Category:The Marketplace
Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments
The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules. The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework. The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).
FDA Warns E-Cigarette Manufacturers: Stop Teen Epidemic or Face Consequences
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.
FDA Declares War on Flavored E-Cigarette
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.
A Way Around HHS 340B Program Delays
Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute.
FDA Faces Forward with Flexible Genetic Guidance
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.
The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For
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?
Dodging Pitfalls on the Path to Success: Sales Tax and E-Commerce Entrepreneur
Imagine you are an e-commerce entrepreneur and you log in to your reporting system to see how sales have been over the past week. You notice that you’ve made a good sale to a customer in the state of Illinois. As you are based out of Florida, you pause for a moment to marvel at the progress of technology and how your products can be delivered to someone’s home thousands of miles away from you. Little do you realize, but you may be on the hook for collecting and reporting sales tax to the California Board of Equalization.
The Balancing Act: Exclusive Ownership Rights and Digital Content Sharing
The Internet has given millions of people the capability to share information with each other with just the click of a button. People have grown accustomed to learning about current events, researching, and gathering information all through digital news sources. Unfortunately, the ease of the Internet has also created complications with regulating how users share that information. As technology rapidly advances, the legal limitations concerning intellectual property rights have become blurred, resulting in different interpretations of the Copyright Act of 1976. This has complicated user compliance and created difficult questions for the courts to answer based largely on law that was created before many of the capabilities of the Internet existed. There is a need for consistency and balance in this area of the law so that copyright owners are afforded adequate protection and the Internet can continue to serve as an information gathering, content sharing platform without fostering infringement.
What Google’s Genericide Win Means for the Future of Trademark Law
In 2014, in the District Court of Arizona, a judge ruled that “Google” was not a generic term and was eligible to receive trademark protection in Elliott v. Google. On appeal, the Ninth Circuit affirmed the district court’s ruling. In 2011, Forbes estimated that the “Google” trademark was worth $113 Billion; the trademark is worth more now in 2018 and the company’s trademark is likely its most valuable asset. The suit first ensued when Elliott purchased over 700 domain names with the word “Google” and after the company had successfully won a name dispute, Elliott filed to cancel “Google” trademarks. Elliott claimed that Google was a generic term and should not receive trademark protection. The Ninth Circuit’s ruling in this case will most definitely affect companies and entrepreneurs of all sizes, perhaps giving companies more protection than they were afforded in the past; what some are calling an unintended consequence.
Dodging Pitfalls on the Path to Success: Entrepreneurs and E-Commerce
The number of Americans who purchase goods online is steadily rising. Recent data published by the U.S. Department of Commerce stated that retail e-commerce had increased by 16.2 percent in 2Q 2017 from 2Q 2016. The report also stated that as a whole retail e-commerce had risen from 3.5 percent of total quarterly retail sales in 2008 to 9 percent as of 2Q 2017. In hard numbers, 2Q 2017 e-commerce generated 111.5 billion dollars in sales. Showing strong growth in under 10 years, these staggering numbers indicate that e-commerce has started to creep up on the traditional brick and mortar (BM) style of retail which has so long dominated the retail landscape. One can only look at the financial data and stock charts of traditional BM stores as well as the REITs that own the malls and land these stores call home to see there has been some effect with this shift.