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Regulatory Focus™ > News Articles > FDA Calls on Industry to Address Lack of Labeling Standardization

FDA Calls on Industry to Address Lack of Labeling Standardization

Posted 05 February 2013 | By

The US Food and Drug Administration (FDA) has announced the launch of a new initiative aimed at voluntarily converting the majority of the pharmaceutical and biologics market to the current standard for content labeling, saying an existing rule leaves too much of the market using outdated standards that could leave consumers at greater risk of safety problems.


Drug labeling has been standardized in the US since 1979, when measures to introduce uniformity were first passed. Since that time, FDA notes that drug labeling has become considerably lengthier and more complex to account for improvements in regulatory science and additional requirements, generally related to the safety of the product.

In 2000, FDA began an evaluation of its labeling processes and requirements with the ultimate goal of improving the labeling to make it more effective at its given purpose: informing its user about the drug's properties, including the risks and benefits associated with its use.

That process resulted in a 2006 final rule, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, better known as the Physician Labeling Rule (PLR).

Under the rule, labeling highlights could be no longer than a half page including the bulleted boxed warning and indications, must contain a "Table of Contents" for easy referencing, must identify all major changes, and must include the date of initial US approval. The label was also reformatted to allow for the most pertinent information to be more prominent, and established 8-point minimum font and other typography requirements to make the type easier to read.

Notably, the new labeling also included contact information (phone number and a website address) to facilitate adverse event reporting.

"Providing healthcare professionals and patients with clear and concise information about prescriptions will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare," said Mike Leavitt, at that time the secretary of the US Department of Health and Human Services (DHHS) under President George W. Bush. "By improving the package insert to make it more useful for healthcare providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients."

The rule applies to all products approved under a New Drug Application (NDA), Biologics Licensing Application (BLA) or efficacy supplement (ES) approved between 2001 and 30 June 2006, as well as all products thereafter. Older drugs may subject themselves to the rule on a voluntary basis, FDA said.

The Rationale for a New, Voluntary Initiative

But changing labels would be a time-consuming affair, and FDA proposed to prioritize labels for new drugs more highly, and then work backward until all drugs utilized a standardized format under the PLR.

That implementation process is set to expire on 30 June 2013, FDA said. But that poses a problem for regulators, which explained that as thorough as the PLR process was, it only accounted for 15% of all drug products on record. "If no further action is taken," FDA said, "the only additional drug products with labeling in the PLR format will be new NDAs, BLAs and ED, which are required to be submitted in that format."

The remaining 75% of drug products generally fall into one of two categories: NDAs and BLAs submitted to FDA before 30 June 2001, and generic drugs.

Generic drugs, it should be noted, were not required under the PLR to convert to the new labeling format unless their reference listed drug (RLD) has done so. By law, generic drugs are required to have the exact same labeling as the RLD. Only 10% of generic drugs have been converted to the PLR, garnering concern from regulators who noted that generic drugs compose approximately 80% of all prescriptions made to consumers.

That being said, "FDA believes that it is in the best interest of the public health to facilitate conversion of generic drug labeling to the PLR format so the labeling is equally useful to prescribers as the labeling for more recently approved drug products."

The Prescription Drug Labeling Improvement and Enhancement Initiative

FDA said in light of the concern that a lack of standardization could potentially harm consumers and was causing difficulties for new electronic systems, it is proposing to implement the Prescription Drug Labeling Improvement and Enhancement Initiative.

The focus of the initiative would be to increase compliance with the PLR for products approved even before 2001, as well as for generic drug products, and would take place over "several years," though FDA's Federal Register notice did not indicate a specific timeframe. Given the huge number of drug products, it would likely be a multi-year process, if not longer.

This process would be strictly voluntary, with FDA prioritizing drugs based on their public health impact. A contractor, not FDA itself, would likely oversee the process, and would facilitate the switch by preparing draft PLR-compliant labeling for applicants who indicate they need assistance with converting the labeling. That supplement would then be sent by the applicant to FDA for review.

The Federal Register notice is somewhat unusual in that it reads much like an advanced notice of public rulemaking, the predecessor of a regulation, but instead notes that FDA would prefer to engage with industry on a voluntary basis. FDA did, however, leave open the possibility of additional rulemaking in the future depending on the response it receives.

The agency is inviting comments on the proposed system, including its feasibility, how to prioritize drug products, how to best facilitate PLR conversions, how to treat generic products that no longer have an active RLD to reference and whether any companies would be interested in participating in a pilot project.

Comments on the proposal are due on 6 March 2013.

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