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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
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.
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.
