Food and Drug Law

A New Year! a New You!: Update Your Look on Regenerative Healing Law

January 2, 2017
Administrative Law, Biotechnology, Ethics, Food and Drug Law, Health Law, Patents

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF)  where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.

Recent Ninth Circuit Ruling an Important One for State and Local Governments Seeking to Regulate Genetically Modified Plants

December 4, 2016
Agriculture, Biotechnology, Food and Drug Law, New Technology, Public Health

Jody Ferris, Note & Comment Editor

Genetically modified plants (GMOs) are and have always been a hot topic in agriculture and food policy.  Since they were first developed, groups have been lobbying at various levels of government to impose regulations on how they are grown or to have them banned outright. A noteworthy decision has come down for those following legal challenges to GMO regulation. In Alika Atay et al. v. County of Maui et al., the Ninth Circuit court in Hawaii has ruled that state and local governments may regulate the production of GMOs in their jurisdictions.

The original suit was filed by GMO proponents after the County of Maui enacted a ban on genetically modified crops.  The court held that federal regulation of GMOs does not preempt state and local regulation after the variety is commercialized. This means that the United States Department of Agriculture holds jurisdiction over all GMO varieties prior to commercialization, which is the period during development and testing before the variety is sold on the market. According to the Ninth Circuit, after the variety is commercialized, however, state and local governments are free to enact regulations, including outright bans of GMO production, without the need to worry about federal preemption.

Interestingly, the county regulations in Hawaii that were at issue in the suit were nonetheless stricken down by the court because the State of Hawaii already has a comprehensive regulatory scheme which the court held to preempt county GMO regulations.  This outcome disappointed local environmental and anti-GMO groups due to their support of the new county level GMO restrictions.  However, the decision will help clarify the respective regulatory responsibilities between individual counties and the State of Hawaii. Despite the disappointment of these groups, the decision that there is no federal preemption on regulation of commercialized GMO varieties is an important one for many of the states in the Ninth Circuit, as there are counties in Washington and California, for example, which have also enacted bans on GMO production.

This decision will likely be an encouraging one for states wishing to enact their own regulations for how GMO varieties are grown and handled.  It is also encouraging for individual counties who wish to enact GMO bans or county level regulations, should state level regulations not be preemptive.  It will certainly be interesting to follow how state and local governments structure any future regulatory activities in light of this ruling.

Industry Giants Praise FDA Draft Guidance on Companion Diagnostics

October 26, 2016
Administrative Law, Food and Drug Law, Health Law, Medical Devices

Na An, MJLST Article Editor

In July 2016, the US Food and Drug Administration (FDA) published a draft guidance document titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.”  The new draft guidance aims to serve as a “practical guide” and assist sponsors of drugs and in vitro diagnostics (IVD) in developing these two products simultaneously.  So far, FDA has received six public comments on the draft guide which are mostly positive, with Illumina calling the document “worth the wait,” and Genentech claiming it “crucial for the advancement of personalized medicine.”

A companion diagnostic includes a medical device, in this case an in vitro device, which provides safety and efficacy information of a corresponding drug or biological product.  It is a critical component of precision medicine, the cornerstone of which is the ability to identify and measure biomarkers indicative of the patient’s response to a particular therapy.  Approximately, a quarter of new drugs approved over the past two years were a drug-IVD companion.  However, the codevelopment process is complicated by the fact that these two products may be developed on different schedules, subject to different regulatory requirements, and reviewed by different center at the FDA.  The long-awaited draft guidance was in the works for more than a decade and intended to help sponsors and the FDA reviewers navigate these challenges.

In this draft guidance, FDA reiterates its general policy that IVD devices should receive marketing approval contemporaneously with the authorization of the corresponding therapeutic product.  FDA states that “the availability of an IVD with ‘market-ready’ analytical performance characteristics . . . is highly recommended at the time of initiation of clinical trials intended to support approval of the therapeutic product.”  FDA also recommends: “Using an analytically validated test is important to protect clinical trial subjects, to be able to interpret trial results when a prototype test is used, and to help to define acceptable performance characteristics for the development of the candidate IVD companion diagnostic.”  The new draft guidance provides much more information about the technical and scientific aspects of the development process.  For example, the draft guidance details the use of IVD prototype tests for the purpose of testing the drug early in the development, considerations for planning and executing a therapeutic product clinical trial that also includes the investigation of an IVD companion diagnostic, the use of a prospective-retrospective study approach, the use of training and validation sample sets, and the use of a master file for the therapeutic product to provide data in support of the IVD companion diagnostic marketing application.

The draft guidance has received high marks from industry giants. Illumina said the draft “has been a long time coming, eagerly anticipated, but worth the wait.”  Yet, the gene sequencing giant also seeks more clarity from FDA on risk assessments and expectations for analytical validation prior to investigational IVD use in trials.  “There is an opportunity here for FDA to add clarity on this important decision making process. We suggest this discussion on significant risk versus nonsignificant risk determinations be expanded and put into an appendix with examples. This is a unique opportunity for FDA to help sponsors get this process right,” Illumina says.  On a similarly positive note, Genentech called the draft “crucial for the advancement of personalized medicine,” and supplementary to two previous guidance documents on next generation sequencing.  In addition, Genentech notes that the scope of this IVD and drug co-development draft guidance “is limited, and therefore it does not address the requirements for development of complementary diagnostics or the challenges of co-development using high-throughput technologies such as Next-Generation Sequencing (NGS) based test panels, which are an increasingly attractive tool for both developers and providers.”  AstraZeneca, on the other hand, seeks more clarity on guidance on complementary diagnostics and clarifying between “patient enrichment” and “patient selection” and the resulting considerations on determination of significant risk uses of investigational devices.

We eagerly wait for FDA’s view of these comments and impacts of the guidance on the codevelopment of a drug-IVD companion.

Food “Hot Off the Printing Press”: Insights Into 3-D Printed Food

October 15, 2016
3-D Printing, Agriculture, Biotechnology, Food and Drug Law

Theodore Harrington, MJLST Managing Editor

Would you food hot off the 3D printing press? In Jaspers Tran’s article, 3-D Printed Food, he explores the potential legal issues surrounding the commercialization of 3D printed food. (see here).

The article suggests that “. . . the 3D printer may become the fundamental daily appliance in every household . . . .” The pros are easy to see—As the demand for food increases at an exponential rate, the ability to create food quickly and avoid the current environmental impacts caused by food production would be a game-changer. The benefits here are fairly obvious and easy to wrap our heads around. However, large barriers still remain.

A tougher point for me to grasp is Tran’s suggestion that 3D printing will solve issues related to malnutrition, particularly over-nutrition, or obesity. Tran seems to leap from personalized nutritional food (tailored to an individual’s exact nutritional needs) to an obesity solution. This reminds me of the old adage, “you can lead a horse to water, but you can’t make him drink.”

Even if 3D printers end up in every household, my gut-feeling is that it will be a very long time before people are accepting of the idea of eating food that was just spit out of a machine (although there is a large amount of processing in today’s food, it goes on behind closed doors. Ignorance is bliss.). As Malcolm Gladwell suggests in his book Blink, the way we taste food is as much psychological as it is physical (see example of declining sales in a pork product when a life-like pig was placed on packaging instead of a cartoon pig).

Something to chew on.

Three’s a Crowd: Identifying the Shifting Parental Rights in Three-Parent Babies

October 3, 2016
Administrative Law, Ethics, Food and Drug Law, New Technology

Daniel Green, MJLST Staffer

Once again, science is spurring the law to adapt in ways it never could have predicted. A baby boy was recently born with genetic material of three different people. Aside from being born slightly premature, the now three-month-old child is very healthy. Even though three-parent techniques have been used before, this child marked the first healthy birth.

Given the obvious religious, safety, and ethical disputes behind such a medical procedure it may seem unclear as to why anyone would want to go through with it. The answer, however, avoids the arguments that the procedure is simply done to “play God” or for polyamorous relationships. The mother underwent the treatment to ensure both the happiness of parents and the health the child.

In this instance, the mother carried genetic defects identified to cause Leigh syndrome. This disorder which affects the brain resulted in the mother having had four pregnancy losses in addition to the death of two previous children at the ages of 8 months and 6 years. Leigh syndrome is caused by defects in a cells mitochondria, and the three-parent treatment was able to bypass the damaged mitochondrial DNA.

The process involves implanting the mother’s DNA into an egg from a donor. The egg has the donor’s main genetic DNA removed prior. The egg is then fertilized with sperm from the father. This process allows the DNA from the mother to pass down virtually unchanged since “mitochondrial DNA makes up less than 1% of the total cellular DNA.” However, small amounts of the donor’s mitochondrial DNA are still left throughout the child’s body.

The treatment was done in Mexico involving a team of fertility specialists from the United States and Great Britain. The procedure took place in Mexico since the treatment used has not yet been approved in the United States by the Food and Drug Administration, but this may not be the case for long due, in part, to recent successes. Another indicator of this possible change is that the treatment has already been approved in Britain.

Given this rapidly changing landscape, the law, in particular regarding parental rights, needs to somehow catch up quickly on an incredibly complex topic. As the donor parent will only be contributing 37 genes out of the total 22,000, it is likely that a donor’s right will be the most contested. Given the precedent already set forth, courts may adopt one of several strategies if and when three-parent babies are no longer barred in the United States.

  1. The donor parent has no legal claims: This would be similar to the mostly commonly accepted view concerning to sperm donors. In most states, if a sperm is donated through a licensed medical professional then the donor loses all legal claims to the child unless the parents are married. It seems logical that the treatment of an egg donor, in a three-parent situation, would be similar given what the term “donor” implies. Great Britain, which has already approved the three-parent treatment, has already adopted a stance similar to this. However, states are in contention regarding of parental rights and even custody of traditional style egg donors. Given the distribution of DNA it may be easier for a court to rule against the egg donor, but this is still very unclear.
  1. The donor parent has an equal claim to the child: California has already passed a version of a three-parent law, but this was mainly for same-sex couples who wish to have the donor on the birth certificate as well. However, the process leaves the door open for unintended parents, such as the donors, to assert claims over a child. In such a case, a court may find that, despite the objections of two parents, the donor has a right to be considered as a parent. Instances of this have already come up in traditional sperm and egg donation. Such conflicts could create a great degree of instability for the life of the child.
  1. The parties agree through a contract prior to the treatment as to what claims exist: The last apparent possibility is that parties may be able to contractually agree what their family is to look like. This would likely create the most amiable way to go about the process, but it is time-consuming and still may run into problems with the existing laws of certain states.

Clearly, there is no solid answer regarding three-parent babies even though three-parent birth certificates are already becoming more common in the United States. It seems like it is only a matter of time before three-parent babies are introduced into the culture as well. This leaves the question as to whether the law will be ready in time so as to hopefully create a circumstance that, whatever the family may look like, is best for the child.

Biosimilar Licensing

April 14, 2016
Administrative Law, Biotechnology, Food and Drug Law, Intellectual Property

Jeff Simon, MJLST Staffer

On February 18th, Sandoz filed a petition for certiorari appealing to the supreme court to revisit the Federal Circuit’s holding in Amgen v. Sandoz. Prior to Sandoz’s petition for certiorari, the Federal Circuit denied a rehearing of the case en banc back on October 16th. Sandoz is seeking the Supreme Court to review the Federal Circuit’s holding that it could not market Zarxio, the biosimilar equivalent of Amgen’s patented biologic Neupogen, until 180 days after Zarxio received FDA approval.

Sandoz will most likely take the stance that the Federal Circuit misinterpreted the BPCIA and particularly 42 U.S.C § 262(l)(8)(A). This paragraph states that a subsection (k) biosimilar applicant seeking approval under the BPCIA shall provide notice of marketing to the reference product sponsor (biologic brand manufacturer) not later than 180 days before the date of the first commercial marketing of the licensed biological product. According to Sandoz, the Federal Circuit incorrectly held that notice shall not be given prior to FDA approval of the biosimilar. The Federal Circuit noted that the statute uses the term “licensed” biologic product, implying that the biosimilar must first obtain FDA licensure before notice of commercial marketing can be given. Sandoz argued that the statute does not require the biosimilar applicant to stay notice until 180 days of licensure, and that such an interpretation would grant the reference product sponsor a six-month extension of exclusivity on the biologic product. Accordingly, Sandoz contends that such an interpretation would result in consequences unintended by the drafters of the Biologics Price Competition and Innovation Act, stating that if such was the intention of Congress, the BPCIA would have been drafted to include a fourteen-and-a-half-year exclusivity period. It’s important to note that the Federal Circuit was unanimous regarding its decision on 180-day notice of commercial marketing.

Earlier, Amgen declined to seek a petition of certiorari regarding the Federal Circuit’s holding that the Patent Dance provisions of the BPCIA are not mandatory. However, on March 24, 2016, Amgen asked the Supreme Court to review both portions of the Federal Circuit’s opinion, including its holding regarding the Patent Dance provisions of the Act. Amgen’s cross petition came in response the Sandoz’s petition for certiorari. In its opinion, the Federal Circuit held that the information exchange and patent dispute resolution mechanisms of the BPCIA were not mandatory, and that a subsection (k) applicant may avoid these provisions subject to the consequences contemplated by the BPCIA.

Amgen v. Sandoz was the first case regarding these provisions of the BPCIA as Neupogen was the first marketed biologic to come of patent since the passing of the BPCIA. If the Supreme Court is to review the decision of the Federal Circuit, it may elect to delay until the decision of pending cases such as Amgen v. Apotex. Regardless, the possible grant of certiorari has important implications for the biotechnology and pharmaceutical industries, as a looming patent cliff is set for the biologics industry in the next 5 years.

The Large Effect of Food Advertising on Children

April 6, 2016
Agriculture, Food and Drug Law, Public Health

Zach Berger, MJLST Staffer

The goal of advertising is to persuade consumers to purchase the advertised product. Advertising, as a form of commercial speech, is given considerable legal protection. Despite these protections, and with the rise of obesity in the you of America, advertising has become a topic of debate in the past several decades. As discussed in the Minnesota Journal of Law, Science & Technology article Food Advertising and Childhood Obesity: A Call to Action for Proactive Solutions by Roseann B. Termini, Thomas A. Roberto, and Shelby G. Hostetter, many theorists believe food advertising targets children “who are too young an immature to distinguish advertising puffery from truth.” Children have limited cognitive abilities, and assume the advertised food products are healthy. Without government regulation or parental intervention, these children can maintain these misconceptions and carry the unhealthy habits they developed at a young age into adulthood.

Unfortunately, the percentage of obese children has only gone up since the aforementioned article was written. According to a recent study, 20.5% of twelve to nineteen year olds are considered obese in the U.S., as well as 17.7% of children age six to eleven. As mentioned by Termini et al., food advertising can contribute to childhood obesity in several different ways: Time spent watching TV detracts from time that could be engaged in exercise, food advertisements encourage unhealthy choices, food products partnering with TV/movie characters encourages children to buy unhealthy products, and children snack excessively while watching TV. Although some companies have attempted to self-regulate, these attempts are not always successful.

Termini et al. suggested several solutions to limited the damage done to children by unhealthy food advertisements. These included: banning fast-food advertising on child-targeted TV, regulating food advertisements directed at children as well as the companies that produce them, eliminating tax breaks for food advertising, and increasing parental intervention. One such solution was recently reintroduced with the announcement of the Stop Subsidizing Childhood Obesity Act. This law would amend the tax code by eliminating tax deductions for advertising that is directed at children and which promotes unhealthy food and drink. The revenue this law would bring will go towards funding the U.S. Department of Agriculture’s “Fresh Fruit and Vegetable Program.” As the name states, this program provides fresh fruit and vegetables to all students at participating schools.

Overwhelming evidence suggests that the programs children watch on TV influences their eating habits. Although some of the onus is on the parents to supervise what their children eat, more consistent regulation of food advertising can help reduce childhood obesity. There is still a long way to go, but we need to be proactive if we want to have any chance of halting childhood obesity in its tracks.

Drug Shortages: A Mask for Reprehensible Activity?

March 10, 2016
Competition, Economics, Food and Drug Law, Healthcare

Ethan Mobley, MJLST Articles Editor

Access to life-saving prescription medication grabbed headlines after Turing Pharmaceuticals raised the price of its HIV drug, Daraprim, by about 5,000% overnight. While the Daraprim price hike initially appears to be driven by pure greed, it’s at least conceivable that basic economic principles of supply and demand may have played a minor role. Indeed, many other drugs have undergone serious price hikes arising from innocent supply constraints. While the defensibility of Daraprim price hikes remains uncertain, the story does bring to focus an issue affecting accessibility of hundreds of other life-saving prescription medications—drug supply shortages.

Drug shortages naturally restrict many patients’ ability to obtain life-saving medication, which can have disastrous effects. The Minnesota Journal of Law, Science & Technology addressed the issue in 2013 with a note written by Eric Friske. Friske found that drug shortages are often caused by a “combination of perturbed supply, manufacturing capacity, and utilization.” Friske then analyzed the efficacy of proposed (and now failed) legislation meant to reduce these supply shortages by requiring manufacturers to notify the FDA of impending shortages; the legislation would have also allowed the FDA to collaborate with manufacturers in order to streamline production. However, Friske determined these tools were insufficient to properly combat the shortage problem and proposed his own solution. In addition to notification requirements, Friske pushed for affirmatively incentivizing manufacturers to produce certain drugs and streamlining the drug manufacturing approval process.

Since Friske’s proposal, we’ve seen new legislation and regulation that aims to reduce the number of drug shortages. What’s more, the legislation and regulations contain notification requirements, manufacturer incentives, and streamlined approval processes—just like Friske proposed. While it’s obvious the drug shortage problem has not been solved, it is equally clear drug shortages have decreased over the past few years. Hopefully the trend continues so that life-saving drugs remain accessible to everyone, and drug companies will no longer be able to use supply shortages as justification for obscene price hikes.

Compulsory Licensing and Health Law

March 10, 2016
Competition, Food and Drug Law, Healthcare, Intellectual Property

Nolan Hudalla, MJLST Staffer

In her articleA Public Health Imperative: The Need for Meaningful Change in the Trans-Pacific Partnership’s Intellectual Property Chapter, Roma Patel discusses the benefits that TRIPS “flexibilities” provide to the pharmaceutical markets in developing nations. Specific to this discussion, Ms. Patel notes that malaria is a permissible reason for a country to declare a “national emergency” or “circumstance of extreme urgency” under TRIPS. Such a declaration would allow a nation to utilize the TRIPS compulsory licensing provision. This permits “a government to allow the sale and manufacture of patented medicine without the patent holder’s consent.” With the recent development of aviable malaria vaccine, what can we expect the impact of this provision to be? In particular, will countries invoke compulsory licensing on the basis of a malaria “national emergency,” and, if so, what results can we anticipate?

According to history, we can’t expect much. According to Nicol & Owoeye, “[t]o date, there is little to suggest that the Implementation Decision and the Protocol [for the compulsory licensing provisions] can meaningfully contribute to reversing the failure of the industrialized world to supply essential medicines to the countries that need them the most. Nor does there appear to be widespread enthusiasm for using Implementation Decision and Protocol mechanisms to facilitate the provision of low-cost or no-cost pharmaceuticals to those most in need.” This certainly appears to be true for impoverished African nations. For example, the continent has already been devastated by the HIV/AIDS epidemic, yet compulsory licensing has not provided a sufficient solution. In fact, according to a UNAIDS report, “[o]f the 21.2 million people in Africa eligible for antiretroviral therapy in 2013 under the 2013 WHO guidelines, only 7.6 million people were receiving HIV treatment as of December 2012.”

Brian Owens’ article Questions Raised about Whether Compulsory Licenses get Best Pricesdiscusses one of the reasons for the disappointing results of compulsory licensing. He notes that “[t]he use of so-called ‘compulsory licenses’ by developing countries to obtain cheaper drugs for HIV and AIDS by circumventing patents has not been the best strategy for achieving the lowest prices over the past decade . . . .” Expanding on this, Owens states that, “of the 30 cases of compulsory licensing from 2003 to 2012 for which reliable data was available, the median price achieved through international procurement was lower for 19 of them [than compulsory licensing]—in the majority of cases by more than 25% . . . . The effect was strongest in the poorest countries, where in six out of seven cases the procurement price was more than 25% lower than the compulsory license price.” Amir Attaran, the director of the study discussed in Owens’ article, asserts that “countries should not rush into using compulsory licenses until they have exhausted all other options. “Countries can save money using compulsory licenses, but they can save more by negotiating and using international procurement channels . . . If saving money is paramount, then compulsory licenses may not be the optimal strategy.”

Unfortunately, saving money is paramount for many African nations. Thus the greatest “flexibility” given to these nations is not always a practical solution. Perhaps the arrival of the first malaria vaccine will motivate international leaders to learn from prior experience. Hopefully the international community will reconsider compulsory licensing, as Roma Patel did, to determine how it can better provide access to life-saving medications.

3D Food Printing and Its Legal Complications

February 17, 2016
3-D Printing, Agriculture, Food and Drug Law

Riley Conlin, MJLST Staffer

According to a recent article in Bloomberg, the FDA has recently approved the use of a drug that was 3D printed for the first time. The first drug the FDA approved is Spritam, which was created by Aprecia Pharmaceuticals. The drug is to be administered orally to treat adults and children for epilepsy. The 3D printing process supposedly allows the pill to dissolved quickly, which means it will enable the pill to act faster in the case of an oncoming seizure. When this approval occurred several attorneys voiced concern, because of the intellectual property issues related to 3D printing. First, it would be difficult to determine the manufacturer of the drug, making the assignment of IP rights quite challenging. Second, because it would be difficult to determine the manufacturer, it would also be difficult to identify liable parties in potential litigation.

While there are undoubtedly legal issues related to 3D printing, a forthcoming article in the Minnesota Journal of Law Science and Technology Symposium argues that the benefits far outweigh potential legal issues that could slow the adoption of 3D technology in the area of food production. Symposium author, Jasper Tran, notes that there are “endless possibilities” associated with 3D food printing. First, the ability to print food has the potential to significantly impact the global food shortage crisis, because healthy food can be mass-produced via 3D printers. He also argues that 3D printing has the potential to reduce environmental harms associated with current food production. However, he does note that there are legal liability issues with 3D printing, including (1) short-term food poisoning on an individual scale or mass scale and (2) long term impacts of food printing. Despite these concerns, Tran argues the legal risks are far outweighed by the potential global benefits of mass-producing food via 3D printers.

As discussed in the Bloomberg article and in Tran’s note, 3D food and drug printing is the future. It is the responsibility of government organizations to take a proactive approach and attempt to enact rules and regulations that anticipate the new legal issues and challenges associated with the process.

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