A Supreme Court decision expected in the next 6 months will probably help to determine whether and how Congress strengthens the FDA’s authority on drug labeling. That decision would come less than 2 years after the agency was granted significant new leverage in the FDA Amendments Act of 2007. Democrats had wanted to include in that bill—signed by President Bush on September 27, 2007—a provision that allowed patients to sue drug companies in state court for failure to update drug labels. The Bush administration, responding to drug manufacturers, threatened to kill the entire bill if a “preemption” amendment was included.
Congress will probably wait for the Supreme Court decision in a case involving Wyeth before moving forward with new drug labeling legislation. The case involves Diana Levine, a plaintiff who was given the Wyeth antinauseant drug promethazine (Phenergan) in the emergency department (ED) of a Vermont hospital.
The drug’s label, approved by the FDA in 1981, contains warning language about administration via the IV-push method. If the drug gets into an artery, as opposed to a vein, gangrene can occur. That is what happened to Levine, whose right forearm was amputated below the elbow. She sued the hospital and its ED staff for malpractice, and that case was settled. She then sued Wyeth, arguing the company should have changed its label—on its own without FDA approval—to eliminate the IV-push language and instruct clinicians to use an IV drip.
Wyeth argued that Phenergan’s label had been approved by the FDA and that it could not be sued over label concerns in state court because FDA law preempts state lawsuits on labeling. Moreover, Wyeth had asked the FDA in 1988 to strengthen Phenergan’s label language in ways the FDA itself had suggested.
Bert Wein, a Washington attorney who represented Wyeth, said that the change requested by Wyeth and actually recommended by the FDA “was a little bit ambiguous, but could have been read to recommend drip over push.” In 1997, the FDA denied the labeling change application, and told Wyeth to keep the 1981 language.
A Vermont jury awarded Levine $7.4 million and the Vermont Supreme Court upheld the verdict. The US Supreme Court heard the case in early November. It must make a decision on the case before the end of its session next summer but could act before that.
While the marquee issue in the Levine case is whether the FDA can preempt labeling lawsuits under state law, the case also opens the door to a second, allied issue: when can drug companies change their labels without the FDA’s approval? The FDA has a rule called “Changes Being Effected” (CBE), which dictates when companies can make quick changes to labels without FDA approval. Generally, companies have to come up with newly acquired adverse reaction data via a meta-analysis before going the CBE route, according to Wein, who represented the company in Vermont courts.
That CBE rule was the subject of a scathing report from Representative Henry Waxman (D-Calif) in late October, who argued that the Bush administration narrowed the grounds for CBE changes because it wants to keep drug companies from making “overly cautious” risk statements so as to avoid lawsuits. Those overly cautious statements might dissuade physicians and consumers from using a drug that has real benefits for many people—one whose benefits outweigh the risks according to the FDA.
Wein explained that pharmaceutical companies face a natural tension. On the one hand, they do not want CBE policy to be so broad that a state jury could pick out one scientific study with technical shortcomings or ambiguous findings and use it to claim that the company should have changed its label immediately under the CBE policy. On the other hand, a company does want CBE policy to be flexible enough so that it can go to the FDA and discuss the kind of data it needs to produce to get a supplemental new drug application (SNDA) approved. SNDAs are needed for label changes. “Now, in the regulatory real world, you can go into the FDA, talk with somebody who understands data and science and have a dialogue,” explained Wein.