Latest Drugwonks' Blog
According to Mental Health America, a new rule proposed by the Centers for Medicare and Medicaid Services (CMS) to remove anti-depressants and antipsychotics from its “protected” status on Part D drug plan formularies would be harmful to consumers.
The proposed rule revises long-standing prior agency policy that required Part D plans to include on their formularies “all or substantially all” drugs within six classes: anti-depressants, antipsychotics, anticonvulsants, antineoplastics, and immunosuppressants. This policy, known as the “six protected classes” policy, has been in effect since the inception of Part D, and has strong congressional support.
David L. Shern, Ph.D, president and CEO of Mental Health America, said the organization is a strong supporter of six classes policy and would join with other advocacy groups in submitting comments opposing the rule, which are due by March 7.
“For many mental health consumers, access to the full range of the most effective medications is a crucial component of successful treatment and recovery,” he said. “Such medically necessary psychotropic medications, and their combination with other services and supports, are often essential to permit people with mental health and substance use conditions to recover and to lead healthy and productive lives in their communities. “
Dr. Shern said policies that restrict access to medically necessary medication not only fail to achieve their intended purpose of reducing overall health care costs but prolong human suffering, and reduce the potential for an individual with a mental health or substance use condition to achieve full recovery.
Per Shern, “These policies fail to acknowledge that physicians and consumers should make individualized treatment decisions, recognizing the unique and non-interchangeable nature of human beings and psychotropic medications, and acknowledging that lack of access to medications has both human and fiscal consequences."
In case you missed it – here's the FDA's latest addition to the social media draft guidance compendium. Nothing earth shattering, but more guidance is better than less.
Some useful tidbits …
* A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.
* A firm is responsible for promotion on a third-party site if the firm has any control or influence on the third-party site, even if that influence is limited in scope. For example, if a firm collaborates, or has editorial, preview, or review privilege, then it is responsible for its promotion on the site and, as such, that site is subject to submission to FDA to meet postmarketing submission requirements. However, if a firm provides only financial support (e.g., through an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for information on a third-party site, and has no obligation to submit the content to FDA. Furthermore, if a firm is merely providing promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site, the firm is responsible only for the content it places there and, thus, is responsible only for submitting to FDA promotional content that was disseminated on that site.
* FDA recommends that a firm be transparent in disclosing its involvement on a site by clearly identifying the UGC (User-Generated Content) and communications of its employees or third parties acting on behalf of the firm.
* ... a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular). FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, messgae boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.
This last item is both new and clear in it's meaning. And it's important as social media is and should be driven by independent UGC.
Will any of this “free” Pharma to pursue more aggressive social media strategies. Probably not. And that’s too bad.
Compliant social media is in the eyes of the engager -- and it's about the content not the platform.
Adherence is a problem of behemoth proportions. According to a report in the report conducted by the New England Healthcare Institute, not taking medications as prescribed leads to poorer health, more frequent hospitalization, a higher risk of death and as much as $290 billion annually in increased medical costs.
There isn’t any one way to solve the problem. Education? Sure, but that only gets you so far. Apps and other social media interventions? Yes. Phone call reminders from physicians and pharmacists? Absolutely. But, alas, there is no one magic bullet.
As any healthcare provider will tell you, the fact that actually taking a medication as prescribed is in a patient’s best interest does not lead to a patient doing what is in his best interest. And, to make matters worse, there isn’t any one single over-riding reason why patients are non-compliant.
Pharmacy programs seem to be the best way forward, and there’s hard data to back that up. Case in point – the successful Appointment-Based Model program being used at Thrifty White, a Midwest chain of pharmacies. (For more information on the Thrifty White program, see the article, Adherence and persistence associated with an appointment-based medication synchronization program, from the December 2013 edition of the Journal of the American Pharmacists Association.)
But what about programs for medicines that are sold (because of regulatory restrictions) via specialty pharmacy? The use of specialty pharmacies to support patients with complex medical conditions is an effective, well-established practice to help ensure patients comply with their physician-directed treatment plan. One example is Exjade, a treatment option for patients with serious blood disorders who have chronic iron overload due to blood transfusions. (Chronic iron overload is potentially life threatening, and does not always have symptoms that are recognizable until serious complications occur. In order to drive compliance. Novartis (the developer and marketer of Exjade) developed a plan to drive compliance by incentivizing the specialty pharmacy BioScrip to develop and implement aggressive patient communications programs. And, yes, “incentivize” means “paying them to do it.”
Success is not always its own reward.
According to Novartis, they “worked with BioScrip to ensure it had the information needed to reach out to patients. BioScrip reached out to patients using its own protocols to provide education, counseling and information about proper administration of the medicine and to fulfill prescriptions that have been prescribed by a patient's treating physician.”
And the programs worked. Patients were more compliant and that’s a good thing, right? Not so fast.
Yesterday New York filed a joint complaint with eight other states alleging that the Novartis program amounted to “kick-backs” paid) per New York State Attorney General Eric Schneiderman, to “promote Exjade drug to treat excessive iron in the blood.
"This arrangement between Novartis and BioScrip was dangerous for patients and is against the law," Schneiderman said in a statement. "Our lawsuit against Novartis and our agreement with BioScrip send a clear message: Drug companies cannot pay pharmacies to promote drugs directly to patients."
But is working to drive patient compliance “promotion?” Is educating a patient on the urgency of compliance “dangerous?”
What message is being sent by Mr. Schneiderman?
Whether or not the Novartis program is against the law is a legal question to be argued in court – but on the face of it, the lawsuit sounds like an ill-considered shakedown with significant unintended public health consequences.
"The company disputes the allegations made by the Attorney General for the State of New York related to Novartis Pharmaceutical Company's (NPC) interactions with specialty pharmacy BioScrip and intends to defend itself in this litigation," André Wyss, NPC President, said in a statement.
This is an important issue. Hopefully Mr. Wyss’ resolve remains firm.
Dear Colleagues:
It is with regret that I inform you that Dr. Jesse Goodman has decided to leave FDA to return to academia and clinical medicine. As FDA’s Chief Scientist, Dr. Goodman has been a strong voice for both our regulatory science enterprise, and for FDA’s role in U.S. and global public health. Among his many accomplishments as Chief Scientist is the development of FDA’s Medical Countermeasure Initiative, which has better positioned FDA to play a strong role in building the nation’s emergency medical counter measures capacity.
Dr. Goodman first came to FDA in 1998 from the University of Minnesota. As Senior Medical Advisor to Commissioners Friedman and Henney, he conceived of and co-chaired the first U.S. Task Force on Antimicrobial Resistance, before moving on to direct the Center for Biologics Evaluation and Research (CBER). Under his leadership, CBER worked closely with government and industry partners to help our nation prepare for and respond to major public health threats, including bioterrorism, West Nile Virus and other threats to blood and organ safety, and both seasonal and pandemic influenza.
After his departure from FDA, Dr. Goodman will be serving as Professor of Medicine and Infectious Diseases and Attending Physician at Georgetown University and the D.C. Veteran’s Administration Hospital. In addition to his teaching and patient care responsibilities, he will direct a new Center on Medical Product Access, Safety and Stewardship.
I am pleased to note that Dr. Stephen Ostroff, Chief Medical Officer in the Center for Food Safety and Applied Nutrition and the Senior Public Health Advisor to FDA’s Office of Foods and Veterinary Medicine, has agreed to take on the role of Acting Chief Scientist.
Dr. Ostroff has served in many distinguished roles prior to joining FDA, including at the Centers for Disease Control and Prevention (CDC), where he served as Deputy Director of National Center for Infectious Diseases and as Acting Director of CDC’s Select Agent Program as well as the Director of the Bureau of Epidemiology and Acting Physician General for the Commonwealth of Pennsylvania. Dr. Ostroff also has consulted for the World Bank on public health projects in South Asia and Latin America.
Dr. Ostroff graduated from the University of Pennsylvania School of Medicine in 1981 and completed residencies in internal medicine at the University of Colorado Health Sciences Center and preventive medicine at the CDC. He is a fellow of the Infectious Disease Society of America and the American College of Physicians, and currently chairs the Public Health Committee of the American Society for Microbiology’s Public and Scientific Affairs Board.
Please join me in thanking Dr. Goodman for his many contributions and his commitment both to FDA and to public health and in wishing him well as he engages important public health issues from his new perspective. Please also help me welcome Dr. Ostroff to his new role.
Sincerely,
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Johnson & Johnson has submitted a citizen petition asking the FDA to require copies of biological products to bear names that are similar and not identical to those of their reference products.
According to J&J's Chief Biotechnology Officer Jay Siegel "Assigning names that are similar but not the same will appropriately reflect the legal and scientific reality that biosimilars are similar to but not the same as their reference products or other biosimilars.”
It’s likely that 2013 will be the year remembered as the year of the ObamaCare website fiasco. It’s a story tailor-made for the media. But the real stories lie elsewhere.
2013 should be commemorated as the year that America began to celebrate the real debut of personalized medicine. New medicines for cancers and orphan diseases were approved by the FDA using a more progressive view of the risk/benefit equation. And, for the first time, the voice of the patient really made a difference in the agency’s calculations. 2013 will be seen as the year when the FDA began to think about a greater dimensionality of benefits via functional endpoints.
2013 may also be viewed by future generations of healthcare pharmacenti as the year when “blockbuster” thinking was replaced with a focus on patient outcomes. The implications for R&D investment in new molecules as well as companion diagnostics make 2013 the year when we finally take to heart both the philosophical and business proposition that getting the right medicine to the right patient in the right dose at the right time is the best way to embrace a patient-centric care paradigm that is also cost-efficient.
But 2013 may also be viewed as the year when Uncle Sam got into the business of telling physicians (and nurse prescribers) how to practice medicine. This is, after all, the year that “government detailing” (aka, “academic detailing” or “counter-detailing”) hit the streets via our tax dollars and minus any federal oversight. It’s an issue that’s been flying under the radar screen – and that makes it more insidious and twice as dangerous.
What will define 2014? There are many possibilities. Certainly near the top of the list is the march towards American biosimilars. 2014 will be the year when the FDA decides on the INN issue. It’s the rare opportunity when we can learn from the mistakes other nations have made. I predict that the FDA will do the right thing and insist that FOBs carry a sim prefix or some such specific identifier. You cannot create comfort among prescribers and patients with therapeutic ambiguity.
Will 2014 be the year when healthcare communicators and pharmacovigilance trackers decide to embrace social media? Will 2014 be the year of more creative and aggressive use of adaptive clinical trials? Will 2014 be a year of developmental and regulatory success for new antibiotics? Only time will tell.
Let’s hope that 2014 builds upon the success of 2013, learns from its failures and surprises us in exciting ways that we didn’t even expect.
When it comes to medication adherence, is knowledge power? Or is that even the right question. Perhaps patients, and healthcare professionals (and payers and regulators) also need to learn how to share knowledge. When it comes to medication adherence in the 21st century, the medium is the medicine.
Are package inserts, hard copy med guides, brochures and “starter packages” still the best way to make important healthcare information “sticky?” Were they ever? Will the tried-and-true ways enhance safe use or drive positive therapeutic outcomes? Or do today’s patients (also known as consumers) want their healthcare intelligence the same way they’re getting enlightenment and orientation on all the other things they want and need to know about the daily details of their lives? In short, on tablets and smart phones.
Is there an app for that?
OH, East is East and West is West and never the twain shall meet.
Nice verse, but unacceptable R&D policy.
This morning the NEJM published "Asia's Ascent: Global Trends in Biomedical R&D Expenditures."
Co-authored by Steve Sammut, Senior Fellow, Health Care Management Lecturer, Entrepreneurial Programs Wharton School, University of Pennsylvania, and board member at the Center for Medicine in the Public Interest, the article provides data to support the positions of Francis Collins and others that the US contribution to research is rapidly eroding relative to other countries, particularly in East Asia.
In recent years, industry has reduced its investment in U.S. biomedical research and development by billions of dollars, while increasing investment in Asia–Oceania. Thus, boosting U.S. government funding alone may be inadequate for retaining long-term R&D leadership.
Francis Collins is sending the article to Congress
Attention must be paid.
India’s Efforts to Aid Poor Worry Drug Makers (New York Times, December 30, 2013) points to the price of cancer medications as the sole impediment to access. Not so.
Price is one variable, but it is not the only one.
Less than 10% of India's 45+ million citizens with cardiovascular disease get even the most common medicines like diuretics and statins. Yet there are 10,500 licensed Indian drug manufacturers producing hundreds of generic anti-hypertensives and other CVD products on the market in India.
While the Times’ story shares a sad tale, the plural of “anecdote” isn’t “data.” The truth is much more complicated and the issue of local production vs. patent protection is a red herring. Almost every drug on the WHO’s list of essential drugs is off-patent – and yet patients in India (and almost every nation in the developing world) lacks access due to poorly run government programs, failing domestic infrastructure, dearth of healthcare providers and, worst of all, lack of diagnosis.
Also, once a lifesaving drug or treatment exists, it’s seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality. As Abraham Lincoln wrote, patents “add the fuel of interest to the passion of genius.”The FTC and biosimilars
Instead of playing name game, it should choose clarity
By Peter Pitts
The Federal Trade Commission (FTC) has started to meddle on a health issue that probably isn’t on the radar of more than a couple of health-policy wonks, but it should be of interest to anyone who treats patients or cares about patient safety.
It’s about a class of medicines called “biosimilars,” copycat versions of innovator biologics — or medicines made from living cells. Most people aren’t even familiar with biologics, let alone biosimilars. Biologics are the fastest-growing segment of the pharmaceutical industry and are primarily used to treat life-threatening or difficult-to-target diseases like cancer, diabetes, multiple sclerosis, lupus, Crohn’s disease, rheumatoid arthritis and epilepsy. Many people aren’t familiar with them yet and only know about traditional chemical compounds, which are vastly different.
Why is the FTC involved? Good question. The FTC’s interest here would be to ensure that “anti-competitive” or “deceptive practices” don’t compromise consumers’ ability to know which product he or she is prescribed, and to ensure it’s the one he or she actually receives. That’s because that’s what “informed consumer choice” is all about — right?
Not in this case. The issue the FTC is actually focusing on is whether any and all biosimilars that follow a particular “reference product” (the innovator biologic) ought to have the exact same name as that reference product. And all current indications point to the FTC is about to concur that they should.
This is no trivial issue. It is a fact that no two biologic products produced by different manufacturers will be the same. A biosimilar can only resemble its reference product. Therefore, how biologics are named will directly impact clarity of information around which products a patient has been using. Greater clarity will obviously occur if biologics and biosimilars have distinguishable names, and that clarity will enable better safety monitoring, “adverse event” reporting and timeliness in managing adverse events if they occur, and can even help us better understand which products work better for certain patients and specific subpopulations.
Let’s employ some common sense here. Suppose parents were to give birth to a set of fraternal twins: would it make sense to name them both “Tim,” on the grounds that it would “level the competitive playing field” as they grow and master their fate? Or do the boys have the right — and the rest of world an interest — in being able to tell them apart? And while we’re on the subject of names, let’s remember that the name “biosimilar” was coined for a reason — as with fraternal twins, who are not identical. (Even if they were — and you wanted to marry one of them — you’d probably want your “choice” to be “informed” by their having distinguishable names.)
In the FTC’s eyes, it seems to come down to clarity of information versus eking out every possible cent of cost savings. It’s not worth the trade-off. Biosimilars have the potential to provide quality alternative medicines and to improve prices in the biologics space. Because of the complexities associated with all biologics (including biosimilars), however, cost savings from biosimilars are not expected to exceed 10 percent to 20 percent over branded products. Chemical compound generics can realize savings of up to 80 percent over brands.
If we go in the direction of non-unique names, and issues arise, we might not have the information we need to quickly understand which among similar products is causing the issue. That can unnecessarily affect trust across a class of drugs and biosimilars as a whole, and that could significantly affect uptake.
Biosimilars are already available in other parts of the world. This gives us a unique opportunity to learn from the experiences of those markets. In Europe, where biosimilars share the same names as the originator product, they’re experiencing an increased number of adverse events, and it can take months for manufacturers to determine if their product is causing the problem.
Thailand also uses nondistinguishable names and rapidly approved biosimilars to treat certain diseases, which has led to both a dramatic increase in the number of cases of life-threatening blood-related adverse events and near futility in efforts to track back to which products are causing the problems. Australia opted for distinguishable codes for all biologics, and they appear to be experiencing successful rollout and uptake of biosimilars.
It’s a universal reality: What’s in a name is a fundamental ability to tell things apart. Nothing more informs American competitiveness and informed consumer choice. No one more than the FTC should recognize that fact — and be its champion.
Peter J. Pitts, a former FDA associate commissioner, is president and co-founder of the Center for Medicine in the Public Interest.
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.
