Latest Drugwonks' Blog
Accutane’s Warning Labels Sufficient, Judge Rules
Drug Industry Daily
Roche adequately warned of the risks of ingesting acne drug Accutane after April 10, 2002, a New Jersey judge ruled last week, resolving lawsuits filed by people in the state who used the product since that date.
The manufacturer’s labeling and warning literature issued to physicians accurately disclosed the potential risk of inflammatory bowel disease, says Superior Court of New Jersey Judge Nelson Johnson in his summary judgment.
Last week’s ruling is limited to cases involving New Jersey plaintiffs who took Accutane since the most recent warnings were issued. The court intends to determine the effect on cases in other states which could involve up to 800 plaintiffs who are being given a chance to convince the court that some other states’ law with more lenient standards could be applicable.
Counsel from both sides will submit legal briefs regarding which jurisdictions permit decisions on label adequacy based on law, and which ones have a heavier burden of proof than New Jersey. A hearing is set for May 11 to finalize a list of all lawsuits impacted by the ruling.
Roche has for many years provided strong warnings of the potential relationship between Accutane and IBD, although the emerging science has largely ruled out any connection, spokeswoman Tara Iannuccillo tells DID.
The ruling should act as a teaching moment for patients and doctors that labeling is important, that all drugs have risks and that those risks need to be carefully explained to patients, says Peter Pitts, president of the Center for Medicine in the Public Interest.
“This ruling reinforces the need for significant tort reform. These ultimately come down to the category of being frivolous lawsuits. Obviously, people took the drug and had negative effects, but that is completely predictable and it’s part of the proposition of taking any drug,” he tells DID.
The plaintiffs did not respond to a request for comment by press time.
A federal advisory group has released a draft version of its National Pain Strategy, which seeks to redefine the way pain is perceived and treated in the U.S.
The report was written by the Interagency Pain Research Coordinating Committee (IPRCC), which is comprised of representation from the FDA, the NIH, the CDC, the Agency for Healthcare Research and Quality (AHRQ), the Department of Defense, and the Department of Veterans Affairs.
It involved six working groups that tackled various aspects of pain care: population research, prevention and care, disparities, service delivery and reimbursement, professional education and training, and public awareness. The strategy is the result of a mandate in the 2010 Affordable Care Act, which asked the Department of Health and Human Services to "increase the recognition of pain as a significant public health problem."
According to strategy co-chair Sean Mackey, MD, PhD of Stanford, "It's not meant to dive into the weeds and recommend specific therapies. It's meant to offer recommendations on how we can change the way we care for patients and incentivize that treatment."
The report discusses gaps in primary care physicians' understanding of pain and how to treat it, since these professionals are often on the front lines of care, and emphasizes that patients need to be more involved in decision-making about their care.
The report acknowledges that more liberal prescribing of the drug class has led to a rise in addiction, abuse, and overdose, but it maintains that the drugs are considered medically appropriate for acute and intractable pain that doesn't respond to other therapies.
Still, it notes that there aren't enough data to help tell which patients are candidates for opioid therapy, on appropriate dosing strategies, or on risk mitigation, and there's a need for further research on the safety and efficacy of long-term opioids for chronic pain.
It’s time to put the Hamburg Manifesto (former FDA Commissioner’s Peggy Hamburg’s pain policy legacy) – which calls for a more robust and regular focus on physician education to the front the pain agenda. It’s also an opportunity for the members of the pain policy ecosystem (manufacturers, physicians, medical schools, CME organizations, social scientists, patient organizations, and regulators) to work together to develop validated methodologies for determining which opioid-appropriate patients are at risk for addictive behavior.
Further, it's time to understand that for differing pain mechanisms there are appropriate non-opioid treatments which most often are bypassed due to cost and access barriers from payers or a need for a quick fix by an overwhelmed physician. Attention must be paid.
In a world driven by social media and ever-more sophisticated e-tools such as mobile apps, it’s time to make smart education a priority. Forewarned is Forearmed.
From the sharp mind of Dr. Sally Satel…
People Who Get Paid By Big Tobacco Should Be Able To Advise The FDA
A few weeks ago the FDA was forced to remove four researchers from its influential Tobacco Products Scientific Advisory Committee (TPSAC). The committee plays a crucial role in providing advice, information and recommendations to the FDA commissioner on the science of tobacco and its implications for regulation.
The TPSAC shake-up came at the order of federal judge Richard J. Leon of the United States District Court for the District of Columbia. Judge Leon concluded that select committee members, including the chairman, were so heavily beset by conflicts of interest that they could not be trusted to deploy sound scientific judgment.
The judge’s decision stemmed from a 2010 complaint filed by tobacco companies Lorillard American and Reynolds American. The complaint was aimed partly at unseating specific TPSAC members who, the companies argued, had “conflicts of interest” by virtue of the millions of dollars in grant money, consulting fees, and expert witness work they collectively received over the years from pharmaceutical companies, also called sponsors.
Because those pharmaceutical companies make and market anti-smoking aids such as nicotine patches, gum, and an anti-smoking medication, Chantix, the plaintiffs reasoned that any advisor who accepts their funding will likely be biased against tobacco interests.
Lorillard and Reynolds prevailed last July when Judge Leon ruled that four members’ financial conflicts of interest represented a violation of federal ethics law. He also ruled that a report on menthol cigarettes by TPSAC (which was the actual focus of the lawsuit) could not be relied upon by FDA. The members’ financial ties, according to the judge, “irrevocably tainted [the Advisory Committee’s] very composition and its work product [is] at a minimum, suspect, and, at worst, untrustworthy.”
While I agree that the membership of TPSAC was problematic, my reason is entirely different from Judge Leon’s. In my view, the real problem with the committee make-up was not, as the Judge indicated, that members receiving support from pharmaceutical companies were reflexively conflicted. But rather that TPSAC had initially welcomed the service of those members while barring entry to any investigator who accepted support from tobacco interests (or who did so within the 18-month period prior to applying for membership.)
The assumption behind the FDA’s inconsistent policy, of course, is based on the misconception that merely accepting financial support from tobacco interests – but never from pharmaceutical interests, mind you –automatically disables one’s capacity to make sound, evidence-based decisions surrounding tobacco regulation.
This is an indefensible double standard on the part of a federal agency. I think it derives from the misbegotten conceit that anyone who accept funding from tobacco sponsors is somehow pro-smoking. In reality, most researchers who accept grants from tobacco interests are working just as hard to reduce smoking. It’s just that their topic of study is smokeless tobacco (and, I hope soon, e-cigarettes whose nicotine comes from tobacco) as a route to smoking cessation. In this context, being “pro-tobacco” is perfectly consistent with advancing public health.
Of particular interest is Swedish snus, a style of smokeless tobacco available in the U.S. Smokeless tobacco is estimated to be 99% less harmful than smoking. The Swedish version, which is conveniently available in spit-less teabag-like pouches, has been the subject of over two decades of epidemiological data. (less is available about the American versions, though it shows similar results). Thanks to its use Sweden now has the lowest rate of smoking-related diseases in Europe, the world’s lowest rate of lung cancer in males, and one of the lowest mouth cancer rates in the EU.
Research on smokeless tobacco is an important public health contribution. Consider examples of the investigations made possible by grants from tobacco manufacturers to researchers’ universities or to the scientists themselves: the danger of misinformation that might convince smokeless tobacco users to switch to smoking conducted by an oral pathologist at the University of Louisville and a researcher at the University of Alberta; the value of tobacco harm reduction by workers at the University of Texas, Houston; the use of smokeless (“snus”) as an effective method to quit smoking; the relationship of smokeless tobacco to lung cancer by investigators at the University of Surrey, UK; among others.
Conflict of interest is a vexing subject. Policies are generally borne of much soul-searching, hand-wringing and hair-splitting and often have unintended consequences. To be sure, all agencies want to insulate their advisors from personal and professional loyalties or other factors that might erode a neutral stance toward the data.
But it is easy to go too far in the pursuit of purity. In fact, many have urged a zero-tolerance policy for advisory committee members and commercial ties. This would be a disaster.
A no-ties rule would force the FDA to recruit its outside s from a far smaller pool of experts.“You’d be getting the second best and the almost brightest,” says Peter Pitts, former Associate Commissioner for External Relations at the FDA and policy adviser to the Commissioner. A 2007 study involving 124 members participating in 16 FDA advisory meetings, found that members who received high levels of support from pharmaceutical companies had more years of experience in their fields and more contributions to peer-reviewed literature compared to members who were funding-free.
Evidence suggesting that funding increases risk of bias in members’ decision-making is mixed. A 2006 paper in the Journal of the American Medical Association (JAMA), meanwhile, found that excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.The FDA re-analyzed the JAMA data and found that members with financial ties to companies actually tend to vote against the financial interest of those companies.
Another 2014 study, which looked at over 15,000 FDA advisory committee members’ votes between 1997 and 2011, painted a more complex picture. With about half of all meetings had at least one participant with such a financial interest, the data showed that members with connections to one company, or sponsor, are somewhat more likely to vote for approval (63 percent) than members with no attachments to a sponsor (a 52 percent chance). This modest preference rose to 84 percent if the member served on the company’s board or steering committee.
More intriguing was the observation that the voting behavior of members with links to more than one company, including board membership, was comparable to colleagues without any ties. This suggests that support from multiple sources cancels out preferences for a given sponsor. It also suggests that perhaps the FDA should require sole-sponsored members or, at the very least, sponsor board members to recuse themselves from voting (but not from group deliberation) when that company’s product is under consideration.
As for TPSAC, it must follow Judge Leon’s order. But a longer view of conflict of interest and advisory practices should lead to a more inclusive scenario wherein TPSAC welcomes any talented investigator who is wedded to norms of scientific fair play and is mature enough to suppress bias. This extends to investigators with financial relationships of all kinds – including tobacco interests. (Yes, there should be some exceptions: See here for conflicts with “direct and predictable effects.”)
The emphasis on members’ capacities to adopt a neutral stance is imperative. It highlights the fact that an advisor’s judgment is just as prone to collapse, if not more prone to falter, under the weight of a strong normative bias, that is, how one thinks health policy should work. I refer here, specifically, to members’ views on “tobacco harm reduction.”
Advocates of harm reduction advance a pragmatic stance that tolerates the use of nicotine in the form of smokeless tobacco or electronic cigarettes because doing so greatly minimizes the harm of smoking.
It’s worth special mention here that the investigators who pioneered the study of tobacco harm reduction, such as those working on smokeless tobacco, were consistently refused research support from government agencies. Thus, they were compelled to ask the industry for funding. Investigating innovative methods to reduce the toll of smoking has thus far mainly relied on industry funding.
Anti-harm reductionists, also called tobacco prohibitionists, see no virtue in making nicotine use less harmful; only complete abstinence is acceptable to them. “Given the long history of tobacco industry deception, such advocates assert that there can be no room for compromise when it comes to a product in which Big Tobacco has any interest,” wrote Amy Friedman and Ronald Bayer, both of Columbia University’s School of Public Health, in Science last January. A strong anti-harm reduction mind-set could easily sway members’ assessment of the risk of smokeless tobacco and e-cigarettes.
If TPSAC were to have pro- and anti-harm reductionists among its members, the advisory committees would have to function as a “team of rivals.” And it would be open for anyone to see. Thanks to federal sunshine laws, commercial ties are made public and FDA advisory meetings are open to the public; anyone can observe the proceedings. Members of the media, financial analysts, patient groups, individuals, and politicians can attend TPSAC meetings which are recorded and transcribed for the public. Sources of funding are public too.
The public’s confidence in the recommendations of federal advisory committees is vital to the functioning of governmental institutions. Judge Leon was right to conclude that the committee was poorly composed, but that was because it was exclusionary, not because members accepting support from pharmaceutical companies were necessarily conflicted. Instead, both the judge and the FDA subscribed to the myth that commercial ties are inevitably corrupting. By operating under this facile conclusion, the FDA sealed itself off from a group of scientists whose knowledge and perspectives are critical to the development of wise tobacco regulation.
Dr. Satel has served as an expert witness in tobacco litigation.
The FDA gets it exactly right -- and the key word is "evolving."
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.
Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.
The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.
“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”
The science of abuse-deterrent technology is still relatively new and evolving. The final guidance is intended to assist drug makers who wish to develop opioid drug products with potentially abuse-deterrent properties. The FDA is working with many drug makers to support advancements in this area and help drug makers navigate the regulatory path to market as quickly as possible. In working with industry, the FDA will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.
“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”
While this final guidance does not address generic opioid products, the agency understands the importance of available generic options to ensure appropriate access to effective opioid drugs for patients who need them. The FDA is committed to supporting the development and use of generic drugs that have abuse-deterrent properties and is working on draft guidance in this area.
To help support the safe use of all opioid products, the FDA is working in many other ways to help prescribers and patients make the best possible choices about how to use these powerful drugs. The agency’s goal is to find the balance between appropriate access to opioids for patients with pain and the need to reduce opioid misuse and abuse.
Senator David Vitter (R, LA) is, once again, trying to fool his colleagues (and the American public) about drug importation. Let’s go, once again, into the abyss and set the facts straight.
Brand-name pharmaceuticals found abroad tend to be significantly cheaper than they are in the States, largely because foreign governments impose stringent price controls on most drug sales.
Advocates claim that “re-importation” will allow American patients to benefit from this price disparity.
But “re-importation” doesn’t actually describe what will happen if foreign drug importation is legalized. Using the term is an act of linguistic misdirection — or outright chicanery, if you’ve got a cynical streak. It’s not “re-importation,” it’s importation. This isn’t about medicines that have ever been inside US borders.
Nor is this about denigrating the Canadian medicines regulatory system -- it’s about reality.
Importing drugs from Canada is exceedingly dangerous for a number of reasons. For starters, many Internet pharmacies based up North are stocked with drugs from the European Union. And while many wouldn’t hesitate to take medicines purchased from countries like France and Great Britain, there’s plenty of risk involved.
The EU currently operates under a system of “parallel trade,” which allows products to be freely imported between member countries. This means that any drugs exported from the U.K. to Canada could have originated in an EU country with significantly less rigorous safety regulations, like Greece, Portugal, Latvia, or Malta.
Just last year, EU officials seized over 34 million fake pills in just two months. And in May, Irish drug enforcers confiscated over 1.7 million pounds of counterfeit and illegal drug packages. So if American customers start buying drugs over the Internet from Canadian pharmacies, they could easily wind up with tainted medicines of unknown European origin.
It’s also important to note that drugs from anywhere in Europe aren’t even legal for sale in Canada. So, when politicians say we can get “the same drugs” that Canadians get, they’re just plain wrong.
Even more worrisome is outright fraud — many “Canadian” pharmacies are actually headquartered somewhere else.
A 2005 investigation by the Food and Drug Administration looked at 4,000 drug shipments coming into the United States. Almost half of them claimed to be from Canada. Of those, a full 85 percent were actually from countries such as India, Vanuatu, and Costa Rica.
As part of another investigation, FDA officials bought three popular drugs from two Internet pharmacies claiming to be “located in, and operated out of, Canada.” Both websites had Canadian flags on their websites. Yet neither the pharmacies nor the drugs were actually from Canada.
As an FDA official told Congress, “We determined there is no evidence that the dispensers of the drugs or the drugs themselves are Canadian. The registrants, technical contacts, and billing contacts for both web sites have addresses in China. The reordering website for both purchases and its registrant, technical contact, and billing contact have addresses in Belize. The drugs were shipped from Texas, with a customer service and return address in Florida.”
And in laboratory analysis, every pill failed basic purity and potency tests.
The on-the-ground reality of s tate and local importation schemes have been dismal and politically embarrassing. Remember Illinois' high profile "I-Save-RX" program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program—which equals approximately .02 percent of the population.
And what of Minnesota's RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
Remember Springfield, Massachusetts and “the New Boston Tea Party?” Well the city of Springfield has been out of the “drugs from Canada business” since August 2006.
And, speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city in the nation to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
The Canadian supplier for the program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
And such programs won't do any better on a national basis. A study by the non-partisan federal Congressional Budget Office showed that importation would reduce our nation's spending on prescription medicines a whopping 0.1 percent—and that's not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally mentioned in foreign drug importation schemes.
Calling foreign drug importation “re-importation” is a clever way to sell the idea to the American people. But the term simply doesn’t fit with the facts. In reality, Americans would end up jeopardizing their health by purchasing unsafe drugs made in foreign countries – while not saving money.
Think again, Senator Vitter.
Senator Jack Reed (D, RI) wants to repeal the Non-Interference Clause. He thinks it will lower the government’s prescription drug bill. He’s wrong. Let’s look at the record.
While Medicare as a whole is a fiscal basket case -- due to run out of money in 2024 -- Part D has been the very model of a well functioning federal program since its implementation.
The Congressional Budget Office (CBO) found that, between 2004 and 2013, Part D will cost an extraordinary 45 percent below what was initially estimated. Premiums for the program, meanwhile, are roughly half of the government’s original projections. Part D enrollees pay, on average, $30 a month -- a rate that has remained essentially unchanged for years.
It’s no wonder that beneficiaries are so pleased with the program. In fact, 96 percent of those enrolled in Part D say that their coverage works well.
These unprecedented results are largely due to Part D’s market-based structure. Beneficiaries are free to choose from a slate of private drug coverage plans, forcing insurers to compete to offer the best options to American seniors. It’s hardly surprising that the program has led to low prices and satisfied customers.
Through their own negotiations with drugmakers, private insurance plans that operate under Part D have already had great success in keeping pharmaceutical prices down. In fact, the CBO has observed that Part D plans have “secured rebates somewhat larger than the average rebates observed in commercial health plans.”
What’s more, the CBO has said time and again that doing away with the non-interference clause “would have a negligible effect on federal spending.” In a report from 2009, they reiterated this view, explaining that such a reform would “have little, if any, effect on [drug] prices.”
In fact, allowing the feds to negotiate drug prices under Part D would likely have a negative effect on the program. The CBO predicts that, when HHS forces pharmaceutical firms to lower the cost of a particular drug, this tactic brings with it “the threat of not allowing that drug to be prescribed.”
Senator Reed is lost in the wilderness.
Many nations in the developing world look to Brazil’s drug licensing agency, the National Agency of Sanitary Vigilance (ANVISA), as a model to emulate. Last week, the outgoing president of ANVISA, Jaime Oliveira, said ANVISA should decrease the time it takes to analyze the registration of new products and spend more time monitoring “what is on the pharmacy counter.”
Per Oliveria, ANVISA should dedicate more time going into drugstores and supermarkets to check whether the products it has already approved are being manufactured and sold according to appropriate quality standards.
This makes ANVISA the latest big nation regulatory agency to recognize the growing urgency in quality management and post-marketing surveillance. As more and more regulatory bodies (including the EMA and the USFDA) refocus their attentions on bioequivalence, API and excipient sourcing, and cGMPs, Mr. Oliveria’s statement reinforces the urgency and importance of both pre-market scrutiny and real world integrity.
Abuse Deterrent Opioids: Don't Fix the Blame, Fix the Problem
By: Peter J. Pitts
Mark Twain quipped, “For every complex problem there is usually a simple answer – and it is usually wrong.” Welcome to the debate over opioid pain medications. What those seeking to solve the problem with one-shot solutions have ignored is that pain in America is a medical problem of enormous proportion.
One-hundred million Americans are now living with chronic pain. That’s a third of the U.S. population. Ten million of those have pain so severe that it disables them. Pain costs the U.S. economy roughly $600 billion dollars a year in lost productivity and healthcare costs. And lawsuits, recalls, and police action won’t change those dire statistics.
The vast majority of people who use opioids do so legally and safely. A subset of approximately 4% uses these medications illegally. In fact, from 2010 to 2011, the number of Americans misusing and abusing opioid medications declined from 4.6% to 4.2%.
One reason is the development of abuse deterrent opioid medications. According to the Journal of Pain, in a real-world study, abuse by snorting, smoking, and injecting prescription opioids declined by 66% after the reformulation of the drug with abuse deterrent properties. The New England Journal of Medicine has reported that, “the selection of OxyContin as a primary drug of abuse decreased from 35.6% of respondents before the release of the abuse deterrent formulation to just 12.8% twenty-one months later.”
“Abuse deterrent formulations” are opioids with physical and chemical properties that prevent chewing, crushing, grating, grinding or extracting, or contain another substance that reduces or defeats the euphoria that those susceptible to substance abuse disorders experience. The new law requires insurance companies to provide the same coverage for the new abuse deterrent formulations as non-abuse deterrents, and they are not permitted to shift any additional cost of these medications to patients. It makes doctors better able to prescribe these medications without pushback from insurance companies.
Abuse deterrent formulations are not the only solution, but they are a good step forward toward balancing the legitimate needs of pain patients with the need to reduce medication abuse. Other efforts must also include more robust education of both medical professionals and consumers to keep the medication out of the hands of potential abusers in the first place. Government statistics show that 78.5% of those who abuse prescription pain medication did not obtain the drugs from a doctor themselves.
“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” said Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research. “Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain.
Abuse deterrence is a worthy goal and will evolve when all the players work together in a more regular and synchronistic fashion. As the Japanese proverb goes, “Don’t fix the blame, fix the problem.”
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
From the pages of The Hill …
Biosimilar drugs need clarification
In a recent op-ed piece on The Hill’s Congress Blog (“More must be done to improve access to biosimilar drugs,” March 19), Ike Bannon erroneously argues that the use of unique international non-proprietary names (INN) for biosimilar medicines would slow the entry of this new class of drugs into the U.S. market. On the contrary, names that clearly differentiate biosimilars from one another and the original biologic medicine will enhance transparency and build physician confidence in this class of medicine, without which robust utilization is not possible.
Biologic drugs are extremely complex medicines. As such, unlike traditional chemical drugs, it is all but impossible for biosimilar drugs to be identical to the approved biologic they are meant to resemble. The naming of these drugs is an important patient safety issue because the INN is used in the surveillance of drugs on the market to quickly identify which drug may be responsible for an adverse event. If biosimilars use the same INN as their reference biologics, it would be more difficult for regulators to recognize exactly which product is causing a problem.
As the Food and Drug Administration (FDA) finalizes its naming policy, the agency must learn from real-world global biosimilar experiences to understand how different a biosimilar can be from the original biologic. These differences will make it resoundingly clear that FDA must finalize its policy in favor of unique names.
Case in point: A poster presentation at the European Crohn’s and Colitis Organization titled “Biosimilar but not the same” offered timely and real-world data on the differences between originator biologics and their biosimilars. The study examined the clinical impact of both the innovator product (Remicade) and its European Medicines Agency-approved biosimilar (Inflectra). The findings show the rates of surgery in Remicade and Inflectra groups were significantly different. Specifically, 80 percent of the Inflectra group required hospital readmission versus 5 percent of the Remicade group. The conclusion of the study is not ambiguous: “Our results suggest that biosimilars may not be as efficacious as the reference medicine.”
Biosimilar approvals are based on similarity — but in the real world, success will be measured by patient outcomes. Biosimilars are here to stay and it is not surprising that physicians will have more confidence in them if they know exactly what drug they are prescribing. Distinguishable names provide that transparency and a necessary safeguard to maximize safety and credibility. It’s really that simple.
From Peter Pitts, president of the Center for Medicine in the Public Interest, New York, N.Y.
Some interesting new regulatory tea leaves in the debate over biosimilar nomenclature.
According to the USP, if Sandoz’s biosimilar (Zarxio – or filgrastim-sndz) meets the filgrastim monograph, it should carry the same nonproprietary name as Neupogen. But the FDA says it’s already determined the monograph does not apply. According to Dr. John Jenkins, director of FDA's Office of New Drugs the naming of this particular drug does not necessarily mean this will become the general policy for naming biosimilars.
An important point to remember is that the USP is not responsible for testing and enforcement of its standards, including comparing products to existing monographs. That’s an FDA responsibility.
While the FDA agrees that the USP has a role “regarding the nonproprietary names of drugs in certain circumstances,” they do not believe that the nonproprietary names FDA assigns for drugs and biologics are temporary until the USP reached a decision.
On March 18 (just under two weeks after the FDA approved Zarxio) USP issued a statement to the effect that it had “just begun a dialog with FDA regarding Zarxio and it is too early to comment further.”
So watch the regualtory fur fly and keep those tea leaves steeping.
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.
