Now that that the Christmas stockings, Hanukkah menorahs and Kwanzaa harvest symbols have been put away until year end, and resolutions for 2013 have been written (and hopefully not broken yet!), it’s time for a little reflection. What follows is my month-by-month list of noteworthy events of 2012 in the food, drug, medical device and agriculture universe.
The Supreme Court got 2012 off to a good start. In January, the Court held, in a unanimous decision, that the Federal Meat Inspection Act preempts more restrictive California requirements regarding non-ambulatory (“downer”) cattle at the time of slaughter. National Meat Association v. Harris. It’s always good to win one, especially before the Supreme Court. (The prevailing trade association party, now known as the North American Meat Association, has been an OFW Law client since the firm’s founding in 1979 and we assisted in representing them before the Supreme Court.)
In February, the Food and Drug Administration (FDA) released a long-awaited set of guidance documents regarding the approval of biosimilars. Congress established the regulatory pathway for approval of these products in 2010. Hopefully, the guidances will lead to the speedy approval of biosimilars, which are often copies of expensive, potentially life-saving drug products produced through biotechnology.
Concerned about the possible transfer of antibiotic resistance from food-producing animals to humans, the FDA in the 1970's proposed to withdraw approval of many so-called “sub-therapeutic” uses of approved antibiotic animal drugs administered in medicated feed or drinking water. Many of these approved uses are for what are called “production claims,” such as increasing an animal’s growth rate with a lower rate of feed consumption. Over the years, the FDA has never followed through on the administrative process to withdraw the drug approvals; more recently, the agency has encouraged, through guidance documents (here and here) animal drug sponsors to modify their product labeling to restrict many uses of these antibiotics. In a March decision, a federal district court ordered the FDA to continue with the withdrawal of approval proceedings. Natural Resources Defense Council v. U.S. Food and Drug Administration. Coupled with later decisions of the district court in the same lawsuit (here and here), the court’s reasoning is squarely at odds with the FDA’s longstanding view that the agency can decide for itself when and whether to engage in different types of enforcement action. As a possible sign of events to come, the appellate court stayed the district court’s decisions pending the FDA’s appeal.
In April, the Supreme Court issued its long awaited decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. In a unanimous decision reversing the Court of Appeals for the Federal Circuit, the Supreme Court interpreted the patent listing provisions of the Federal Food, Drug, and Cosmetic Act (FDC Act) that, in many cases, effectively govern the time at which generic versions of innovator drugs may first be marketed. The details of the case are beyond the scope of this paragraph. Suffice it to say, many observers concluded that the Supreme Court’s decision was necessary to prevent innovator drug sponsors from “gaming the system” by manipulating patent information submitted to the FDA to delay the availability of generic versions of their products.
In May, the U.S. Department of Agriculture (USDA) celebrated its sesquicentennial (I had to look that up!) anniversary, 150 years after President Abraham Lincoln signed legislation establishing the department. The USDA is home to a number of agencies before which our lawyers and policy advisors practice, including those responsible for meat and poultry inspection, school lunch and nutrition programs, commodity standards and inspection, perishable commodities, crop insurance, animal welfare, rural development, natural resources and forestry policy. OFW Law is also extensively involved with the Department-wide effort to pursue investments in renewable energy.
Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) in June. (It would be signed into law by the President early in July.) Among other changes, FDASIA established user fees for human generic drugs and biosimilars for the first time, reauthorized human innovator drug and medical device user fees, made substantial changes to requirements for medical devices, enhanced FDA’s inspectional authority, and addressed the security and integrity of the drug supply chain.
July is notable for what did not happen. Under the FDA Food Safety Modernization Act (FSMA), which was signed into law in January 2011, the FDA was required to adopt final rules in a number of food-related areas, including in particular final hazard analysis and preventive controls requirements for human and animal food by July 2012. In fact, the FDA has not even issued proposed regulations yet.
Nothing much happened in August. This is consistent with the often-repeated view that the world is a saner place when Congress, federal employees, and the lawyers, lobbyists and consultants who work with them, all leave town in August.
Congress amended the FDC Act in 1994 to provide for the marketing of dietary supplements for human use. However, those provisions do not provide for dietary supplements for animal use. In September, FDA’s Center for Veterinary Medicine (CVM) issued a draft Compliance Policy Guide (CPG). Under the CPG, FDA will exercise enforcement discretion and permit the marketing of certain dog and cat foods intended to help in the nutritional management of a disease or condition if the products are available only through, and promoted to, licensed veterinarians. The CPG appears to represent CVM’s first baby step in finding a workable way to regulate some “dietary supplement”-type products for animals.
In October, public health authorities discovered that a contaminated steroid injection made and distributed on a large scale by a so-called compounding pharmacy was responsible for dozens of deaths and hundreds of serious illnesses. See our prior posts here, here and here. It seems that there will certainly be a substantially higher degree of regulatory scrutiny over firms operating in this market segment, whether under existing federal and state authorities or under new authorities.
In November, President Barack Obama was reelected. I leave larger scale prognostications to my colleagues who practice in our public policy arena. On a smaller scale, hopefully the President’s reelection will mean that some “stalled” rulemakings, such as FDA’s FSMA regulations (see July above) or the long-awaited final rule modifying federal medical privacy regulations from the Department of Health and Human Services (see the July 2010 proposal here), may see the light of day soon.
That gets us to December, when the U.S. Court of Appeals for the Second Circuit issued its decision in United States v. Caronia. The court reversed, on First Amendment free speech grounds, the criminal conviction of a pharmaceutical company sales representative stemming from his promotion of an approved drug product for unapproved uses (often called “off-label” uses). As this decision is at odds with decades of FDA enforcement policy and practice, it seems likely that the government will seek further review.
Thanks for reading. Best wishes to all for a happy, healthy and prosperous 2013!