House passes 21st Century Cures Act that would allow some off-label sharing
Rep. Fred Upton (R-MI), who sponsored the 21st Century Cures Act, speaks on the House floor Wednesday.
Lawmakers in the House of Representatives passed the 21st Century Cures Act, a medical innovation bill two years in the making, by a vote of 392 to 26.
The legislation will require the FDA to draft guidance, within two years of the bill's passage, on how real-world evidence can be used to support the approval of a new indication for a drug already approved by the FDA. The bill also aims to also clarify how drugmakers can share healthcare economic information with payers and formulary committees.
The bill includes $1.8 billion in funding for Vice President Biden's Cancer Moonshot initiative as well as state grants to combat opioid abuse.
Although the Cures Act has received bipartisan support, it has also seen its share of critics. Sen. Elizabeth Warren (D-MA) said Wednesday that the bill is a “giant giveaway to drug companies” and that it includes a “provision to make it easier for drug companies to commit off-label marketing fraud by taking drugs approved for one use and using them for another use without any evidence.” Rep. Rosa DeLauro (D-CT) also voiced her opposition, saying Wednesday on the House floor that the bill “allows drugs to be approved with only limited evidence of the drug's safety and efficacy” and noting that the bill does nothing to combat the “excessive” prices of pharmaceuticals.
Public Citizen, the watchdog group, took issue with the bill as well. Michael Carome, director of Public Citizen's Health Research Group, criticized the Cures Act, saying it “undermines requirements for ensuring safe and effective drugs and medical devices.”
Industry groups representing drugmakers and insurers hailed the legislation's passage in the House. PhRMA President and CEO Stephen Ubl said in a statement that the organization believes the legislation “includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development.”
One provision would require regulators to evaluate the usefulness of data collected outside of randomized clinical trials — information that is currently considered off label. It specifically calls for the Department of Health and Human Services to establish a regulatory framework that would be used to determine the usefulness of real-world evidence within two years of the bill's enactment.
The legislation also aims to clarifies the scope of information that drugmakers are allowed to share with payers. The Energy and Commerce Committee, which drafted the bill, has said this provision will clarify “how medical product manufacturers can discuss healthcare economic information of therapies and technologies with insurers and formulary committees.” An expert said this section is designed to instruct the FDA to finalize a provision of the FDA Modernization Act of 1997, which was designed in part to allow manufacturers to provide healthcare economic information to formulary committees under certain conditions.
The FDA is already considering whether to evolve its stance on certain off-label communications. The agency held a two-day public hearing in early November to gather information about off-label communications, after a series of lawsuits were decided in favor of the pharmaceutical industry. During the hearing, drugmakers told the FDA that allowing them to share off-label information with payers is critical as prescribing decisions are increasingly made by health systems and formulary committees rather than physicians.
A provision that would have created new reporting exemptions for the Physician Payments Sunshine Act was dropped on Tuesday. The exemption would have allowed manufacturers to no longer report their payments made to physicians for medical textbooks, journal reprints, and for speaking at continuing medical education events. That provision was struck from the bill after vociferous opposition from Sen. Charles Grassley (R-IA), who co-authored the Sunshine Act, and Warren.