Drugs & Devices
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.
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.
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.
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.
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.
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.
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.
COVID-19 has rapidly changed the healthcare field unlike anything has before. With the continued spread, healthcare providers have started to adopt telehealth as a way to access patients and continue to provide quality care, without breaking their self-isolation. One avenue that has long been closed off for physicians has been online prescribing, but COVID-19 appears to be changing even that.
Amid the epidemic levels of youth use of e-cigarettes, the U.S. Food and Drug Administration, released a policy on January 2, 2020, requiring enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. According to the policy, the FDA intends to prioritize enforcement against fruit and mint flavored, cartridge-based electronic nicotine delivery system (“ENDS”). The FDA looks to regulate all ENDS products that manufactures have failed to make safe for use, as well as any ENDS product marketed for use by minors. The 2019 National Youth Tobacco Survey (“NYTS”), a survey conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, shows approximately 1.6 million youths were using ENDS products frequently, with nearly one million using e-cigarettes daily. The FDA’s enforcement policy is not a “ban” on flavored cartridges. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considerations on how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.
On September 10, 2019 the Federal Trade Commission (FTC) sent warning letters to three companies that sell oils, tinctures, capsules, “gummies,” and creams containing cannabidiol (CBD) regarding the companies’ false advertising practices. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). CBD does not cause intoxication like THC.