FDA higher-ups pushed forward with a controversial rule that makes it harder for patients to learn of drugs' side effects despite objections from its own experts, a new report shows. The rule also removes patients' ability to sue pharmaceutical manufacturers when harmed by a drug. In 2006, FDA changed its policy for updating drug labels. Drug makers must now seek FDA approval before adding new information to labels, even if that information is critically important to public health. Critics say the mandatory FDA approval is inefficient and that FDA does not have the resources to act quickly on all label-change requests. The rule also reversed the agency's longstanding position on preemption of common law, according to the new report, released by House Oversight and Government Reform Committee Chairman Henry Waxman (D-CA). If FDA approves a drug and its label, drug makers are shielded from liability, removing the right of citizens harmed by a drug to seek legal redress. From the report: FDA has historically viewed state lawsuits as providing a valuable complement to the agency's regulation of these products.3 The agency has asserted that these cases help to uncover risks that are unknown to the agency at the time of approval and that they provide an important additional layer of consumer protection against unsafe products. The two issues (label-change approval and preemption) are interrelated. By mandating FDA approve changes to drug labels, the agency provides drug makers even more protection from citizen suits. Since the rule preempts common law, FDA approval shields drug makers from so-called "failure-to-warn" claims. The Waxman report shows that experts inside the FDA opposed both controversial aspects of the rule. Dr. John Jenkins, who works in FDA's drug review office, said, "We know that many current approved drug labels are out of date and in many cases contain incorrect information (e.g., the overdose section) … [I]t is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information." Like many others at FDA, officials from research centers inside the FDA objected to preemption of common law: [T]he centers believe that an extensive discussion of preemption should not be included in this rule. The question of preemption is tangential to the purpose of this rule and any controversy that results from including it in the final rule may detract from the public health benefits that will be realized from revising prescription drug labeling. The White House could have been responsible for including preemption in the rule, known as the Physician's Labeling Rule. Waxman's report says Bush administration officials have not turned over all documents related to FDA's communications with the White House. "The documents that have been provided, however, suggest that officials in the White House and the Department threatened to block the Physician Labeling Rule, a major public health initiative on which FDA career officials had worked for many years, until the preemption changes were included," the report says. FDA's rule is bad for consumers and is a prime example of the Bush administration's penchant for making sure regulated industries are subject to as little government and legal oversight as possible. In Waxman's report, Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research, sums it up best: "The rule is not, as it purports to be, consistent with the agency's role in protecting the public health."