New FDA Rule Will Require Revisions to Prescription Drug Package Inserts
FDA on Wednesday issued a new rule that will require "major changes" to the design of package inserts for prescription drugs "with the hope of reducing errors in medication use," the Washington Times reports (Howard Price, Washington Times, 1/19). The current design of package inserts is "notoriously complicated," and "there is evidence that physicians don't always follow the labels' recommendations," the Wall Street Journal reports (Wilde Matthews, Wall Street Journal, 1/19).
Under the rule, package inserts must include a new highlights section that summarizes the most important information required to ensure patient safety. The section must list safety warnings, summarize recent revisions to the warnings, provide information on how to use and dose the medication and offer advice to physicians on instructions for patients (Harris, New York Times, 1/19). The section also must use "clear and concise" language, the Baltimore Sun reports (Rockoff, Baltimore Sun, 1/19).
The rule also will require package inserts to include a table of contents, the initial date of FDA approval and a toll free number and online contact to allow patients to report adverse events (Washington Times, 1/19). In addition, diagrams of the chemical structures of medications and legal warnings will appear toward the end of package inserts (Bridges, AP/Detroit Free Press, 1/19).
The rule, the first proposed revision to prescription drug packages in 25 years, will not affect the exterior of packages and will not require new information in the package inserts. Pharmaceutical companies must revise package inserts for new prescription drugs by June 30 and must revise the inserts for medications between one and five years old within seven years (Baltimore Sun, 1/19). New prescription drugs are those that reach the market after May 11 (AP/Detroit Free Press, 1/19).
FDA in a preamble to the rule on package inserts said that product liability lawsuits against pharmaceutical companies should not proceed in state courts (Kaufman, Washington Post, 1/19). The provision states that FDA approval of prescription drug labels "pre-empts conflicting or contrary state law."
The provision included specific cases in which pre-emption would apply but said the scope could extend to other cases. According to the provision, preemption also would apply in lawsuits filed against health care providers who do not inform patients about safety risks "beyond what is included in the label" (Won Tesoriero/Wilde Matthews, Wall Street Journal, 1/19).
FDA officials said that, although the provision does not have legal or regulatory authority, they hope that state judges accept the pre-emption. Scott Gottlieb, deputy commissioner for medical and scientific affairs at FDA, said pharmaceutical company officials convinced the agency officials that they should receive more support because the rule on package inserts will make them more vulnerable to lawsuits (Washington Post, 1/19).
Gottlieb said, "What we are saying is that if a sponsor brings us all their evidence, everything they know about a drug, and we decide what should and should not be included in the label based on our scientific review, then that federal process should have some merit in these 'failure to warn' cases in the state courts" (Reichard, CQ HealthBeat, 1/18). Gottlieb added, "We think that if your company complies with the FDA processes ... you should not be second-guessed by state courts that don't have the same scientific knowledge" (Washington Post, 1/19).
The "real impact" of the provision "will play out case by case," and pre-emption could "change the tactics of plaintiff lawyers and drug-industry defense attorneys," the Journal reports (Won Tesoriero/Wilde Matthews, Wall Street Journal, 1/19).
FDA officials said that advertisements for prescription drugs could change "considerably" as a result of the rule on package inserts, the New York Times reports.
The detailed pages of small print included in magazine and newspaper ads "will most likely disappear," and new print ads likely will include "shorter, clearer statements about common drug risks," according to the New York Times. FDA officials said that television ads also might have to change how they discuss the safety risks of medications (New York Times, 1/19).
The rule on package inserts was "widely applauded," but the liability provision "was quickly attacked by trial lawyers and members of Congress as another effort by the Bush administration to limit the public's ability to bring and win lawsuits," the Post reports (Washington Post, 1/19).
Jonathan Moss, a medical professor at the University of Chicago, said, "The streamlining of package inserts will be very useful."
However, Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "Revisions released Wednesday will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it" (Gorner, Chicago Tribune, 1/19).
In reference to the liability provision, Sen. Edward Kennedy (D-Mass.) said, "It's a typical abuse by the Bush administration -- take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
Joy Johnson Wilson, health policy director for the National Conference of State Legislatures, said, "Where is the authority to pre-empt state law?" She added, "They put in this rule to make it look like it's settled law" (Timiraos, Los Angeles Times, 1/19).
Ken Suggs, president of the Association of Trial Lawyers of America, said that the provision is "the scariest example yet of how much control these big corporations have over our political process" (Washington Post, 1/19).
However, Alan Goldhammer, vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said, "It is important that a pharmaceutical company's efforts to provide vital information in a useful format not be undone by 50 different sets of product liability laws, particularly after a label has undergone the detailed and thorough review and approval of the FDA after years of study by its experts and access to extensive clinical data" (Baltimore Sun, 1/19).