Latest Drugwonks' Blog
On a wet and cold December 8, 2003, I sat in Constitution Hall and watched President Bush sign Part D into law. I helped (in my own small way) to make it happen. It’s something of which I’m proud.
Nearly a decade later that pride is stronger than ever. A new, nationally representative survey shows that an overwhelming nine out of 10 seniors with Medicare prescription drug coverage are satisfied.
· Ninety-seven percent report that their coverage works well, and nearly three out of four seniors say it works “very well.”
Some specifics:
Part D Reliability at Its Highest Level: Those feeling “peace of mind” by having Part D coverage reached an all-time high level of 96 percent this year, with 73 percent saying they feel a “great deal” of peace of mind and 23 percent saying they feel “some” peace of mind.
Multiple Factors Drive High Satisfaction: Of those surveyed, 95 percent say their plan is convenient to use (a six percent increase from 2006), 84 percent say both their premiums and copays are affordable, and 88 percent say that their Part D plan is meeting their expectations.
Seniors Know What to Look for in a Part D Plan: Seniors believe that a variety of factors are important when deciding on a Part D plan. Eighty-eight percent think that the co-pays or coinsurance amounts are important, 86 percent believe that identifying the pharmacies where they could use their benefit to purchase their medicines is important, and 81 percent believe that the quality ratings of the plan are important to examine.
High Satisfaction Seen across Major Demographic Groups: High satisfaction levels within African American (95 percent) and Hispanic (94 percent) constituencies, as well as within various income levels (93 percent for both those earning less than $15,000 per year or more than $50,000 per year), reinforce the overall findings of a successful program. Additionally, 92 percent of men and 89 percent of women are satisfied with their coverage.
Seniors Rely on the Program: This year, 72 percent of beneficiaries said that they’re better off now than before they had Part D coverage – a four percent increase from last year. Eighty-six percent of seniors fear that eliminating Part D would increase their out-of-pocket prescription costs, and without a plan, 62 percent say they would be forced to cut back or eliminate some prescription regimens – a nine percent increase from 2012.
Seniors Would Recommend Coverage to Others: 89 percent of Part D enrollees say they would recommend the program to someone considering Medicare enrollment.
The full survey can be found here.
Per the FDA’s import alert for drugs made in Ranbaxy's Mohali plant in northern India, the agency said it found "significant" violations of manufacturing rules, "including failure to adequately investigate manufacturing problems."
Now at least three of Ranbaxy's eight plants in India are unable to export to the U.S. Among its facilities outside of India, the Gloversville, N.Y., plant received a warning letter from the FDA in December 2009 for manufacturing violations. That facility has since been closed.
For more on this issue, see Indians and Cowboys.
Yes, Virginia. Quality counts.
Ranbaxy, the Indian generics manufacturer that recently paid half a billion dollars to settle fraud allegations and quality problems, has just received an FDA import alert against their production facility in Mohali, Punjab state.
The plant was set to make generic versions of blood-pressure pill Diovan.
Ranbaxy facilities in Dewas and Paonta Sahib, India, have both been on the FDA’s import alert list since 2009.
The relevance for more complicated products (like Gleevec) and biosimilars more broadly – is obvious.
According to Bloomberg report, the latest FDA notice “is a surprise,” said Prakash Agarwal, a health-care analyst with CIMB Securities India Pvt. Ltd. “The understanding was that, given the past experience with the two other facilities, the management would be on their toes to resolve these issues.”
Fast and loose is not an option.
TGIF. Now let’s talk about Prescription Drug Monitoring Programs (PDMP) and the intended and unintended consequences thereof.
How wide a net should PDMPs cast before they begin to have the unintended consequence of restricting legitimate patient access? Well, according the general consensus at Tuesday’s Capital Hill conference on Personalized Medicine and Responsible Access to Pain Medication, PDMPs should include Schedules 2-4. To infinity and beyond may make for good soundbites, but makes no practical sense.
What about e-standards for inter-operability with electronic health records? This point was made by Bob Twillman, of the American Academy of Pain Management. Big Data is certainly part of the answer. Knowledge is Power.
And speaking of data – what about data entry? PDMPs should allow not only pharmacists, but also physicians and their staffs to be able to enter and update electronic records. Let’s get real – this is already the reality on the ground. But this must also be matched with proper oversight for both quality control and appropriate access.
This raises the prospect of doing something that Indiana started doing with its PDMP a couple of years ago -- and that a lot of other states want to do. The Hoosier State made it possible for prescribers to communicate with other prescribers about patients—so, if prescriber B sees a patient and discovers that Prescriber A has prescribed before, B can contact A and make arrangements for which one of them is going to follow the patient. Notes also can be left behind for other providers, for instance, if an ER doc gets a doctor shopper, he can leave a note about it so others are forewarned.
What about pharmacists? What’s their role? Should they have broader access to patient data? Beyond being deputized by the DEA, the pharmacy community must be able to play a more appropriate role as a healthcare professional.
Perhaps one of the toughest issues is the role of abuse deterrent formulations (ADF). Beyond the debate over whether the FDA should insist that all generics be abuse deterrent (and the related IP debate), how should PDMPs instruct physicians and pharmacists? And what about formularies? Can we trust physicians to make the right call? Do all patients need abuse deterrent formulation? And, if not, what are the decision criteria? What about dose and duration limitations?
Or should there be state regulations per ADFs at all? Shouldn’t those decisions reside within the FDA? Can you say federal preemption?
This places both education (of the CME variety) and best practices (developed not just by PDMPs but also by physicians, pharmacists, and patient organizations) front and center. What about REMS training? And what about more precise criteria for what a “pain specialist” or a “pain clinic” even mean? As the saying goes, “if you can’t measure it, then it doesn’t count.”
What about take-back programs? Should they only be limited to opioids? And who should pay for them?
Lastly, amercement. On a state-by-state level, does the punishment fit the crime? Should there be national standards on criminal and civil penalties?
Many tough questions – but they deserve thoughtful and timely answers. It’s time for a focused national dialogue that recognizes the need for effective oversight through the use of Big Data and broader constituent alliances.
The conventional view serves to protect us from the painful job of thinking.
-- John Kenneth Galbraith
Pierre Trudeau once said, “There's no place for the state in the bedrooms of the nation.“ But what’s the appropriate place for the state in our nation’s pharmacies and medicine chests – particularly for opioids?
Yesterday was the day to address that question.
First there was the FDA’s announcement of class-wide labeling changes and new post-market study requirements for extended-release and long-acting opioids.
Until now, the FDA had said the drugs were appropriate for the treatment of "moderate-to-severe" pain. The new drug label drops the word "moderate" and says it should be used only to manage "pain severe enough to require daily, around-the clock, long-term treatment." Additionally, FDA is adding a boxed warning on the risk of neonatal opioid withdrawal syndrome.
The agency said manufacturers must conduct one or more post-marketing studies to quantitatively estimate the risks of misuse, abuse, addiction, overdose and death associated with long-term use, as well as a clinical trial to evaluate the risk of developing increased sensitivity to pain with long-term use of extended-release and long-acting opioids. Companies also must conduct a study of "doctor/pharmacy shopping" -- a practice in which patients visit multiple doctors and pharmacies to obtain prescriptions -- and whether it is "suggestive of misuse, abuse and/or addiction." Per a report in BioCentury, “FDA said companies should work together on the post-marketing studies.”
Once the labeling changes are finalized, FDA said it will modify the classwide REMS for extended-release and long-acting opioids. The REMS, which the agency approved in 2012, requires companies to make educational programs available to prescribers at no or nominal cost but does not require prescribers to participate and does not include a prescriber registry.
The other big new was a Capital Hill conference on Personalized Medicine and Responsible Access to Pain Medication (sponsored by the Center for Medicine in the Public Interest – the think tank home of drugwonks.com). I was honored to chair the event.
Speakers included Bob Twillman of the American Academy of Pain Management, Cindy Steinberg of the US Pain Foundation, Stuart Kim of Mallinckrodt Pharmaceuticals, Steve Usdin of BioCentury, syndicated healthcare columnist Judy Foreman, and Professor Charles Inturrisi of Weill Cornell Medical Center.
The speakers and attendees rocked the Rayburn Building. Video of the event will soon be posted on the CMPI website.
I tried to set the tone with my opening comments:
Joshua Lederberg, the Nobel Prize Laureate once observed that the failure of regulatory, legal and political institutions to integrate scientific advances into risk selection and assessment was the most important barrier to improved public health.
Lederberg noted that in the absence of such changes, "the precedents affecting the long-term rationale of social policy will be set, not on the basis of well-debated principles, but on the accidents of the first advertised examples."
Policies and regulations that seek to limit risk are often shaped by the immediate fear of sensational events. This perspective is commonly called "The Precautionary Principle" which in various forms asserts that unless innovators can demonstrate that a new technology is risk free, it should be not allowed into the marketplace. Moreover, any product that could possibly be dangerous at any level should be strictly and severely regulated.
But precaution is not always safer than the alternatives.
Some current examples of precaution and the public health
· The National Action Plan for Adverse Drug Event Prevention, just announced in a Sept. 4 Federal Register notice, outlines a comprehensive strategy to reduce AEDs for opioids. Much of the research actions called for by the plan seem designed to decrease prescribing. For instance, the plan calls for research by CDC, NIH and, public-private collaborations to look into adopting adjunctive and behavioral modalities to augment and reduce opioids use for chronic pain;
· Upscheduling and the relabeling of medicines to treat depression, diabetes, chronic and acute pain;
· And, finally, the role of tamper-resistant technologies in the appropriate management of pain medicines (both innovator and generic).
It’s also important to consider the DEA’s “Thug Regulation” strategy that results in a decline in appropriate patient access; an increase in regulatory time and cost and, ultimately, a decline in innovation.
The California Medical Association has received reports from physicians that Walgreens pharmacists are refusing to fill controlled substances prescriptions without additional information from the prescriber.
Per dictates from the DEA, Walgreen’s pharmacists are now demanding that physicians provide information on diagnosis, ICD-9 codes, expected length of therapy and previous medications tried and failed.
In other words, tighter restrictions for patients who really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow regulations.
When you have a hammer, every problem looks like a nail. The DEA sees opioid abuse and seeks to minimize access to them. That’s a law enforcement solution. They mean well – but are behaving like a bull in a china shop
Arbitrarily limiting choice is not generally associated with the Scientific Method.
Should regulation be shaped by factors other than science or should advances in medicine and digital information be used to right-size regulation, reduce the excessive reductionism that leads to regulatory overreaction and promote resilience rather than ever increasing restrictions?
Consider the program recently instituted by CVS (and detailed in a recent New England Journal of Medicine Perspective piece) where, via the use of “Big Data” the chain pharmacy identified “outlier prescribers” and took appropriate and responsible actions.
The DEA’s attempt to deputize pharmacists on the one hand and the CVS program on the other raise some interesting questions:
· What will the role of the 21st century pharmacist be in improving drug safety and medication adherence via more proactive (and remunerated) patient education?
· How can pharmacists become better integrated (beyond Med Guides) into the FDA’s Safe Use of Medicines initiative?
· When will pharmacy synchronization programs really kick into gear, and how will states help to jump-start these important initiatives?
To paraphrase the American political scientist Aaron Wildavsky, we at the Center for Medicine in the Public interest believe in a strategy of resilience based on experience. We must learn from adverse consequences in order to develop a capacity to advance the public health. Variability is the key to survival.
THANK YOU.
From: CDER Center Director
Sent: Friday, September 06, 2013 11:24 AM
To: FDA-CDER-wide
Subject: FDA Establishes the Program Alignment Group
CDER Staff:
In order for FDA to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, the Commissioner has formed a Program Alignment Group (PAG). Comprised of senior Agency leaders, the PAG is charged with identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives. This group of senior leaders will achieve this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its mission.
As a member of the PAG, I am pleased to share with you the email and memo (below) that I received from the Commissioner this morning. This initiative will provide an opportunity for CDER to continue modernization of operations in order to address the challenges noted above and to implement our new legislative responsibilities, including those imposed by the Food and Drug Administration Safety and Innovation Act and the Generic Drug User Fee Amendments of 2012 (GDUFA).
Many of CDER’s current modernization efforts center around the regulation of pharmaceutical quality. Most of you are aware of the proposed elevation of the Office of Generic Drugs to a super office, and the concomitant efforts to establish a new Office of Pharmaceutical Quality (OPQ). The work to establish OPQ will need to be closely coordinated with the Office of Regulatory Affairs (ORA). We recognize that in order to accomplish GDUFA and other commitments, CDER and ORA need to have an integrated program for regulating pharmaceutical quality, with well-defined leads, coherent policy and strategy development, well-designed and coordinated policy implementation, and a de-layered management structure. Moving toward this new model will take time and a level of organizational change across CDER and ORA, including streamlining management and decision making and clarifying roles and responsibilities, metrics and accountability, and decision rights. Similar considerations apply to other inspectional programs.
I am confident that any changes implemented as a result of this evaluation will not only improve efficiency in our program areas and in our collaborations across the Agency, but also provide us with a solid foundation that allows us to continuously adapt to the ever-changing challenges and new demands placed on CDER. This is important as we continue to meet our critical public health and regulatory mission to ensure safe, effective, and high-quality drugs are available to the American public.
I look forward to participating in the PAG discussions. The first report from the PAG is due to the Commissioner in the next several months. FDA will then assess the recommendations and decide how to proceed. I am committed to keeping you informed about the outcome of the PAG’s evaluation; you may expect additional communications from me once the Agency determines its next steps in this process.
Janet Woodcock
From: Hamburg, Margaret
Sent: Friday, September 06, 2013 10:09 AM
To: Dunham, Bernadette M; Landa, Michael; Midthun, Karen; Plaisier, Melinda K; Shuren, Jeff; Solomon, Steven M; Taylor, John M.; Taylor, Michael R; Woodcock, Janet; Zeller, Mitchell
Subject: Program Alignment Group
Over the past few years, FDA has experienced unparalleled challenges and demands posed by the increasing breadth, depth, and complexity of the products it regulates. That, combined with significant strides in scientific innovation and increased biomedical discovery, the globalization of the food system and medical supply chains, as well as the expansion in FDA’s regulatory authorities via many new forms of legislation, require the Agency to continue to find ways to ensure that we are meeting our critical public health and regulatory mission.
Therefore, to be in the best position to effectuate the steps necessary to successfully address these challenges, I am pleased to formally appoint you to the Program Alignment Group (PAG). The PAG will be comprised of senior Agency leaders charged with identifying and developing plans to modify FDA’s functions and processes in order to address the challenges noted above and to best achieve mission-critical Agency objectives. This group of senior leaders will attain this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its public health mission.
More information about the PAG can be found in the attached memorandum. The group will look at what changes may be necessary from an operational standpoint to transform the Agency from a domestic Agency operating in a globalized world to a truly global Agency fully prepared for a regulatory environment in which product safety and quality know no borders.
I want to thank you, as senior FDA leaders, for engaging in this important work together to move FDA into the future as a modern and globalized public health-regulatory Agency. I look forward to watching your progress in the months ahead as we embark on this path together.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
The California Senate passed a state bill that would impose restrictions on when pharmacists may dispense a biosimilar in place of an innovator product. The California Assembly already passed the bill, which will now be sent to Gov. Jerry Brown. A spokesperson for Brown said the governor does not comment on pending legislation, but Brown will have until Oct. 13 to sign the bill into law.
The California bill would allow substitution of a biosimilar for an innovator product only if FDA declared the biosimilar interchangeable for the specific use; the prescriber had not expressly prohibited use of a biosimilar; the substitution was communicated to patients; the cost to the patient was the same or less than the innovator product; and the pharmacist notified the prescribing physician within five days. The requirement for physician notification would sunset after three years (Jan. 1, 2017). Additionally, the California State Board of Pharmacy would maintain a list of biosimilar products FDA determines to be interchangeable on its website. A spokesperson for the Biotechnology Industry Organization (BIO) said the bill applies only to retail pharmacies.
Despite what you may read in the papers, sometimes legislation that’s supported by innovator pharmaceutical companies is also in the best interest of the public health. This is one of those times.
I am very pleased to announce the appointment of Melinda “Mel” Plaisier as the Associate Commissioner for Regulatory Affairs (ACRA), effective immediately. As many of you know, Melinda has been steadfastly serving in this position in an acting role since October 1, 2012. During that time, Melinda has led the Office of Regulatory Affairs (ORA), utilizing her deep operational knowledge, her proven leadership skills, and her professional and collaborative demeanor.
Melinda brings a wealth of experience to this position. She joined FDA in 1995, after serving as a Congressional staffer for more than a decade. Melinda spent more than 13 years in the Office of the Commissioner where, among other roles, she served as the Associate Commissioner for Legislation, providing executive leadership in directing and managing the Agency’s congressional relations and legislative activities, and the Associate Commissioner for International Programs, where she focused on negotiating international agreements and working with developing nations. Immediately prior to serving as the Acting ACRA, Melinda served as the Regional Food and Drug Director for ORA’s Central Region for several years.
Melinda will report directly to the Deputy Commissioner for Global Regulatory Operations and Policy and will lead the 4300 extraordinary men and women of ORA who are dedicated to furthering FDA’s public health mission in many important ways, including by inspecting regulated products and manufacturers, by conducting sample analysis on regulated products, and by reviewing imported products offered for entry into the United States.
Going forward, Melinda will play a critical role in helping FDA adapt to the continuing program-based specialization within FDA’s regulated industries and in implementing FDA’s expanded authority in recent groundbreaking legislation in many important areas. I am confident that Melinda will help position FDA as a public health regulatory agency fully prepared to deal with the many challenges of an increasingly complex global regulatory environment.
Please join me in congratulating Melinda as she assumes this official role.
Sincerely,
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
What part of "unbranded" didn't you understand?
AstraZeneca has pulled paid advertisements on the Associated Press’s Twitter feed after it was made aware that the unbranded content it believed it paid for actually included the name of a prescription drug.
Note – “paid advertisements.”
Per the Pink Sheet, “At first glance, two Aug. 27 tweets sponsored by AstraZeneca read like straightforward disease awareness ads, but when the tweets are expanded, they reveal the name of its acid reflux treatment Nexium(esomeprazole), appearing to place the company in a more heavily regulated landscape.”
On Aug. 27, the Associated Press ran a tweet sponsored by the pharma on the micro-blogging site that permits 140 character messages including links to websites or pictures. The tweet read: “Sponsored Tweet: 15M+ Americans experience #GERD symptoms each day. Visit AstraZeneca’s YouTube channel bit.ly/1aZ6BiK.”
At the bottom of the tweet users can click a “view summary” tab that pulls up an expanded version of that tweet. This expanded version includes a preview of the YouTube site the company links to: “the official YouTube channel of Nexium (esomeprazole mangesium).”
So the question becomes, when these two components are placed side-by-side, are they still the “unbranded tweets” the company thought it was posting?
Per AZ, the tweets are unbranded and were not sent to FDA for approval. The ads did go through all of AstraZenca’s own internal reviews and approvals to ensure compliance with applicable U.S. laws and regulations.
AstraZeneca: “The sponsored tweet we paid for was the tweet text itself. We weren’t aware that additional text would appear under a summary button. We are going to inform the FDA of this as soon as possible. We will also assess if any changes need to be made.”
That’s the key point – it was a “sponsored” tweet. In other words – a paid advertisement. This isn’t about social media. It’s the same issue that arouse over the FDA letters regarding “sponsored” Google links. “Sponsored” means paid – and “paid” is not social media.
So, please hold the hyperbole about the FDA retarding the use of social media.
Speaking of hyperbole, OPDP panjandrum Thomas Abrams said in late June that the long-awaited guidance is one of the highest priorities for the agency in terms of time and resources.
Down boy.
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.
