Category:Drugs & Devices
The New Hope and Frustration for Alzheimer’s Patients
For the first time in about twenty years, the U.S. Food and Drug Administration (FDA) approved a drug to combat the progression of Alzheimer’s. The newly approved drug is manufactured by Biogen and will be called Aduhelm. The FDA granted fast track designation of the drug to speed up access to patients. While Aduhelm will not reverse already developed Alzheimer’s symptoms, it will slow down the advancement of the disease by removing deposits of beta-amyloid, a protein found in early-stage Alzheimer’s patient’s brains.
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.
Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA
Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.
Politicizing a Pandemic: Emergency Use Authorizations for COVID-19
The Food and Drug Administration (“FDA”) is one regulatory agency that has been on the forefront of the American fight against COVID-19. Historically, the agency has been highly respected for its success in apolitical operation despite its mission of (1) protecting the public health and (2) innovating in the development of medical products. One of its most important tools in the face of a public health crisis is the once obscure regulatory mechanism called the Emergency Use Authorization (“EUA”). But as public trust in the FDA falters, Americans are surely wondering how effective a protective measure can be when it seems to be used as political ammo.
The War on Drug (Prices)
Prescription medications are one of the most common forms of health care intervention, with approximately sixty-six percent (66%) of adults in the United States using prescription drugs. Prescription drugs can provide major benefits to an individual as well as the general population’s health; if successful, prescription drugs can lead to longer and higher-quality lives. However, as drug prices rise unnecessarily, nearly a fourth of American patients experience difficulty affording their medications. A majority of these patients are people with lower incomes and those who are nearing Medicare age.
The United States has higher drug prices than all other developed nations, where in 2010 the average post-rebate medication price was fifteen percent (15%) higher in the United States than in Canada, France, and Germany. Domestic drug companies argue that the price is due to the cost of research and development, however it is the lack of market regulation by the United States government that allows these exorbitant prices. In response to the outcry against high drug prices, on September 13, 2020, President Trump signed an Executive Order on Lowering Drug Prices by Putting America First. The Order includes a “most favored nations” pricing scheme that includes both Medicare Parts B and D, meaning that Medicare now is able to refuse to pay more for drugs than other developed nations. However, this is not enough. The United States needs to take action at both the state and federal level to ensure that prescription drugs are accessible and affordable to all Americans.
A Joint Venture: Medical Cannabis and Workers’ Compensation
In the long standing and highly regulated field of workers’ compensation, a look into the recent landscape of laws, regulations, and court decisions in New Mexico could provide a snapshot into the rapidly accelerating trajectory of medical cannabis regulation within a state’s workers’ compensation system.
DEA Proposes New Rules Aimed to Increase Federal Cannabis Research
On Monday March 24, the Drug Enforcement Agency (DEA) proposed amending the rules under the Controlled Substance Act to expand cannabis research in accordance with a 2016 policy statement. Among these changes includes directing the DEA to take title and physical possession of cannabis plants and increasing the number of entities permitted to manufacture cannabis for research.
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.
Establishing Expanded Use Programs
The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.