Happy New Year, readers! Yet another year has come and gone. I hope that 2015 was a good year for you, professionally and personally. As I look back on 2015, here are a few developments that caught my attention.
In January, the House Energy and Commerce Committee released a long awaited discussion draft of the “21st Century Cures Act.” The draft legislation was a combination of new and old concepts, advanced by a wide range of stakeholders, to help advance biomedical research and cures, including drugs, biologics, and medical devices. Of particular interest to this author, the draft legislation included a number of new exclusivity provisions.
In February, FDA Commissioner Dr. Margaret Hamburg announced that she would step down the following month, after nearly six years as FDA Commissioner. (Subsequently, President Obama nominated Dr. Robert Califf to be the FDA Commissioner. Although there does not appear to be significant opposition, Senate confirmation of Dr. Califf, who is currently serving as a Deputy Commissioner, is still pending.)
In March, FDA approved Sandoz’s Zarxio™, a biosimilar version of Amgen’s Neupogen®. Both products have the same indications for use, primarily for cancer patients undergoing chemotherapy. Zarxio was the first (and only, so far) biosimilar product approved by FDA under the new regulatory pathway established in the Biologics Price Competition and Innovation Act of 2009. (Subsequently, in July, the U.S. Court of Appeals for the Federal Circuit cleared the path for Sandoz to launch Zarxio in its decision involving the complex (and convoluted, in this author’s view) “patent dance” provisions of the BPCIA. Sandoz launched Zarxio in September.)
Ever wonder about homeopathy and homeopathic products? Well, I have. Homeopathy is a form of alternative “medicine,” based on the use of homeopathic preparations (commonly known as “remedies”) formed by sequential dilution of a variety of substances. The number of sequential dilutions may be such that the finished “remedy” is not reasonably likely to contain even a single molecule of the original substance. Although seemingly at odds with modern (or even not-so-modern!) science and medicine, homeopathy has its followers. Under longstanding FDA compliance policy, FDA has not required that homeopathic prescription and OTC drugs be the subject of approved drug applications. In April, FDA held a public hearing regarding FDA’s regulatory framework for homeopathic drug products. (The Federal Trade Commission held a similar hearing several months later.) Perhaps the longstanding “free ride” that homeopathic drug products have gotten will come to an end.
Since the early 1970’s, FDA has been trying to get its bureaucratic and scientific “arms” around the use of low level antibiotics in feed for food-producing animals, based on concerns that such drug usage may compromise the effectiveness of antibiotics in human medicine. FDA’s current approach is to restrict, but not necessarily completely eliminate, the animal feed use of antibiotics that are important in human medicine. FDA’s approach – which is a work in progress – only sanctions “therapeutic” uses of these drugs (as compared with so-called “production” claims such as improved feed efficiency or growth promotion), under the supervision of a licensed veterinarian. In May, FDA proposed to require manufacturers and distributors of these antibiotic products for animal feed use to submit information to the agency regarding sales by animal species. Some segments of industry have commented that FDA does not have any legal authority to do so.
FDA has been trying to reduce trans fat consumption in the interest of reducing coronary heart disease and preventing heart attacks. In June, FDA issued a final order, declaring that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are no longer “generally recognized as safe” (or “GRAS”) for use in human food. In essence, all uses of PHOs in human food that are not the subject of approved food additive petitions (no approvals to date) will be prohibited.
In July, FDA unexpectedly issued a supplemental proposed rule to establish a Daily Reference Value (DRV) for “added sugars.” FDA asserted that its action was based on evidence in the 2015 Dietary Guidelines Advisory Committee report. USDA and HHS have jointly published “Dietary Guidelines for Americans” every 5 years since 1980. (It does not appear that the 2015 Dietary Guidelines will be published until early 2016.) As mandated by Congress, the Dietary Guidelines are supposed to be based on a preponderance of current scientific and medical knowledge. Nevertheless, the 2015 Dietary Guidelines Advisory Committee report appears to be venturing into the support of policy initiatives, such as recommending limits on the amount of “added sugars” in the diet even though there is no scientific basis for differentiating between added sugars and naturally occurring sugars.
In August, the federal district court for the Southern District of New York granted a preliminary injunction to pharmaceutical company Amarin Pharma. Amarin had sued FDA to prevent FDA from taking action against Amarin for disseminating information regarding off-label (unapproved) uses of its drug Vascepa®, intended for patients with high cholesterol levels. The crux of the dispute is whether First Amendment commercial free speech protections permit Amarin to disseminate truthful, non-misleading communications related to a clinical trial that did not lead to an FDA approval. The district court’s decision against FDA is definitely a win for the pharmaceutical industry and a loss for FDA, but is hardly the last word on this important topic. As to the next step, FDA and Amarin have kicked the can down the road several times as they apparently try to reach a settlement.
In September, FDA finally issued two companion final rules to implement the Food Safety Modernization Act (FSMA) regarding current good manufacturing practices, hazard analysis, and risk-based preventive controls for human food and for animal food. FDA was well behind the 8 ball, as FSMA mandated final rules by July 2012. The final rules are part of FDA’s effort, as mandated by Congress, to modernize the regulation of human and animal food safety and represent major expansions of FDA’s authority.
In October, the United States and 11 other Pacific Rim countries finally reached agreement on the Trans-Pacific Partnership. TPP would set terms for international trade and business investment between nations that account for, roughly, one-third of world trade. TPP appears to be the most far-reaching trade deal for the United States since NAFTA in the tail-end of the prior century. Congressional approval is the next step. Some commenters have opined that Congress will not pass TPP unless the Obama Administration can address data exclusivity concerns for biologics in a way that makes data protection under TPP consistent with U.S. law.
In November, FDA approved a long-pending new animal drug application for AquAdvantage salmon, a genetically engineered farm-raised Atlantic salmon that reaches market size more quickly than non-GE farm-raised Atlantic salmon. FDA determined that food from AquAdvantage salmon is safe for human consumption and equally nutritious as food from non-GE Atlantic salmon. The approval is very restrictive, in that it only allows AquAdvantage salmon to be raised in land-based hatchery tanks in two specific facilities in Canada and Panama. The approval does not allow AquAdvantage salmon to be bred or raised in the U.S. To put things into perspective, the approval was FDA’s very first approval for a GE animal. In comparison, FDA regulates GE plants using a “voluntary” consultative process. Over the years, FDA has evaluated over 150 GE plant varieties.
While on the subject of fish: I am not usually a teller of jokes because I generally botch the punchline. But here’s one that sticks in mind, courtesy of my partner David Durkin: “Q: What’s the difference between a lawyer and a catfish? A: One is a bottom feeding, scum sucking, lowlife. The other’s just a fish.” Practitioners of food law know that catfish have a unique place in federal food law. First, catfish is the only species of fish that is referenced in the Federal Food, Drug, and Cosmetic Act, which since 2002 has identified by scientific name the varieties of fish that can be labeled as “catfish.” Second, the 2008 Farm Bill subjected “catfish” to mandatory continuous slaughter inspection and labeling preapproval under the Federal Meat Inspection Act, just like cattle and swine. USDA’s Food Safety and Inspection Service published a final implementing rule in December. Thus, in the eternal wisdom of Congress, catfish is not just another fish. Other fish, including species such as salmon and tilapia that are widely raised in aquaculture, remain subject to FDA jurisdiction, with no continuous slaughter inspection and no labeling preapproval.
Thanks for reading. Have a great 2016!