Proposed law would restrict prosecution for off-label communication in U.S.

April 7, 2017 – 8:13 AM | By Andrea Gonzalez | No comments yet

By Mark McCarty, Regulatory Editor

With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government’s ability to pursue charges against manufacturers of drugs and devices based merely on “actual or constructive knowledge” on the part of the manufacturer that the drug, device or biologic will be used outside the FDA-approved labeling. Should the bill pass into law, it would close the book on one of the most hotly contested areas of commercial speech law in recent memory, but there are skeptics about the need for such legislation.

Several cases regarding off-label discussions of drugs and devices have made their way through the courts in recent memory, including two cases the government lost, U.S. v. Caronia and U.S. v. Root. The Medical Information Working Group has filed several petitions with the FDA to revisit its approach to off-label communications regarding life science products of various sorts, and the agency responded earlier this year with two documents intended to clarify some of the underlying issues, one of which was a memo that served as an attempt to clarify some of the issues raised during a November 2016 public hearing on the subject.

In that memo, the agency proposed several alternatives to its current approach to off-label discussions, including an odd proposal consisting of an outright ban on unapproved uses, a highly implausible alternative given that the statute provides no limits to a provider’s authority to treat patients off label.

The legislation by Rep. Morgan Griffith (R-Va.), dubbed the Medical Product Communication Act of 2017 (H.R. 1703), arrives as Congress is examining the user fee deals between the agency and industry, and hence might be seen as an addition to the user fee reauthorization package.

Mit Spears, formerly the general counsel at the Pharmaceutical Research and Manufacturers of America, told Medical Device Daily “the FDA has a very tough job” in that the agency has to ensure that commercial speech about off-label uses does not incur injury to patients and consumers. However, he indicated that while the FDA and attorneys at the Department of Justice are likely to prove more flexible than in times gone by on these issues, changes in the government’s positions on these issues is likely to be evolutionary rather than revolutionary.

Spears, who was also formerly the general counsel for the Federal Trade Commission, said “you can’t just look at one particular document” to establish where the federal government’s position might eventually land. He said the now-suspended final rule published in January “reflects their best judgment at this point in time,” and that while he does not agree with the entirety of the document, that document is nonetheless “well within the scope of a reasoned discussion.”

There may be some question as to where the candidate for the next FDA commissioner stands on this point, but Spears said, “What I’ve seen from [Scott] Gottlieb is that he basically reflects what we’ve reflected in industry for a while,” in that truthful and non-misleading communication about alternative uses for products “is useful and needed by health care providers, and that they can be provided in a way that does not significantly undercut the FDA’s regulatory mission.

“How one goes about moving the policy needle is an open question,” Spears continued, noting that there are a number of constituencies at the agency on this debate, and hence the next FDA commissioner will have to demonstrate a subtle hand in dealing with those constituencies. Robert Califf was still on the job at the FDA when the agency inked the two most recent guidances on the subject, Spears pointed out, and thus “I think he gets some credit for that.”

“I don’t think anybody is going to go over there and sign a piece of paper that changes things overnight,” Spears said. “It’s going to be ‘let’s adjust it and see what happens,’” in an iterative fashion.

Spears did not give voice to outright opposition to Griffith’s legislation, but he observed that thanks to recent case law, “as long as its truthful and non-misleading, [speech is] protected,” and that speech alone will not support an intended use allegation.

“I’m not sure what this bill does beyond that,” Spears said. He also noted that both industry and the Department of Justice can attempt revisit the questions in Amarin and Caronia in other jurisdictions, but he suggested that such an effort is probably superfluous.

“The notion this is somehow limited to the Second Circuit” where Amarin and Caronia were heard is not plausible, Spears said, adding that drug and device makers “can test that theory any time they want.” He stated further that scientific exchange is a limited concept that has a precise meaning, adding, “instead of running down a new constitutional path … we’d all be a lot better off trying to establish what constitutes truthful and non-misleading speech.”

Spears said it is not rational to assume that sponsors of drugs and devices should be prohibited from making known their views on their offerings, simply because the sponsors are possessed of the greatest body of knowledge about those products. The health care system is pressed to maximize its leverage of the available offerings, and hence some sort of communications from the sponsors are essential.

“I would be much happier if [Congress] said FDA had to establish rules that spell out the meaning of ‘truthful and non-misleading,’” Spears said.

Khatereh Calleja, senior VP for technology and regulatory affairs at the Advanced Medical Technology Association, told Medical Device Daily that AdvaMed “believes that robust scientific discourse is in the best interest of the public health, which necessitates access to truthful and reliable information to support patient care.”

“Such communications can and should be clearly recognized by FDA as it will support safe and proper use of sophisticated medical technologies, facilitate further research, and promote robust clinical evaluation for the benefit of the overall public health and move towards realization of a value-based health care system. Such communications should be truthful, not misleading, and scientifically grounded,” Calleja said.

Calleja added that the association is still reviewing Griffith’s bill, but said that any measures that ensure scientific exchange “will provide doctors, nurses and other members of the health care community the latest information on the use of a medical technology to support better care for patients.”


It may not be rational to expect a bill about off-label use to reflect only what the FDA has not committed to, but the new legislation by Griffith covers a fair amount of established turf, including that communications with those with a stake in health care economic information are a legitimate audience for those communications.

As currently written in H.R. 1703, intended use would be determined “by reference to the objective intent” of the manufacturer or representatives thereof “as demonstrated by statements contained in labeling, advertising or analogous oral statements.” However, the draft legislation would not allow the FDA or government prosecutors to determine intended use by any “actual or constructive knowledge” on the part of the manufacturer that the product will be used in a manner inconsistent with the FDA-approved labeling.

The bill would not allow any scientific exchange about the product to be characterized as labeling, advertising or evidence of a new intended use, and offers several conditions under which communications would be legally deemed “scientific exchange.” Among these are that the communication is supported by “scientifically appropriate and statistically sound data, studies or analyses,” and that any communication include “a conspicuous and prominent statement” that the product has not been approved or cleared by the FDA for the use in question.

Griffith spells out the types of exchanges that would qualify as scientific exchange, a list that includes communications at scientific or medical conferences, and dissemination of medical or scientific publications, reference texts or clinical practice guidelines. Despite that the FDA has attempted to relieve the angst over communications with payers in its January release of documents, Griffith added proactive and reactive communication with payers regarding outcomes and health economic information to the list. The final section of the bill would not allow the FDA to require that sponsors clear their communications with the agency prior to dissemination.




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