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# Attorney Praises Off-Label Article
- URL: https://www.fdaweb.com/attorney-praises-off-label-article/
- Published: 2017-06-27T12:00:00.000Z
- Updated: 2026-09-14T22:31:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139031

A *Journal of Law, Economics & Policy* article on how off-label promotion may help patients is being praised by attorney **Stephen McConnell** (Reed Smith) in a *Drug & Device Law* blog [post](https://www.druganddevicelawblog.com/2017/06/law-review-article-on-off-label-is-on-target.html?ref=fdaweb.com). McConnell says the article is “a sane, clear-eyed appraisal of why off-label use of drugs or devices can be necessary, why truthful communication about benefits of off-label use can be necessary, and why current FDA regulation of off-label communications is incoherent and harmful to patients.”

He quotes the article that “the current framework of the off-label use of pharmaceuticals is as follows: physicians are free to prescribe off-label as they see fit; FDA acknowledges the value of off-label use (going so far as to say physicians could have an obligation to prescribe off-label in certain circumstances; but, per FDA policy, drug manufacturers are restricted from sharing truthful and non-misleading information about off-label uses. The scheme, on its face, is inconsistent and, as could be expected, raises significant concerns regarding free speech, consumer protection, and public safety.”

According to McConnell, the journal article makes FDA “seem either clueless or defiant.” He says the author “makes the point that FDA’s truculence and incoherence on the issue are bad for patient welfare in several ways: 

- barriers to truthful off-label communications ensure that poorer patients will get less access to life-saving medications;
- regulatory compliance has been reduced to guesswork; and
- uncertainty about the scope of regulation reduces investment in new drug research.