Tag:FDA
A Penny for Your Thoughts and a Billion Dollars for My Medication
As you read this, you’re most likely using a phone or laptop that carries a few patents. A patent is awarded to a person or company in order to protect their intellectual property. Protection of intellectual property rests on the idea that one should be compensated for the time and effort required to produce the patented medium, while others should not be able to profit from the work of another. The patents awarded to your phone or laptop manufacturer allow them recoup research and development expenses and remain competitive against competition. However, the patent system can be abused through patent evergreening and patent thicketing. Evergreening is the practice of obtaining a secondary patent on a slightly modified version of the original patented medium. Thicketing protects the patented medium by creating a web of overlapping or interdependent patents. Recent legislation aims to empower the FDA to decline patent extensions when the slightly modified version of a drug does not yield a clinical benefit.
Exploring COVID-19 Vaccine Authorization by the FDA
As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.” When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.
The FDA Steps in to Stop Unlawful Tranquilizer Imports
The FDA has taken action to stop the unlawful importation of a drug called xylazine by announcing on February 28 that they have issued an Import Alert for drug products or ingredients that have xylazine active products within them. Xylazine is a drug used in the veterinary field and is contained in drugs that sedate animals such as horses and deer (animal tranquilizers). It has increasingly been found within drugs in the illegal drug trade and has been linked to overdose deaths all over the country including California and Pennsylvania. The FDA’s action is part of its initiative to protect public health and stop the presence of xylazine in the nation’s illicit drugs.
FDA’s Role in Food Chemical Safety
The U.S. Food and Drug Administration (FDA) protects people from exposure to adverse chemicals in food through the implementation of rigorous regulations. The FDA can do so through the close evaluation of the use of chemicals as food ingredients and the substances that come into contact with food, as well as the broad monitoring of the food supply for chemical contaminants. This can include the food packaging process, storage process, and other handling measures.
Infant Formula Shortage: How has the FDA Altered Regulations to Help?
Over the past year, the nation has been concerned over an infant formula shortage that has become a crisis for many families in the United States. The Food and Drug Administration (FDA) is responsible for offering support and relief to families affected by this shortage in any way they can. Accordingly, the FDA loosened infant formula regulations. Specifically, the FDA allowed for an increased supply of infant formula by the announcement to infant formula manufacturers of the agency’s intention to temporarily exercise enforcement discretion. Enforcement was on a case-by-case basis, for specific infant formula requirements. This went into effect from May 16, 2022, through November 14, 2022, and was specifically designed to protect infants’ health. Essentially, selective enforcement would allow the FDA to grant permission for formulas despite not meeting all the regulations.
Federal Safeguards Against Drug Shortages
From October 2022 to January 2023, there was a nationwide Adderall shortage. This recent shortage is no surprise since the Food and Drug Administration (FDA) has announced several Adderall shortages since 2019. Although the recent shortage has ended, researchers fear there will be more Adderall shortages in the coming year as prescribing rates continue to rise. More importantly, the recent shortage has made patients worried about future shortages and concerned about why the federal government has not done more to prevent drug shortages.
FDA Restrictions, State Action, and Pharmaceutical Responses to the Abortion Pill
As of March 3, 2023, Walgreens, the second-largest pharmacy store in the United States, has announced that it will not offer mifepristone, the abortion pill, in twenty-one states. This decision followed letters written by Republican attorneys generals in the twenty-one states urging Walgreens not to stock the product, and even threatening legal action against Walgreens if they did decide to move forward with stocking mifepristone in those twenty-one states. Rite Aid and other pharmacies have not yet made a decision on whether they will sell mifepristone.
Got (Plant-Based) Milk? New FDA Guidance for Plant-Based Milk
Plant-based milks have been on the rise congruently with the movement towards living a plant-based diet and lifestyle. The FDA calls these products Plant-Based Milk Alternatives (PBMA). There are many different PBMA’s on the market, because there are a wide array of sources that can be used to produce PBMA’s and methods for processing. Some of the most popular examples of PBMA’s include oat milk, almond milk, and soy milk, but there are many PBMA’s made from other nuts, seeds, and alternative sources. PBMA’s are currently in the news because the FDA has just released draft labeling guidance (guidance) and recommendations for nutrition fact labeling. This draft guidance applies to any PBMA that uses “milk” in its name. The FDA’s draft labeling guidance will likely help educate more consumers on PBMA’s and their nutrition facts, hopefully leading to generally more informed consumers and labeling transparency.
EPA Finalizes Rule Requiring Reporting of “Forever Chemicals”
On September 28, 2023, the U.S. Environmental Protection Agency (EPA) finalized its rule for manufactures of per- and polyfluoroalkyl substances (PFAS), which requires that these manufacturers provide information about what chemicals and the amount that they produce. Effective November 13, 2023, persons that manufacture, have manufactured, or have imported PFAS in any year since January 1, 2011, will now be required to report a wide range of information of PFAS including chemical identity and structure, uses, production volumes, exposures, by-products and health and environmental effects. EPA is taking this action not only to fulfill its obligations under the Toxic Substances Control Act (TSCA) Section 8(a)(7), but also to address this legacy pollution that has been, and continues to be, endangering people across the nation.
From Chatbots to Diagnosis: The Power and Pitfalls of AI in Healthcare
The capabilities of generative artificial intelligence (AI) could completely transform our healthcare system as we know it. For better or for worse, the technology advancements in healthcare are rapidly growing. Given the accelerated rollout, experts have yet to predict all the risks associated with such high-functioning computations in the healthcare system. Even though the Food and Drug Administration (FDA) regulates software being used as medical devices (SaMD), there is an overall lack of urgency, agency oversight, and sufficient regulations to tame AI technology in the healthcare system.