Findings; sense of Congress

(a) Findings Congress finds the following: (1) Prescription drug prices are, on average, 2.78 times more expensive in the United States compared to comparable countries in the Organisation for Economic Co-operation and Development (OECD). Drugs that are still under a patent are 4.22 times more expensive in the United States than those in comparable nations in the OECD. (2) Multiple studies have demonstrated that tens of millions of Americans have opted to not fill a prescription due to the prohibitive cost of the prescription. (3) The Food and Drug Administration has entered into Mutual Recognition Agreements with the United Kingdom, the European Union, and Switzerland to recognize drug manufacturing inspections conducted by each entity as valid and equivalent to an inspection conducted by their own inspectors. (4) The Food and Drug Administration, in testimony provided to Congress, acknowledged that fewer negative inspection outcomes were assessed to drug manufacturers in the European Union than in the United States, representing a drug manufacturing industry that is comparably safe and effective to that of the United States. (5) In 2022, the Food and Drug Administration found that 57 percent of all finished dosage form manufacturing sites for drugs categorized as essential medicines were located in foreign nations and relied on importation to reach American patients. (6) Millions of Americans every year already benefit from safely importing their prescription drugs for personal use, which Federal law permits through enforcement discretion and waivers, but such importation remains technically illegal under most circumstances because many foreign drugs do not have the exact same formulations as the Food and Drug Administration-approved versions. Despite Federal law recognizing that patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration the existing restrictions mean Americans who are able to obtain relief from high prescription drug costs by importing prescription drugs for personal use may occasionally lose access to these drugs as they are seized upon importation. (b) Sense of Congress It is the sense of Congress that— (1) the cost of prescription drugs in the United States represents a crisis that endangers the safety of millions of Americans who must choose between their health and financial stability; (2) prohibitions on drug importation originally intended to protect American consumers have resulted in artificially raised prices that harm the American people, even while the same drugs sell for significantly less in other countries; (3) since the initial prohibitions on drug importation were put in place, foreign nations, including Canada, the United Kingdom, Switzerland, and members of the European Union, have significantly advanced their ability to safely approve, manufacture, and transport prescription drugs, including small molecules and biologics; (4) the American pharmaceutical supply chain already heavily relies on drugs that are manufactured overseas and then imported to American patients, a process that has been done safely for decades and with exporting nations with which the Food and Drug Administration does not have a Mutual Recognition Agreement; and (5) it is possible for the American people, with appropriate oversight from the Secretary of Health and Human Services and the Food and Drug Administration, to safely engage in a global pharmaceutical marketplace in order to obtain prescription drugs for fair prices.