Life Science Compliance Update

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22 posts from August 2015

August 31, 2015

EHR: Congress Moves to Delay and Modify Timeline for Meaningful Use


There is a growing movement in Congress to push the Department of Health and Human Services (HHS) to postpone Stage 3 of the electronic health record meaningful use program. Recently, Rep. Renee Ellmers (R-N.C.) introduced a bill (HR 3309) that would delay federal rulemaking for Stage 3 of the meaningful use program until 2017 or when certain conditions are met. Under the proposed Stage 3 rule, eligible providers would have the option of applying for the incentives in 2017 and would have to attest to meeting the criteria in 2018. The comment period on the proposed rule ended May 29, and the CMS is expected to finalize it soon.

During a hearing on meaningful use Stage 3, interoperability and patient access to data, Sen. Lamar Alexander (R-Tenn.) stated: "To put it bluntly, physicians and hospitals have said to me that they are literally terrified of the next implementation stage ... because of the complexity and because of the fines that will be levied,” Fierce Health IT writes.

Industry and Medicine’s Response

As reported in Medscape, industry's response to the Stage 3 proposal has been mainly negative. The Medical Group Management Association (MGMA), for example, said that Stage 3 should not be finalized until more providers had participated in Stage 2. As of May 2015, just 50,983 eligible professionals and 1461 eligible hospitals had attested in Stage 2, according to the CMS. The MGMA also wants CMS to eliminate Stage 3 objectives that require patient engagement.

The American Medical Association (AMA) also criticized the proposal, saying more time is needed to evaluate the impact of the first two stages and that the Stage 3 criteria were too ambitious. And both the American Hospital Association and the College of Health Information Management Executives (CHIME) said the CMS should not finalize Stage 3 until it had had more experience with Stage 2.

It comes as no surprise the AMA strongly supports Congressional intervention to delay Stage 3. "The AMA thanks Rep. Ellmers for sharing our deep concern with a Meaningful Use program that continues to move ahead without first fixing barriers faced by physicians, hospitals, vendors and patients," said AMA President Steven J. Stack, M.D. "Under Rep. Ellmers' leadership, federal regulations would be revised to provide greater flexibility for physicians to meet the Meaningful Use requirements and ensure that Stage 3 of the program is developed in step with other efforts to modernize our nation's health care system."

The bill also addresses key interoperability challenges by ensuring EHR systems are capable of sending, receiving, and seamlessly incorporating patient data.

"This important bill addresses many of the fundamental shortcomings in government regulations that have made many EHR systems very difficult to use," said Dr. Stack. "We heard loud and clear from physicians at the AMA's first-ever town hall meeting on EHRs and the Meaningful Use program that the systems they use are cumbersome, poorly designed and unable to 'talk' to each other thereby preventing necessary transmission of patient medical information."

Struggling to Adopt

Physicians are struggling, as noted in a recent AMA report. One physician the article profiled is in his fourth year of meaningful use, and said the program has slowed down productivity in his practice by about 25-30 percent.

“There are so many more things that you have to report on that I don’t think really add to patient care,” the doctor said. “I’m trying to work with it. I think meaningful use is not necessarily a bad thing. But I don’t think [patients] have an idea what we’re going through. To give them a copy of their note, it’s not just printing it … there are four or five steps just to give somebody a copy of their note.”

The government has known about the problems cited by physicians for a long time. Back in May 2014, CMS delayed for a year the compliance date by which certain early participants in the program meet Stage 2 requirements. The relatively high percentage of providers—62%—still stuck on Stage 1 in the fourth full year of the program bears out the wisdom of the CMS' Stage 2 compliance extension.

The latest data tracks with an analysis done earlier this year by the American Academy of Family Physicians, according to Dr. Steven Waldren, director of the AAFP's Alliance for eHealth Innovation. Waldren said the number of family physicians who attested to meaningful use in 2014 fell nearly 40% to about 23,500 practitioners compared with 2013. Physicians specializing in internal medicine experienced a similar drop-off, he said.

Additionally, a new study from Weill Cornell Medical College describes the emergence of "systematic differences" between physicians who participated in the Medicare and Medicaid EHR Incentive Programs and those who did not. That "could lead to disparities in patient care," according to Weill Cornell researchers, who examined 26,368 physicians across New York State, using payment data from 2011 to 2012, the first two years of meaningful use.


This issue raises serious questions for broader federal health care goals. As we previously wrote, HHS aims to tie 30 percent of payments to quality, including the use of electronic records, by the end of 2016, and 50 percent by the end of 2018. The new MACRA legislation and recent CMS Medicare proposed rules operate as if meaningful use is moving forward as scheduled. Should Congress delay implementation of the next stage of meaningful use, it could have a ripple effect across HHS goals, possibly causing added confusion for physicians and hospitals. It will be important to monitor this as it develops; legislation may need to be passed soon, as CMS wishes to finalize its Stage 3 meaningful use regulations.


August 28, 2015

Be Careful What You Wish For? FDA’s Biosimilars Naming Guidance Proposes New Identifiers For All Biologic Products

Name tag

Yesterday, the Food and Drug Administration (FDA) released much anticipated guidance on how they plan to address nonproprietary naming of biologics and biosimilars. In it, FDA proposed that all biologics—both reference products and biosimilars—will share a core drug substance name and also a new “FDA-designated suffix” that is unique for each product. While brand-biologic manufacturers pressed FDA to ensure biosimilars carry unique names, the agency’s proposal in fact places a large burden on these manufacturers and prescribers to adopt the new naming model. 

In March, FDA approved the first biosimilar product, Zarxio—Sandoz Inc.’s copy of Neupogen (filgrastim). At the time, FDA referred to Sandoz’s biosimilar as “filgratism-sndz,” which seemed to suggest that FDA was headed towards a unique-naming scheme for biosimilars. However, it turns out the agency only partially showed their hand. Their draft guidance reveals the agency wants all biologics, including the reference product, to be renamed under a four-letter suffix scheme.

Janet Woodcock, the Director of the Center for Drug Evaluation and Research (CDER) and Karen Midthun, Director of the Center for Biologics Evaluation and Research (CBER) published an overview of their agency’s plan and how how the naming would work. “This suffix would be composed of four lowercase letters, and not carry any meaning,” they write. “For example, the nonproprietary name of a reference product could be replicamab-cznm, and a biosimilar to that product could be replicamab-hixf.”

In the time leading up to this guidance, most of the commentary surrounding the “naming” issue focused primarily on the biosimilar product. In broad terms, the biosimilar industry and insurers argued that FDA should assign a biosimilar the same nonproprietary name as the reference product on which it was based in order to facilitate substitution by providers and pharmacists. Brand manufacturers argued that because biologics are inherently complex and impossible to replicate in the way small-compound drugs can, biosimilars should carry different nonproprietary names. Specialists who often prescribe biologics also called for unique naming for biosimilar products, arguing this was necessary to clarify that biosimilars are not identical to reference products and may not be approved for all the same conditions as the reference, as well as to prevent confusion regarding adverse event reporting.

Interestingly, neither side seemed to be lobbying for a change in the naming scheme for all biologics, including reference products. Gillian Woollett, Senior Vice President at Avalere Health, notes that the immediate impact of the proposed guidance and accompanying regulation on the originator products is actually much greater than the impact on biosimilars. It is unclear how manufacturers will retroactively change the names for their products, and the implementation of FDA’s proposal could result in substantial disruption along the supply chain as data systems have to accommodate multiple names for the same product, some concurrent. This has never happened before. We expect this issue to feature prominently in the comments FDA receives.

“[W]e must also consider what we need to do to address previously approved biological products that have nonproprietary names without a suffix,” the FDA Directors acknowledged. “Applying the naming convention to these products would encourage routine use of designated suffixes in ordering, prescribing, dispensing, and recordkeeping practices and avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.” FDA is seeking comment on the best approach to implement this naming convention for previously licensed products.

FDA is also issuing a proposed rule to designate nonproprietary names that contain a suffix for six previously licensed biological products. Each of the six products is either a reference product for an approved or publicly disclosed biosimilar product application or a biological product that is either biosimilar to or related to one of these reference products. For example, Johnson & Johnson’s arthritis treatment Remicade (infliximib) would be have to be changed to infliximab-hjmt, according to the proposed rule.

Woodcock and Midthun note that FDA’s aim with the proposed naming convention is to address two issues, both of which were put forth by the brand industry as reasons to apply unique names to biosimilars. 

First, FDA wants to help prevent inadvertent substitution of biological products that are not determined to be “interchangeable” by the FDA. The agency has not yet issued guidance on how they will determine whether biosimilar products rise to the level of “interchangeability,” but FDA is getting a jump start on the naming issue. The agency is soliciting feedback about whether the nonproprietary name for interchangeable products should include a distinct suffix, or should share the same suffix as its reference product. The FDA will presumably also need to address currently marketed biologic products that share nonproprietary names as these may also be in danger of now being presumed to  be interchangeable if nonproprietary names are to become the basis of interchangeability.

Second, FDA is seeking to facilitate “safety monitoring of all biological products after they are on the market, by making it easier to accurately track usage of biological products in all settings of care, such as outpatient, hospital, and pharmacy settings.” Peter Pitts, President at the Center for Medicine in the Public Interest agreed that FDA’s proposal is an important one. “FDA has come out in favor of patient safety with the ability to track adverse events back to the manufacturer,” he noted.

View FDA’s draft guidance that explains FDA’s proposal on nonproprietary naming of biologicals (comments close in 60 days). View FDA’s proposed rule for renaming existing biologics (comments close in 75 days).

August 27, 2015

FTC Urges FDA To Reevaluate Current Approach To Regulating Homeopathic Drugs


Last week, the Federal Trade Commission (FTC) recommended that the Food and Drug Administration (FDA) consider regulating homeopathic products more like other pharmaceuticals. The recommendation is in response to FDA’s call for input on how it regulates homeopathic products—the first time in 25 years they have done so since releasing the guidance document “Conditions Under Which Homeopathic Drugs May be Marketed.” The FDA has not scrutinized homeopathic products for safety or efficacy as it does with other conventional products. They can be sold over the counter (OTC) for "self-limiting" conditions, like headaches or colds, which go away on their own. However, things have changed since 1988 when homeopathic remedies were offered by a limited number of manufacturers. Today, the homeopathic market is a $3 billion industry, and, as FTC indicates in their comment, these products may confuse consumers into believing that they are subject to the same strict approval standards as other drugs.  

As a background, homeopathy was developed in the 18th century and based on the idea that a product that causes an illness can also treat that same illness when taken in a highly diluted dose. “[H]omeopaths claim that a substance becomes more potent the more it becomes diluted by intense shaking” in a process known as “succussion,” indicates Forbes. However, in some cases the mixtures are so highly diluted that no molecules of the chemical remain in the final product. “Scientists now agree—overwhelmingly—that the remedies don't work,” states a recent article in Bloomberg. “But each year, billions of dollars worth of homeopathic products are sold in the U.S.” Oftentimes these products are sold right next to pharmaceutical products, with little noticeable differentiation to consumers looking for treatment.

Back in March, the FDA stated that it was “evaluating its current enforcement policies for drug products labeled as homeopathic from scientific, risk, and process perspectives.” The agency noted it was “now soliciting opinions about whether and how to adjust the current enforcement policies to reflect changes in the homeopathic product marketplace over the last approximately 25 years.”

Last week, FTC, which acts as the government’s consumer watchdog, took the opportunity to provide their recommendation that FDA should revise or repeal its current regulations for homeopathic products. This is a noteworthy comment; as Bloomberg notes, “Federal agencies don't normally tell each other how to do their jobs.”

FTC indicated that FDA's current approach to homeopathic products may conflict with advertising regulations, which often align well with FDA requirements, that require advertisers to have “competent and reliable scientific evidence” for any claims related to health, safety or efficacy. “Neither the FTC Act, nor any FTC rule or policy statement, exempts advertising claims for homeopathic drugs from these standards,” the FTC wrote in its comment.

Further, FTC offered evidence that consumers are confused about the evidentiary or approval requirements for traditional pharmaceuticals compared to homeopathic products, and this confusion is magnified when the products are side-by-side in the store. Forbes writer David Kroll notes that homeopathic products “can confuse consumers because they make disease treatment claims but then carry, in very small print, the disclaimer that, ‘These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.’”

In addition to consumer confusion, FTC also points to issues with advertisers "mistakenly" believing that compliance with FDA's 1988 homeopathic guidance "exempts them from compliance with the FTC Act’s substantiation requirement." In fact, FTC points out that these companies may "unwittingly subject themselves to liability for injunctive and monetary remedies in an FTC enforcement proceeding."

View FTC’s full response to FDA’s request for comments on “Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century,” here.


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