Medicare Compliance & Reimbursement

Long-overdue redesign improves information but sparks controversy.

Physicians may soon find prescription drug labeling information a much more useful tool--but critics worry that the Food and Drug Administration's package insert revisions conceal a hidden agenda.

The potential revisions, which would take effect June 30, 2006, are the first significant changes to package inserts in 25 years and will apply to all new drugs, as well as those the FDA approved within the last five years. FDA hopes the changes will help reduce medication errors, improve physicians' abilities to locate important information about drugs' risks and benefits, and increase adverse reaction reporting among patients.

New Sections, Better Organization Make Important Info Easier To Find

Complex health information and information overload are diluting the public health message, according to U.S. Surgeon General Richard H. Carmona. "This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively," Carmona notes in a recent statement. "This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information."

The FDA drafted the following changes to incorporate actionable health information on drug labeling:

• A new "Highlights" section at the top of the page to provide health care professionals with quick access to important information about drug benefits and risks. In addition, the Highlights section will list recent major changes to the product's prescribing information, contact information for adverse drug reaction reporting and the drug's initial product approval date to help identify how long the drug has been on the market.

• A new "Contents" section to provide easy reference and navigation to all sections and subsections.

• A new "Patient Counseling" section to help doctors advise their patients about medications' uses and limitations.

• Toll-free contact information and instructions for reporting adverse reactions.

• Minimum graphical requirements.

Additional cosmetic changes bring important sections to the front of the insert, such as "Boxed Warning," "Indications and Usage," "Dosage and Administration," and "Dosage Forms and Strengths." The "Adverse Reactions" and "Warnings and Precautions" sections are now back-to-back to consolidate risk information.

"The new label design makes it easier for doctors to get access to important information about drug safety and benefits, and this in turn will help them have more meaningful discussions with their patients," acting FDA commissioner Andrew von Eschenbach asserts in an FDA press release.

The new label information will also integrate with FDA's ongoing electronic health initiatives, including DailyMed, an interagency, online health information clearinghouse. "The revised prescription information format, in combination with new requirements for electronic labels announced earlier this month, and requirements for barcodes on drugs, will dramatically improve the way health care professionals and consumers obtain information about prescription drugs," Eschenbach adds.

Revisions And Preemption Provisions Ignite Mixed Reviews

The American Medical Association applauds FDA's changes, but consumer watchdog group Public Citizen feels they're "a sneak attack on consumer rights." The National Conference of State Legislatures even asked Health and Human Services secretary Mike Leavitt to withdraw the rule or republish it without its controversial preemption language.

"We are pleased that FDA is moving toward development of a comprehensive electronic database to help physicians and patients access the most current prescription drug information online," says AMA's senior public information officer Katherine M. Hatwell.

Although Public Citizen agrees the revisions will help provide better information to doctors and patients, the watchdog group notes that most consumers receive information leaflets that drug companies design and won't benefit from FDA-regulated information. But the watchdog agency's main concern is language in the proposed rule's preamble that could protect drug manufacturers and providers from liability claims. The preemption language could prevent consumers from submitting the old label format as evidence that providers or manufacturers gave inadequate drug warnings. "Product liability lawsuits have directly threatened the agency's ability to regulate manufacturer dissemination of risk information," FDA maintains.