Some tidbits from Salvatore J. Giorgianni, Jr.’s docket submission to the FTC hearing on biosimilar naming, (Giorgianni, PharmD, BSc, CMHE, is Chair of the American Public Health Association Caucus On Men’s Health and President, Consultant Pharmacist, Griffon Consulting Group, Inc.)

Patients across the US and in every other country in the world will be best served if distinguishable names are required for all biologics and their biosimilar follow on compounds.  Providing clarity of information with distinguishable names or codes that are transparently traceable back to the point of bio-manufacture and ending at the point of dispensing/administration to the consumer is essential to keeping a secure process that insures patient safety.  As history shows, the integrity of drug and biologic supply and the ability to properly manage clinical care require clear unique product identification. Such unique naming/coding also continues FTC’s long and valued tradition of advocating for full and transparent disclosure of product information for the consumer

The importance of providing for specific and precise product identification is of heightened importance with biosimilar products and their presumed biotherapeutic equivalents because of the large proportion of immunocompromised, frail and vulnerable populations with complex and life-threatening medical conditions that are most likely to receive these products.

In the truest sense of the word, the assertion of biotherapeutic equivalency by some in support of non-unique product designations is by any convention a scientific hypothesis that needs to be validated.

As a practicing pharmacist and compounding pharmacist for 30 years and former pharmacy educator I feel strongly that the ability to precisely know and rapidly trace back product components and identity is fundamental to protecting the health of patients. Having distinguishable product identification for biosimilar products, in my view, seeks to provide the most direct route back to the root of an issue if an adverse event occurs and being able to do this is part of the standard of practice for all pharmacists. 

Salvatore J. Giorgianni, Jr., PharmD, BSc, CMHE                                                                 
Chair, American Public Health Association Caucus On Men’s Health 
and President, Consultant Pharmacist, Griffon Consulting Group, Inc.

Giorgiann’s complete docket submission can be found here.

Witness the support of the GPhA to Florida’s pending legislation on biosimilars.

FDA News reports that, GPhA has jumped into the biosimilars substitution debate, saying it prefers that doctors not be notified when a pharmacist substitutes a biosimilar for a name-brand biologic, and it is supporting legislative language that would implement that approach in states throughout the U.S.

GPhA and other critics believe the physician notification provisions of the compromise will deter pharmacists from making substitutions.

Making sure that a patient gets the best treatment should never be viewed as "impeding access." That's a canard and shows the venality of a certain approach to biosimilars. 

This bill should be called "The Biosimilars Don't Ask, Don't Tell Act."  Rather than placing the burden of knowledge on physicians and pharmacists, this bill forces a patient  (often a very ill patient) to demonstrate an advanced level of pharmaceutical sophistication. Is it plausible that patients are educated enough to know what a biosimilar is, let alone ask whether or not they are getting a biologic or a biosimilar? This is clearly not the case with small molecule generics – a much less complicated proposition. The fact that physicians have the ability to use "prescribe as directed" is good. But it is not enough.

A more practical Washington State bill offers a better, holistic and appropriate approach, specifically the language that reads:

If a biological product is dispensed, the pharmacist or the pharmacist's designee shall within a reasonable time but not to exceed ten days following the dispensing, record the name and manufacturer of the product dispensed in an interoperable health records system shared with the prescribing practitioner, to the extent such a system is available; or, in the case that an interoperable electronic health records system is not in place, communicate to the prescribing practitioner the name and the manufacturer of the biological product dispensed to the patient. No communication to the prescribing practitioner is required under this subsection where there is no interchangeable biological product for the prescribed biological product, or for a refill prescription that is not changed from the product originally dispensed.

This makes it much better legislation than the Florida version and a superior piece of "model legislation."

As the February 4^th FTC workshop on follow-on biologics approaches, here’s another VIP (Very Important Perspective) that the Commission has chosen not to bring to the public. Today’s VIP is a physician with experience prescribing and treating patients with biologics. Dr. Bert Petersen, a surgeon, is director of the Breast Surgery Clinic of St. Barnabas Hospital in New York City and an adjunct associate professor of surgery at New York University School of Medicine. Dr. Petersen is an advocate for the elimination of health disparities, particularly in terms of cancer and chronic diseases. Here are his thoughts on why the biologics naming issues matters for both him and his patients.

Q: What role do biologics play today in treating patients?

A: In my field, cancer – specifically breast cancer, we’ve seen great success in treatment for early and advanced stages with biologics. As we move toward more targeted therapies for chronic disease, they play an increasingly important role.

Q: Do you think there may be certain populations who are more at risk to an immunologic response from a biologic?

A: Yes. Any populations that may have a compromised immune system—specifically, many patients with chronic disease—can be impacted. These include at risk populations such as the elderly, immune deficient and chronic renal disease patients, etc.  Additionally, at-risk populations tend to be patient populations that may lack quality insurance or access to healthcare. Furthermore, many of these chronic diseases disproportionately impact the poor. This makes access to biosimilars even more important for this population

Q: What value could biosimilars offer patients?

A: Two of the biggest reasons to look at biosimilars are cost and access. Can we offer the same effective treatment while controlling cost? My biggest concern is how we increase equal access to quality health care. We want to increase our reach in expanding healthcare, but it must be quality health care. Biosimilars offer a chance to meet the goals of affordable and quality treatment options.

Q: What is your view on the best approach FDA could take on biologics naming and how does distinguishable naming help keep our biologic supply safe?

A: Unlike any other field, medical decisions must be met with great scrutiny and thoughtfulness because any mistakes or missteps can be fatal. Patient safety should be the FDA’s overarching principal when it comes to approving biosimilars and any other drug.

In terms of distinguishable naming, I believe that biosimilars definitely should have different names, so you can determine if drugs are equal in their effectiveness. In my opinion, it’s unethical to treat patients with something pretending to be something else when it may or may not be. It’s also unsafe. I have a real problem with this as a practicing physician who treats patients with life threatening illnesses.

Q: Why is it important for patients and doctors to know what biologic is being, and has been put into, a patient’s body?

A: Much of how we practice is based on evidence-derived medicine. This is how we gather our evidence to know what is effective and what is not. Understanding which biologics patients have used will help us as we move toward the future to make any modifications that are found necessary.

Q: What impact would distinct naming have on trust in biosimilars?

A: I think if we could distinguish drugs, providers would have less hesitation in prescribing them. If providers are more educated and they have a clear pathway to report adverse effects—they would be more motivated to trust and prescribe biosimilars.

WASHINGTON (AP) — It seems to be something of an occupational hazard for President Barack Obama: When he talks about his health care law, he's bound to hit a fact bump sooner or later.

OBAMA: "More than 9 million Americans have signed up for private health insurance or Medicaid coverage."

THE FACTS: That's not to say 9 million more Americans have gained insurance under the law.

The administration says about 6 million people have been determined to be eligible for Medicaid since Oct. 1 and an additional 3 million roughly have signed up for private health insurance through the new markets created by the health care law. That's where Obama's number of 9 million comes from. But it's unclear how many in the Medicaid group were already eligible for the program or renewing existing coverage.

Likewise, it's not known how many of those who signed up for private coverage were previously insured. A large survey released last week suggests the numbers of uninsured gaining coverage may be smaller. The Gallup-Healthways Well-Being Index found that the uninsured rate for U.S. adults dropped by 1.2 percentage points in January, to 16.1 percent. That would translate to roughly 2 million to 3 million newly insured people since the law's coverage expansion started Jan. 1.

OBAMA: "Because of this (health care) law, no American can ever again be dropped or denied coverage for a preexisting condition like asthma, back pain or cancer. No woman can ever be charged more just because she's a woman. And we did all this while adding years to Medicare's finances, keeping Medicare premiums flat, and lowering prescription costs for millions of seniors."

THE FACTS: He's right that insurers can no longer turn people down because of medical problems, and they can't charge higher premiums to women because of their sex. The law also lowered costs for seniors with high prescription drug bills. But Medicare's monthly premium for outpatient care has gone up in recent years.

Although the basic premium remained the same this year at $104.90, it increased by $5 a month in 2013, up from $99.90 in 2012. Obama's health care law also raised Medicare premiums for upper-income beneficiaries, and both the president and Republicans have proposed to expand that.

Finally, the degree to which the health care law improved Medicare finances is hotly debated. On paper, the program's giant trust fund for inpatient care gained more than a decade of solvency because of cuts to service providers required under the health law. But in practice those savings cannot simultaneously be used to expand coverage for the uninsured and shore up Medicare.

Although FDA is tasked with creating naming policy for biosimilars before they enter the U.S. market, FTC is trying to force its misguided view on the issue in the hopes of building advocates for non-unique names. During a workshop scheduled for February 4 will delve into the biosimilars naming issue, but somehow they forgot to include a number of VIPs (Very Important Perspectives). Amazingly, patient advocates are nowhere to be found on the agenda; also absent are physicians who prescribe biologics and health system pharmacists.

Because of FTC’s slight – presumably so they could through the workshop arrive at near consensus on the need for biosimilars to share the same name as the innovators to which they related, and in doing so muddy the central facts that distinguishable naming is the right approach for efficient adverse event reporting, patient safety and even promoting uptake of and competition among biosimilars.

Today’s VIP on the issue is that of the first person – the actual long-time and life-long biologics user.  Donna Cryer is really a patient-plus though – in addition to using a mix of biologics and synthetic medicines for rheumatoid arthritis, inflammatory bowel disease, to preserve a transplanted liver she received nearly 20 years ago, and to deal with kidney issues that impair her body’s ability to make red blood cells, Donna is a Harvard-trained health policy lawyer, a patient representative on an FDA advisory committee and the first patient to serve as Chairman of the American Liver Foundation. Here’s Donna’s perspective on why the right naming policy for biosimilars and all biologics matters for her and the millions of other biologics users like her.

Q: What role do biologics play in treating patients?

A: Biologics play an incredibly important role in treating patients, like me, who have multiple autoimmune conditions. My life really depends on biologic medications. And for so many thousands of other patients, our health, our productivity, our ability to work and be with our families all are because we have access to biologic medications.

Q: What value could biosimilars offer to patients like yourself?

A: Biosimilars often offer lower cost options, so that can provide more access to medications for more patients.

Q: Why is it important for patients and doctors to know which biologic is being and has been put into a patient's body?

A: It is essential that doctors and patients know exactly which medication, particularly with biologics, they are prescribing and using. Being able to manage a disease based on the reactions of your immune system is really tricky. You want to make sure that you are not suppressing the immune system so much that you are open to every infection, every cold, as well as more serious conditions like tuberculosis.  Knowing exactly which biologic medication you're taking is absolutely vital because if there is a side effect, an adverse event, or just a change in your condition and your body's response, you want to be able to track it back to exactly the drug that you were prescribed, exactly the drug that you took.

Q: Since biologics are more complex than normal, chemical prescription medicines, how does that alter the conversation and relationship you have with your doctor?

A: The doctor/patient relationship is based on trust. In fact, the patient relationship within the entire healthcare system is based on trust, and a high degree of confidence, that what we're being prescribed, what we rely on for our very lives, is safe and effective. We want to be able to know, and have confidence that our biosimilars and biologic medications are distinguishable, so that we can know what we're taking, how we're taking it, how it differs.

Q: From your view as a patient, what would be the best approach the FDA could take when creating a naming policy for biosimilars?

A: Well, the issue of biosimilars naming is really important, because unless FDA ensures that unique distinguishable names for biosimilars are given, patients and doctors really will be left without any recourse to track back and understand what medication might have caused their adverse event or their side effect.  We want to be able to track back if there is an issue, a side effect, a serious adverse event, or just a change in our condition. We want to be able to know. We deserve the right to know what we have taken so that we can have recourse, if need be, about what has happened and what is happening to our bodies. As a patient, I'm not really sure why there is even an argument about having a distinguishable name for a biosimilar: it's such a simple solution to have a distinguishable name.

Thank you, Donna.
 

The Wall Street Journal reports:

NEW DELHI—Workers at a Ranbaxy Ltd. drug plant repeatedly fudged test results to make it appear that raw materials and active pharmaceutical ingredients met required standards when they didn't, according to a report by inspectors from the Food and Drug Administration.

FDA officials visited Ranbaxy's Toansa factory in the northwestern Indian state of Punjab early this month and said they discovered workers retesting "until acceptable results are obtained" and deleting evidence of failed tests.

The FDA inspectors also noted that analytical and microbiological laboratories at the plant were in "significant disrepair," with windows that couldn't close and a sample-preparation room with flies that were "too numerous to count."

In one lab, the FDA report said, inspectors "identified the presence of numerous sticky notes" that were found to "contain instructions for corrections to be made to the raw data" for testing. The inspectors also wrote that they had observed a worker in the quality-control lab backdating a log entry.

"We immediately questioned this analyst regarding the reason for backdating his record, who responded that he had only entered '2014,' despite our visual observation of him entering a signature and full date entry a few moments earlier," the report said.

On January 6^th, CMS issued a proposed rule that would result in foundational changes to Medicare Part D and negatively impact America’s seniors, and other constituencies. Most disturbingly (if not surprisingly) it reveals the Administration’s authentic view of Part D by attempting an unprecedented level of government interference with what was intended to be a competitive, market-based proposition.  Specifically, the proposed rule:

·      Interprets the statutory non-interference provision for the first time since the MMA passed in 2003.

·      Imposes new, non-statutory restrictions on sponsor contracts and plan bids, limiting sponsors to no more than two plans per region.

·      Intervenes in private market contracting between Part D plans and network pharmacies.

·      Further encourages the displacement of employer-provided coverage that the MMA intended to preserve.

·      Introduces enormous uncertainty into the market for plan sponsors as they prepare for the 2015 bid cycle.

·      Places new restrictions on access to medicines in classes of clinical concern, including mental health drugs and drugs to prevent organ transplant rejection.

Why this rule and why now? One explanation is that it shows the continuing cognitive dissonance of the administration (and career CMS staff) that anything driven by the free-market could possibly work –- and that seniors are not capable of making their own healthcare choices. And it doesn’t matter that both of these almost religious beliefs fly in the face of all facts and figures to the contrary.

This rule is designed to solve a problem that doesn’t exist – but which its authors believe should exist. The proposed rule creates a Bizarro Part D wherein the role of free-market forces and the imperative of citizen choice are replaced by the heavy hand of the infallible Uncle Sam, MD. 

Think about it: This proposed rule would limit competitive bidding, limit patient choice, and stifle innovation in plan design. In short, it would gut the philosophical framework of Part D –- a framework that has consistently resulting in government spending coming in under budget with 90%+ user satisfaction.

All this and the proposed rule also revises long-standing prior agency policy on the “six protected classes” policy. Specifically targeted are medications for mental illness. 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 has been in effect since the inception of Part D, and has strong congressional support.

And just wait until they start exporting biosimilars.

WASHINGTON (AP) -- U.S. health regulators said Thursday they are barring imported drugs from an overseas factory operated by Ranbaxy Laboratories, India's largest drugmaker, due to quality control violations.

The Food and Drug Administration ban effectively stops the company from shipping drugs and raw ingredients from its Toansa plant in the Punjab province. A Jan. 11 inspection by FDA staffers uncovered factory workers retesting drug ingredients that had failed quality testing, in an apparent effort to return positive results. Those practices and others found at the plant violate manufacturing standards for drugmakers that do business in the U.S.

"The FDA is committed to ensuring that the drugs American consumers receive - no matter where they are produced - meet quality standards and are safe and effective," said FDA compliance director Carol Bennett.

Ranbaxy did not immediately respond to requests for comment Thursday.

Ranbaxy will be required to hire an outside inspector to review the plant and certify that it is meeting U.S. quality standards before the ban can be lifted.

In September the FDA placed a similar hold on imports from Ranbaxy's Mohali facility. Both actions were taken under a 2012 legal settlement with the FDA, which subjects Ranbaxy to extra scrutiny and inspections to improve its drug production.

With annual revenue of more than $2 billion, Ranbaxy is the leading drugmaker in India's $26 billion generic pharmaceutical industry, but it has faced penalties from U.S. regulators for years.

In May, the company's American subsidiary agreed to pay $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators, the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.

Yesterday 28 Republican lawmakers from both the House and Senate (led by Senate HELP ranking member Lamar Alexander and House Energy and Commerce Chairman Fred Upton) sent a letter to the FDA voicing their concern over the agency’s proposed rule that would allow generic drug companies to change the safety information on the labels of their products. Their fear is that “equivalent products could temporarily” end up showing “different safety information” before “the FDA determines if the changes are warranted.”

Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, said the proposed change would create better parity between brand-name drug manufacturers and generic companies, which is especially important given that more than 80 percent of prescriptions in the United States are currently dispensed as generic drugs. “Now, with the generic industry having grown up, most people are taking generic drugs,” she said. “It’s really time to level the playing field.”

But, methinks, the 28 signatories have been pretty heavily lobbied, because there’s another issue here that’s not safety related.

The proposed rule would also pave the way for lawsuits from patients who could now claim that generic companies did not sufficiently warn them of a drug’s dangers. In 2011, the Supreme Court ruled that such lawsuits were not valid because generic companies were required to use the same label warnings as brand-name manufacturers and thus could not be blamed for failing to warn patients about the risks of taking their drugs.

It’s interesting to note that Senator Alexander has also been front and center in lobbying the FDA on the biosimilar INN issue. He does not believe in differentiation.

Why does his concern about safety and clarity apply only to small molecules? Hm.

For more on this issue, see “Generic Originals.”

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.

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

By Virgil Dickson

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.

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.”