In September 2018, the Food and Drug Administration (“FDA”) announced a new policy that provides for the release of a list of retailers that have received a food subject to recall. In the past, the FDA did not release such information because the agency deemed it confidential commercial information. The lack of information on the part of the FDA has been a huge detriment to the public. Prior to the new guidance, the public would only find out information about the particular food that was being recalled, not where this recalled food was available for purchase. The public was told just to stop purchasing that recalled food, whether it be romaine lettuce or beef, even if there were retailers who were selling non-contaminated products. This procedure not only hurts the public but also has a huge financial effect on those retailers who are not selling contaminated or recalled products. The FDA has effectuated a new guidance because they have found that such information is necessary to enforce a recall and to ensure public safety.
Following a public meeting in October, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) agreed to share joint regulation of cell-culture “meat” technology. This decision came on the tail end of public squabble between the two regulatory bodies regarding the oversight of cell-culture, or lab-produced meat. The regulatory framework for this type of quasi-agriculture has been unclear, especially after the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology initiative that attempted to coordinate the roles of various agencies involved in emerging biotechnology. The new, definitive regulatory structure has been thoroughly praised and welcomed by top cell-culture meat companies, who have expressed open frustration with the older, confusing framework, claiming that it hindered both consumer protection and technological innovation.
The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.
In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.
In early August 2018, the Food and Drug Administration (“FDA”) announced the availability for guidance in Clinical Research projects relating to expansion cohorts used in first-in-human (“FIH”) clinical trials that are used to expedite the development of Oncology Drugs and Biologics. The guidance is directed towards clinical sponsors in their design and conduct of FIH clinical trials intended to expedite the development of cancer drugs, including biological products that use multiple expansion cohort study designs. These studies typically employ multiple, concurrently accruing, patient cohorts, which use individual cohorts that assess the different aspects of the safety, pharmacokinetics, and antitumor activity of the drug. The FDA provides guidance for (1) the characteristics of drug product best suited for consideration for development under a multiple cohort study; (2) information to include in investigational new drug application submissions to justify the design of multiple expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.
In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.
Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?
After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.
For the first time since 2013, on Saturday, January 20th, 2018, the U.S. government ran out of money when Congress failed to pass a spending bill to fund the federal government. Much of the federal government’s operations have ground to a halt due to the lack of funding. Because Congress is seemingly at an impasse over immigration policy, the shutdown may last several days, if not weeks. In light of Loyola’s upcoming symposium exploring what happens when regulation is not enforced, it is interesting to consider how, in a similar vein, the shutdown affects compliance.
The cosmetics industry, unknown to many, is essentially not regulated by a federal regulatory agency. Cosmetics technically fall under the purview of the Food and Drug Administration (“FDA”), but there are few requirements that manufacturers must comply with. The FDA only requires that manufacturers comply with several labeling regulations so companies can avoid listing a product’s total ingredients, and the FDA does not require manufacturers to report health complaints. The FDA instead relies on direct reports of adverse events from consumers, which has the potential to delay remedying a potentially dangerous situation. A study published in JAMA Internal Medicine found that between 2015 and 2016, the number of complaints of adverse health results related to cosmetic products more than doubled from the previous years. Additionally, the FDA only has the equivalent of six full-time inspectors to monitor three million shipments of cosmetics that come into the United States each year. Last year, inspectors only conducted tests on about 364 of those shipments, and 20 % of those shipment that were inspected led to adverse findings.