Washington, D.C. - U.S. Senators Susan Collins (R-ME) and Claire McCaskill (D-MO) were encouraged by recent remarks by the head of the Food and Drug Administration in support of solutions to help keep prescription drugs affordable and improve patients’ access to medication, echoing the Senators’ bipartisan efforts.
“We share your commitment to increasing generic competition as a way to help improve access and lower prices,” wrote Senators Collins and McCaskill in a letter to Food and Drug Administration Commissioner Scott Gottlieb. “… Last month, we introduced legislation that encourages market competition and makes the approval process more efficient for certain generic drugs, particularly in cases where there is insufficient competition.”
The Senators continued, “We look forward to working with you in your new role to enact our legislation and develop other common-sense solutions to address rising prescription drug costs.”
The Senate Committee on Health, Education, Labor and Pensions recently approved the Senators’ Making Pharmaceutical Markets More Competitive Act as part of the Food and Drug Reauthorization Act.
The Senators’ bipartisan legislation takes a number of steps to enhance regulatory certainty for generic drug companies by setting forth a priority review timeline for generic applications, providing enhanced communications with eligible sponsors, improving transparency, and setting clear expectations about facility inspections.
This legislation builds on the only bipartisan investigation into the causes, impacts, and potential solutions to the egregious price spikes for certain drugs, which was led by the Aging Committee last Congress. From the beginning, the investigation strived to understand why companies can make these large price increases and to identify which policies should be considered to counter these disturbing practices.
Full text of letter HERE.