Latest Drugwonks' Blog
ObamaCare and mandatory contraception coverage is a hot button issue. But flying well below the national media’s radar is the other side of the coin – how insurance companies are denying care to pregnant Americans.
According to WebMD, “Nothing can blast the euphoria of discovering you're pregnant faster than morning sickness.” Perhaps a close second is knowing there’s an FDA-approved treatment for this condition – and that your insurance company refuses to pay for it. As my wife commented, “If men got morning sickness, this wouldn’t be a problem.”
In a study based on a survey recently published in the medical journal Obstetrical and Gynecology Survey, more than two-thirds of all survey respondents reported that “morning sickness” diminished their general enjoyment of pregnancy, and some women, especially those with moderate/severe symptoms, reported anxiety about the health of the baby and lacked confidence that they were doing the best they could for their unborn child.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, or “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health.
Consider Diclegis, a medication specifically developed and recently approved by the FDA to treat Nausea and Vomiting of Pregnancy (aka, “Morning Sickness”), a condition experienced by 70-85 percent of pregnant women. (Diclegis is the first and only treatment for nausea and vomiting of pregnancy approved by the FDA in more than 30 years, and the only treatment granted a Pregnancy Category A rating by the FDA, the highest level of pregnancy product safety.)
Not only are some insurers (such as Aetna) restricting access to this FDA-approved treatment, they’re requiring health-care providers to first prescribe off-label medications, or a combination of over-the-counter treatments neither developed nor approved for use during pregnancy. It’s only after a pregnant woman has failed to control her morning sickness through trial and error with these untested-in-pregnancy propositions before being allowed access to the only medication tested and FDA-approved as safe and effective for pregnant women who suffer from this condition.
Importantly, for women who have morning sickness, it's critical to get treatment early to reduce their complications – and that means getting the best treatment as soon as possible, not “failing” their way up the therapeutic ladder.
Aetna’s decision to deny cutting-edge care for America’s Moms also illustrates the danger to the development of important new treatments for a host of other diseases. According to Tufts University it costs about one billion dollars to bring a new medicine to market. That's one billion per drug -- and those are the ones that make it through the clinical and regulatory processes. The innovation ecosystem is a fragile wetland and investment dollars are harder to come by than ever before. Why would a pharmaceutical company invest in high risk R&D if there is likely to be no insurance company willing to pay for the therapeutic benefits it can deliver?
Pregnancy is a difficult journey– but its travails are worth the result. That’s also true for healthcare innovation. Today, it takes about 10,000 new molecules to produce one FDA-approved medicine. And only three in 10 new medicines earn back their research and development costs. And here's the kicker: Unlike other R&D-intensive industries, biopharmaceutical investments generally must be sustained for more than two decades before the few that make it can generate a profit. But ask any patient whose life has been saved or prolonged through the miracles of modern medicine, whether or not the investment has been worthwhile.
Protecting “sustainable innovation” is crucial for both the public health and to maintain America’s lead as the global hub for biotechnology.
Harvard University health economist (and Obama healthcare advisor) David Cutler has noted that: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost." To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation.
America’s mothers-to-be are on the front lines. A “pregnant pause” in appropriate access is not acceptable.
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 4th 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.
Thank you, BertWASHINGTON (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 6th, 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.
Why? Why fix something that isn’t broken? Maybe it’s all a “fix” of a different kind. Maybe this proposed rule is designed to ruin Part D so the argument can be made for direct government interference and, ultimately, a move to a single payer system.Remember, you’re not paranoid if they’re really out to get you.
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.”
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.
