Making Objective Drug Evidence Revisions for New Labeling Act Introduced to Senate

On Thursday, September 27, 2018, Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) introduced the Making Objective Drug Evidence Revisions for New Labeling Act or MODERN Labeling Act. The bill provides a solution to a recently identified public health issue impacting patients and their medical providers across the country.

The legislation specifically addresses the prevalence of outdated labels for drugs by giving the U.S. Food & Drug Administration (FDA) the authority to require updating labels to reflect new information relevant to the drug and its use. This Act also establishes a process through which the FDA can identify labels to be updated, notice label holders, and allows for a process for label holders to submit modifications to the notice.

“Medical providers need the most up-to-date information to make the right health care decisions for their patients,” Sen. Bennet said. “We must ensure the FDA has the authority to update prescription drug information for older treatments using the latest clinical evidence. Passing this bipartisan legislation is an important step we can take to modernize prescribing in our health care system.”

Earlier this year, Friends of Cancer Research (Friends) published a study “Outdated Prescription Drug Labeling: How FDA-Approved Prescribing Information Lags Behind Real-World Clinical Practice,” in the peer-reviewed journal Therapeutic Innovation and Regulatory Science. The article showed that most FDA-approved cancer drug labels are missing critical information on drug effectiveness. To discuss this issue, Friends hosted a congressional briefing on the topic of outdated labels. This bill would provide a new mechanism to help ensure consistent and accurate information about medicines over time.

“In an ideal world, a drug’s label would contain all available information healthcare professionals need to prescribe it effectively. Due to a variety of reasons, that is not always the case and physicians are sometimes left to consult outside sources for up-to-date prescribing information,” said Sen. Hatch. “I am pleased today that Senator Bennet joins me in providing the tools the FDA needs to better protect public health. I look forward to continuing to work with my colleagues, stakeholders, and the FDA to advance this policy into law.”

The authors of the report analyzed information on 43 drugs approved during a 12-year period from 1999 to 2011, comparing the number of FDA-approved indications visible on labeling to the number of uses recommended in the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. The report found there were more than four times as many uses on the Compendium than on drug labels, a huge discrepancy considering both purport to offer prescribers guidance on the appropriate uses of cancer drugs. The report also found that 56% of the uses included in the Compendium were “off label,” meaning that these uses were not approved by the FDA.

Friends’ President & CEO, Jeff Allen, said, “We are truly grateful for the work Sen. Hatch and Sen. Bennet, along with their staff, did to translate a study that was conducted by Friends into a legislative solution in such a short amount of time. We commend their bipartisan action to improve public health and urge Congress to pass the MODERN Labeling Act into law.”

For the full legislation text, click HERE.

To read a recently published article in STAT on the bill, click HERE.