Happy 2017, everyone! 2016 has come and gone. Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention.
As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!), individuals in a position of responsibility can be prosecuted criminally for what are often called “strict liability” (no showing of intent to violate the law needed) misdemeanor violations of the Federal Food, Drug, and Cosmetic Act. The government can do so under what is commonly called the “Park Doctrine”, based on the U.S. Supreme Court’s 1975 decision in United States v. Park. In that case, the Supreme Court upheld the criminal conviction of Mr. Park, the President of a major supermarket chain with over 36,000 employees and 16 warehouses, for a warehouse sanitation violation. Mr. Park had previously received written notice of a similar sanitation problem in another of his company’s warehouses. Fast forward to January, when the Eighth Circuit upheld the criminal misdemeanor conviction of a low level “store clerk” with “limited responsibilities” for selling misbranded drugs (United States v. Carlson). Moreover, unlike Mr. Park, the store clerk had not received any written notice from FDA that the drugs in question were misbranded. Presumptively, the case involved what the government regarded as extenuating circumstances (the sale of synthetic analogues of controlled substances in a “head shop”). Nevertheless, in terms of general legal principles, this case appears to represent a new “high water mark” in the government’s efforts to hold individuals criminally responsible for strict liability violations of the FDC Act (and similar regulatory statutes). As lawyers are won't to say, bad facts make bad law.
As I noted in my 2015 retrospective, in November 2015 FDA had approved a then-long pending new animal drug application for a genetically engineered farm-raised salmon that reaches market size more quickly than comparable non-GE salmon. That approval was FDA’s very first approval of a GE animal, using the agency’s (for lack of anything better) “square peg in a round hole” approach of regulating GE animals as animal drugs. In February, FDA issued an Import Alert prohibiting the importation of GE salmon. FDA acted in response to a directive from Congress in the Appropriations Act for 2016. FDA’s action likely has no meaningful commercial effect on the availability of GE salmon, but it does not provide encouraging news to companies interested in marketing GE animals generally.
In March, the Feinstein Institute for Medical Research, a 501(c)(3) institution that conducts and supports clinical research, paid a penalty of almost $4 million as part of a settlement agreement with the government regarding violations of federal A medical privacy rules. The settlement is noteworthy in that it involved a major nonprofit research institution and a disclosure of personal medical information that was apparently not intentional. Having altruistic aims does not lead to a “pass” in the exercise of enforcement discretion.
FDA started the formal administrative process to withdraw approval of the animal drug carbadox (brand name Mecadox®), an antimicrobial drug used in medicated swine feed, in April. Although the regulatory status of any particular drug is usually not of general interest to me, FDA’s action is noteworthy because of the provisions of the FDC Act involved. Carbadox was known at the time of its approval over 40 years ago to be a carcinogen. The “Delaney Clause” in the FDC Act generally prohibits FDA from approving carcinogenic animal drugs for use in food animals. However, FDA was able to approve carbadox by relying on the so-called “DES Proviso” to the Delaney Clause, which allows the approval of a carcinogenic animal drug if no residues of the drug are found in edible animal products derived from treated animals. FDA’s proposal to withdraw approval of carbadox is based, in relevant part, on the rationale that available assay methods to detect carbadox residues in human food are not sufficiently sensitive to allow FDA to utilize the DES Proviso. To the best of my knowledge, FDA has never tried this approach before. Phibro Animal Health Corporation, the sponsor of the drug application for carbadox, maintains that the drug is safe and is opposing FDA’s efforts to withdraw approval. Based on FDA’s track record, a number of years will likely pass before this matter is finally resolved. Earlier this century, FDA’s most recent effort to withdraw approval of an animal drug took 5 years to resolve.
In May, FDA published a final rule that makes some format and content changes to the “Nutrition Facts” information that is required to appear on the great majority of food products. A casual observer probably would not notice the differences, which do not go into effect until 2018. There is room for disagreement about some of the details (such as the new declaration of “Added Sugars”), but FDA’s Nutrition Facts format has been quite successful, as FDA subsequently adopted analogous “Drug Facts” for over-the-counter drugs and “Supplement Facts” for dietary supplements. USDA’s Food Safety and Inspection Service adopted the same Nutrition Facts format for the meat and poultry products under its jurisdiction. The Federal Trade Commission has adopted “Lighting Facts” using the same general format for light bulbs. Some have advocated that the Treasury Department’s Alcohol and Tobacco Tax and Trade Board should require “Alcohol Facts” for beer, wine, and spirits products.
On to June, when FDA issued a draft guidance intended to help achieve a reduction in sodium intake over a 10 year period. From a public health perspective, a reduction in sodium intake is intended to lead to a reduction in the incidence of hypertension, which in turn should reduce the incidence of heart disease and stroke. FDA has had concerns about salt (sodium chloride) and sodium intake since the 1970s. Rather than trying to change the regulatory status of salt (such as by declaring it to be a “food additive” and imposing restrictions and limitations on its use), FDA has tried repeatedly to seek voluntary reductions in salt and sodium intake. The draft guidance is FDA’s latest effort in this arena.
July brought summer weather and the National Bioengineered Food Disclosure Standard. The law requires USDA to adopt implementing regulations within 2 years; those regulations are to require the disclosure of GE content in most FDA-regulated food products and in some USDA-regulated products. Although details were generally left for USDA to address in the rulemaking, one important point is that the law expressly states the meat and dairy products for human consumption need not be labeled as having any GE content solely because the animals from which the human food products were derived were fed GE feed. The law immediately preempted state laws requiring disclosures regarding GE ingredients in food, most notably a Vermont law that had gone into effect on July 1.
Not much happened in August when most federal regulators and policy makers and people who deal with them were on vacation. In fact, not much happened during September and October, either, as the upcoming elections became the center of attention.
The big event of November was, of course, Election Day, when the American electorate cast a sufficient number of votes for Mr. Trump in the right states to make him our next President, much to the surprise of most professional and amateur pundits and watchers-of-all-things-political. Time will tell what changes Mr. Trump’s election will bring. As my partner Rick Frank noted in a post-election blog post, periodic reexamination of rules and policies is good for our system of government, so let the debate begin. Nevertheless, it is safe to say the regulatory activities that keep many of us occupied will continue. FDA is not going to stop evaluating drugs for approval, FSIS is not going to stop inspecting meat and poultry, and so on.
December was the culmination of a rare display of bipartisanship, as the 21st Century Cures Act was passed by both Houses of Congress by very substantial margins, and signed into law by Mr. Obama. The legislation is intended to increase funding for biomedical research, speed the development of innovative drugs and medical devices, improve mental healthcare, and combat opioid abuse.
So much for 2016. On to 2017! By the way, 2017 is a prime number. I hope that 2017 is a prime (in the non-numerical sense) year for you. We will not have another prime number year for 10 years, until 2027.
Thanks for reading.