Gonzalez argued that the high price is justified by investments into research and development. Committee members on both sides of the aisle questioned him on his anticompetitive use of excessive price hikes, patent thickets, and shadow pricing. Committee Democrats focused on how AbbVie charges American patients thousands of dollars more than patients in other countries for American developed and manufactured drugs, while Republicans debated the tradeoff of lower prices and less innovation. To read the full testimony, click here.
The Fairness in the Orphan Drug Exclusivity Act amends the cost recovery prong pathway, where the manufacturers must demonstrate that they do not expect to recoup development costs. The bill is aimed to increase access to affordable opioid abuse treatments. The bill had previously been stalled from unrelated tension between the two lead co-sponsors but passed by a 402-23 vote. To review the legislation, click here.
Eli Lilly filed a motion against the HHS order to repay overcharges and to participate in the discount program moving forward. The lawsuit claims that the acting head of HRSA gave “no legal explanation or justification for the arbitrary June 1deadline.” Eli Lilly requested the Indiana district court to block HHS from moving against them until their suit is resolved. AstraZeneca also requested a judge postpone the June 1 deadline, so that their previous case against the 340B program may be heard in court on June 9, as scheduled. To read the articles on Eli Lilly and AstraZeneca, click here and here, respectively.
The report found that the aggregate spending on research and development for the top 15 drug manufacturers was a record high in2020. Throughout 2020 there was also an increase in clinical trials, not including COVID-19 vaccine trials, with oncology trial starts at an all-time high. To read the full report, click here.