A Modern Approach to Drug Labeling
What's in a label? A drug's label is an unbiased source of information available to healthcare providers that helps them prescribe treatments safely and effectively. Federal regulations require that the label contain a summary of scientific information about a drug, and that the information is informative and accurate. The content of the label is written by the drug manufacturer and approved by the Food and Drug Administration (FDA) to ensure that it meets standards laid out in regulations.
The Problem: A new study by Friends of Cancer Research (Friends) shows that many drug labels are considerably out of date, despite the critical role they can play in informing treatment decisions. The study identified more than four times as many uses for drugs on the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium than on drug labels (99 uses on labels vs. 451 uses in the Compendium), a staggering difference between two sources that both intended 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 included in the FDA approved label. However, the FDA can only approve additional uses to labels if the manufacturer submits new data.
The Solution: Patients and their caregivers, physicians and nurses, need high quality sources of information about the prescription drugs they use, and that means up-to-date drug labels. While many sources of information exist, none can deliver as strong assurances of reliability and scientific accuracy as FDA-approved product labels. Labels are the most carefully-vetted sources of prescribing information available today and play a critical role in safeguarding the public health.
On Friday, September 28, 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 responds to a recently identified public health issue and proposes a solution to this issue, which is impacting patients and their physicians across the country. The legislation specifically addresses the prevalence of outdated labels for certain types of drugs by giving the FDA the authority to require updating of labels to reflect new information relevant to the drug and its use. This Act also determines 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.
On June 19, 2019, Senate health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) introduced S.1895, the Lower Health Care Costs Act of 2019, including Section 213 titled "Modernizing the labeling of certain generic drugs." Section 213 of S. 1895 addresses the public health issue of outdated labels identified by Friends work as well as the previously introduced MODERN Labeling Act.
- Click HERE to access the press release from the Senate HELP committee announcing the introduction of the S. 1895.
- Click HERE to access the press release from Sen. Bennet announcing the introduction of the bill to the Senate floor.
- Click HERE for a Friends' announcement on the introduction of the bill to the Senate floor.
- Click HERE for a post-event recap for the March Congressional briefing.
- Click HERE to access the Friends Annual Meeting whitepaper and click HERE for the panel video detailing the initial framework.