Public Citizen picks apart Cures 2.0 draft legislation, criticizing several RWE provisions
Consumer advocacy organization Public Citizen on Thursday sent a letter to congressional leaders, seeking changes to a key piece of legislation that will create new FDA reforms if it’s enacted.
The organization took particular issue with the bill, which is the second iteration of the mammoth 21st Century Cures Act or Cures 2.0, as it would increase the FDA’s reliance on real-world evidence in certain circumstances, such as verifying the clinical benefit of drugs following accelerated approvals. Public Citizen said that would:
substantially weaken the FDA’s post-approval study requirements for new drugs approved under the accelerated-approval pathway by allowing the FDA to rely on analyses of clinical care data repositories, patient registries, and other sources of real world evidence — rather than well-designed, randomized, controlled clinical trials — to confirm that drugs approved under this regulatory pathway based on their effect on a surrogate endpoint have an effect on irreversible morbidity or mortality or other clinical benefit.
On the section of Cures 2.0 that would provide $11 billion to establish a new subscription contract program for certain antibiotics, Public Citizen writes in its letter to House Speaker Nancy Pelosi (D-CA) and minority leader Kevin McCarthy (R-CA) that the program “would be unlikely to spur development of truly innovative drugs to combat infections resistant to current treatments…A subscription model is not suitable for critical-need antibiotics because unlike hepatitis C treatments, there is not urgent unmet need driven by high prices domestically, and there may not be competing therapies that are clinically substitutable.”
House lawmakers have already suggested combining the Cures 2.0 bill with a new multi-billion-dollar NIH center, to be known as ARPA-H, which would seek to conduct more high-risk, high-reward research along the lines of DARPA.
“ARPA-H and Cures 2.0 are complementary and the chair will seek to move them together so that we can advance the legislation, not only through the full committee, but through the full House of Representatives,” California’s Anna Eshoo, who serves as chairwoman of the House Energy & Commerce subcommittee on health, said in a statement earlier this month.
Public Citizen also seeks to add several provisions to the Cures redux bill, including a rule to allow generic drug manufacturers to update their labels more promptly to reflect certain types of newly acquired information related to drug safety, regardless of whether the revised labeling differs from the brand name drug (the FDA currently requires generic and brand labels to be identical), adding:
New safety issues commonly arise after generic versions have entered the market, underscoring the imperative of maintaining incentives for robust manufacturer surveillance of safety concerns throughout the life of a drug product. The Food and Drug Administration (FDA) currently does not allow generic drug manufacturers to initiate safety updates to product labeling when they become aware of new risks, although brand-name manufacturers have long had that ability and responsibility. Although the FDA in 2013 proposed a new rule to correct this safety gap, the rule was not finalized and was later withdrawn in 2018.