No one knows this better than Indiana’s resident drug access warrior, Laura McLinn. Just before his fourth birthday, Laura’s son Jordan was diagnosed with Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease. To ensure that her son and other terminally diagnosed patients had access to experimental drugs that have not been fully approved by the Food and Drug Administration, Laura worked tirelessly to make “right to try” legislation law.
And, with help from my predecessor, Sen. Joe Donnelly, and my colleague Sen. Ron Johnson of Wisconsin, Laura got it to the president’s desk to be signed (with some help from Jordan, who handed the president each of the pens).
Getting to know the McLinns and working with Laura on prescription drug access and price initiatives has been an inspiration for me. The Right to Try Act, which Laura worked tirelessly to advocate for, was an important first step for patients with rare diseases who lack access to meaningful treatments here in the U.S.—like her son Jordon.
But patients like Jordan still cannot use thoroughly evaluated, safe and effective treatments approved by foreign regulators not yet approved by the FDA. And in traveling the state and talking to Hoosiers, I know Americans are tired of paying double, triple or even hundreds of times more for the same drug sold in other countries, especially when drugs that are available in those countries often take critical years to make it to the U.S. market.
Some in Washington are proposing drug importation to solve our drug-pricing and access problems. Others are proposing big-government solutions that only address the demand side and will leave people wanting. The likely result could be reduced access to drugs in other countries, like Canada, and fewer innovative treatments actually launched by drug companies—with little impact on price.
We need to find a responsible solution to high drug prices and access issues that focus not just on the demand side of things—but also on supply side. That’s why I introduced the Accelerated Drug Approval for Prescription Therapies Act.
The ADAPT Act would amend the Food, Drug, and Cosmetic Act to create an accelerated approval pathway to act as a “passing lane” for prescription drugs that have already been approved for sale in other developed countries like the U.K. and Canada with a history of good clinical trials and available data. This pathway would allow U.S. patients more rapid access to meaningful treatments already sold in other developed countries that are proven to work.
The ADAPT Act is not a drug importation bill. Instead, it adds a layer of FDA review that would focus on quality control, supply-chain safety and manufacturing processes in order to increase access to potentially life-extending drugs, drive down prices through increased competition, cut down on a long list of drug shortages, and create a better-functioning overall drug market more reflective of the global economy—all without sacrificing safety for American patients.
Most drugs sold in the U.S. are produced outside of the country, and if we can ensure supply-chain safety for these drugs, introducing more of them to the market quicker could mean major differences in the price of drugs, quality of life for patients, and for some Americans the difference between life and death.
More commentaries from members of the 116th Congress on the state of healthcare