PDUFA amendment would broaden off-label rules

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A bill that would give drugmakers more leeway to engage in certain off-label communications is being considered as an amendment to the Prescription Drug User Fee Authorization (PDUFA).

The Medical Product Communications Act was introduced by Rep. Morgan Griffith (R-VA) in March. If enacted, it would change how the FDA interprets a drug's intended use.

The provision is being considered as a potential amendment to the PDUFA, which partially funds the FDA by allowing them to receive fees from drugmakers to review their products. The Senate is expected to vote on the user-fee bill this summer. However, media reports have indicated that opponents of off-label regulatory changes are opposing the addition of the amendment.

See also: Califf calls for marketers to develop off-label 'code of ethics'

John Kamp, executive director of the Coalition for Healthcare Communication, said the bill's chances of staying in the PDUFA reauthorization bill seemed unlikely at this point. “My guess is that the provision will be stripped out to avoid the partisan fight,” he said in an email.

Some patient groups have been vocal critics of changing the way off-label communications is regulated in favor of drugmakers. The bill is “dangerous legislation,” that would allow drug and device makers to “circumvent FDA review,” Michael Carome, director of Public Citizen's Health Research Group, said in a June 5 release.

The definition of a drug's intended use is an important part of the ongoing debate as to whether drugmakers can to share truthful and non-misleading information about their products. Currently, the agency may determine a drug's intended use from a manufacturer's advertising as well as from other forms of communications it has developed about its products. If a company shares information outside of a drug's approved labeling, it would signal to the FDA that the company is declaring a new intended use for that product and as a result it would be considered misbranded.

See also: 5 questions raised at the FDA's off-label hearing

This bill would amend the Federal Food, Drug, and Cosmetic Act so that “the scientific exchange of information shall not constitute labeling, advertising, or evidence of a new intended use.”

It would allow the publication of results of scientific studies, communications at scientific or medical conferences, and communication around a drugmaker's R&D efforts to no longer be considered off-label communications, as long as it is “supported by scientifically appropriate and statistically sound data, studies, or analyses.” The proposed legislation will not allow off-label communications to patients. 

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