Lobbyists create off-label principles following FDA lawsuits

A set of principles compiled by two lobbying organizations that represent U.S. pharmaceutical companies is the latest push from industry to address the lack of updated FDA regulations for drugmakers seeking to communicate truthful, non-misleading product information.

The guidelines, released in late July by BIO and PhRMA, follow a recent case between Amarin and the FDA over Amarin's right to engage in truthful and non-misleading speech with providers about its fish oil pill, Vascepa, despite not having the FDA approval to do so. There have now been multiple court cases that ruled in favor of drugmakers, and not the FDA, on this issue.

The U.S. District Court for the Southern District of New York had ruled in favor of Amarin that the First Amendment protects manufacturers from FDA charges of off-label marketing if the communications are truthful and not misleading. The FDA in December settled a similar case with Pacira Pharmaceuticals. The company had sued the agency after it issued a warning letter saying it could not market its pain treatment Exparel beyond the two surgeries cited in the company's clinical data. The FDA formally withdrew the warning letter as part of the settlement.

See also: The FDA settles with Pacira, rescinds warning letter

BIO and PhRMA set out three key concepts that govern its new information-sharing principles for drugmakers communicating with payers and healthcare providers: communications must be based on scientific- and statistically-sound data; communications should disclose limitations of the data; and those disclosures should be related to data accuracy, not the identity of the speaker.

“The FDA's current regulatory regime is out of step, and inconsistent with the First Amendment, as the courts have increasingly made clear,” Deborah Shelton, BIO's deputy general counsel for healthcare, said in an email. “Clarifying the ability of companies to share truthful and non-misleading information about medicines is essential … to ensure that patients are able to get the right medicines at the right time for them.”

Wayne Pines, president of healthcare for APCO Worldwide, and a former FDA associate commissioner for public affairs, said these principles are a good framework to think about the regulation of medical communications but he doesn't expect the agency to respond to the principles. “It's an important addition to what needs to be an evolution of policy in this area,” he said.

Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner of external affairs, said the principles adhere to practical conditions. “More information is better,” he said, adding that “the question becomes who is the arbiter of truthful and non-misleading information.”

See also: Off-label cases against the FDA move forward

PhRMA spokesperson Andrew Powaleny defended the principles, saying that patients, providers, and insurers want more information about their treatments. “Federal regulations governing information-sharing about medicines have not kept up with this new reality,” he said.

The principles also touch on the importance of using approved labeling as the primary source of information, customizing communications for specific audiences, and what information should be shared with payers.

They note that FDA-approved labeling should continue to be the primary source of communication for approved medicines. In addition, the principles state that communications should be tailored to specific audiences by taking the provider's training and experience into account, and drugmakers should also be allowed to share information about their pipelines, the status of any FDA applications, and pharmacoeconomic information with insurers, pharmacy benefit managers, and government healthcare programs to aid discussions about reimbursement.


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