Two reports in FDC’s “Pink Sheet” focus on the controversial new rule issued by the FDA:
At a January 17 meeting of the committee of the Institute of Medicine whose charge is to examine FDA’s handling of drug safety issues, panelists said drug labels were “irrelevant in terms of changing behavior.”
“It’s well recognized that the label is irrelevant in terms of changing behavior, either physician or patient behavior. There are other ways to change physician and patient behavior and we need to research those and investigate those,” Scott Weiss (Harvard University) said.
The IOM panelists’ assessment flies in the face of FDA’s newly released Final Rule which on the surface places emphasis on labeling changes–changes that some IOM panelists regards as “a waste of time.”
“I think labeling is a complete waste of time,” Vanderbilt University’s Alastair Wood agreed. “It’s much beloved by industry, it’s much beloved by FDA and it’s much beloved by lawyers, but it’s worthless nonetheless.”
Thus, it becomes ever more apparent that the real purpose of FDA’s new rule is to provide drug manufacturers with a blanket shield against product liability by providing the preemption argument with regulatory standing.
This is but another demonstration of the FDA’s lack of good faith with the public. Top agency officials make pronouncements aimed at placating the public when the agency’s abysmal performance is a matter of public hearings, only to push further the interests of drug manufacturers when the heat appears to be down.
Thus, in 2005, when the FDA was under the gun of congressional hearings prompted by a series of revelations showing the agency’s failure to warn about concealed lethal drug effects—such the hazardous suicidal effects SSRI antidepressants produce in children, and the preventable strokes and hreart attacks suffered by patients prescribed Vioxx– top agency officials issued pronouncements to reform the system, making much about FDA contracting the IOM to convene an independent committee to evaluate FDA’s handling of drug safety issues.
But that was in 2004 and 2005. In January 2006, when FDA officials believed the political moment was right, they did not bother to wait for the IOM committee recommendations—for which the agency paid with taxpayer funds—and issued a rule that gives drug manufactures immunity.
FDC reports: “The insertion of FDA’s preemption claim has drawn criticism from some Congressional Democrats who for view the language as a handout to the pharmaceutical industry helping shield them from legitimate product liability.
The National Conference of State Legislatures also criticized the labeling rule for trying to exert unsupported federal power. “This attempt to insert preemption language is a thinly-veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling,” NCSL said. “
Contact: Vera Hassner Sharav
FDS “Pink Sheet”—January 23, 2006
Volume 68 | Number 004 | page 8
FDA Needs Alternative To Labels To Change Behavior, IoM Safety Cmte. Says
FDA needs to develop a more proactive tool to change prescribing behavior rather than relying on labeling, panelists said at the Jan. 17 meeting of the Institute of Medicine’s Committee on the Assessment of the U.S. Drug Safety System.
“It’s well recognized that the label is irrelevant in terms of changing behavior, either physician or patient behavior. There are other ways to change physician and patient behavior and we need to research those and investigate those,” Scott Weiss (Harvard University) said.
“It’s not a question of just knowing the risks and it’s not a question of labeling against risk. The question is how do you change behavior?”
“I think labeling is a complete waste of time,” Vanderbilt University’s Alastair Wood agreed. “It’s much beloved by industry, it’s much beloved by FDA and it’s much beloved by lawyers, but it’s worthless nonetheless.”
The panelists’ discussion came one day prior to FDA’s release of its final rule on updated professional labeling.
FDA’s purpose in reformatting labeling was to make the information it contains more accessible to users. Many of the revisions relate directly to presentation of safety information, to make it clearer and more easily apparent.
During the meeting of the IoM drug safety committee, Wood sparked a debate over the utility of labeling as a viable tool for risk communication.
He claimed labeling fails to steer physicians away from prescribing risky drugs, equating labeling with “these signs on the side of the road that say ‘beware of falling rocks.'”
“The warning that was put on Vioxx said that caution should be used in patients with heart disease,” Wood noted. “I had absolutely no idea what that meant. Did it mean that patients should take it with the light on?”
Wood urged FDA to craft labeling in a way that makes clear the specific issue and instructs prescribers on appropriate use.
“There’s a big distinction between what I would distinguish as ‘action items’ and ‘good to know items,'” he explained. ” If you’ve got an ‘action item’ that says ‘don’t give this drug to children for fever,’ that’s actionable and clearly improves safety. If you’ve got something that’s just ‘oh by the way, people seem to get this problem,’ that doesn’t help.”
FDA’s Judith Racoosin, a safety team leader in the Center for Drug Evaluation & Research, defended labeling as the agency’s best current communication option.
“I understand your feeling that labeling is not worthwhile. But right now that’s one of the main tools we have. We try to warn people, we let them know through letters, we post things on the CDER website.”
However, Racoosin acknowledged that “there’s certainly more we can do to communicate the message.”
In December, FDA sponsored a two-day public hearing to solicit input on the effectiveness of the agency’s risk communication program.
Labeling revisions alone, as well as FDA’s proposed patient information sheets to “convey critical facets of a product’s approved labeling in lay terms,” were criticized as being insufficient; participants advocated more active processes such as educational efforts for risk communication (1” The Pink Sheet” Dec. 19, 2005, p. 30).
Aside from labeling’s role in communicating risks, Wood questioned its ability to prevent adverse events.
“Do you think in your heart that labeling changes have prevented a single case from occurring?” Wood asked FDA’s Racoosin.
“I’m not saying that there aren’t other ways of letting people know,” she admitted. However, Racoosin stood behind labeling’s value in promoting transparency: “I think it’s important when we learn of a potential important side effect of the drug that we let people know.”
“We’re in the business of trying to change outcomes,” Wood said. “The question, it seems to me, that we as a group here need to be addressing is can we introduce interventions that [produce] important outcomes.”
“I don’t believe we prevent these cases by changing the label,” he said.
“Labeling may not change the outcome, but the prescriber and the patient should be that much more aware of the potential risks when they decide to take the medication,” Racoosin responded.
Abbott Pharmaceuticals President Jeffrey Leiden emphasized the role of education in changing prescribing behavior.
“I’m a little more optimistic that it is possible to educate patients and physicians about how to use drugs properly,” Leiden said. “If we do that we can actually leave drugs on the market and improve their benefit/risk ratio if you will, by understanding who should and shouldn’t take it and when they should and shouldn’t take it.”
The utility of spontaneous surveillance systems were also debated by Wood and Racoosin.
“The really scary thing I think is, despite all the effort industry and FDA spend on spontaneous reporting systems, the action items seem to always come from a paper in a journal,” Wood noted. “That’s surprising.”
Wood further scrutinized spontaneous reporting by asking, ” where are all these issues we’re discovering from spontaneous reporting systems that arise and are brought to light by either industry or the FDA? You’re not seeing them.”
Racoosin defended unprompted adverse event reporting by noting that “it’s important to recognize that there’s no doubt about it that many of the things we work on come out of case reports. Many of the things we work on also come out of [the Adverse Event Reporting System] and sponsors looking at their safety databases.”
The Jan. 17 meeting was the fourth time the committee convened to review FDA’s handling of drug safety. The ad hoc committee was created last year as part of FDA’s drug safety reforms, and charged with an independent assessment of the current post-marketing drug safety system. A final report from the committee is expected in July.
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January 23, 2006
Volume 68 | Number 004 | page 7
FDA Makes Preemption Case Once And For All In Final Labeling Rule
The product liability preemption language in FDA’s physician labeling rule applies to all drugs regardless of whether they are regulated by the final rule.
The new language stems from comments by industry that the changes in labeling format could become fodder for liability suits, especially against drugs approved before 2001 that will not be required to reformat their labeling.
“These comments expressed concern that labeling in the old format might be characterized by plaintiffs as inferior to labeling in the new format and, as a result, could be used as evidence that a manufacturer did not provide adequate warnings,” FDA said.
Manufacturers asked FDA to present its stance that the agency maintains the sole regulatory discretion to determine the content of product labeling which preempts many product liability claims (1″ The Pink Sheet” July 9, 2001, p. 22).
“FDA believes that under existing preemption principles, FDA approval of labeling…whether it be in the old or new format, preempts conflicting or contrary State law,” the 2preamble of the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” rule states.
FDA has had mixed success with the amicus briefs it has filed supporting its policy of preemption in several state product liability cases.
“In some of these cases, the court determined that the state law claim could not proceed, on the ground that the claim was preempted by federal law, or was not properly before the court by operation of the doctrine of primary jurisdiction,” the rule states. “In some cases, however, the court has permitted the claim to proceed.”
The presentation of FDA’s preemption position in the physician labeling rule will likely serve as a one-size-fits-all amicus brief for product liability cases.
The legal framework provided in the labeling rule will alleviate the need for FDA to intervene in every case where state action is perceived to conflict with the agency’s mandate.
Because decisions about whether a product liability claim is preempted by FDA’s federal authority will be decided case-by-case at the court level, the agency undoubtedly hopes that its argument – that the integrity of product labeling is essential to FDA’s regulatory function – will be persuasive.
“It will be up to the individual judges, but if they follow our policy advice, then the court cases will turn on the question of whether or not information was properly disclosed to the FDA, not whether it was included in the product label,” FDA said.
The labeling rule enumerates six product liability claims that the agency expects to be preempted by its regulation of drug labeling (see chart: “3The Claim Game”).
FDA acknowledged situations in which the labeling rule would not preempt state law. “The Supreme Court has held that certain state law requirements that parallel FDA requirements may not be preempted,” the rule states.
For example, a state law that assesses damages for violation of FDA requirements “does not impose an additional requirement upon…manufacturers but ‘merely provides another reason for manufacturers to comply with federal law.'”
The original proposed version of the labeling rule – first proposed in December 2000 – did not claim to preempt state laws.
“FDA has determined that this proposed rule does not contain policies that have federalism implications or preempt state law,” the 4draft rule states.
While preemption has been a long-standing issue for the agency, FDA’s assertion of authority attracted considerable attention under former agency Chief Counsel Dan Troy, now with Sidley Austin Brown & Wood (5″ The Pink Sheet” Nov. 22, 2004, p. 15). The insertion of FDA’s preemption claim has drawn criticism from some Congressional Democrats who for view the language as a handout to the pharmaceutical industry helping shield them from legitimate product liability.
The National Conference of State Legislatures also criticized the labeling rule for trying to exert unsupported federal power. “This attempt to insert preemption language is a thinly-veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling,” NCSL said.
While FDA feels its preemption authority is well established in case law, an “FDA defense” clause has been a prominent component of many pieces of tort reform legislation proposed in Congress over the years.
Although tort reform bills have not been successful, product liability protections were provided for bioterror products under a recently signed appropriations bill (6″ The Pink Sheet” Jan. 2, 2006, p. 27). The long-delayed labeling rule, which goes into effect June 30, 2006, is built around a new highlights section at the top of labeling.
Among the documents released in conjunction with the final rule is a draft guidance on the content and format of the warnings and contraindications sections – parts of labeling that are often critical to many product liability suits (see 7preceding story).
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