Latest Drugwonks' Blog
Sometimes statements of the obvious are useful. Here’s one from Yale University’s Nicholas Downing, a third year medical student at Yale University School of Medicine and lead author of a new study, which examined nearly 200 new drug approvals between 2005 and 2012:
“Not all FDA approvals are created equally.”
According to the Washington Post, “Downing and his team found broad differences in the data it took to get a thumbs up from FDA. For instance, the agency required that many new drugs prove themselves in large, high-quality clinical trials. But about a third won approval on the basis of a single clinical trial, and many other trials involved small groups of patients and shorter durations. Only about 40 percent of approvals included trials in which the new drug was compared with existing drugs on the market.”
“There was a lack of uniformity in the level of evidence the FDA used,” Joseph Ross, assistant professor of internal medicine at Yale and a senior author of the study, said in announcing the findings.
Well, duh.
The Yale study, funded by the Pew Charitable Trusts and published Tuesday in JAMA, acknowledges that the FDA has valid reasons for its varied requirements.
“Such regulatory flexibility allows for a customized approach to approval,” it states, “including the ability to rapidly approve potentially effective therapies for life-threatening diseases, such as certain cancers, or those diseases for which there is no existing effective treatment, such as orphan diseases.”
Downing, the study’s lead author, said the analysis is not intended to suggest that the FDA should use a one-size-fits-all approval process or that it somehow has approved the wrong drugs. Rather, he said, it was meant to educate people who assume that all new drugs have cleared the same amount of safety testing before ending up on the market.
“It’s very understandable that regulators have a flexible standard for approval, but patients and doctors need to be aware the standard is flexible,” he said. “It’s important for doctors and patients to have a discussion about how much we know about the potential benefits or risks of taking a drug before they take it . . . [and] it underscores the need to continue to study these drugs after approval.”
Yep. Not new – but worth repeating.
Missing from the Yale study is the relevant fact that, per PDUFA V, the FDA is designing a five-item grid as a management tool to explain its risk-benefit decisions in a more concise format. The model that it has created as a working template confirms a truism about its drug approval tendencies that industry has suspected for years: the baseline for FDA approval is a high rating of the severity of the disease being treated and the medical need for the product.
The agency is developing a grid of the five basic factors that need to be addressed in any decision on the commercial availability of a drug. The top two are the seriousness of the condition addressed and the need for a new treatment of the condition. Then comes the traditional heart of the NDA package: analyses of clinical data on the benefits of the drug and the risks associated with its use.
The fifth fundamental factor is explicitly the level of risk management associated with the product. The FDA is going to take it into consideration in every decision; sponsors who ignore or underplay the identification of who should use the product and who might use it will have a gap in their filings.
The grid proposal does not call for a fixed mathematical formula behind each approval. The agency has not tried to reduce the judgments in an approval decision to a rigid calculation.
Judgment? You mean FDA decisions aren’t black and white?
In the words of John Jenkins, director of the Office of New Drugs at the Center for Drug Evaluation and Research, disagreement “happens a lot in the decisions that we have to make. Very few of the decisions that we make on drugs are easy. Very few of the drugs we see have a dramatic overwhelming benefit with relatively no risk. We see that most drugs have marginal to moderate benefits on a population basis and they have general safety but they have the risks of serious toxicities at some low levels." In other words, every decision is very complex.
The unspoken danger is that regulators love ambiguity because ambiguity is power. That’s different than regulatory flexibility – which is a good thing. But it’s a fine line and the distinction is often in the eyes of the beholder. But it is certainly a distinction with a difference.
Some snippets from the National Council on Patient Information and Education’s report, Accelerating Progress in Prescription Medicine Adherence: The Adherence Action Agenda: A National Action Plan to Address America’s “Other Drug Problem”
At the same time that medical science has transformed HIV and many cancers into treatable conditions and significantly reduced the burden of chronic diseases like diabetes, many Americans are not benefiting from these treatment advances due to the persistent problem of poor prescription medicine adherence—a pervasive problem the leads to unnecessary disease progression, disease complications, a lower quality of life, preventable deaths, avoidable medical spending and lost work productivity.
Based on the latest estimates, half of the estimated 187 million Americans who take one or more prescription medicines—or up to 93.5 million patients—do not take these drugs as prescribed. In fact, studies show that 20% to 30% of prescriptions are never filled by patients, while 50%–60% of medications to treat chronic disease are not taken as prescribed. In terms of the toll in morbidity and mortality, lack of medication adherence is associated with poorer health outcomes, resulting in approximately 125,000 preventable deaths a year and many as 40% of nursing home admissions in people with type 2 diabetes. From the standpoint of the cost to the economy, new research estimates that $105 billion is wasted annually on medication therapy nonadherence of which 69%—or $72.5 billion—is spent on hospitalizations. Other findings project that poor medicine adherence, along with suboptimal prescribing, drug administration, and diagnosis, costs the health care system an estimated $290 billion per year in avoidable medical spending and lost work productivity, translating into 13 percent of total health care expenditures.
The future state of medication adherence will be affected by the move towards a patient-centered health care system through implementation of the Patient Protection and Affordable Care Act (ACA), including efforts to reduce avoidable hospital readmissions, which is driving innovative approaches to medication management.
A NEW ADHERENCE ACTION AGENDA
NCPIE’s Adherence Action Agenda advocates for an increased focus on the overlooked challenge of multiple chronic conditions, where the need for patient adherence is most acute, and lays out these ten policy and programmatic solutions to improve medication adherence:
1. Establish medicine adherence as a priority goal of all federal and state efforts designed to reduce the burden of multiple chronic conditions. Because patient adherence is not viewed as an essential element of government initiatives to reduce the burden of multiple chronic conditions, the report calls for adherence to be integrated throughout the range of efforts now underway through a new HHS Multiple Conditions Strategic Framework to improve health systems change and facilitate new research efforts.
2. Establish the role of the patient navigator within the care team to help patients with multiple chronic conditions navigate the health care system and take their prescription medicines as prescribed. Building on the patient navigator model now used in hospitals and cancer clinics nationwide, the action plan advocates for pairing patients treated for multiple chronic conditions with specially trained adherence navigators who will, in collaboration with patients and caregivers, obtain the patient’s medical records, create an accurate medication list, set up medication counseling as needed, schedule timely follow-up physician visits, and facilitate communication between the patient and his or her different physicians.
3. Promote clinical management approaches that are tailored to the specific needs and circumstances of individuals with multiple chronic conditions. Since patients with multiple chronic conditions differ in the severity of their illnesses, prognosis, and functional status, the report encourages health professionals to adopt the American Geriatric Society’s guiding principles for treating older adults with three or more diseases, which calls for eliciting and incorporating patient preferences and choosing therapies that optimize benefits and minimize the harm for older patients.
4. Incentivize the entire health care system to incorporate adherence education and medication support as part of routine care for MCC patients. With research showing that the interactions between patients and their healthcare providers affect how well patients manage their chronic conditions, the report advocates for an expanded investment in patient/provider education and engagement tools to help clinicians implement best practices for medication adherence and counsel their patients on the importance of following treatment plans.
5. Eliminate the barriers that impede the ability of patients with multiple chronic conditions to refill their prescription medicines. One of the reasons patients fail to refill their prescriptions is the need to pick up prescriptions at different times and sometimes at different pharmacies, requiring numerous trips. T o reduce these obstacles, stakeholders support implementing the “pharmacy home” model, which gives patients a single pharmacy point of contact for filling prescriptions, and adopting refill synchronization, which allows patients to fill different prescriptions at one time and therefore, reduce the number of visits they must make to the pharmacy.
6. Reduce the cost-sharing barriers for patients by lowering or eliminating patient copayments for prescription medicines used to treat the most common chronic diseases. The report makes clear that the cost of medications for some patients is a barrier to filling their prescriptions and taking their medicines as prescribed and advocates adopting policies that will reduce the out-of-pocket costs for medications, especially for patients on multiple prescriptions for chronic conditions.
7. Accelerate the adoption of new health information technologies that promote medication adherence. Because significant innovations in health technology have the potential to improve the flow of timely and complete information on medicine use between patients and providers, the report calls for the swift adoption of new standards for using electronic health records, incentivizing providers to use health information technology to identify patients at risk for medication misuse, and the expanded use of electronic reminders and personal health records to improve medication adherence.
8. Establish medication adherence as a measure for the accreditation of healthcare professional educational programs. Currently, the nation’s medical residency programs are moving towards an outcomes-based accreditation system, where medical residents will be evaluated on the basis of required core competencies, including interpersonal skills and communication. From the standpoint of medication adherence, this represents an opportunity to integrate medication management and e-prescribing into the curriculum of medical residency programs and paves the way for establishing medicine adherence skills as core competencies within the curricula of schools of pharmacy, nursing, and other allied health professions and as an accreditation measure.
9. Address multiple chronic conditions and optimal medication management approaches in treatment guidelines. Clinical practice guidelines typically focus on managing a specific chronic condition and do not take into account the presence of multiple chronic conditions. The report advocates the accelerated development of updated treatment guidelines where information is included on the most common comorbidities clustering with the incident chronic condition, this can start with the most common combinations of multiple chronic conditions, called dyads and triads, which have already been identified by the Centers for Medicare and Medicaid Services (CMS).
10. Stimulate rigorous research on treating people with multiple chronic conditions, including focused research on medication adherence to promote the safe and appropriate use of different medicines in this patient population. There is a paucity of evidence-based data on how to treat patients with two or more concurrent diseases who are taking drugs developed and tested in people who have a single condition. Accordingly, the report supports incorporating medicine adherence throughout the research agenda for multiple chronic conditions and advocates for increasing the budget for HHS research efforts examining the best ways to treat the most prevalent clusters of concurrent diseases.
Because the stakes are so high, the report lays out a new Adherence Action Agenda to coalesce stakeholders around the common goal of improving patient adherence to reduce the burden of chronic disease. Ultimately involving the support and active participation of many constituencies—the federal government, state and local government agencies, professional societies and healthcare practitioners, health educators and patient advocates—it is hoped that this report will serve as a catalyst for action and provide a blueprint for accelerating progress.
This is thoughtful and actionable plan and the complete report is worth a careful read and candid debate.
From the pages of the San Jose Mercury News ...
Antibiotics in animals: In food safety, a noteworthy policy consensus
By Peter J. Pitts
It's always a surprise -- and therefore newsworthy -- when opposing groups in Washington, D.C., find common ground and a policy moves forward at the national level.
That's what happened recently when the Food and Drug Administration published documents implementing its policy that medically important antibiotics should only be used when there's a disease or a disease threat. As a result, "growth promotion" uses will be phased out over the next three years. An accompanying rule will require a veterinarian to oversee the use of medically important antibiotics in feed.
The policy ensures antibiotics that are similar to those used in humans will be used in animals in the same way: to address a specific disease or disease threat, and only under the supervision of a licensed medical professional. It affects farms nationally, making state-based efforts -- including those in California -- unnecessary.
This collaborative effort is noteworthy for animals, veterinarians and the millions of Americans who depend on those animals for food supply.
The FDA and animal health representatives share broad agreement on this national position. Animal health organizations, along with the companies that develop animal antibiotic medicines, have supported the policy since its inception and announcement in 2012. Consumer organizations that have criticized the use of antibiotics in agriculture asked for this policy in a letter to the White House in 2009 and supported the FDA's announcement.
While some have criticized the policy as being voluntary, the fact is that the FDA has succeeded because it pursued its agenda in a collaborative way. The agency met with everyone involved, including farmers and ranchers, the pharmaceutical industry and consumer groups, to understand and address concerns.
As a result of this collaboration, the agency has enacted change more quickly than with a regulatory or legislative approach. On the day the agency released the documents, the two largest companies selling these products publicly announced their support and cooperation. Other companies have 90 days to make their intentions known.
The other benefit of this collaborative approach is that it should avoid the unintended consequences that resulted when Europe legislated a ban on growth promotion uses of antibiotics. That ban resulted in increased animal disease and death. The FDA's collaborative approach gives farmers and ranchers the chance to adjust to these changes more gradually and avoid these negative consequences.
The policy is a significant change in the way antibiotics are used to keep food animals healthy. It is unfortunate that many seem to think that antibiotics are used only "to fatten animals." That's not true, but now no medically important antibiotics will be used to promote growth. In addition, no antibiotic will be used in feed unless a licensed veterinarian verifies that it is needed to treat or prevent a disease.
Consumers should be heartened by this development. While eliminating what the FDA believes to be unnecessary uses of antibiotics, the limited and important uses needed to protect animal health with continue.
That's important, because animals get sick -- just like humans do.
Farmers and veterinarians work hard to prevent disease and avoid the use of medicines to treat disease. We all know that there's a nexus between animal health and human health, and the food supply is one of the key areas of that nexus. Farmers and veterinarians need a variety of tools to keep animals healthy because healthy animals help produce safer food.
The FDA has made significant progress on a divisive issue. As a result, consumers benefit from knowing that antibiotics can only be used to address disease challenges in food animals under the supervision of a veterinarian.
If someday it should happen that draft guidance must be sound
I’ve got a little list. I’ve got a little list
Of social media platforms where user content can be found
And if a product’s disssed it never will be missed.
Some further thoughts on the FDA’s latest social media operetta, the draft guidance entitled, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” – or as fans of Gilbert & Sullivan might prefer to call it, “Patience.”
The real nugget is to be found between lines 188-193:
However, 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, message 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.
In it’s September 21, 2009 Federal Register notice (the one that announced the now famous November 12, 2009 Part 15 hearing), the FDA asked about the issue of property owner vs. property user and user-generated content more broadly:
When should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products?
As I testified at the hearing, “Would letters to the editor be liable for an FDA warning letter? What about radio call-in comments? What about freedom of speech? Relative to intended to promote -- how can this be differentiated from intended to share and educate? And whose job is it to define such differentiation? As Don Draper said, I'm enjoying the story so far, but I have a feeling it's not going to end well.”
(For my complete Part 15 testimony, see here.)
Four plus years later, the property owner vs. property question is asked and answered. So far so good on the UGC front. Better late then never.
Now the question is, does regulated industry really want uncontrolled, unfiltered, and unpredictable user-generated comment on their sites? Because, let’s be honest, it ain’t all gonna be pretty. Is Big Pharma ready to mix it up in real time with real people?
On another note, there’s a peculiar little codicil in the draft guidance that appears on lines 246-249, to wit:
Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real- time communications with the monthly updates.
Hugely cumbersome? To be sure. But what’s really troubling is the good folks at OPDP think such a “running list” is even plausible. Do they really think that regulated healthcare companies are centralized to such a degree that any one person or department knows the full extent of social media participation? And even if this was the case, is this information really any business of the FDA? Are companies currently required to submit their media plans along with creative for agency review – on a running basis no less?
And just who is going to review these lists? What are the qualifications of such reviewers? Since OPDP isn’t hiring, where in the review queue will these lists reside? Will they be made public? This is mission creep extraordinaire. Danger, Will Robinson. Danger.
Like Old Man River, social media keeps on rolling along with or without FDA guidance (draft, bottled, or otherwise). List making isn’t going to limit it. And no amount of hoping/wishing/praying is going to make it static. Social media jes’ keeps on rolling along.
And regulated industry jes’ keeps falling further and further behind the curve.
How can the FDA help to facilitate, encourage, and expedite more activity on the part of regulated industry? After all, as Janet Woodcock has said, “Social media is where the people are.”
The answer isn’t “more process.” It's more prowess.
And maybe it's time for another Part 15 hearing.
Per a press release, Med Ad News (www.medadnews.com) will return “under new parent company Outcomes LLC, founded by Med Ad News Director, Daniel Becker. Many familiar faces will continue playing a critical role in both the production of the publication and the awards ceremony itself. Med Ad News continues the 30 year tradition of the highly anticipated 25th Anniversary Manny Awards along with the April release of the Annual Healthcare Communications Agency Issue.”
"Despite the growing uncertainty and hype surrounding the future of pharma B2B media, these past few years, Med Ad News and the Manny Awards had its best year ever. Outcomes LLC was developed to continue this momentum and is dedicated to providing our customers with access to a valuable suite of integrated marketing opportunities, events, and content marketing services. We have nothing but hope and optimism for the New Year and future and look forward to continuing to serve the pharmaceutical market with the forward-looking expertise and industry professionalism our customers, both readers and partners, have come to rely on," said Founder, Brand Director, Daniel Becker.
And editor Chris Truelove too!
FDA won't hold companies responsible for independent user content on their social media properties
The Food and Drug Administration won't hold pharmaceutical manufacturers and distributors accountable for information patients and clinicians post about their products through social media channels that the companies support.
The industry has been reluctant to fully embrace the platforms because they lacked direction from the FDA on how to use them without veering into prohibited promotion. The FDA held a public hearing on the issue in 2009 but until now had not offered any guidance.
“This excuse for ignoring patients on social channels just went 'poof' in these seven pages of draft guidance from the FDA,” said Leerom Segal, CEO of Klick Health, a digital marketing firm. “This document clearly shows the FDA's position on third-party user-generated content, and healthcare companies are not responsible for it, even when it's on their properties.”
Drug companies were concerned about being held accountable for user-generated content because they couldn't control the promotion of their products for off-label uses, which is permissible for physicians but prohibited for drugmakers. Also, because the companies are obligated to disclose information such as side effects when promoting a drug, it was possible they could be dinged for failing to provide that balance when consumers or physicians express enthusiasm for products online.
Under the draft guidance, pharmaceutical companies are also not responsible for content published on sites that they support financially but have no editorial control over. Nor are they on the hook if they promotional materials to a third-party website, such as those run by foundations for particular disease groups, as long as they did not direct the placement of the promotion within the site and had no other control or influence on that site.
Still, by including such language as “generally not responsible” there could be some instances where companies can find themselves in trouble, said Maura Monaghan, a partner in the law firm Debevoise & Plimpton.
For instance if a company posts a message on Facebook suggesting consumers share stories about how a certain product has helped them, the subsequent comments may not be viewed as “independent,” Monaghan said.
U.S. pharmaceutical companies may have gotten off easy compared to other areas of the world, said Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner at the FDA.
The European Court of Justice recently ruled that online remarks about drugs posted by a third party on the manufacturer's Web property could constitute advertising, even though the post's author has no connection with the product's manufacturer or marketer.
“That's carte blanche for an almost complete gag order on anyone who wants to discuss anything to do with medicines,” Pitts said.
Still, experts say there are crucial questions not outlined in the guidance that may still prevent some companies from jumping on the social media bandwagon. These include knowing when a post on a social media site crosses the line and becomes advertising and how a company can include balanced information in formats that allow 140 characters or less.
The industry trade group Pharmaceutical Research and Manufacturers of America is still reviewing the policy, which it hopes “will allow for a full spectrum of online communication about medicines to benefit patient care,” said Jeffrey Francer, its vice president and senior counsel.
The FDA is accepting comment on the proposal through April 14.
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
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.
