Congress Considers Loosening Restrictions on Off-label Discussions

Health insurers may soon have more data to inform their decisions about which prescription drugs and medical devices they cover.

The Pharmaceutical Information Exchange Act, H.R. 2026, would ease current communication restrictions, permitting drug and medical device companies to discuss off-label information with health insurers. The bill recently passed out of Congress’ Energy and Commerce health subcommittee.

Such a change could benefit patients.

When the FDA approves a drug, it’s typically for one purpose—the primary indication—though doctors may also prescribe it for a host of other reasons. This use is termed “off-label.” Doctors may prescribe off-label if there is not an FDA-approved drug to treat a certain disease or condition, or after their patient has exhausted all other treatment options.

Doctors stay abreast of medical advances by reading peer-reviewed articles, government briefs and professional society newsletters. This keeps them informed about current prescribing guidelines and new evidence—a principle called “informed prescribing.”

Being an informed prescriber might also entail discussions with drug and device company representatives. Yet even though doctors prescribe some medicines off-label, the law forbids them from talking about anything other than a drug’s primary indication during these meetings.

Health plan representatives face the same restrictions.  And while these rules limit doctors’ ability to know about the most recent research outcomes when treating their patients, the restrictions also undercut insurers’ ability to make informed decisions about coverage.  Health plan representatives may determine how to cover prescription drugs, including emerging therapies, without all of the relevant information.

The Pharmaceutical Information Exchange Act would allow drug and device representatives to share findings from research their company conducted in preparation for FDA review of the drug for another indication. The bill requires the information to be truthful and not misleading.  It also requires the company to detail the differences between the existing FDA-approved labeling and the off-label information.

Detractors argue that loosening communication rules will undermine the FDA’s authority and could jeopardize patient safety. But, the reality is that off-label prescribing already happens. It makes sense for everyone involved to have the most relevant and reliable information—directly from the source.

To learn more about informed prescribing and how it furthers patient access, read the Institute for Patient Access’ health policy brief on the subject.

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