The Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (RESULT Act), would amend the Food, Drug, and Cosmetic Act to allow expedited review of drugs, biologic products, and medical devices approved in trusted countries. Expedited review would not be allowed for products that were banned or previously withdrawn in the United States for safety reasons.
The FDA could reject an application for safety or effectiveness or require additional study, but denials would be subject to congressional review.
Expects Bipartisan Support
Two senators—Ron Johnson (R-WI) and Mike Lee (R-UT)—have signed onto the bill. Cruz told the Washington Examinerhe thinks the reform can draw bipartisan support.
“The RESULT Act is a much-needed reform of the FDA to expand access to medical innovations, mitigate critical drug shortages, and lower the cost of medical devices and drugs,” Cruz said. “I call on my colleagues to champion medical innovation and unleash a supply-side medical revolution for patients in the United States.”
Because the producers of drugs, biological products, and medical devices almost always seek approval in the United States, the RESULT Act may open the door for a limited number of treatments. Products for which the owners are seeking FDA approval must undergo a long, arduous, and expensive process which the Tufts Center for the Study of Drug Development found requires an average of more than a decade and $2.9 billion in research costs to get a treatment to market.
Sees As Positive
Ed Hudgins, author of A Modern System for Approving Cures of the Future and research director at The Heartland Institute, which publishes Health Care News, says passage of the bill would be a step in the right direction.
“The RESULT Act would shine a light on the FDA’s unnecessarily slow approval process that leaves so many Americans suffering and even dying as they wait for treatments being used safely by patients in other advanced countries,” said Hudgins.
Hudgins says the approval delays may soon cost the United States its comparative advantage in medical treatment.
“[Without reciprocity], it could mean more investment dollars going to pharmaceutical research outside the United States,” said Hudgins. “Products approved more quickly overseas might then have a faster track to patients in the U.S. through the RESULT mechanism.”
Suggests Further Reform
Hudgins says the FDA process needs even more reform.
“The RESULTS Act would not create the kind of simple parallel track to the FDA efficacy determination as does Free to Choose Medicine reform,” said Hudgins.
“That approach, developed by The Heartland Institute, would allow American drug manufacturers to offer safe, promising treatments to patients who, in consultation with their physicians, need to access treatments years ahead of final FDA approval,” said Hudgins. “It would create a tradeoff evaluation drug database that would allow researchers and patients to provide vital information to the FDA to help it judge which treatments are most effective.”
AnneMarie Schieber ([email protected]) is managing editor of Health Care News.
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act, July 19, 2019: https://www.cruz.senate.gov/files/documents/Bills/2019.07.18_RESULT%20Act-BON19370.pdf
A Modern System for Approving the Cures of the Future, Edward Hudgins, April 2019: https://heartland.org/publications-resources/publications/a-modern-system-for-approving-the-cures-of-the-future