the cost of treating people with liver disease, the horrible side effects of current treatments and how a 12 week cure could and would affect productivity, disability costs, etc., etc.
And while there was a lot of moaning about drug prices, there was scant discussion about the price of liver transplants, bone marrow grafts, intensive care, etc.
Innovator drug firms have usually done a lousy job thinking about or making the case for the value of their products. But even when they are good at it, they are not consistently making the case. Too often they are on defense, using lobbyists to fend off regulation with apologies and explanations about the price of drugs.
And by playing defense, pharma, more than ever, is in danger of being booed and reviled. The audience expects both sides to mount an offense. Thus, “A team that dared to play passively for even the briefest period of a match was guaranteed to hear derisive howls from the Brazilian crowds, no matter how hot and humid it was or how tactically intelligent slowing down the game might have proven.
"Every team has realized you need a balance, that you need to attack and defend," said Avram Grant, the former manager of the English club Chelsea. "If all you do is defend, you lose."
All pharma does is play defense. At it’s peril. That’s what the dinner discussion about Solvadi and the World Cup showed me.
Imagine waking up in the morning and finding your beloved pet on the floor convulsing, motionless or dead.
Now stop imagining, because this was the real-life nightmare for horse trainers in both Lexington, Kentucky and Ocala, Florida when they found their horses experiencing seizures and thrashing in their stalls. In total, more than a dozen horses died or were severely injured – in some cases, paralyzed.
The cause of these horrific scenes – illegally compounded medicines.
These horses were prescribed illegal drug concoctions that contained unsafe levels of pyrimethamine. By one account 25 times the amount it was supposed to contain. A deadly overdose for innocent animals.
There is legal and appropriate animal drug compounding. All legally compounded product starts with an FDA-approved product. The product may then be modified by a trained pharmacist on the order of a veterinarian to treat the medical needs of an individual or group of animals such as adding flavorings, or turning tablets into an oral liquid for easier administration.
But some animal drug compounding pharmacies go far beyond those parameters – with deadly results. They mass produce and market drugs that attempt to mimic FDA-approved products, often using untested bulk active ingredients, imported from countries that may not enforce the strict controls on drug manufacturing that FDA requires for approved products. These copies carry a cheaper price tag than approved drugs, but none of the consumer protection.
Why does this black market exist? It’s both expensive and time-consuming to take a drug through the FDA approval process. For animal drugs, this can take up to 10 years and cost up to $100 million. But it is a process that protects consumers and their animals – by ensuring that the approved drug is both safe and effective at the labeled dose.
FDA permits a limited amount of necessary compounding from bulk ingredients in order to make sure medical needs can be met when there is no approved drug. But these compounding pharmacies have taken the proverbial inch and run for murderous miles. Despite their attempts to muddy the waters with lawsuits and rhetoric, the law is clear: FDA and three federal appeals courts have ruled that compounding animal drugs from bulk substances is illegal. Period.
Illegally compounded animal drugs have caused harm to more than just horses. One university veterinary hospital has reported that dogs and cats are brought in for medical care because their medicines aren’t working, only to find they were being treated with illegally compounded drugs. The literature is full of reports showing these compounded drugs contain far more or far less than the amount of advertised active ingredient. This is not acceptable.
As a former FDA Associate Commissioner (and a current dog owner), I know the agency has rigorous enforcement authority. Pharmacies that engage in illegal manufacturing cannot be allowed to ignore the law and put animal health at risk in the name of selling a cheaper product.
For several approved animal drugs, FDA has sent warning letters to these pharmacies, but often they were simply ignored and the illegal practices continued. Unfortunately there has been little to no follow up by the agency. The FDA must do more and commit to strong and sustained enforcement to protect animal health.
What can you do? It’s frightening to think a drug given to your pet might not carry the guarantee of safety and effectiveness that comes with FDA approval. The first step is to talk to your veterinarian about best treatment options for your pet. Ask if the drug being prescribed is FDA-approved. If there’s no approved drug and compounding is necessary, make sure the pharmacist preparing the compound has the credentials and license to do it safely and legally. Why that might sound obvious it is the only – and best – way to ensure the prescribed drug is what is best for your pet. If you have concerns about a pharmacy, check with your state Board of Pharmacy. At the same time, FDA must do its job of protecting our pets and animals by more regularly and aggressively enforcing the law and regulations.
Here is my commentary in the most recent edition of BioCentury.
Net/Net -- let's not do the wrong thing by trying to do the right thing.
From the pages of the Burrill Report …
Cracking the Social Media Code
The U.S. Food and Drug Administration recently issued two long-awaited draft guidances for drug and device makers' use of social media. The first concerns risk and benefit information, and the second addresses correcting misinformation published by others on the web. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest, about the issues of concern to the agency, why the industry has been slow to embrace social media, and how these new ways to communicate with patients are accelerating broader changes in the healthcare landscape.
Let's ignore the fact that health plans have calculated, down to the penny, that they make more money discouraging people with chronic conditions from using new medicines or enrolling in their plans than they do in performing the mission they claim they pursue: maintaining health and preventing disease. The claims about drug costs skyrocketing are lies. Don't take my warped word for it.. Here's the headline from a news release put out by the IMS Institute for Health Informatics..
IMS Health Study: Cancer Drug Innovation Surges As Cost Growth Moderates..
From the study: U.S. market for oncology drugs has grown at a 3.5 percent CAGR over the past five years, reaching $37 billion last year.
Total revenues of US health plans in 2013 are estimated to be $432 billion. In 2008, total revenues were $346 billion. That's nearly 6 percent a year increase.
Prescription drugs are 15 percent of total health care expenditures paid for by health plans. They are 13 percent of revenue. In 2008, Rx was $46 billion. In 2013 Rx costs were about $56 billion. That's a 4.3 percent increase.
I know how you are feeling after reading that.. my heart weeps for AHIP too...
Meanwhile, back on planet Earth, HIV organizations and the National Heath Law Program are suing four health plans for discriminating against people with HIV. From Brianna Ehley's article in The Fiscal Times:
Obamacare Insurers Hit High-Cost Patients with High Drug Prices
Some insurance companies are finding ways to get around one of Obamacare’s most popular provisions that requires everyone to be covered equally—regardless of any pre-existing condition.
The anti-discrimination rule was meant to guard against insurers who historically charged higher premiums to sick people. But some insurers are still charging certain patients more by passing the extra costs on in the form of higher drug prices.
Meanwhile, the results of a 3 year study show what dozens of others have demonstrated. Use of new drugs reduce other health care costs.. by a lot.
Changing Physician Incentives for Affordable, Quality Cancer Care: Results of an Episode Payment Model
I'll have more on this study later as well as the befuddlement of the authors who can't believe the results clash with the AHIP propaganda...
AHIP's hashtag should be #AHIP4letterwordforlie.
The First Amendment, In Your Medicine Cabinet
No American in 2014 who watches television, reads a magazine, goes online or visits a doctor’s office can escape the ever-present promotion of prescription drugs. Pharmaceutical promotion, both directly to doctors and to patients, has been the backbone of prescription drug sales for decades, with sales driving everything from drug access to stock prices to research and development. So what happens when the third largest industry in the United States changes the way it promotes products? We might find out.
Scott Liebman, head of the FDA Regulatory and Compliance practice at Loeb & Loeb LLP explains, “A confluence of events has primed the life sciences industry for a paradigm shift. First Amendment challenges to restrictions on off-label communications, evolving transparency in pricing and payments, the Affordable Care Act and other key regulatory developments are coming together in a way that could fundamentally change the sales of drugs, devices, and biologics in this country.”
The Promotion Paradigm: “Ask Your Doctor About…”
The United States is one of only two nations in the world that allows direct-to-consumer advertising of regulated medical products. It is no coincidence that we also rank as the world leader in pharma research and the world’s largest market for pharmaceuticals. “In order to protect consumer safety while preserving consumer choice, regulators have developed numerous and rigid standards for promotional communications, especially those related to the marketing or advertisement of drugs off-label, in other words outside of their FDA-approved indication,” says Liebman.
At present, any promotional statements about a prescription product that are inconsistent with the prescribing information in the label are prohibited according to the Food, Drug and Cosmetic Act. Liebman further explains, “Any promotional statement must be accurate, complete, not misleading and balanced with information related to both benefits and risks.” Along with these regulations comes a highly active enforcement system that generates billions of dollars in revenue at the federal and state levels through settlements and penalties.
In reality, many drugs may be effective in treating disease states or patient populations outside their FDA-approved indications, creating the potential for billions of dollars in new sales. The burdensome regulation placed on manufacturer’s speech is not, however, intended to stop doctors from prescribing drugs for any use they believe to be safe and effective. According to a 2006 Stanford study, an estimated 21% of all written prescriptions are for non-primary label use. Dr. Randall Stafford says in his 2008 New England Journal of Medicine article that, “Although off-label prescribing — the prescription of a medication in a manner different from that approved by the FDA — is legal and common, it is often done in the absence of adequate supporting data. Off-label uses have not been formally evaluated, and evidence provided for one clinical situation may not apply to others.” If that is true, however, how are doctors predicating their off-label prescribing decisions?
Off-Label Communications: The FDA Loses Ground In Court
Doctors have access to off-label information from the manufacturers themselves through a legal carve out for scientific communications made in response to an unsolicited request. If a representative provides off-label information without receiving an unsolicited request, however, the communication can be deemed illegal. In 2009, Allergan sued the FDA asserting that the FDA’s prohibition on the dissemination of off-label information violated the company’s First Amendment right of free speech.
At that time, Allergan had allegedly been promoting Botox® for the treatment of migraine and other indications that were not yet approved. The three resulting whistle-blower suits left Allergan facing enormous civil and criminal penalties, so in 2010 it negotiated a $600 million settlement to resolve its liabilities and entered into a Corporate Integrity Agreement that required the withdrawal of its First Amendment complaint.
A mere six weeks later, Botox® received FDA approval for prevention of headaches in adult patients with chronic migraine.
Allergan’s withdrawal left the industry without appropriate jurisprudence to guide decision making about off-label communications. That changed in 2012 when the US Circuit Court for New York decided US v. Caronia, determining that a sales representative for a pharmaceutical manufacturer had the constitutional right to discuss products for off-label uses. The Caronia case raised questions regarding the authority of the FDA, and to date, the FDA has not appealed. “Although only valid in the Second Circuit, the Caronia case opened the door for additional challenges,” says Liebman.
Since the Caronia case, the FDA revised and reissued a draft Guidance document related to the distribution of scientific and medical publications on unapproved new uses for drugs. Echoing Allergan’s 2009 complaint, the Washington Legal Foundation, a prominent public interest law and policy center, has submitted a comment challenging the Constitutionality of this draft Guidance.
How Much Does That Cost?
Several sections of the Affordable Care Act (ACA) address the cost of healthcare services, including prescription drugs. On the highest level, the ACA intends to shift from a fee-for-service model to a value-based outcomes model. In addition, the law mandates the disclosure of vast amounts of pricing and outcome information. The ACA drew attention to the issue of transparency around the pricing and usage of drugs, such as the costs associated with promotion of regulated products. Further, the FDA recently requested comments regarding use of comparative price information in direct-to-consumer and professional prescription drug advertisements.
“Because of new reporting requirements, a shift toward insurers reimbursing for value to the patient and the ability to make information publicly available online, consumers have an unprecedented amount of information available to make healthcare decisions,” explains Liebman. The New Consumer
Today’s patient has far better tools to become informed about the prescription drugs available to them. The proliferation of information publically available on the internet has left the FDA racing to issue guidance for the monitoring of interactive media and flooding federal websites with new data sets every month. This same information is available to health care providers. Patients and physicians alike now have access to everything from peer reviewed journal articles to patient blogs. The industry is seeing the information gap close, creating a new patient-consumer who is able to make complex decisions that balance health and economic considerations. If a $50 injection can be used off-label to treat a patient’s condition with comparable safety and effectiveness to a $500 injection used on-label, wouldn’t price information be of great value in making the decision about which drug to use? More and more, patients have access to that type of information.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
