Food and Drug

United States v. Caronia After-the-Fact: What Was All That Fuss About, Again?

April 9, 2013
Administrative Law, Food and Drug, Pharmaceuticals

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

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

April 3, 2013
Agriculture, Food and Drug, Healthcare, Pharmaceuticals, Public Health

by Maya Suresh, UMN Law Student, MJLST Staff

Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm’s financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.

Searching for .08: Marijuana Laws and the Problem of Detecting “Drugged Driving”

January 3, 2013
Criminal Law, Food and Drug, Transportation

by Nathanial Weimer, UMN Law Student, MJLST Staff

We’ve all seen the commercial. Some car comes swerving down the road, veering in and out of the proper lane and generally wreaking havoc on the neighborhood. Upon being pulled over, the driver is visibly intoxicated and the police officer quickly notices. The officer breathalyzes the driver, and if alcohol is found takes the driver back to the station for blood testing. If the driver’s blood alcohol level reaches .08, it creates a presumption that the he or she was driving under the influence of alcohol. The law enforcement process is simple and mostly effective, even if the car wasn’t actually filled with the driver’s drink of the night.

The recent passage of laws in Washington and Colorado legalizing the recreational use of marijuana will obviously increase the number of “drugged drivers” on the roads. At first glance, this might not seem like an issue–after all, police have a fairly simple method for measuring whether, and to what extent, someone is intoxicated by alcohol. Seemingly, they could employ a similar system for marijuana (driving under the influence of marijuana is, of course, still illegal). It turns out, however, that detecting the influence of marijuana presents a different set of challenges that law enforcement will have to grapple with.

The legal question for a drug DUI is whether or not one’s driving was impaired by the influence of the drug. One prominent marijuana detection method is the blood test, which measures the amount of tetrahydrocannabinol (THC), the psychoactive component in marijuana, in the blood. If some amount is found, that indicates recent use. There are problems with this test, though. First of all, THC blood levels don’t indicate the time of use because THC remains in the blood for a long period of time, according to DUI Blog. Some say it remains for days, while others claim the period can be weeks or months. Regardless, the point is that THC may be present while the effects of the drug are not; since the legal standard is impairment, a THC finding of a certain level does not necessarily meet that burden.

Effectiveness aside, blood tests also fall short from the perspective of administrative ease and individual rights. As might be expected, conducting and interpreting blood tests is time consuming and costly. As also might be expected, it’s a frustration to the driver to have to submit to a blood test taken at a police station, especially if it comes back negative. While traffic safety is clearly an important concern, well worth a few false alarms, it’s clear that a “drugged driving” detection system suffers from the lack of a breathalyzer-like device that can quickly indicate marijuana use and support blood testing of a driver.

Users, too, have a need for a short-term test that can be easily administered and understood. Drinkers of alcohol should have a general idea of their intoxication, at least up to the point where they know they should no longer drive. Most drinks have a known amount of alcohol in them, the alcohol is roughly the same strength, and there is only one way to ingest them. Marijuana on the other hand varies in strength depending on type, has multiple methods of ingestion which also vary the strength of the drug’s effect, and it’s more difficult to keep track of the amount consumed. Legal users who have ingested hours earlier and feel no effects may wonder whether their THC level is acceptable.

Technological development has provided a few solutions to the problem of short term detection. One “new” test (it is currently used in Australia and other places) is the saliva test. According to a blog on The Verge, this test is done by swabbing the driver’s mouth, can be completed within 3-5 minutes, and can measure the presence of marijuana for a few hours after ingestion. This would solve the invasiveness issue and the short-term issue. However, the amount consumed cannot be measured, and there are also accuracy based concerns–the test tends toward reporting false negatives. Still, the saliva test seems to be a promising tool for law enforcement in the future.

Another potential solution is being developed by Intelligent Fingerprinting, which is working on a fingerprint drug screening method. The device would use “high sensitivity detection reagents to identify metabolite substances in the sweat contained in fingerprints”, and would compute results in a matter of minutes. While this test would similarly fail to pinpoint the time of ingestion, or the level of impairment, it could be a very useful roadside tool. This device is still in development, however, and could still be a few years away.

With the new marijuana laws in Colorado and Washington, the pressure is on law enforcement to effectively detect drivers under the drug’s influence. While the ultimate step may be to conclusively link detection to impairment, the current step that must be taken is the development of a non-intrusive, short term device that can accurately measure a driver’s chemical levels. Possibly the saliva test will satisfy this need; possibly inventors have yet to create a viable device. In the meantime, it’s important to be careful while driving–especially if you see a car swerving like it’s in a commercial, and it’s entirely filled with smoke.

Pharmacists Refusing to Dispense OTC Birth Control

November 19, 2012
Food and Drug, Healthcare, Pharmaceuticals, Reproductive Health

by Katelyn DeRuyter, UMN Law Student, MJLST Staff

Can your access to a legal method of birth control be blocked by your pharmacist? It seems likely. Although emergency contraception (EC) is legal in America and a recent poll found that 77% of Americans object to pharmacies refusing to fill birth control prescriptions, a woman that goes to pick up EC may face a denial of the drug by her pharmacist. According to the Appellate Court of Illinois Fourth District, in recent case Morr-Fitz, Inc. v. Quinn, the state’s “Conscience Act” (protecting health care personnel from liability when they refuse to act due to their conscience) protects pharmacists who refuse to dispense EC. Illinois is not alone in providing pharmacists the ability to deny EC. Six states have laws that explicitly permit pharmacists to refuse to administer EC. Five more states (including IL) have “conscience clause” laws that are worded broadly enough that pharmacists may be included.

Under the Patient Protection and Affordable Care Act, as of August 1, 2012 medical insurance plans must completely cover the costs for birth control–including emergency contraception–STD screenings and many other preventive health measures for women. Depending on which articles you read, this expansion in required insurance coverage either marks a hallmark step in women’s rights or an egregious affront to one of this country’s ideological pillars–the freedom of religion. Regardless of your stance on the new legislation, the fact remains that increased financial access to such services is meaningless if physical access is blocked. This is especially true in regard to emergency contraception which must be taken as soon as possible after intercourse in order to be effective. Thus when a pharmacist refuses to provide access to EC, they are putting their objections to EC above a woman’s right to exercise control over her body.

In Pharmacists and the “Morning-After Pill”: Creating Room for Conscience Behind the Counter, published in Volume 7 issue 1 of the Minnesota Journal of Law, Science & Technology, Tony J. Kriesel faces this question of whether a pharmacy or individual pharmacist can constitutionally refuse to administer EC. Kriesel starts with the proposition that EC can be viewed as an abortive drug. It is this possibility of EC acting as an abortive that motivates pharmacists’ denials. Whether or not EC is considered an abortive drug depends on at what point in reproduction one considers pregnancy to have begun. If pregnancy begins when the egg is fertilized, then EC can act as an abortive if taken during ovulation. If taken during ovulation, EC prevents the egg from implanting in the lining of the uterus, thus causing the fertilized egg to be aborted. However if pregnancy begins when a fertilized egg successfully implants in the lining of the uterus, then EC is not abortive but acts like all other forms of birth control and simply keeps a potentially viable pregnancy from beginning.

After acknowledging there is controversy in the medical community over whether fertilization or implantation begins pregnancy, Kriesel asserts that EC is in fact an abortive and that pharmacists can constitutionally refuse to administer the drug. Kriesel’s legal analysis of this issue focuses on the protections provided to the pharmacist by the free exercise clause of the First Amendment and the fact that a woman’s right to EC (regardless of its classification as an abortive) does not entail a right to have access to EC wherever is most convenient.

The U.S. Supreme Court has not addressed this question of whether a pharmacy or individual pharmacist can constitutionally refuse to administer emergency contraception (EC). What are your thoughts on the issue? Can (and should) states pass laws that allow pharmacists to deny access to a legal form of birth control? Does the right to freedom of religious expression trump a woman’s right to exercise control over her body?

Juggling GMOs: Balancing Benefits, Risks, & Unknowns

October 26, 2012
Agriculture, Environment, Food and Drug, 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.

TV Advertising Not the Only Problem in Fight Against Childhood Obesity

October 26, 2012
Agriculture, Food and Drug, 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
Agriculture, Food and Drug, 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.

Food Label Regulations Fall Short

October 2, 2012
Agriculture, Food and Drug

by Bobbi Leal, UMN Law Student, MJLST Articles Editor

A recent study, published in Agricultural Economics, found that the average body mass index for consumers that read nutrition labels is lower than those that do not read the labels. This finding implies that understanding and utilizing food and nutrition labels provides consumers with the information needed to make informed decisions about what they eat. However, a recent article by J.C. Horvath published in the Minnesota Journal of Law, Science & Technology, “How Can Better Food Labels Contribute to True Choice?” makes evident that food labeling has a long way to go before it truly gives consumers the information necessary to make informed decisions.

Food label regulations, outlined by the Food and Drug Administration, have a number of flaws. The FDA has declined to define strict standards for use of the food label “all-natural,” claiming that the term is too nebulous to be strictly defined and standardized across the entire food industry. Undoubtedly, consumers assume that a food labeled as “all-natural” has not been chemically processed or structurally altered from its natural state. Unfortunately, this is not the case. The FDA has a vague policy which defines the term “natural,” to mean “nothing artificial or synthetic…is included in, or has been added to, the product that would not normally be expected to be there.” According to the Wall Street Journal, some ingredients that have been labeled as “all-natural” include high fructose corn syrup, genetically modified plants, and sodium benzoate.

Similarly, the approved use of certain terms, such as “artificial flavor,” “natural flavor,” and “artificial coloring” often hide significant details about the nature of the food. These three phrases can stand in for over 3900 food additives that come from a wide range of sources, giving the consumer no real notice of the substance or origin of the “flavor” or “coloring.” For example, beef tallow, gelatin, and lard can all be covered by these three phrases. Even the requirements for listing allergens is incomplete, as the FDA only requires that eight of the known allergic-reaction-inducing ingredients be explicitly listed: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

This recent study concerning the use of nutrition labels makes clear that when consumers read and understand food labels, they can make better choices for their health. In order for this to occur, however, it is imperative that the food labels which consumers rely upon are transparent and accurate. Food label regulations have not yet accomplished this objective.

Got GMOs?

September 17, 2012
Agriculture, Bioethics, Environment, Food and Drug

by Ude Lu, UMN Law Student, MJLST Staff.

GMOs, genetically modified organisms, have long been a part of our daily diet. For example, most of the soybeans and corn on the supermarket shelves are GMOs. Currently, the issue of whether these GMOs should be labeled so that customers can make informed purchases is in a heated debate in California. California Proposition 37, which would require labeling of GMOs, will soon be voted in November this year. Proponents from both sides have poured millions of dollars into the campaign.

GMOs are plants that have been genetically engineered to be enhanced with characteristics that do not occur naturally, so that the harvest can be increased and the cost can be lowered. One example of a prominent GMO is soybean. Monsanto–a Missouri based chemical and agriculture company–introduced its genetically modified soybean, Roundup Ready, in 1996. Roundup Ready is infused with genes that resist weed-killers. In 2010, 93% of soybeans planted in the United States were Roundup Ready soybeans.

Although GMOs are one of the most promising solutions to address the sustainability of food supply in view of the growing global population, there are concerns in the public regarding their safety, and confusion as to which federal agency has responsibility for regulating them.

Amanda Welters in her article “Striking a balance: revising USDA regulations to promote competition without stifling innovation” published in the Minnesota Journal of Law, Science, and Technology explains the current regulatory scheme of GMOs. Three primary agencies regulate GMOs: the Food & Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). The FDA regulates GMOs in interstate commerce that are intended to be consumed by animals or humans as foods, the EPA monitors how growing of GMOs impacts the environment, and the USDA assesses the safety of growing GMO plants themselves.

Specifically, the Animal and Plant Health Inspection Service (APHIS) in the USDA is responsible for ensuring crops are free of pests and diseases. APHIS is currently in the process of revising its regulations for GMOs in an attempt to improve transparency, eliminate unnecessary regulations and enhance clarity of regulations. Under the proposed regulations there will be three types of permits for GMOs: interstate movement, importation, and environmental release.

Taking the position that GMOs are generally beneficial and unavoidable, Welters suggests that the USDA should frame a regulatory structure similar to the Hatch-Waxman Act and the Biosimilar Act to promote both innovation and competition. Readers interested in the regulatory issues of GMOs and the balance between the interests of patent innovators and generic follow-ons would find Welters’ article informative and insightful.

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