As always, the American Society for Pharmacy Law (“ASPL”) gathered pharmacy attorneys and pharmacists for an excellent three-day conference focusing on pharmacy legal issues. Some of the highlights of the conference:
Regulatory updates: Despite various state and federal attempts to lower drug prices, they continue to grow mostly due to high deductible plans, cost-sharing, increased drug utilization, and expanded coverage. There are several bills pending attempting to lower drug costs. In addition, speakers discussed federal bills to promote generic and biosimilar competition, such as CREATES Act, bills promoting faster market entry, bills limiting “product hopping” and “patent thickets.”
DIR fees: PBMs’ retroactive claw-backs continue to grow despite many discussions on the federal level and state actions limiting retroactive claw-backs.
Drug importation: drugs are still prohibited from importation unless the importation fits within the “Personal use exception.” Several states have enacted drug importation laws (Colorado, Florida, Maine, Vermont). It will take some time to determine the success of such bills.
340b reform: federal government is ready for a 340b reform due to a belief that 340b discounts create additional pressure on manufacturers to increase prices.
HIPAA: data breaches and HIPAA non-compliance continue to cause troubles for pharmacies despite numerous fines assessed by federal government against multiple pharmacies.
CBD updates: Products containing CBD are still not allowed to be sold in pharmacies. Speakers discussed Boards’ and FDA restrictions and possible enforcement actions. The speakers discussed the ubiquitous nature of CBD products and difficulties in enforcing federal and state laws regarding such products.
Online pharmacies: the number of online illegitimate pharmacies continue to increase. About 95% of online pharmacies are selling illegitimate, adulterated or/and misbranded products. The speakers discussed enforcement actions and ways to identify legitimate online pharmacies.
Employment issues: the speakers discussed good business practices to document and analyze employment termination focusing on three major considerations: severity, breadth, and specificity.
Thank you ASPL and the speakers for your dedication to the profession and for keeping us abreast of the developments in pharmacy law.