U.S. Sen. Lamar Alexander (R-TN) recently stated that the new U.S. Food and Drug Administration (FDA) proposal could stop over 60,000 lab-developed tests that many Americans need to receive lifesaving treatments and cures.
The proposed “double regulation” could stop such tests from being available; in turn, it could stop people from receiving diagnoses, treatments and cures for their diseases.
Rather than adding more regulations, Alexander believes the FDA should be allowing Americans to benefit from new scientific discoveries.
In addition, the “double regulation” would add further costs for these tests. If just one of the 105 tests that are in question is included in the new regulations from the FDA, it would cost $30-75 million for the treatments to gain double regulation. Furthermore, the fact that the other 104 treatments could also be under FDA approval would make the costs even steeper.
“You can quickly see how costs could add up — even into the billions,” Alexander said. “The chair of the Department of Laboratory Medicine at the University of Washington wrote Sen. Murray and me suggesting the proper approach would be to modernize the system to ‘promote continued patient access to affordable, high-quality tests without duplicative regulations.’”
