New FDA Rules Say When Pharma Can Act Alone

Aug 27, 2008
By Pharmaceutical Executive Editors

Depending on your perspective, FDA last week either issued a final rule that gave pharma companies a narrowly defined ability to add warnings to a drug label without FDA approval, or it approved a rule designed to shield drug companies from lawsuits.

The rule covers "change being effected" (CBE) supplements. Makers of drugs, devices, and biologics have to file a supplemental application with FDA when they wish to change a product's label. Under certain circumstances, they may distribute the product, with the new label, before receiving FDA approval.

These are CBE supplements, and the new rule defines when they're permitted. Under the new rule, a company can make a CBE change to add or strengthen a contraindication, warning, precaution, or adverse reaction:

  • when the company has new data
  • when the data are of different type or greater severity or frequency than previously included in submissions to FDA, or
  • when there is sufficient evidence of a causal association with the drug, biologic, or medical device.

That's not a big change from FDA's past practice. "The FDA has long-held the position that a 'change being effected' supplemental application may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only to reflect newly acquired information, and where there is sufficient evidence of causal association with the drug or biologic," stated Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson.

Warning Worry
To understand why some critics are getting excited about the document, you need to look further, to the section where FDA answers comments it received about the ruling. There, FDA asserts that the rule pre-empts state-level lawsuits, at least as long as pharma companies follow the rules. It reasserts its position that FDA-approved labeling is not a minimum—or to use its language, it is not a floor, but a floor and a ceiling—and it declined to make a distinction between situations when a pharma company must warn and when it may warn.

All of this goes very much against the kinds of strategies plaintiffs have been using in recent liability suits against pharma companies.

Gerie Voss, director of regulatory affairs at The American Association for Justice, told Pharm Exec that the association is concerned that the rule will provide drug and medical device companies with the ability to claim complete immunity from claims that might have been brought by consumers injured by defective drugs without proper warnings.

"We don't want to see this [rule] used as a total shield for pharma," Voss said. "And FDA is using their limited resources to put out a rule that essentially gags prescription drug manufacturers from putting out information that could potentially harm innocent Americans."

FDA makes it clear in the final federal register that it "does not agree that this rule will make it more difficult to provide appropriate warnings regarding hazards associated with medical products. This rule is intended to describe FDA's existing labeling standards and policies, but does not amend the standards under which sponsors must provide warnings regarding risks."

PhRMA is siding with FDA, noting that the federal government should have the final say on what are appropriate warning labels.

"Federal law grants the FDA national oversight over drug safety and labeling," Johnson stated. "Congress delegated such a complex task to this agency for a simple reason: FDA's expert staff is the most qualified to make such highly scientific and technical judgments about pharmaceutical benefits, risks and appropriate communication of those risks."

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