FDA

Major Medical Institutions Allegedly Failing to Report Clinical Trials

December 16, 2015
Drug Policy, FDA

Jessica Jayasuriya, MJLST Managing Editor

The Food and Drug Administration Amendments Act of 2007 requires that parties responsible for clinical trials submit clinical trial inform to the Director of NIH no later than one year after either the end date or the estimated end date of the trial.

However, several sources are alleging that Stanford University, Memorial Sloan Kettering Cancer Center, the University of Pennsylvania, the University of Pittsburgh, the University of California San Diego, and other major medical research institutions are failing to submit their clinical trial results within the deadline, and sometimes even at all.

The public database created by the legislation was intended to help the public, particularly medical professionals, scientists, and other researchers, to quickly access the latest findings on human testing of drugs, medical devices, and the like.

Institutions’ failure to turn in their results, however, is directly counteracting this legislative purpose. This is particularly concerning because doctors may not be getting critical information including adverse events in drug trials.

Interviews with the offending institutions indicate that the primary reason for these deadline lapses on the institutions’ end is due to being too busy and a lack of funding. Memorial Sloan Kettering, however, specifically stating it submitted some of its reporting in order to finish medical journal articles related to its trials. On top of institution failures to submit, is clear that the NIH is compounding the issue by failing to follow up on clinical trial deadlines.

Experts interviewed by the sources have further expressed concern that pressure from sponsoring drug companies may also be part of the reason why these clinical trials are not coming to light.

Just Not Mayo

December 2, 2015
Competition, FDA, Food and Agriculture

Nolan Hudalla, MJSLT Staffer

In August 2015, the U.S. Food and Drug Administration (FDA) issued a warning letter to Hampton Creek Foods, the makers of the popular vegan mayonnaise substitute “Just Mayo.” This letter informed the company that its product had a misleading name and label imagery, because, by FDA regulation, mayonnaise must contain one or more eggs. This opinion by the FDA was in response to a high-profile lawsuit brought against Hampton Creek by Unilever (the makers of Hellmann’s Mayonnaise) and a similar class action filed in Florida state court, both alleging violation of the Florida Deceptive and Unfair Trade Practices Act and unjust enrichment. But, in an era of healthier alternatives – a world of Whole Foods, Thanksgiving Tofurky, and even eggless mayo – is the FDA missing the point? Instead of relying on food recipes enshrined in agency regulations from the 1970’s to identify whether an eggless substitute is mayonnaise or not, maybe the FDA needs to modernize its definitions instead.

In an effort to demonstrate just how committed the government is to keeping Just Mayo from poaching the traditional mayo market, consider the American Egg Board’s (AEB) response to Just Mayo. The AEB, a group appointed by the US Department of Agriculture, may have used public funds to conspire against Just Mayo. According to a Guardian article, “the government-backed egg lobby had organized a concerted effort to tackle Hampton Creek, a company described in leaked emails as a ‘major threat’ and ‘crisis’ for the $5.5bn-a-year egg industry.” This investigation led to the resignation of the AEB’s CEO Joanne Ivy. In addition, the FDA sent Just Mayo its warning letter despite an enormous show of popular support against the agency’s policy. Over 112,000 petitioners scrambled to sign a petition started by Food Network star Andrew Zimmern entitled “Stop Bullying Sustainable Food Companies,” to Unilever Chairman Michael Treschow. This public uprising boiled to the point that Unilever voluntarily dropped its initial lawsuit within two days of filing.

Even if the Florida state court suit amounts to nothing, this issue will not be over easy for the FDA. As demonstrated by the petition, consumer preferences are changing, and not just for mayonnaise. Similar battles are being fought over peanut butter, milk, yogurt, and ice cream. Retail sales of vegan products rose by over 6% last year, and 36% of U.S. consumers use milk or meat alternatives. This raises the question of whether it is really worth all of the government’s money and effort to maintain 1970’s ideas of food. Instead of deviling these modern alternatives, maybe the FDA should buy in too. After all, it’s just mayo.

Let’s Talk: The Cold & Flu Season & Personalized Medicine

November 13, 2015
Drug Policy, FDA, Pharmaceuticals, Public Health

Allison Kvien, MJLST Managing Editor

As we approach cold and flu season, it is time we all start thinking about properly taking care of ourselves. Many individual factors have been linked to your heath. A Newsweek article reported that people who get less than 5 hours of sleep a night are 4.5 times as likely to become ill. According to The L.A. Times, an elevated heart rate could mean that a cold is on the way. Finally, an article from Harvard found a link between your popularity and how early in the season you become ill (yes, really—and I guess this explains why I haven’t gotten the flu since I was a kid). While this is all helpful information, it represents only a few factors that contribute to a person’s overall health. Over the years, the practice of medicine has become more accepting of the concept that “one size does not fit all” and that patients may need more personalized medicine.

One interesting development in personalized medicine was ten years ago, in 2005, when FDA approved the first race-specific drug, BiDil. As Dorothy E. Roberts explained in her MJLST article, BiDil, is “a combination drug that relaxes the blood vessels, [and] was authorized to treat heart failure in self-identified black patients.” Many scholars and citizens alike have found the approval of BiDil controversial, for a variety of reasons, legal, political, ethical, and otherwise. It may be, however, simply one more step on the path to personalization of medicine for patients. As Roberts reported, “BiDil increased survival by an astonishing 43 percent. Hospitalizations were reduced by 39 percent.” Roberts’s opinion, however, was that BiDil should have been approved for all heart failure patients, regardless of race because there was no underlying genetic difference in African Americans that the drug relied on for its positive results. The economic results of the BiDil drug may prevent others from going developing race-specific drugs for a while, though; BiDil has been described as a “flop.”

Cold season medicine is normally pretty generic. Think: Airborne, Sudafed, Advil, and cough drops, my favorite of which are the less-than-pleasant tasting Fisherman’s Friends that completely numb your throat—seriously, try them. I think the concept of personalized cold and flu medicine is particularly interesting because our current cold season medicine is normally over-the-counter and generalized. Can you imagine a future where you pick up a cold medicine tailored specifically to your genetic background? Well, it may already be happening. Just two years ago, FDA approved personalized flu vaccines for three groups: the elderly, children, and those with allergies. These personalized vaccines may allow some groups of our population to receive them when they wouldn’t otherwise be able to, or to at least receive them more safely. Specifically for flu vaccines, anyway, this step in personalization may not also reflect increased overall effectiveness in preventing illness. But let’s not give you an excuse to not get your flu vaccine. Go get that flu shot that was made just for you!

Let’s Talk: The Cold & Flu Season & Personalized Medicine

November 13, 2015
Drug Policy, FDA, Pharmaceuticals, Public Health

Allison Kvien, MJLST Managing Editor

As we approach cold and flu season, it is time we all start thinking about properly taking care of ourselves. Many individual factors have been linked to your heath. A Newsweek article reported that people who get less than 5 hours of sleep a night are 4.5 times as likely to become ill. According to The L.A. Times, an elevated heart rate could mean that a cold is on the way. Finally, an article from Harvard found a link between your popularity and how early in the season you become ill (yes, really—and I guess this explains why I haven’t gotten the flu since I was a kid). While this is all helpful information, it represents only a few factors that contribute to a person’s overall health. Over the years, the practice of medicine has become more accepting of the concept that “one size does not fit all” and that patients may need more personalized medicine.

One interesting development in personalized medicine was ten years ago, in 2005, when FDA approved the first race-specific drug, BiDil. As Dorothy E. Roberts explained in her MJLST article, BiDil, is “a combination drug that relaxes the blood vessels, [and] was authorized to treat heart failure in self-identified black patients.” Many scholars and citizens alike have found the approval of BiDil controversial, for a variety of reasons, legal, political, ethical, and otherwise. It may be, however, simply one more step on the path to personalization of medicine for patients. As Roberts reported, “BiDil increased survival by an astonishing 43 percent. Hospitalizations were reduced by 39 percent.” Roberts’s opinion, however, was that BiDil should have been approved for all heart failure patients, regardless of race because there was no underlying genetic difference in African Americans that the drug relied on for its positive results. The economic results of the BiDil drug may prevent others from going developing race-specific drugs for a while, though; BiDil has been described as a “flop.”

Cold season medicine is normally pretty generic. Think: Airborne, Sudafed, Advil, and cough drops, my favorite of which are the less-than-pleasant tasting Fisherman’s Friends that completely numb your throat—seriously, try them. I think the concept of personalized cold and flu medicine is particularly interesting because our current cold season medicine is normally over-the-counter and generalized. Can you imagine a future where you pick up a cold medicine tailored specifically to your genetic background? Well, it may already be happening. Just two years ago, FDA approved personalized flu vaccines for three groups: the elderly, children, and those with allergies. These personalized vaccines may allow some groups of our population to receive them when they wouldn’t otherwise be able to, or to at least receive them more safely. Specifically for flu vaccines, anyway, this step in personalization may not also reflect increased overall effectiveness in preventing illness. But let’s not give you an excuse to not get your flu vaccine. Go get that flu shot that was made just for you!

USDA Heightened Country of Origin Labelling Laws: Good Start, Can be Tightened

April 25, 2015
FDA, Food and Agriculture

Vinita Banthia, MJLST Staff Member

The Country of Origin Labeling (COOL) laws have long been debated and amended in the Unites States. COOL regulation dictates the degree to which a product’s label must indicate which countries were involved in the production of the product. Currently, a product’s countries of origin must be labelled for the all of its ingredients, with the exception of where the product has been processed. These standards apply to food such as meat that had been born and raised in the United States but contains elements that have been produced in other countries like China. Hence, all raw foods and its ingredients must be labelled, including “raw muscle cuts, ground commingled meat, or live imported animals are not excluded.”

However, if meat has been born and raised in the United States, and then shipped to China for processing, then shipped back to the United States for consumption, it does not need to be labelled as being processed in China. Except for locations of processing, meat must be labelled for the countries where the animal lived during its life, and where it was subsequently “raised, slaughtered, butchered, and prepared for sale.” These laws have become increasingly strict since changes in the U.S. Department of Agriculture (USDA) consumer information policies in 2009 and 2013.

The recent Note, Country of Origin Labeling Revisited: Processed Chicken from China and the USDA Processed Foods Exception published in the Minnesota Journal of Law, Science, and Technology, by Daniel Schueppert highlights the stringent COOL requirements for raw and live foods. The Note discusses the recent change in the USDA funding and regulation policies that allowed the United States to export chicken to China for processing, and then import it back in to the US for commercialization without labelling the meat’s journey. The agricultural industry and grocery stores have been largely opposed to the laws as requiring excessive labelling for non-processed meats. Canada and Mexico have challenged the U.S. COOL laws at the WTO, stating that the COOL requirements for non-processed meat are overly burdensome on Canadian and Mexican beef exporters, thereby creating an unfair advantage for U.S. domestic beef. In October 2014, the WTO ruled in favor of Canada and Mexico. Canada has threatened retaliatory actions if the U.S. does not relax its COOL laws.

In contrast, Schueppert argues that some, limited COOL standards should also be applied to meat processed in China. This position supports greater restrictions not only for non-processed and raw foods, but also for processed meats. In addition, Schueppert argues that the current definition of processed foods is too broad and over-inclusive, leading to potential safety concerns in non-processed products. This argument holds more ground that the views of industries and countries unwilling to invest greater resources in ensuring the safety and disclosure of products. The USDA should continue to take measures to ensure that meat products are increasingly safe and well-labelled for consumers.

The FDA’s Role in Innovative Change

April 11, 2015
Administrative Law, FDA

Paul Overbee, Articles Editor

In Volume Six, Issue Two of the Minnesota Journal of Law, Science and Technology, Susan B. Foote and Robert Berlin penned a piece titled “Can Regulation be as Innovative as Science and Technology? The FDA’s Regulation of Combination Products.” Published in 2005, this piece set out to explore whether an agency as slow as the FDA could keep pace with ongoing technological innovations and respond in an appropriate and timely manner. Ultimately the authors concluded that the FDA is an agency that progresses in an iterative and incremental manner, and that both politics and administrative law were likely to prevent the FDA from being a force for innovation. The authors tried to justify the potential block to innovation by arguing that innovators and manufacturers benefit from the predictability and certainty and that a slow regulatory is the essential cost of these benefits. As such, the authors offered that regulation would come after innovations occurred rather than predicting upcoming innovation and issuing preliminary regulation.

Since the time of the author’s predictions, they have been proven correct in many ways. For instance, nanotechnology is an emerging technology with many predicting how it will be implemented in the future, and it has already has appeared in products such as sunscreens and spray paints. Despite its current presence in society, the FDA has failed to issue a formal definition of what nanotechnology is and what it is not. As such the predictability and certainty that is desired by innovators is lacking. One of the most recent developments that continue to show that the FDA is ill-equipped to deal with fast paced innovation is their recent draft guidance on combination products. A full 10 years after Foote and Berlin criticized the FDA’s ability to act swiftly, the FDA has finally issued a draft guidance to clarify and explain the current good manufacturing practices for combination products. This guidance has been made available by the FDA

The FDA defines a combination product as any combination of a drug, device, or biological products, taken individually as constituent parts of the combination product. Additionally, a combination may be two or more separate products that have been packaged together in a single package such as pre-filled syringes. The new FDA guidance gives multiple options for combination products to meet current good manufacturing practices. First, the producer may demonstrate compliance under the current drug manufacturing practices or by meeting qualify system regulations; this option is available where the combination is both a drug and device. The other option is that the manufacturer may demonstrate compliance will all good manufacturing practices that are applicable to each constituent part that makes up the whole combination product.

Both Berlin and Foote justified the slow moving nature of the FDA by stating that it may provide the type of predictability and certainty that is desired by innovators. Since that date, actions by the FDA have put that predictability and certainty in question. Instead of having a clear practice in place, the FDA may leave manufacturers guessing for years before the agency comments on their appropriateness. Berlin and Foote both agreed that perhaps the FDA wasn’t properly tooled to deal with ongoing innovation, but ongoing developments continue to drive that point home.

A Story to Warm Your Iron-Rich Hemoglobin

April 4, 2015
FDA, Pharmaceuticals

Becky Huting, MJLST Articles Editor

While recently home in Chicago on spring break, I offered to make my dad a spinach-packed smoothie. My dad (a good sport) agreed, but asked me to make it light on the spinach as he understood men at his age (60) should be taking it easy on the iron intake. I had heard this principle before, and knew that men’s and women’s vitamin supplements were different in part due to the additional iron needs of women. My dad was right about one thing: he needs a lot less iron than me. His recommended dietary allowance for iron is 8 mg/day whereas mine is a lofty 18 mg/day. In actuality, men rarely suffer from iron deficiency so supplements are usually unnecessary, and in fact too much iron can indeed be harmful. There are possible links with excessive iron consumption to diabetes as well as neurodegenerative disease.

But where his concerns are unfounded are in the nutritional numbers. One cup of uncooked spinach contains only .8 mg of iron. That is only one-tenth of his daily iron needs. Three ounces of ground beef containing 15% fat contains 2.2 mg of iron. What about his daily serving of canned, drained clams, you ask? Fine, you have me there: if my father actually consumed such item, he’d have gone over at 23.8 mg of iron. It is very hard though for a human to overdose on iron from food, because an adult body has systems in place to regulate the amount of iron it absorbs. In short, my dad need not be concerned about spinach in his smoothie, except for reasons of palatability.

So given the different nutritional needs of men, women, and also children, what entity is telling consumers whether a vitamin is for them by way of labels? The Food and Drug Administration (FDA) relinquished that duty back in October of 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. This law created a new regulatory framework for the safety and labeling of dietary supplement that places the responsibility on the product manufacturers rather than the FDA. The DSHEA was a response to lobbying by health food companies to vote down several bills that would have had the effect of increasing the FDA’s powers over supplement labeling. Celebrities even got involved. In one commercial, Mel Gibson portrayed a citizen being raided and arrested by FDA agents for possessing a bottle of Vitamin C.

This mentality that too much government oversight is a bad thing is a popular ideal. After all, it’s only a vitamin. Perhaps a label signifying use by pregnant and nursing moms is enough, but consider the 60-year-old guy grabbing this supplement in haste. He is now getting 27 mg iron per day from the vitamin alone, perfect for a pregnant woman, but over 3X his nutritional needs. Are a few words on a label enough to signify safety to a consumer? Certainly there is an argument that too much information will lead to a cluttered, confused label. So where do you come down, bring the FDA back in or leave it to the companies? And do you feel like a green smoothie? I promise you the banana masks the spinach flavor.

An Eyedropper’s Worth of Juice

April 29, 2014
FDA, Food and Agriculture

Nihal Parkar, MJLST Notes and Comments Editor

Coca Cola’s Minute Maid Pomegrenate Blueberry Juice Blend contains about an eye-droppper’s worth of pomegranate and blueberry juices, with apple and grape juices constituting 99.4% of the blend. POM Wonderful, a competitor that mainly markets pomegranate juice, filed a false advertising suit against Coca Cola under the Lanham Act. The Ninth Circuit held that federal food regulations preclude private actions challenging food product labels.

Specifically, the federal Food, Drug, and Cosmetic Act grants the FDA authority over food labeling. However, it is not quite clear if the FDA has exclusive authority over potentially deceptive food labeling. Coca Cola has argued that exclusive authority was granted to the FDA so that food manufacturers could rely on a uniform set of standards for food naming and labeling. POM has countered by saying that the FDCA and FDA regulations only provide a minimum floor for food regulations, while other laws intended to protect consumers and competition are still applicable to food manufacturers.

The Supreme Court granted cert and recently heard oral arguments. Coca Cola has continued to argue that its labeling meets all federal regulations. However, various Justices expressed skepticism, and asked why meeting federal labeling regulations, while necessary, would be sufficient to grant Coca Cola immunity even if the labeling did mislead consumers. The following exchange from the oral arguments is indicative of the tenor of the hearings:

Kathleen M. Sullivan (for Coca Cola): Because we don’t think that consumers are quite as unintelligent as POM must think they are. They know when something is a favored blend of five juices, non-min — the non-predominant juices are just a flavor.
Justice Anthony Kennedy: Don’t make me feel bad, because I thought that this was pomegranate juice.

It remains to be seen though, if the Supreme Court ultimately agrees with POM. A decision is expected later this year.

E-Cigarette Trend Will Likely Subside After Federal and State Regulation Weighs In

March 16, 2014
FDA

George David Kidd, MJLST Managing Editor

Who could have predicted that development of better portable-battery technology would unleash such a radical transformation of tobacco consumption? By vaporizing nicotine-infused water vapor via the e-cigarette, the new trend, called “vaping,” has certainly turned a few heads. Not only has the use of electronic cigarettes doubled among middle and high school students from 2011-2012, but Bloomberg Industries predicts that the sale of electronic cigarettes might surpass the sale of other tobacco products by 2023. As of 2014, e-cigarette sales are still growing rapidly. Bold predictions in e-cigarette sales growth, however, fail to take into account the role that tobacco regulation will play in discouraging the trend. Federal and state regulations have yet to definitively weigh in on the issue.

Despite its announced plans to regulate e-cigarettes as tobacco products in 2011, the FDA has not yet taken action. Future FDA regulation will almost certainly be modeled upon current tobacco regulation to the extent that e-cigarettes are comparable to combustible tobacco products. For example, nicotine is still addictive. It can still be dangerous for those with heart problems and might cause other cardiovascular ailments over time. Those who stop the consumption of nicotine may face withdrawal symptoms that could include irritability, depression, restlessness, and anxiety. However, e-cigarette vapor avoids consumption of carcinogenic chemicals in smoke that are released by the combustion process.

To the extent current federal tobacco regulations are concerned with the direct consumer consequences of smoking, such as the disclosure of ingredients, labeling requirements, and ingredient quality, FDA regulation of e-cigarettes will closely mirror that of traditional tobacco products. Consequently, quality-control procedures and required labeling will only serve to increase the cost of e-cigarettes to consumers, and discourage sales.

State laws, such as those discussed in Smokers: Nuisances in Belmont City, California–In Their Homes, But Not on Public Sidewalks, by Georges Tippens, are primarily concerned with the effects of secondhand smoke. As of 2014, most states have banned smoking in enclosed public places due to concerns over the dangers of secondhand smoke. However, there is no definitive study as to whether e-cigarette vapor has any secondhand effect. Some states are, nevertheless, proactively seeking to extend current regulations, which ban smoking in enclosed public areas, to e-cigarettes. Other states, however, seem to be waiting until more information becomes known about whether e-cigarette smoke is harmful.

Even if e-cigarette vapor is found to be harmful, the question of whether e-cigarette vapor is “as dangerous” as the smoke produced by traditional combustible tobacco products will take decades of research to answer. In this day and age, if scientific evidence provides that secondhand smoke does have a secondhand effect on others, it is improbable that the question of how similar e-cigarettes are to traditional combustible products will have any impact on the extent of state regulation. In this case, e-cigarette regulation will feasibly mirror current state regulations that ban the use of combustible tobacco products in enclosed public places, and will provide a disincentive to e-cigarette sales.

Uh-Oh Oreo? The Food and Drug Administration Takes Aim at Trans Fats

December 4, 2013
Administrative Law, FDA, Food and Agriculture

by Paul Overbee, UMN Law Student, MJLST Staff

In the near future, food currently part of your everyday diet may undergo some fundamental changes. From cakes and cookies to french-fries and bread, a recent action by the Food and Drug Administration puts these types of products in the spotlight. On November 8th, 2013 the FDA filed a notice requesting comments and scientific data on partially hydrogenated oils. The notice states that partially hydrogenated oils, most commonly found in trans fats, are no longer considered to be generally recognized as safe by the Food and Drug Administration.

Some partially hydrogenated oils are created during a stage of food processing in order to make vegetable oil more solid. The effects of this process contribute to a more pleasing texture, greater shelf life, and stronger flavor stability. Additionally, some trans fat is naturally occurring in some animal-based foods, including some milks and meats. The FDA’s proposal is meant to only to restrict the use of artificial partially hydrogenated oils. According to the findings of the FDA, exposure to partially hydrogenated oils raises bad cholesterol levels. This raised cholesterol level has been attributed to a higher risk of coronary heart disease.

Some companies have positioned their products so that they should not have to react to these new changes. The FDA incentivized companies in 2006 by putting rules in place to promote trans fat awareness. The new regulations allowed companies to label their products as trans fat free if they lowered the level of hydrogenated oils to near zero. Kraft Foods decided to change the recipe of its then 94-year-old product, the Oreo. It took 2 ½ years for Kraft Foods to reformulate the Oreo, and once that period was over, the trans fat free Oreo was introduced to the market. The Washington Post invited two pastry chefs to taste test the new trans fat free Oreo against the original product. Their conclusion was that the two products were virtually the same. This fact should act as a form of reassurance for consumers that are worried that their favorite snacks will be pulled off the shelves.

Returning to the FDA’s guidance, there are a few items worth highlighting. At this stage, the FDA is still in the process of formulating its opinion on how to regulate these partially hydrogenated oils. Actual implementation may take years. Once the rule comes into effect, products seeking to continue to use partially hydrogenated oils will still be able to seek approval on a case by case basis from the FDA. The FDA is seeking advice on the following issues: the correctness of its determination that partially hydrogenated oils are no longer considered safe, ways to approach a limited use of partially hydrogenated oils, and any other sanctions that have existed for the use of partially hydrogenated oils.

People interested in participating with the FDA in determining the next steps taken against partially hydrogenated oils can submit comments to http://www.regulations.gov.

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