Consumer advocates fear a proposed settlement between a drugmaker and the Food and Drug Administration may embolden more pharmaceutical companies to try marketing their medications for unapproved uses.
Others, however, say the agreement's potential implications have been overblown, though the case behind it continues to raise questions about regulation of drugs used in ways the FDA didn't specifically approve.
The FDA and Amarin agreed Tuesday that the drugmaker may promote an off-label use of Vascepa, a drug approved for lowering triglycerides, so long as the company uses "truthful and non-misleading" speech. According to the proposed settlement agreement, Amarin has the option of submitting up to two proposed communications about the drug's off-label uses to the FDA each year for review.
The settlement follows a ruling in the case last August by a U.S. district judge in New York that the FDA cannot bar truthful, off-label marketing without violating freedom of speech. Doctors have long been allowed to prescribe drugs for off-label uses, but manufacturers have been prohibited from marketing their products for off-label uses.
Dr. Michael Carome, director of consumer advocacy organization Public Citizen's health research group, called the Amarin settlement agreement “troubling.”
“This essentially signals to companies if they want to engage in off-label promotion the FDA is willing to negotiate with you,” Carome said. “It undermines public health and is continuing to chip away at the agency's authority to regulate drugs and make sure they are safe and effective.”
David Rosen, a former FDA official who now represents drugmakers as a partner at Foley & Lardner, said some companies may now want “to test the boundaries here a little bit more.” He does not, however, expect a flood of drugmakers to try to engage in off-label marketing because of the agreement.
“Most of the companies I know of are pretty conservative, all in all, and would rather not spend the time and energy and disruption associated with taking on the FDA,” Rosen said.
Joshua Sharfstein, a former FDA principal deputy commissioner, said he doesn't think the settlement agreement has broad implications. He said the FDA likely settled precisely so the case would not set precedent for other cases. He called settling “the best of a bunch of bad options” for the FDA given the judge's decision in the case last year tying off-label marketing to free speech.
The FDA itself noted in a statement that “this settlement is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech.”
Carome also said that the FDA probably didn't want to appeal the ruling to a higher court and risk setting wider precedent. He wondered whether the shifting makeup of the U.S. Supreme Court—due to the recent death of Justice Antonin Scalia—might inspire the FDA to be more aggressive in defending its regulatory authority in the future.
Sharfstein said the court decision that preceded the settlement is part of a trend of judges limiting the FDA's regulatory powers.
“This trend is very dangerous not only for patients, but also for the long-term interests of the companies because if the FDA is not there to call the balls and strikes on marketing, then companies will be able to get away with a lot and there will be far less of an incentive for good research,” said Sharfstein, now associate dean for public health practice and training at Johns Hopkins Bloomberg School of Public Health.
The case, and settlement agreement reached Tuesday, raise other questions as well, such as about what exactly constitutes “truthful” and “not misleading” marketing about off-label uses of drugs, Rosen said.
Drugmakers should have strong, scientific bases on which to support their claims, he said. “The question is where will companies push that a little bit and how close to the line they're going to get."
In a statement following news of the settlement agreement, Mit Spears, executive vice president of Pharmaceutical Research and Manufacturers of America, said the industry group's members believe “communications with healthcare professionals should be based on analysis using scientifically and statistically sound methodologies, clearly disclose appropriate contextual information about the data presented and ensure that data about medicines presented is represented accurately.”
Spears added that the settlement Tuesday “reinforces the need for the FDA to move quickly to help ensure that healthcare professionals have science-based, methodologically sound medical information available for patient treatment.”
Amarin also said in a statement it remains committed to continued clinical study of Vascepa.
“With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides,” John Thero, Amarin president and CEO, said in the statement.
Carome, however, said it's important not to forget public health when weighing free speech rights.