By Arthur Y. Tsien
As MMXIV starts, it’s time for a retrospective look at MMXIII. What follows is a list of noteworthy events from MMXIII in our food, drug, medical device, and agriculture corner of the universe, focusing on matters that were of particular interest to OFW Law’s attorneys and Senior Policy Advisors and our clients.
We start, of course, with January, when three long awaited rulemaking documents finally saw the light of day, albeit well behind statutory rulemaking deadlines. The Food and Drug Administration (FDA) published two major proposed rules – hazard analysis and preventive controls for human food; standards for growing, harvesting, packing, and holding produce for human consumption. See our memoranda on these two new proposed rules here and here. Both proposed rules are part of FDA’s efforts to implement the FDA Food Safety Modernization Act (FSMA), which became federal law in January 2011. FSMA is the biggest expansion of FDA’s authority in the food safety arena since the Federal Food, Drug, and Cosmetic Act became federal law in 1938.
Later in the month, the U.S. Department of Health and Human Services (HHS) published a long awaited final rule to revise federal medical privacy requirements, commonly called the HIPAA Privacy Rule. Restrictive interpretations in the rulemaking preamble had the potential to disrupt many customized pharmacy communications programs sponsored by pharmaceutical companies. Following substantial public outcry and a lawsuit challenging the rule on First Amendment grounds (subsequently voluntarily dismissed by the plaintiff), HHS issued a guidance in September that provides substantially more flexibility than the interpretations set forth in the preamble to the final rule. See our blog posts here, here, here and here.
In February, the Federal Trade Commission (FTC) set in motion events that may dramatically alter the beverage alcohol labeling landscape. To settle a complaint, the FTC ordered a maker of a flavored malt beverage to have an “Alcohol Facts” panel, similar to “Nutrition Facts” for food, “Supplement Facts” for dietary supplements, and “Drug Facts” for over-the-counter drugs. See our February 13 blog post here. As a follow-up (and possibly spurred to act by the FTC’s action), in May, the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) issued a ruling that allows beer, wine, and distilled spirits makers to voluntarily add Serving Facts to their labels. See our May 29 blog post here. A 2007 proposed rule to require Serving Facts remains pending.
Rick Blumberg, FDA’s longstanding Deputy Chief Counsel for Litigation, passed away unexpectedly in March. I had the privilege of learning from Rick when I worked in FDA’s Office of Chief Counsel from the waning days of the Carter Administration through the first half of the Reagan Administration. My partner Steve Terman’s tenure with Rick as a colleague in FDA’s Office of Chief Counsel exceeded mine on both ends. For those of us in private practice, Rick was a tough cookie with whom to negotiate, but he was always principled. Above all, he believed in his work and in FDA’s mission. Steve and I, and the rest of the food and drug bar that works on FDA enforcement matters, will miss him.
Oxycontin (oxycodone) Tablets, an opioid pain relief medicine, is the “poster child” for the public health crisis stemming from the abuse of FDA-approved prescription drug products. In MMX, FDA had approved the current Oxycontin formulation, which has properties that make it more difficult to abuse. In April, FDA decided that the prior (MMX and before) version of Oxycontin had been withdrawn for safety reasons. FDA’s decision effectively prolongs the monopoly for Oxycontin by delaying generic competition. To put FDA’s decision into context, later events confirm that FDA’s decision-making in this area is on a case-by-case basis. The next month, FDA decided that a prior version of Opana (oxymorphone) Tablets, another prescription opioid pain medicine, had not been withdrawn for safety reasons, even though the reformulated version was said to be more abuse-resistant.
In May, the U.S. Supreme Court issued its decision in Bowman v. Monsanto Co., holding that a patent holder’s rights in biotech seeds extends to subsequent generations of crops grown by farmers. Widely viewed as a victory for biotech seed producers and American farmers, that decision should provide seed trait developers with the confidence that they will be able to protect their substantial research and development investments in seed biotechnology. OFW Law attorneys authored an amicus brief for several agricultural trade associations in support of Monsanto Co. See our May 15 blog post here.
The Supreme Court was on a roll, issuing another important decision in June. In Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court held in a 5-4 decision that federal law preempts state law product liability design-defect claims based on inadequate labeling warning statements. Although the decision represented a major victory for the generic drug industry, that victory may not be a permanent one. The Supreme Court’s decision in Bartlett arguably leads to an unfair result, as a seriously and permanently injured plaintiff was unable to collect any damages despite a jury finding – untouched on appeal – that a drug product design defect was the cause of her injuries. In response to the decision, FDA published a proposed rule in November that would create a regulatory mechanism generic drug application sponsors could use to revise their labeling in light of new safety information, before receiving FDA approval for the revised labeling. Having said that, FDA’s proposed solution appears to go too far and would undermine the longstanding basis for the approval of generic drugs under the Hatch-Waxman Amendments, namely, that (with certain exceptions not relevant here) a generic product have the “same” labeling as the innovator product being copied.
In July, the House of Representatives passed, by a narrow margin, a pared-back farm bill, stripping out the Supplemental Assistance Nutrition Program (commonly known as food stamps) to satisfy some from the conservative Republican wing, but losing what little Democratic support the bill had when a broader version unexpectedly failed to pass a month earlier. It was the first time food stamps have not been a part of the farm bill since MCMLXXIII, and created a great deal of uncertainty regarding the future of agriculture policy as the food stamp program remained the centerpiece of the Senate’s bipartisan version of the farm bill. (Currently, farm bill conferees are said to be making progress on a conference report, which could be passed when Congress returns to work in MMXIV.)
Not much happened in our universe in August, just as in MMXII, because most of us – along with Congress and federal employees – left town on vacation.
In September, the meat and livestock industry received a setback when the U.S. District Court for the District of Columbia rejected a request for a preliminary injunction that would have stopped the United States Department of Agriculture’s (USDA) new mandatory Country of Origin Labeling (COOL) rule from taking effect. That decision is on appeal. The new COOL rule requires retailers to notify purchasers of fresh cuts of meat and poultry where the derivative animal was born, raised, and slaughtered. Complying with the COOL rule is particularly onerous for beef and pork feeders and packers located near the Canadian and Mexican borders because of the costs that come with segregating livestock based on their various COOL categorizations before packaging. The Farm Bill conferees have been debating whether to repeal the labeling requirement in the 2014 Farm Bill. So, stay tuned!
As the entire country knows, much of the federal government shut down for 17 days in October. Turning to our little corner of the universe, the shutdown was, at most, a minor hiccup for the meat, poultry, and egg products inspection activities of the USDA’s Food Safety and Inspection Service. The shutdown also did not affect the application review activities of FDA that are funded by user fees. However, many other USDA and FDA activities ground to a complete halt. Despite the shut down, FDA was able to publish a proposed rule on hazard analysis and preventive controls for animal feed late in the month. FDA’s proposed rule paralleled, in most respects, its proposed rule on hazardous analysis and preventive controls for human food from January. Arguably, FDA’s proposed rule would have an even greater impact on the animal feed industry than its companion rule (see January above) would have on the human food industry.
Also in October, the World Food Prize was held in Des Moines, IA, honoring three leaders in agricultural biotechnology research for their contributions towards improving the quality, quantity and availability of food in the world. Their research has made it possible for farmers to grow crops with improved yields, resistance to insects and disease and the ability to tolerate extreme variations in climate such as excessive heat and drought. It was the presentation of Cardinal Peter Turkson, President of the Vatican’s Pontifical Council for Justice and Peace, which may have had the most profound impact. Cardinal Turkson directly addressed the controversy surrounding biotechnology and genetic modification in the production of food using Catholic thought and Vatican II as his reference points. A major coalition of farm, food and anti-hunger organizations joined 30 institutions of higher education in praising the World Food Prize Foundation for shining a spotlight on agricultural biotechnology with this year’s World Food Prize theme.
In November, FDA published an advance notice of a proposed rulemaking, tentatively concluding that partially hydrogenated oils are no longer generally recognized as safe (GRAS) because of the presence of trans fatty acids. See our November 8 blog post here. FDA did so even though consumption of trans fats in the U.S. has declined sharply – by more than 75 percent – because the food industry has reformulated foods and replaced most partially hydrogenated oils with other ingredients.
Also in November, the President signed into law the Drug Quality and Security Act (DQSA). DQSA is the culmination of a decade-long effort by the drug distribution industry to establish interoperable, uniform, electronic “track-and-trace” requirements for prescription drug products. These requirements will preempt state requirements, thereby preventing a potential mish-mash of state requirements that could present real burdens to trade. DQSA also increased federal authority over pharmacy drug compounding. See our blog posts here and here. DQSA was passed by Congress on a bipartisan basis and offers a glimmer of hope that partisan differences have not resulted in total gridlock.
That brings us to December. FDA issued a final guidance to implement its “voluntary” plan to help phase out and reduce the use of medically important antimicrobial drugs in food animals for “production” purposes, such as using less animal feed to gain weight. The plan set forth in the final guidance, which has been under discussion with industry for a number of years, is FDA’s latest step in its efforts to address the possible transfer of antimicrobial resistance from food animals to human beings, thereby resulting in compromises in human medicine. FDA started this process in MCMLXXII with the publication of a policy statement in the Federal Register. Only time will tell whether FDA’s latest step in its 40-year journey represents a real public health advance.
My apologies to readers who are too young to have learned Roman numerals in grade school. For MMXIV, consider adding Roman numerals to your adult learning list, along with other no-longer-taught subjects like U.S. geography and English grammar.
Thanks for reading. Best wishes to all for a happy, health, and prosperous MMXIV!