Black box warnings are assigned to prescription drugs by the U.S. Food and Drug Administration (FDA) to alert of serious sides effects, such as injury or death. The smoking cessation drug, Chantix, previously had one of these black box warnings attached to it, but that warning has since been removed. This transition from a “dangerous drug” to a non-dangerous drug raises various important regulatory concerns regarding the marketing of this drug and other popular prescription drugs as well as the role of the FDA in regulating “dangerous” drugs.
Prescription drug price increases have long been a detriment to Americans. The Inflation Reduction Act (the Act) is in part designed to assist in this corporate pharmaceutical problem. This Act plans to do this through the implementation of seven major prescription drug provisions. Two of the major ones are requiring negotiations for certain drug prices by the federal government and limiting the monthly cost-sharing for insulin to $35. Through these changes along with various others, advocates hope that the burden will be lifted off Medicare beneficiaries. It has also been estimated that the Act will work to reduce the federal deficit by $237 billion over 10 years (2022-2031).
In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action. PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.