The third priority area was to dramatically lower drug prices and to use the savings to pay for public health expansion. The CPC wants to improve H.R. 3 in alignment with both drug pricing advocates and the Biden-Sanders Unity Taskforce. Those improvements include expanding the savings to everyone, increasing the number of drugs eligible for pricing intervention (negotiation, launch prices, and inflation caps), capping prices, enforcing negotiation through penalties, and using the savings to expand Medicare. To read the full set of priorities, click here.
The report notably addressed pre-approval facility inspections, which are required for generics to qualify for the 180-day exclusivity period. In the guidance, the FDA stated that they will make a case-by-case decision for ANDA exclusivity as it relies on “specific facts and circumstances”. The industry guidance also answered questions regarding disruptions in the product development phase, ANDA submission and assessment, and marketing as it relates to the pandemic. To review the full report, click here.
Both states’ governors have introduced legislation that will charge drug companies 80% of the price increase above the consumer price index, plus 2%. This is the most recent effort from Governor Baker to lower drug prices in Massachusetts, last year he approved legislation to allow the state to negotiate directly with drug manufacturers for the state’s Medicaid program, saving the state $100M. The fees that manufacturers will be forced to pay will offset the expenses of health centers serving vulnerable populations in Massachusetts. In Connecticut, the fees will go towards the Covered Connecticut Program, which provides insurance subsidies to residents. To read the full article, click here.
The FTC recently announced that they will be working with Canadian and EU regulators to review guidelines on evaluating drug company mergers. Feldman highlights how over the past three decades, pharmaceutical mergers have resulted in the 60 leading pharmaceutical companies merging to 10 companies. In 2017, more than 50% of generic drugs were made from only four companies. Feldman argues that this dramatic consolidation has allowed the drug manufacturers to trade innovation for increased market power and larger product portfolios. To read the entire op-ed, click here.
The study examined Medicare beneficiaries who are not eligible for Medicaid but have an income less than 200 percent the federal poverty level and lack supplemental coverage, such as Medicaid, employer sponsored insurance, or a Medigap plan. These beneficiaries were found to spend an additional $2,288 on out-of-pocket expenses over a two-year timespan and filled fewer prescriptions. The researchers accounted for the fewer prescriptions by the low take-up of Part D subsidies, which the Medicare beneficiaries would automatically receive if they were on Medicaid. To read the full study, click here.