Drugs & Devices
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.
On Wednesday, September 11, 2019, the Trump Administration issued a statement regarding the recent outbreak of illnesses and deaths related to the use of electronic cigarettes (“e-cigarettes”). Soon after, the Food and Drug Administration (“FDA”) quickly followed suit. The Trump Administration’s statement comes after reports of 380 cases of lung illness associated with the use of e-cigarettes in 36 states, in addition to 7 deaths. Both political parties have pressed for flavor bans, age restrictions, and other restrictions on the sale of vaping products. They have urged the FDA to move quickly and decisively to investigate and regulate e-cigarettes. E-cigarettes have been touted by manufacturers as a way to wean people from traditional cigarettes but have recently led to an “epidemic” of youth vaping of nicotine. E-cigarettes are popular among teens due to their availability, advertisements, e-liquid flavors, and the belief that they are safer than cigarettes. The long-term risks of vaping are currently unknown, but a growing numbers of studies show that e-cigarette vapor has severe health risks, including damaging lung tissue and blood vessels.
At first, the story of John Kapoor’s rise to the top of the pharmaceutical industry sounds like the American dream played out in real life. The first to attend college in his family, Kapoor graduated from Bombay University in India with a degree in pharmacy. He came to the United States after securing a fellowship at the University of Buffalo, and earned his Ph.D. in 1972. His scientific and business savvy was evident from the start – in a matter of a decade, Kapoor took over a struggling pharmaceuticals business, turned it around, and netted a personal gain of $100mm. From there Kapoor became a serial entrepreneur, with INSYS Therapeutics marking the pinnacle of his success. The company made him a billionaire, but later made him the target of a criminal racketeering investigation and the face of one of America’s darkest problems.
The Department of Health and Human Services, along with National Institute for Occupational Health and Safety and the Center for Disease Control have begun a concerted effort to fill the knowledge gaps in defining the hazards, exposures, and risks involved with handling nanomaterials. Investigators are working to provide guidance for those working in the field of nanotechnology to address the risks associated with working with animals exposed to various engineered nanomaterials, epidemiologic research, and exposure limits. The National Institute for Occupational Safety and Health has summarized its progress and recommended risk management strategies for those in the field.