Regulatory Focus™ > News Articles > Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further

Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further

Posted 28 August 2014 | By

Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further

Earlier this year, the US Food and Drug Administration (FDA) released a much-anticipated draft guidance document which could potentially expand the ways in which pharmaceutical and medical device companies could distribute information regarding the safety of their products, even if that information isn't for an FDA-approved indication.

Now the US pharmaceutical industry's largest group, PhRMA, is weighing in on the guidance, giving it rare praise for what it calls the guidance's "balancing of the interests at stake."


FDA has long regulated the dissemination of company-sponsored or –generated studies that include information that have not been specifically cleared or approved by FDA, or do not meet rigorous standards (e.g. aren't Phase III, controlled trials).

But the intent of that policy has been to limit the promotion of products. Industry groups, including PhRMA, have long complained that the policies limit free speech by stifling the exchange of scientific information as well. For example, if a company wants to distribute clinical practice guidelines which mention non-FDA-approved uses of a drug, existing FDA policies limited their ability to do so.

But in February 2014, FDA released a draft guidance, Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices, which is meant to allow companies greater leeway to distribute information pertaining to their products, even when that information isn't necessarily FDA-approved.

For more information, please see our February 2014 story on the Scientific Reprint Guidance.

New Guidance on Risk and Reprints

Then, in June 2014, FDA released its second so-called "reprint" guidance, Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices. Like the first reprint guidance, it focuses on the distribution of quality information. Unlike the first guidance, however, it narrows its focus to the distribution of safety information.

FDA said it "does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study," with the added condition that the study must meet pre-defined criteria for suitability and quality, similar to those contained within its February 2014 guidance. (More Here)


But while the guidance received some negative reviews from consumer watchdogs like Sidney Wolfe of the group Public Citizen, the pharmaceutical trade group PhRMA had mostly praise for the guidance—a rarity for the organization, which has often found itself opposed to FDA actions when it comes to issues of free speech.

PhRMA "supports FDA‘s focus on providing concrete guidance regarding the types of disclosures and other steps manufacturers should take in order to disseminate new risk information without risking regulatory or even criminal enforcement," it wrote in an FDA filing provided to Focus.

"PhRMA believes that the Draft Guidance in many respects reflects an appropriate balancing of the interests at stake," it added, noting that data about a drug's safety and efficacy is collected throughout a product's lifecycle, and not just at the time of approval.

'Good Start… go Further'

That said, PhRMA does have at least one major critique of the guidance: That it doesn't go far enough in some respects.

The group said it was urging FDA "to apply the standards and levels of substantiation proposed in the Draft Guidance not only to manufacturers‘ dissemination of new information about risk, but also to the dissemination of new information about efficacy." To do otherwise would be to "impermissibly restrict truthful and non-misleading communication to healthcare professionals," PhRMA wrote.

The group also indicated that it thought FDA's first guidance adopted an "overly restrictive" stance on the distribution of information by requiring companies to only distribute information which comes from "adequate and well-controlled studies." This requirement exceeds the scope of FDA"s statutory authority, PhRMA wrote.

Comments on the guidance closed 25 August 2014, and will be available on FDA's public docket website.


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