Administrative Law

Biosimilar Licensing

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

Jeff Simon, MJLST Staffer

On February 18^th, 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 16^th. 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 Path of Pollutants Under the Clean Water Act

March 19, 2016
Administrative Law, Environmental Law

Ted Harrington, MJLST Staffer

In 1972, the Clean Water Act set forth a lofty goal—to “[r]estore and maintain the chemical, physical, and biological integrity of the nation’s waters.” (33 U.S.C. §1251(a)). Yet, the Clean Water Act only regulates point sources that discharge pollutants into navigable waters (33 U.S.C. §1251(a)(1)). As a result, many forms of water pollution escape federal jurisdiction, most notably, groundwater. This is because CWA regulation depends on how a pollutant reaches navigable water, instead of focusing on the end result. This added constraint is hardly logical when juxtaposed against the stated goal.

For example, if a pollutant is discharged into groundwater, and eventually reaches navigable Water Body B, the CWA does not have the ability to regulate the groundwater. In other terms, if the polluted effluent passes through groundwater, considered a “nonpoint source,” before it reaches Water Body B, no CWA regulation occurs.

To combat this issue, Federal District Courts in Hawai’i, North Carolina, and Pennsylvania have begun adopting the “Conduit Theory” (See Allison Kvien note Volume 16). The conduit theory states that if a body of water (groundwater) simply acts as a conduit, it should be viewed as an extension of the point source from which it is receiving the pollutant. This theory directs its attention to the ultimate result—the pollution of Water Body B. It is only logical that if Water Body B is being polluted, the source should fall under CWA jurisdiction. Why should we leave a source of pollution unregulated simply because the effluent isn’t being directly discharged into a navigable water? As the Court in Rapanos v. United States noted, “The [Clean Water] Act does not forbid the ‘addition of any pollutant directly to navigable waters from any point source,’ but rather the ‘addition of any pollutant to navigable waters.’”

The issue of groundwater as a pollutant is receiving increasing attention in the courts. In the Northern District of Iowa, a case concerning the discharge of groundwater through tile drains is currently in litigation‑ Board of Water Works v. Sac County Board of Supervisors. This could be an opportunity for Iowa to take one of the first stances on the conduit theory in the 8th Circuit. Stay tuned!

The Threat of Antibiotic Resistance: The Use of Antibiotics in Animal Agriculture and Proposed Regulations to Increase the Involvement of the Food and Drug Agency

February 17, 2016
Administrative Law, Agriculture, Food and Drug Law

Jody Ferris, MJLST Staffer

Antibiotic resistance purportedly caused by the immoderate use of antibiotics in animals raised for human consumption is currently a hot button issue in the news today. It is an issue important to human health and to the food and agriculture industries. In her note, Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals, Jennifer Nomura discusses this issue and makes recommendations regarding which government agency should regulate antibiotic use in animals and how it should best be regulated.

According to Nomura, antibiotics that had been used to treat animal diseases are also being utilized for growth purposes. She says that, “it is now common in the United States for farm animals to be fed low doses of antibiotics on a daily basis.” The species in which antibiotic use is most common are pigs and poultry. She states that “[b]ecause farmers have been feeding antibiotics to animals for so many years, animals are becoming resistant to the effects of these drugs.” She also states that it is also possible for the antibiotic resistant bacteria in animals to pass to humans and that, “as humans become resistant to antibiotics, health care for treatable diseases becomes more costly. Antibiotic resistance can lead to hospitalization, longer-term care, and potentially even death.” However, despite the grave risk that antibiotic resistance poses, Nomura states that “no direct connection has been established” between antibiotic use in animals and antibiotic resistance in humans. Some studies have showed a causal link between the two.

Over the course of her note, Nomura argues convincingly that the primary authority for the regulation of antibiotic use is the Food and Drug Agency in connection with the United States Department of Agriculture and the Center for Disease Control, along with the World Health Organization and the European Union. She proposes that the Food and Drug agency should enact a full scale ban on the animal use of any antibiotic that is also used in the human population. Her note also suggests that the Food and Drug Agency should then establish a monitoring program to keep an eye out for any threats posed to human health through the continued use of antibiotics that would not be covered by the ban.

One regulation that has since been promulgated by the Food and Drug Agency since Nomura authored her note, is the Veterinary Feed Directive rule. This rule will require agricultural producers to get prescriptions for the animal use of antibiotics “considered important to human health, such as penicillin or sulfa” (see Nikki Work’s article Veterinary Feed Directive Will Impact Whole Livestock Industry, But Many Aren’t Aware of the Regulation at http://www.greeleytribune.com/news/20358154-113/veterinary-feed-directive-will-impact-whole-livestock-industry#). The rule will be fully implemented on Jan. 1, 2017.

While the above regulation does not go so far as Nomura’s proposal to ban all antibiotic use in animals when the medications may also used for human health purposes, it is a step in the direction of increased oversight of antibiotic use by the Food and Drug Agency. It will certainly be interesting to follow future regulations in this area as they appear on the horizon, and how the Veterinary Feed Directive impacts antibiotic use and food production.

Major Medical Institutions Allegedly Failing to Report Clinical Trials

December 16, 2015
Administrative Law, Food and Drug Law

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.

Circumventing EPA Regulations Through Computer Programs

December 16, 2015
Administrative Law, Data, Environmental Law

Ted Harrington, MJLST Staffer

In September of 2015, it was Volkswagen Group (VW). This December, it was the General Electric Company (GE) finalizing a settlement in the United States District Court in Albany. The use of computer programs or other technology to override, or “cheat,” some type of Environmental Protection Agency (EPA) regulation has become seemingly commonplace.

GE uses silicone as part of its manufacturing process, which results in volatile organic compounds and chlorinated hydrocarbons, both hazardous byproducts. The disposal of hazardous materials is closely regulated by the Resource Conservation and Recovery Act (RCRA). Under this act, the EPA has delegated permitting authority to the New York State Department of Environmental Conservation (DEC). This permitting authority allows the DEC to grant permits for the disposal of hazardous wastes in the form of an NYS Part 373 Permit.

The permit allowed GE to store hazardous waste, operate a landfill, and use two incinerators on-site at its Waterford, NY plant. The permit was originally issued in 1989, and was renewed in 1999. The two incinerators included an “automatic waste feed cutoff system” designed to keep the GE facility in compliance with RCRA and the NYS Part 373 Permit. If the incinerator reached a certain limit, the cutoff system would simply stop feeding more waste.

Between September 2006 and February 2007, the cutoff system was overridden by computer technology, or manually by GE employees, on nearly 2,000 occasions. This resulted in hazardous waste being disposed of in amounts grossly above the limits of the issued permits. In early December, GE quickly settled the claim by paying $2.25 million in civil penalties.

Beyond the extra pollution caused by GE, a broader problem is emerging—in an increasingly technological world, what can be done to prevent companies from skirting regulations using savvy computer programs? With more opportunities than ever to get around regulation using technology, is it even feasible to monitor these companies? It is virtually certain that similar instances will continue to surface, and agencies such as the EPA must be on the forefront of developing preventative technology to slow this trend.

Just Not Mayo

December 2, 2015
Administrative Law, Agriculture, Competition, Food and Drug Law

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
Administrative Law, Food and Drug Law, Health Law, 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
Administrative Law, Food and Drug Law, Health Law, 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!

EPA Revises Agricultural Worker Protection Standard, to the Disappointment of Agriculture Industry Groups

November 13, 2015
Administrative Law, Environmental Law

Jody Ferris, MJLST Staffer

An important development on the regulatory front has some agriculture industry groups shaking their heads. The U.S. Environmental Protection Agency has released finalized revisions to the 1992 Agricultural Worker Protection Standard on Sept. 28, 2015 (40 CFR 170). These regulations apply to millions of agricultural workers in fields, forests, orchards, and greenhouses across the country. The regulations are meant to enforce the observation of good safety practices in the use of pesticides by agricultural workers.

The changes to the current requirements include:

-a new minimum age requirement that prohibits children under the age of 18 from handling pesticides.

-mandatory posting of no-entry signs on fields that have been recently treated with highly dangerous pesticides.

-whistleblower protections to protect employees who alert authorities to illegal practices.

-increased frequency of employer provided safety training (now required annually, up from the previous requirement of every five years).

-recordkeeping requirements (records of training must be kept for two years, previous requirements did not require any record keeping).

-increased requirements for use of safety equipment, including fit testing and employee training on use of safety equipment. Recordkeeping of completion of safety equipment training and fit testing is also required. The previous requirements did not require any training, formal fit testing, or record keeping.

Agricultural industry groups are unhappy with many of the revisions to the regulations. A coalition including the National Association of Wheat Growers, the National Council of Farmer Cooperatives, the American Farm Bureau Federation, and the American Seed Trade Association submitted a 14-page comment letter during the public comment period and claim that their comments were not taken under proper consideration in the final revision of the rule. The coalition argued that since the original regulations were introduced in 1992, there have been significant improvements in worker safety and that acute poisoning events have been greatly reduced, thereby eliminating the need for more stringent regulations. In addition, they argue that the EPA has severely underestimated the financial costs that the new requirements place on agricultural producers. Criticism from the Agricultural Retailers Association includes the concern that the new rules will put employers at risk for increased liability without significantly increasing worker safety.

It is currently unclear whether any regulated parties will seek to challenge the revised regulations in court. It also remains unclear precisely how great a burden the new requirements will place on agricultural producers or how much they will improve the safety of workers until they are followed in practice for some time. It remains to be hoped that the new requirements will indeed significantly improve the safety of agricultural workers on the job and justify any increased burden on employers.

H.R.8 and the Hydropower Improvement Act of 2015—Another Missed Opportunity

October 28, 2015
Administrative Law, Energy Law, Environmental Law

Catherine Cumming, MJLST Lead Note & Comment Editor

While many people see the hydropower industry as a clean and sustainable energy source, most hydropower facilities are decades old and have severe environmental, economic, and social externalities. Relicensing provides an opportunity to bring aging dams up to modern environmental standards and compliance requirements. Over the past thirty years, American Rivers and the Hydropower Reform Coalition used the licensing process to improve hydropower dams and restore rivers. With over 6,000 megawatts of hydropower due for relicensing within the next five years, there are hundreds of dams and thousands of miles of river with an opportunity for improvement. Recent legislation, however, has failed to address the amount of hydropower due for relicensing and the opportunities it presents for increased energy production and environmental compliance. When Congress passed the Hydropower Regulatory Efficiency Act of 2013, it failed favored efficiency over oversight and failed to the amount of hydropower due for relicensing and the opportunity it provided for efficiency upgrades.

This fall, Congress missed yet another opportunity to modernize hydropower and decrease its negative externalities. Rather than “modernize” hydropower, the Energy & Commerce Committee’s approval of a hydropower amendment to H.R.8, the “North American Energy Security and Infrastructure Act of 2015” and Senator Lisa Murkowski’s “Hydropower Improvement Act” ignore the opportunity for increased efficiency and sustainability by creating compliance loopholes for the hydropower industry. If enacted, these bills would allow energy companies to opt out of Clean Water Act, Endangered Species Act, and state water quality and wildlife protections; allow dam owners to pass the costs and burdens of obeying water quality standards, wildlife laws, and cleaning up pollution caused by dams to taxpayers; and transfer state and federal agency authority to protect natural resources to the Federal Energy Regulatory Commission. While 2011 was the “Year of the River,” 2015 is becoming the “Year of Hydropower.” Community interest groups and environmental organizations are concerned that H.R.8 and the “Hydropower Improvement Act” will “turn back the clock and take the hydropower industry back to a time when they could destroy rivers with impunity.”

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