A major cancer research advocacy organization wants key House lawmakers to include in their upcoming Cures 2.0 package a policy that would give FDA authority to require generic drug labels be updated to reflect new information about the drug and its use.
The request is one of several proposals Friends of Cancer Research (FOCR) includes in a letter to House Energy & Commerce oversight subcommittee Chair Diana DeGette (D-CO) and Rep. Fred Upton (R-MI) on areas to include in the second installment of the 21st Century Cures Act, dubbed Cures 2.0.
In November, DeGette and Upton released their vision for Cures 2.0 and called on stakeholders to propose policies to be included. Those recommendations were due Dec. 16. Several key health care groups have submitted proposals.
In its proposal, FOCR suggests lawmakers include the Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519), which former Sen. Orrin Hatch (R-UT) and Sen. Michael Bennet introduced in September 2018 and which had also been included in the Senate health committee’s original drug pricing bill earlier this year.
Under current regulations, drug sponsors must update labels when they become false, inaccurate or misleading, but according to FOCR, new scientific information about the effectiveness portion of the label often is never incorporated.
MODERN would give FDA authority to identify drugs that have outdated labels and to require the manufacturers update those labels.
A September 2018 press release from Bennet’s office explained that older drugs with expired patents are most likely to have outdated labels because the brand drug sponsors have few, if any, incentives to undertake costly and time-consuming label updates.
“In many cases, the sponsor of an off-patent product may withdraw its drug from the market, which causes generic versions of that drug to rely on a label that cannot be readily updated,” the press release said. “This is because, under current law, a generic drug is required to have the same label as its reference. Therefore, when a reference product is pulled from the market, the generic is unable to update its label.”
The inability to update drug labels can have implications for patient safety and prescription drug competition, FOCR says.
“Out-dated generic drug labels may limit prescribing information available to physicians relative to generic substitutes, effectively reducing competition and patient access to more affordable drugs,” the organization wrote. “Mechanisms should also be explored to give FDA additional authority to assist in updating older labels for which the reference product label has been withdrawn and, according to former Commissioner [Scott] Gottlieb, ‘promote more widespread use of low-cost, generic alternatives.’”
FOCR notes that MODERN requires a House co-sponsor, adding it could be incorporated into a Cures 2.0 package.
In previous discussions about MODERN, health care lawyers told Inside Health Policy the legislation should include liability protection for generics, and they called for extending the bill’s 30-day deadline by which generics must respond to FDA’s label update request.
The Senate health committee’s original drug pricing bill, the Lower Health Care Costs Act (S. 1895), included generic drug labeling language, but that provision was stripped from the latest version of the bill.