Regulatory Focus™ > News Articles > Legislation Looks to Overhaul Requirements for Presentation, Content of Drug Information

Legislation Looks to Overhaul Requirements for Presentation, Content of Drug Information

Posted 25 April 2013 | By Alexander Gaffney, RAC

A new piece of legislation introduced in both the US Senate and House of Representatives last week seeks to make changes to the statutory requirements surrounding the authorship, content, format and dissemination of information about pharmaceuticals.

Background: General

Drug labeling has been mostly standardized in the US since 1979, when measures to introduce uniformity were first passed. But since that time, the US Food and Drug Administration (FDA) has noted 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), which was aimed at standardizing the drug labeling process.

That process notably did not apply to drug information dispensed alongside a product, such as information dispensed by a pharmacist at the time the prescription is filled.

Background: Legislation

That's where a new piece of legislation, the Cody Miller Initiative for Safer Prescriptions Act (H.R.1608 and S.752), stands to make a difference. The legislation, which has been introduced during past sessions, was again introduced on 17 April 2013 by New York legislators Sen. Kirsten Gillibrand (D) and Rep. William Owens (D).

In a statement announcing the legislation, Owens said the legislation was a tribute and a response to Cody Miller, a teenager who reportedly committed suicide after switching to a once-a-day version of Merck's Singulair (montelukast) to control his allergy to ragweed. The company subsequently updated its warning label to include the possibility that some patients taking the drug might experience suicidal thoughts and ideations, but the connection was never definitively established, particularly similar effects were never observed during controlled conditions. The issue has since largely fallen off the radar on account of FDA concluding its investigation into the drug, saying that "available data were limited" given the uncontrolled conditions.

Miller's unique circumstances aside, the broader rationale for the law, said Gillibrand in a 2012 statement, is to make sure everyone is aware of potentially dangerous drug-drug interactions (DDIs) or other side effects. At present, that information can either be out of date or not present at all.

"Consumers have a fundamental right to know the risks associated with their prescription medications," Gillibrand said.

"Many consumers do not understand that without this being done, they will receive watered-down information that may or may not be completely current and accurate," said Kate Miller, Cody's mother, in a statement provided by Owens. "It is a no-brainer, we must look at this as just another consumer safety issue, one that has been sorely overlooked and can be corrected with these changes this bill proposes."

Legislative Provisions

The Cody MillerAct has several primary provisions which would serve to require the US Department of Health and Human Services, likely through FDA, to issue regulations on the content, format and distribution of drug-related information in what Owens described as "consumer-friendly language."

"This information would be updated and uniform regardless of the store or service from which the prescriptions were received," according to Owens.

The rule would principally apply to patient medication information, sometimes better known by the acronym PMI. FDA has already looked into the issue of standardizing PMI, which includes package inserts, consumer medication information, and medication guides (MedGuides).

"By objective measures, current systems for providing high-quality, easily accessible prescription medication information to patients have failed," FDA wrote in a Federal Register notice published in 2010. A 2008 study cited by FDA showed that just 75% of consumer medical information met "minimum criteria for usefulness," and the agency's Risk Communication Advisory Committee (RCAC) issued a statement in 2009 that FDA should move toward a single standard for communicating PMI.

To date, however, that has not occurred despite FDA's efforts to build such a standard.

Owens' and Gillibrands' legislation would force FDA to issue such a system within two years. Among the various requirements for PMI:

  • Information would have to be scientifically accurate and based on approved labeling.
  • it would have to be written in " nontechnical, understandable, plain language that is not promotional in tone or content.
  • it would establish minimum content requirements, including the name, directions for use, contraindications and ways to reduce side effects.
  • Updates would need to be timely, information applied consistently and the process tested by consumers.

The legislation would also charge the National Institutes of Health (NIH) with maintaining copies of these PMI on its "DailyMed" web database, which tracks FDA labeling and other drug information.

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