FDA Lawyers Blog

Earlier this week, the U.S. Supreme Court denied GlaxoSmithKline's certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)'s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention "solely for uses reasonably related to the development and submission of information under [federal drug laws]," does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)'s safe harbor and explained that Classen held that 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."

Written by Scot B. Pittman

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As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK's petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit's Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court's interpretation of the provision.

Adverse event reports submitted voluntarily by doctors and companies recently released by FDA state that the deaths of five people over the past three years may have been linked to drinking Monster Energy, an energy drink containing high levels of caffeine. The reports filed using the Center for Food Safety Adverse Event Reporting System spanned a period from 2004 to June 2012, but all of the deaths occurred in 2009 or later. An FDA spokesperson, Shelly Burgess, stated that energy drink manufacturers are responsible for investigating these accusations and that the FDA is investigating these cases, but has not established a causal link between the deaths and the drinks.

The reports were released through the Freedom of Information Act ("FOIA") to the mother of a 14-year-old girl who recently died after drinking two 24-oz. Monster Energy drinks in a 24 hours period. The parents of the girl have recently brought survival and wrongful death actions against Monster Beverage Corporation ("Monster Beverage"), the manufacturer of Monster Energy, in the Superior Court of the State of California for the County of Riverside using these reports. According to the complaint filed on October 17, 2012, the two 24-oz cans of Monster Energy consumed by the girl contained 480 milligrams of caffeine or the equivalent amount of caffeine in fourteen 12-oz. cans of Coca-Cola. The girl's autopsy and death certificate state the cause of death as "cardiac arrhythmia due to caffeine toxicity complicating mitral valve regurgitation in the setting of Ehlers-Danlos syndrome" according to the complaint. Ehlers-Danlos syndrome can affect the body's connective tissue, including blood vessels.

Written by Shelly Fujikawa, Ph.D.

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The complaint further asserts that, in addition to caffeine, Monster Energy drinks contain guarana and taurine. Guarana contains caffeine and taurine effects cardiac muscles in a similar way compared to caffeine. Caffeine, guarana, and taurine have also been shown to work synergistically. The complaint also alleges that Monster Beverage "avoided meaningful regulation of its products" by FDA since it classified its drink as a "dietary supplement." Monster Beverage has denied these allegations responding that "Monster is unaware of any fatality anywhere that has been caused by its drinks."

In an effort to further investigate the position in emerging economies, FDA commissioned the Institute of Medicine ("IOM") to study and identify the core elements of food, drug, medical product, and biologics regulatory systems in developing countries with a view to identifying the main gaps in those systems and to design a strategy for FDA and other stakeholders, which can be used to strengthen the food and medical products regulatory systems abroad. FDA is under relentless pressure to increase the number of inspections it carries out of foreign medicinal product manufacturers. However, FDA cannot do this without help and without substantial improvements in the capacity of their counterpart agencies, particularly those in emerging economies.

The report compiled by the IOM Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries and entitled "Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad" put forward several recommendations as to how the United States can play its part in helping strengthen the regulatory systems in low- and middle-income countries by promoting cross-border partnerships, including government, industry, and academia, to foster regulatory science and build a core of regulatory professionals. In putting together their report IOM staff travelled to China, Brazil, South Africa, and India to meet with regulators, representatives of regulated industry, academics, and health and development workers.

Written by Howard E. Rosenberg, Ph.D.

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The IOM recommended that the FDA should use enterprise risk management to assist its inspection, training, regulatory cooperation, and surveillance efforts and should facilitate training for regulators in developing countries. The objective being workforce training and professional development through an ongoing, standard regulatory science and policy curriculum. The IOM stated that, "[E]nsuring the safety of food and medical products imported from around the world is a difficult task, and one that the FDA has executed fairly successfully so far. There is no reason to believe that their luck will hold over the next 10 years without substantive improvements in the capacity of their counterpart agencies abroad."

On April 24, at the Food and Drug Law Institute's ("FDLI's") 55th Annual Conference 2012, reflecting on history of the FDA and FDLI, FDA Commissioner Margaret A. Hamburg, M.D., noted that dating back to the first FDLI/FDA informal conference back in 1957, FDA continues to regulate an "enormous scope" of products with a continuing need for more resources. Hamburg said that FDA is now at a "turning point"--there is a need to develop medical countermeasures for biological threats either natural- or terrorism-oriented, such as new antibiotics, and there are needs for new product such as treatments for type II diabetes and obesity. At the same time FDA is poised for various riders expected to be added to the four user fee bills presented to Congress. Some of those riders include new provisions for accelerated approval, increased authorities for FDA to regulate products or component of products made overseas (e.g., 85% of the active ingredients are manufactured outside us and 40% drug products are made outside the United States), increased monitoring for drug shortages, and strengthening FDA's rare disease program. Hoping to create a "brand" for FDA, Hamburg said there is a need for stronger and more sophisticated science to help bolster reliance by the world on FDA's decision-making as the "gold standard."

Following Hamburg, three of FDA's relatively-new Deputy Commissioners discussed key issues confronting each of them. Michael R. Taylor, Deputy Commissioner for Foods, said that he believes resource allocation is important. Taylor's key issues include antimicrobial resistance, nutrition labeling, nanotechnology, chemical contaminants, a new strategic plan for foods and veterinary medicine, and executive leadership management--all with a need to involve stakeholders in the process. Stephen P. Spielberg, M.D., Deputy Commissioner for Medical Products and Tobacco, said that he is excited to be working at FDA at a time when the medical community is better understanding the causes of diseases. He is looking at the potential for more synergies between the centers and also looking at his own responsibilities, including how to help prevent children from initiating smoking and becoming addicted to nicotine. Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, said she is interested in "leap frogging" and developing an enterprise management where domestic and foreign inspection are handled the same in an increasingly global environment with statutes and regulations drafted with domestic manufacturing primarily in mind. Autor is hoping that manufacturers take a better look at the supply chain and components that go into their products, while developing better risk analytics to maintain quality.

Written by Brian Malkin

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Following a discussion on FDA regulatory science and a lunch session highlighting FDLI's new upcoming conference in Brazil, each of the FDA centers presented their outlooks for the upcoming year. Presenting for the Center for Drug Evaluation and Research ("CDER"), Deputy Center Director, Douglas C. Throckmorton said that a key priority will be to finalize and implement the requirements of FDA's requested user fees. CDER plans to fill a number of key senior leadership position: an additional Deputy Center Director and directors for the Office of Generic Drugs, the Office of Biostatistics, the Office of Clinical Pharmacology, and the Office for Surveillance and Epidemiology. In addition,

FLH Partner Brian Malkin will attend the Food and Drug Law Institute's ("FDLI's") Annual Conference in Washington, D.C. on April 24-25. For 55 years, FDLI's Annual Conference has been considered the venue for food and drug law lawyers and professionals to hear from FDA and industry about new and emerging topics covering all the products FDA regulates. FDLI has reported that this year's event is expected to draw more than 600 attendees, who will hear directly from FDA's key leaders including Commissioner Margaret Hamburg; Deputy Commissioners Deborah Autor, Stephen Spielberg, and Michael Taylor, various representatives from FDA's six product Centers; newly-appointed Chief Counsel Eliabeth Dickinson, as well as a number of former Chief Counsels. An updated agenda is available here.

FDA Lawyers Blog is a Media Partner of FDLI's 55th Annual Conference. Prior to FDLI's Annual Meeting, Mr. Malkin will participate in a FDLI Monograph Committee Meeting on April 23 and will be working out of Frommer Lawrence & Haug LLP's Washington, D.C. office next week. Mr. Malkin looks forward to seeking you and catching up at FDLI's Annual Conference this year.

For more than 50 years, the Food and Drug Law Institute's ("FDLI's") Annual Conference has provided the venue for food and drug law professionals to discuss and debate emerging topics, as well as participate in valuable education programs. At this year's event, more than 600 attendees will hear directly from FDA leadership including Commissioner Hamburg; Deputy Commissioners Autor, Spielberg, and Taylor; representatives from FDA's six product Centers; Chief Counsel Dickinson and former Chief Counsels.

Programming at the Conference addresses a range of topics including: regulatory science; global developments and emerging markets; economic, legal and regulatory challenges of innovation; social media and mobile apps.

Join FDLI for the largest networking opportunity for food and drug law professionals. We look forward to seeing you at the 2012 FDLI Annual Conference next week.

FDA Lawyers Blog is a Media Partner of FDLI's 55th Annual Conference.

by Brian Malkin

On March 30, FDA denied the Natural Resources Defense Council, Inc.'s ("NRDC's") Citizen Petition to remove the chemical bisphenol A ("BPA") from food packaging and other products where it comes in contact with food. NRDC said that BPA may be found in a wide variety of the liners of metal food cans and hard plastic containers such as baby bottles.

As we previously reported here, on August 19, 2011, NRDC sued FDA for declaratory and injunctive relief for FDA to grant the citizen petition and issue a regulation prohibiting the use of BPA in food packaging. NRDC's original Citizen Petition was filed in October 2008 yet remained unanswered by more than 1000 days, as of the complaint filing date. According to NRDC's complaint, FDA should have responded to its type of petition within 90 days and had a maximum time of 180 days to respond. NRDC had asserted that FDA's failure to respond to NRDC's Petition prolonged its members from unwanted exposure to BPA in food packaging. FDA's failure to respond to the Petition, NRDC further claimed, denied NRDC from seeking judicial review, if necessary.

NRDC's latest suit on this Petition resulted in a Consent Judgment, where FDA agreed to issue a final decision to NRDC's Citizen Petition "on or before March 31, 2012" as the "settlement of all claims that were asserted, or could have been asserted . . . related to the allegations in the Complaint." NRDC was also awarded $10,500 as "attorney feed and costs arising out of this Action" in a Stipulation and Order that followed the Consent Judgment.

by Brian Malkin

On March 7, FDA announced in a Request for Comments in the Federal Register a two-day public hearing to obtain feedback and suggestions regarding ways that FDA can modernize its regulations, policies, and practices that apply to the conduct of clinical trials for FDA-regulated products. FDA hopes that with this input it can modernize the regulatory framework that govern clinical trials and form approaches for good clinical practice ("GCP") providing for greater effectiveness and efficiencies in the process.

FDA explained in its Request for Comments that FDA's clinical trial regulations are now more than twenty-five years old and has been showing its age. In the past years, clinical trial management has changed dramatically, including increased size and complexity of clinical trials, increased number of clinical trials performed globally, greater use of contract research organizations ("CROs"), increased participation of "vulnerable" populations (children, individuals with orphan-designated diseases, others), and numerous scientific and technological advances, including increased use of the Internet. FDA has learned in various forums that FDA's current regulations and compliance policies may not facilitate the use of innovative methods to improve clinical trial quality, the Request for Comments observes. For example, CROs or other clinical investigators may continue to use older data collection methods given the uncertainties involved in using new procedures that may not be aligned with FDA's older guidances and recommended procedures.

FDA said that its focus is on good clinical practice, including enhanced clinical protocol design to take advantage of newer technologies to ensure reliability of data, safety surveillance reporting, quality control processes including auditing, data integrity, and human subject protection. FDA is interested in workshops or strategic alliances that may help to encourage the implementation of innovative methods in clinical trials including risk-based methods in the design, oversight, and conduct of clinical investigations.

by Brian Malkin

Whose seafood is your seafood, or, more appropriately, how do you know the fish you ordered is the fish you ordered? In October, FDA approved a new DNA barcoding system that can identify fish species similar to a supermarket scanner to prevent mislabeling of locally produced and imported seafood in the United States. Reportedly, other national regulators are considering adopting similar measures, which are described as fast, reliable, and cost-effective.

In most cases, the DNA barcoding system should prevent restaurant patrons from consuming inferior fish from the one that they thought they were consuming. In other cases, it may prevent unwanted health consequences for individuals who may be allergic to specific types of seafood, including exotic species that are banned. Just in 2007, several individuals became seriously ill following consumption of illegally imported toxic pufferfish from China that had been mislabeled as monkfish to circumvent U.S. import restrictions.

Seafood mislabeling is notorious. For example, a a pair of high school students in New York found 25% of the fish that they sampled around New York was incorrectly labeled as higher-end-type seafood.

by Fitz Beckwith Collings

FDA has given the green light to AquaBounty's genetically-engineered salmon, the "AquAdvantage." The fast-growing fish, an Alaskan salmon supplemented with genes from the ocean pout and the Chinook salmon, can mature in 18 months instead of 36. The company first submitted its food to FDA for review in 1995 and now it appears, after a lengthy period of review and public comment, that it is closer than ever before to supermarket shelves. FDA's approval now sits on the desk of the White House's Office of Management and Budget.

As the world's first genetically-engineered animal food, AquAdvantage salmon would undoubtedly require strict oversight. AquaBounty insists that all its genetically-engineered salmon would be bred in inland farms, far from flood plains. But, in contrast to invasive species like the asian carp and the snakehead that must travel in a mating pair, a single escaped AquAdvantage salmon could breed with native salmon species and contaminate the gene pool. Of greater is concern is the possibility that, with its superior growth abilities and its improved resistance to cold temperatures, an escaped AquAdvantage salmon could eventually supplant Alaskan salmon in the wild.

In light of this threat, several groups have mobilized to oppose the approval, including the U.S. Senate. Senators Mark Begich (D-AK) and Lisa Murkowski (R-AK) have introduced an agricultural appropriations amendment--the Prevention of Escapement of Genetically Altered Salmon in the United States (PEGASUS) Act--that would make it a crime "to have custody, control, or possession of, with the intent to ship, transport, offer for sale, sell, or purchase genetically altered salmon or other marine fish, or a product containing genetically altered salmon or other marine fish, in interstate or foreign commerce." The senators sponsoring the amendment represent the state of Alaska, where salmon fisheries are relatively fertile. A similar bill was introduced in the House in June, and both bills would prevent FDA from using funds to approve genetically-engineered fish. House and Senate bills seeking mandatory labeling of genetically-engineered foods are also pending.

by Charles J. Raubicheck

On September 27, FDA and Del Monte Fresh Produce N.A. resolved their ongoing battle over imports of cantaloupes from Guatemala in what has been called an "amicable resolution."

In March of this year, the Agency linked these melons to a salmonella outbreak in Oregon, and imposed an import alert on July 15 detaining the produce from being brought into the U.S. Del Monte, the country's largest importer of cantaloupes, then sued FDA, asserting that the alert was unjustified because it was based on the Agency's speculative and erroneous claim that the cantaloupes were harvested and cleaned under contaminated conditions. Del Monte also files an ethics complaint against Oregon's senor epidemiologist William Keene and threatened to sue Oregon's health authorities for making the implication against Del Monte without evidence that its cantelopes had tested positive for the outbreak strain, Salmonella Panama.

Former FDA Associate Commissioner of Foods David Acheson and Oregon health officials reportedly are concerned that Del Monte's suit and threatened suit could hamper future alerts to consumers of potential food-related health risks, noting that the suit questions the role of epidemiology as a valid scientific methodology to trace foodborne illness.

A statment by FDA said that FDA has now lifted the alert after tests for bacteria proved negative, and a third-party audit showed that Del Monte's plant is following GMPs. In turn, the company has dropped its lawsuit.

by Fitz Beckwith Collings

Center for Food Safety, have asked FDA to bring its regulatory power to bear on genetically-engineered ("GE") foods to prevent economic fraud and consumer confusion. They seek several definitional changes in the Federal Food, Drug, and Cosmetic Act ("FD&C Act") and U.S. Code of Federal Regulations ("C.F.R."), as well as the institution of mandatory labeling for all GE foods.

Definitional Changes

First up is rescission of FDA's 1992 policy statement regarding the definition of a "material" production process under FD&C Act Section 201(n). The current definition turns on processes that a consumer can detect using his senses. Petitioners seek to define a production process as material "if it results in a change to a food at the molecular or genetic level because a significant share of consumers would find it relevant to their purchasing decisions." Changing the definition, they argue, is consistent with FDA's authority and a failure to change it would be arbitrary, capricious, or contrary to the law.

Next, petitioners request the inclusion of definitions for "genetic engineering" and "genetically engineered food." The definitions highlight petitioners' food safety argument. "Genetic engineering" means "a process that alters an organism at the molecular or cellular level by means that are not possible under natural conditions or processes," and specifically excludes established selection processes like breeding, conjugation, fermentation, hybridization, in vitro fertilization, and tissue culture.

by Erin A. Lawrence

On September 29, FDA added a supplement to the 2009 Food Code that addresses recommendations made at the 2010 Meeting of the Conference for Food Protection. The new supplement would require businesses in the food service industry to hire certified food protection managers. The supplement aims to mitigate risk factors that contribute to foodborne illnesses.

FDA's Food Code is a set of model food-safety regulations for keeping food safe at retail and food-service operations including restaurants, schools, and food stores. FDA guidelines are not mandatory, but are adopted by many states to delineate food safety standards. Food Codes are issued by FDA every four years. The next complete revision to the Food Code will be published in 2013.

Forty-nine states pattern their food safety codes after versions of the federal Model Food Code. Twenty-four states already require certified food protection managers. To become a certified food protection manager, an employee must complete an educational program that is approved by a Conference for Food Protection-recognized agency. Recognized agencies include the National Restaurant Association's ServSafe program, Prometric, and the National Registry of Food Safety Professionals. The supplement calls for "[a]t least one employee that has supervisory and management responsibility and the authority to direct and control food preparation and service shall be a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program. " The certified food protection manager would be responsible for: 1) developing and implementing the operating procedures required by the food code; 2) apprise employees about their obligation to report certain health conditions; 3) make sure that any food delivered after operating hours is done so in a way that does not create a food safety hazard; 4) mandate a proper clean-up plan for an employee or customer that has gotten physically ill; 5) educate employees regarding the guidelines of using bare hands with ready-to-eat foods and; 6) clarifying the guidelines for storage of meat and poultry.

In addition to the supplement, FDA also announced that it established a cooperative agreement with the National Association of County and City Health Officials ("NACCHO"). Under the agreement, FDA and NACCHO will promote the use of best practices by local authorities, develop tools to strengthen retail food safety oversight, and implement FDA's Voluntary National Retail Food Regulatory Program Standards for retail food regulatory programs.

by Andrew S. Wasson

As the East Coast deals with the damage (flooding, wind, or otherwise) left by Hurricane Irene, we note that FDA provides a substantial amount of resources to those wondering whether they can consume food, drugs, or water affected by the storm. Generally, as you can expect, FDA says to generally err on side of caution. The full guidelines can be found here, but a few key guidelines dealing with food, water, and drugs during the aftermath follow. We have also compiled a list of FDA resources at the end of the post. We hope that everyone stayed safe during the storm and that any damage sustained was minimal.

Food
• Do not eat any food that may have come into contact with flood water. If in doubt, throw it out.
• Do not eat food packed in plastic, paper, cardboard, cloth and similar containers that have been water-damaged.
• Discard food and beverage containers with screw-caps, snap lids, crimped caps (soda bottles), twist caps, flip tops and home canned foods, if they have come in contact with flood water. These containers cannot be disinfected.
• Check to ensure that the freezer temperature is at or below 0°F and the refrigerator is at or below 40°F.
• Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature.