October 2012

510(k) Process Comes Under Renewed Scrutiny by Legislators, Awaiting FDA Response as Proposed Legislation Remains Stagnant

October 31, 2012
Medical Devices

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

Several months ago, Representative Edward J. Markey (D-Mass.) and Senator Jeff Merkley (D-Ore.) wrote a letter to Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration, calling for an overhaul of the 510(k) pre-market notification database. The legislators cite reports of defective medical devices cleared via the 510(k) process in recent years, such as the DePuy® artificial hip, that have caused “grievous[] and irrevocabl[e]” harm to patients.

The issue? Most devices subject to premarket review are cleared through FDA’s 510(k) process which provides expedited approval for products that are deemed “substantially equivalent” to an existing predicate device. While the 510(k) process allows patients earlier access to devices, the system is inherently flawed. Referred to as “predicate creep,” the 510(k) process clears generations of devices–none of which have been subject to the exacting scrutiny of pre-market approval (the PMA process). As Markey and Merkley cite in their letter to Shuren, many predicate devices upon which new products rely for 510(k) clearance themselves have been recalled by manufacturers due to “fundamental design flaw[s].”

The legislators asked Shuren and the FDA to retrospectively update the 510(k) database to clearly indicate devices recalled for serious design flaws that could adversely affect safety or effectiveness. The letter also asked FDA, among other things, to develop a mechanism for identifying certain 510(k) entries to “reflect instances where a device’s clearance traces back to a predicate recalled for a serious design flaw adversely impacting its safety, even if the original problematic device is not the immediate predicate.” For additional in-depth discussion of issues surrounding the existing 510(k) process and substantial equivalence, including product liability considerations see “Rethinking Lohr: Does ‘SE’ Mean Safe and Effective, Substantially Equivalent, or Both?”

After the Institute of Medicine released its highly controversial report on the current 510(k) process last year (stating that the process is flawed and recommending a new pre- and post-market regulatory framework to provide a reasonable assurance of safety and efficacy), the issue of device safety has been omnipresent in policy debates surrounding related concerns of access and innovation. For a critique of the IOM report and a summary of its findings, see “A Failure to Comply: An Initial Assessment of Gaps in IM’s Medical Device Study Committee” and “Left to Their Own Devices: IOM’s Medical Device Committee’s Failure to Comply.” In January, Representative Markey and others introduced H.R. 3847, coined The SOUND Devices (Safety of Untested and New Devices) Act of 2012. The bill proposes to amend the Federal Food, Drug and Cosmetic Act to allow the FDA to reject a claim of substantial equivalence for a device whose predicate has been “recalled, corrected or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety . . . .” in light of these concerns.

In testimony given to the House Committee on Energy and Commerce on device user fees back in February, Shuren discussed strategic priorities for the 510(k) process, including developing methods and procedures for the systematic analysis and use of medical device recall information by September 30, 2012. However, now that the Medical Device User Fee Amendments (MDUFA III) have been enacted, reauthorizing device user fees through fiscal year 2017, perhaps the FDA and CRDH will finally be able to make progress in revamping the 510(k) system. As Shuren noted in his testimony, “[w]hile it is true that providing more user fee resources alone won’t solve the problems with our premarket programs, insufficient funding is at the root of, or a contributing factor to, several of these problems. Adequate and stable funding is one key component to our and industry’s success in bringing safe and effective devices to market quickly and efficiently.”

Currently, the 510(k) process remains unchanged. Though legislators requested an official response no later than September 19, 2012, the FDA and Shuren have yet to release a statement (at least publicly) regarding these concerns. Additionally, it is unclear whether CDRH has made any headway in meeting its target goals. As we approach the end of 2012, 510(k) still leaves much to be desired–the highly anticipated changes to the pre-market clearance process are provisional at best. It seems as though Markey isn’t having much luck in Congress either. H.R. 3847 is awaiting approval from the House Committee on Energy and Commerce (and has been since shortly after its introduction). According to GovTrack.us, an online bill tracking website, the bill has only an estimated three percent change of being enacted.

Obama, Romney probably know what you read, where you shop, and what you buy. Is that a problem?

October 31, 2012
Elections, Internet, Privacy

by Bryan Dooley, UMN Law Student, MJLST Staff

Most voters who use the internet frequently are probably aware of “tracking cookies,” used to monitor online activity and target ads and other materials specifically to individual users. Many may not be aware, however, of the increasing sophistication of such measures and the increasing extent of their use, in combination with other “data-mining” techniques, in the political arena. In “It’s the Autonomy, Stupid: Political Data-Mining and Voter Privacy in the Information Age,” published in the Spring 2012 volume of the Minnesota Journal of Law, Science, & Technology, Chris Evans discusses the practice and its implications for personal privacy and voter autonomy.

Both parties rely extensively on data-mining to identify potentially sympathetic voters and target them, often with messages tailored carefully to the political leanings suggested by detailed individual profiles. Technological developments and the widespread commercial collection of consumer data, of which politicians readily avail themselves, allow political operatives to develop (and retain for future campaigns, and share) personal voter profiles with a broad swath of information about online and market activity.

As Evans discusses, this allows campaigns to allocate their resources more efficiently, and likely increases voter turnout by actively engaging those receptive to a certain message. It also has the potential to chill online discourse and violate the anonymity of the voting booth, a central underpinning of modern American democracy. Evans ultimately argues that existing law fails to adequately address the privacy issues stemming from political data-mining. He suggests additional protections are necessary: First, campaigns should be required to disclose information contained in voter profiles upon request. Second, voters should be given an option to be excluded from such profiling altogether.

Biobanks Revisted

October 31, 2012
Bioethics, Public Health

by Jeremy So, UMN Law Student, MJLSTManaging Editor

On October 28, Australian researchers published new information about the genetic basis for endometriosis, a condition where the cells lining the uterus flourish in other areas of the body. The researchers, instead of recruiting their own research subjects, analyzed samples stored in biobanks in Australia, Japan, and Europe. Because of their approach, the researchers were able to identify common markers that appeared across the ethnically-diverse study population. The Australian team’s findings highlight the increasing importance of biobanks–repositories for biological research samples–which have become a valuable resource in the fields of genomics and personalized medicine

The increasing importance of biobanks was recently highlighted in a symposia sponsored by MJLST. In the accompanying Spring 2012 issue, researchers and lawyers discussed the one of the primary problem facing researchers who use biobanks: whether to return research results and incidental findings to research participants.

While the Australian researchers have decided to track down the original participants in order to share their findings, other researchers have hesitated to use the same approach. Karen J. Maschke highlighted several such reasons in her recent article “Returning Genetic Research Results: Considerations for Existing No-Return and Future Biobanks.” In the article, Maschke focuses on the approaches of American biobanks researchers, who generally do not share their results with individuals whose DNA was analyzed.

For American researchers, Maschke notes that samples stored for biobank research are regularly deidentified, making it difficult to impossible to contact the original donor. Such a system exists in part because of concerns over whether consent would be granted for samples to be used in certain types of research. Combined with conflicting interpretations of government regulations and other difficulties in actually returning sample results, researchers have hesitated to adopt a disclosure-based system for research results.

Although some may remain hesitant, cooperation between researchers and biobank participants has not necessarily led to negative outcomes.

The importance of resolving this conflict is highlighted by the increasing prevalence and importance of biobanks to scientific research. Several countries are working on expanding their biobank networks. Now, before competing standards come to dominate the field, a uniform system for the return of results should be determined and implemented.

Ask Not What Your Country Can Do For Your Patent . . .

October 26, 2012
Intellectual Property, Patents

by Caroline Marsili, UMN Law Student, MJLST Staff

The candidates aren’t talking about patents (with the exception of a brief quip about IP piracy in last Tuesday’s debate). But if it’s “all about the economy,” they should be talking patent policy.

In the presidential and vice-presidential debates of recent weeks, the candidates have exchanged vitriol and “gotchas,” and have established a contrast in both policy and character for voters. Notably absent from the debates has been discussion of innovation, and more specifically, the role of IP policy in innovation. IP policy would seem an attractive platform for discussing job creation, as IP industries account for a vast portion of the Nation’s jobs and GDP (“IP-intensive industries” accounted for 27.7 of all jobs in the economy in 2010). It’s possible that the candidates find common ground on this issue. Alternatively, the topic is, for the time-being, moot in the wake of the America Invents Act, the full effects of which are yet to be seen.

Since its passage just over a year ago, some critics have expressed doubt that the Act will create jobs and promote innovation as promised. Others argue not that the Act is failing, but that it represents a misplaced effort to reform patent policy.

The solution? “Don’t just reform patents, get rid of them.” A recent working paper by Boldrin & Levine makes the bold case that our patent system is ultimately more trouble than it’s worth. The authors admit that abolishing patents “may seem ‘pie-in-the-sky'” and acknowledge the glut of transitional issues that would need addressing; just the same, they conclude that the key to reforming our patent system is to get rid of it. Their central beef with the system is the want of empirical evidence that it does what it purports to do: promote innovation and productivity. Meanwhile, there are other incentives for innovation and many negative externalities of the patent system.

Other authors have proposed less radical approaches to revamping the patent system. In her recent article in MJLST, “An Organizational Approach to the Design of Patent Law“, Liza Vertinsky also finds that empirical literature fails to decisively connect patents to innovation and economic growth. However, Vertinsky takes a more optimistic approach to the floundering patent system, arguing that policy-makers should seize reform efforts as an opportunity to tailor the patent law to innovation objectives. The America Invents Act, she argues, isn’t a significant change in the direction of patent policy and instead seeks to remedy narrower concerns with administrative backlog, litigation costs and patent quality. In her view, patent policy should be revamped to encourage innovation based on how individuals and organizations–corporations, Congress, the PTO–really function.

Vertinsky’s “organizational approach” entails a new way of thinking about patents in terms of how patent policy, informed by economic theory, should be fashioned to strengthen the organization of innovation rather than focusing on incentivizing acts of invention. For example, patent laws can be tailored to the needs of different innovation processes across different industries. While sweeping changes in patent policy are unlikely at this time (witness the battles encountered in passing and implementing the America Invents Act), Vertinsky’s proposals should inform discussion among policy-makers about what the patent system can and should do. The Obama Administration’s national innovation strategy neglected to give patent policy a more central role in encouraging innovation, but the desire to build an “innovation economy” is certainly there, and a rational and successful patent policy is vital to attaining the kinds of high-level jobs and industry the country needs and the candidates promise.

(Others think patent policy may not matter at all. What do you think?).

Juggling GMOs: Balancing Benefits, Risks, & Unknowns

October 26, 2012
Environment, Food and Agriculture, Public Health

by George Kidd, UMN Law Student, MJLST Staff

The recent multi-billion dollar loss as a result of the 5th worst drought ever recorded in U.S. history adds fuel to an already raging debate over genetically modified organisms (“GMOs”). Amanda Welters, in “Striking a Balance: Revising USDA Regulations to Promote Competition Without Stifling Innovation,” delivers a fantastic overview of key issues in the GMO debate while also introducing novel legislative ideas garnered from the pharmaceutical industry. Ms. Welters’ article provides important insights into the continuing struggle to provide society with an optimal outcome.

While recent documentaries such as “Food Inc.” and “King Corn” give informative, although one-sided, analyses of the GMO debate, GMO’s may indeed be necessary for the future. The recent drought only emphasizes why utilizing GMO crops may be so necessary. Benefits of using these crops could include increased resistance to severe weather, increased food production from less land, and decreased pesticide use. With so many benefits it is easy to see why these types of crops may have a lasting future.

But the road to societal riches as a result of using GMOs may be a tightrope walk with a long fall. Most of the pushback comes from the fact that the effects of consuming GMO products are largely unknown. Further, when all farmers use GMO seed, biodiversity is reduced, opening up problems if a disease were to effectively eradicate a particular GMO crop. Lastly, while Monsanto has done a good job of creating essentially “self-destructing” seed, reducing the crop yield of further generations of their soybean to encourage farmers to purchase new yearly seed, introduction of modified genetic material may have an irreversible environmental impact.

In light of the World Bank issuing a global hunger warning, perhaps we should accelerate our efforts in moving toward a legislative balancing act in either moving forward with GMO crops or looking elsewhere for innovative ideas. Producers of new GMO technology need to remain adequately incentivized to make GMOs more effective and safer for human consumption. But competition also plays an important role in improving GMO’s future viability. Expiration of Monsanto’s Roundup Ready soybean patents in 2014 will allow generic brand competition to spur price drops and competitive innovation.

In the end, when we do find that optimal balance between innovation and competition, the only winners are us.

Juggling GMOs: Balancing Benefits, Risks, & Unknowns

October 26, 2012
Environment, Food and Agriculture, Public Health

by George Kidd, UMN Law Student, MJLST Staff

In the end, when we do find that optimal balance between innovation and competition, the only winners are us.

TV Advertising Not the Only Problem in Fight Against Childhood Obesity

October 26, 2012
Food and Agriculture, Public Health

by Bryan Morben, UMN Law Student, MJLST Staff

What happened to the days when kids would get together to play a game of football in the neighborhood? Or what about playing with Barbie dolls, cabbage patch kids, or a slumber party? Children today are just not entertaining themselves like this anymore. I have three younger brothers, and all I ever see them doing is sitting on the computer, playing videogames, or watching TV.

All of my brothers are as skinny as it gets, but probably only because they are also very active in school sports, especially hockey. Many other kids their age and younger also waste hours in front of a monitor or TV screen, but without the physical activity. Childhood obesity is turning into what some would call an “epidemic.” More than twenty-three million children and teens in the U.S. are overweight or obese, a four-fold increase over the past four decades.

A relatively recent study in Canada suggests that banning fast-food advertising to children may lower obesity rates. For the last thirty-two years in Quebec, it has been illegal for fast-food companies to advertise to kids. Researchers have estimated that as a result, children in Quebec consumed 13.4 to 18.4 billion fewer calories per year. Additionally, Quebec has the lowest childhood obesity rate in Canada.

Childhood obesity is generally the result of eating too many calories and not getting enough physical activity. Banning fast-food advertisements to kids may be one solution to help reduce the first part of that equation. Check out the article “Food Advertising and Childhood Obesity: A Call to Action for Proactive Solutions” in Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology. It gives a great analysis of the relationship between food advertisements and childhood obesity and proposes solutions that may assist in reducing the impact of advertisements on children’s health.

But I question whether banning fast-food ads is really the answer we should be focusing on. I think the problem runs deeper than that. If kids were forced to put down the controller or remote and burn off some calories outside they wouldn’t be in the position to be watching a fast-food ad in the first place. Let me know what you think the most effective solution might be by commenting below.

Food Trends: Mid-Calorie Foods

October 25, 2012
Food and Agriculture, Public Health

by Johanna Smith, UMN Law Student, MJLSTStaff

Looking at the packaging on a food item can be very overwhelming. Not only does the product contain required nutritional information and an ingredients list, many products also contain health claims or statements on the front of the package to grab the customer’s attention. Common terms to see include organic, low-fat, high fiber, and low-carb. In “How Can Better Food Labels Contribute to True Choice?,” recently published in the Minnesota Journal of Law, Science & Technology, J.C. Horvath discusses the evolution of the regulation of claims made on food packaging. In addition to regulatory pressure, the other major source of pressure that determines what shows up on food packaging is consumer preference.

A decade or so ago, the hot trend was to highlight items as being non-fat or low-fat. However, consumers quickly realized that eliminating all fat and calories eliminated the taste of the food that they liked and the popularity of these items declined. This set the stage for the successful marketing of mid-calorie foods. These foods have less fat and fewer calories than the original version of the food, but more than the typical diet food. The goal is to mimic the taste profile of the regular version of the product, but reduce the calories and fat. Examples of recent marketing successes include Edy’s/Dreyer’s Slow Churned ice creams and Hershey’s Simple Pleasures chocolates. Many different drinks, including soda, sports drinks, and juice are also trying to find success in this balancing act.

While I applaud the effort to provide “healthier” options to consumers, mid-calorie foods should not be thought of as diet foods. The labels used on mid-calorie food packages should not lead consumers to think that it is a low-fat or low-calorie diet food. In many instances, the mid-calorie food still contains relatively high amounts of fat and calories per serving. If incorporated into a person’s diet correctly, mid-calorie foods are an easy way to eliminate unnecessary fat and calories. For example, if someone has already decided to eat some chocolate, choosing Hershey’s Simple Pleasures over a regular Hershey’s chocolate bar is a good choice. But, the better choice may be to not have any chocolate at all. Moderation and variety are still the keys to a healthy diet.

Censorship, Technology, and Bo Xilai

October 25, 2012
Internet, Privacy, Social Media

by Jeremy So, UMN Law Student, MJLST Managing Editor

As China’s Communist party prepares for its once-a-decade leadership transition, the news has instead been dominated by the fall from power of Bo Xilai, the former head of the Chongching Communist Party and formerly one of the party’s potential leaders. While such a fall itself is unusual, the dialogue surrounding Bo’s fall is also remarkable–Chinese commentators have been able to express their views while facing only light censorship.

This freedom is remarkable because of the Chinese government’s potential control over the internet, which was recently outlined by Jyh-An Lee and Ching-Yi Liu in “Forbidden City Enclosed by the Great Firewall: The Law and Power of Internet Filtering in China” recently published in the Minnesota Journal of Law, Science & Technology. Lee and Liu explain how early on in the internet’s development, the Chinese government decided to limit a user’s ability to access non-approved resources. By implementing a centralized architecture, the government has been able to implement strict content filtering controls. In conjunction with traditional censorship, the Chinese government has an unprecedented amount of control over what can be viewed online.

Lee and Liu argue that these technological barriers rise to the level of de facto law. Within this framework, the Chinese government’s history of censorship indicates that there are rules against criticizing the party, its leaders, or its actions.

Chinese internet reactions to the Bo Xilai case are notable because thy have included criticism of all three. Posts expressing differing opinions, including those criticizing the government’s reaction and those supporting the disgraced leader, have not been taken down. Such posts have remained online even while commentary on China’s next leader, Xi Jinping, has been quickly taken down. Given the Chinese government’s potential control and past use of those controls, the spread of such dissent must be intentional.

Whether this is part of a broader movement towards more openness, a calculated response by the party, or a failure of Chinese censorship technology remains to be seen. Regardless, the changing nature of the internet and technology will force the Chinese government to adapt.

Incidental Findings: It’s My DNA, and I Want to Know if Something is Wrong With it.

October 15, 2012
Bioethics, Public Health

by Ryan J. Connell, UMN Law Student, Joint Degree Program Fellow, MJLST Staff

As genetic research continues to develop, researchers are more apt to make incidental discoveries in the course of the research on a subjects DNA. Susan Wolf, Founding Chair of the University of Minnesota’s s Consortium on Law and Values in Health, Environment & the Life Sciences, points out in her article “The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science,” that, with this development, there is a serious question that must be asked, but that the law does not really answer: do researchers have to report these incidental findings to the subject?

Is this something that necessarily must be addressed by the law? I think so. Researchers need guidance on this front. Right now if a researcher finds something that may or may not have adverse health consequences for a subject the researcher must balance competing interests. What if they do disclose the risk? Is a pure researcher qualified to evaluate medical risks? The researcher could be very wrong in their analysis; could a subject who was told that they might be at risk for a serious health problem, but was not, hold a researcher liable for emotional stress? On the other hand, if a researcher comes across some potential risks and does not tell the subject, and the subject suffers as a result, should the researcher be liable?

I think the answer to this problem lies in waivers. Before people make themselves subject to research they should sign a waiver to either not hold a researcher liable for any incidental findings reported, or agree to not receive any information about any incidental findings.

This really should be the patient’s decision. Some geneticists think that it is better not to let people know if they have a risk for Huntington’s disease, or Alzheimer’s disease because there are no interventions. Likewise some geneticists feel that they would only report a risk of cancer if it is specifically requested.

From my point of view, if my genes are used for research and the researchers find that I am at risk for something, I want to know. I don’t care if there is nothing that I can do about it; I should know about it. My personal view is not shared however, some feel like they want to contribute to research, and then they don’t want to be bothered again.

This is a complicated issue with no clear solution. How do you feel? Do you want a researcher to tell you if they think you are at risk? Would you hold a researcher liable if they mistakenly told you that you were at risk for a horrible disease? Or would you be more likely to hold a researcher liable for not telling you that you were at risk for a disease? Do you think a waiver, or some other agreement is necessary between a researcher and a subject before any research is conducted?

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October 2012

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