FDA To Evaluate Prescribing In Pregnancy With “Mental Modeling” Of Doctors

An FDA study to monitor prescribing decisions among care physicians who treat pregnant women could help pave the way for a better understanding of how to communicate drug risks in general.

In the study, "mental modeling" will be used to compare decisions made by physicians who treat chronic conditions, such as allergists and cardiologists, to those made by pregnancy "experts" - obstetrician/ gynecologists, nurse midwives and primary care physicians.

"This data collection and analysis is designed to identify knowledge gaps that FDA could then address, which would ultimately improve decision making and potentially improve health outcomes," according to the Federal Register ¹ announcement of the study.

Identified knowledge gaps can then be "redressed through messages or information campaigns designed by FDA," the announcement explains.

A Broader Trend In Risk Communication

The study underscores the significance of two of FDA's recent initiatives: redesigning the pregnancy section of labeling and implementing the new safety oversight powers created under the FDA Amendments Act of 2007.

The proposed pregnancy labeling rule, with its emphasis on narrative descriptions and registry listings, could represent a new template for risk communication and even data collection, although some of its major tenets have been questioned in industry comments (² (Also see "Pregnancy Registries Should Not Be Mandated In Drug Label, Amgen Tells FDA" - Pink Sheet, 1 Sep, 2008.), p. 18).

The FDAAA safety powers give FDA the authority to impose Risk Evaluation and Mitigation Strategies on products, which can include limiting prescribing for products to specialist physicians. Any evidence that specialists are better at gauging a product's risks could encourage FDA to impose those kinds of limits as part of a REMS.

Any such decisions are sure to raise concerns among stakeholders worried that the agency is already moving into regulating the practice of medicine. However, it is difficult to envision how FDA could decide how to employ any of its new REMS tools without weighing how physicians would use the drug in the absence of restrictions.

[Editor's note: Further discussion of the criteria FDA chooses to impose a REMS is included in a ³ roundtable discussion with agency leadership recently published by The RPM Report, a publication affiliated with "The Pink Sheet." To read the story and sign up for a free trial, please visit ⁴ www.TheRPMReport.com .]

In many ways, FDA's dilemma stems from the fact that while the agency painstakingly crafts the labeling language with sponsors, it has little data on how physicians interpret and use the information.

The agency has long lamented that changes to the official prescribing information often do not change usage patterns, but it is also concerned about what may be an overreaction to safety updates, such as a drop in antidepressant usage that followed the addition of a black box to labeling.

As the agency learns more about what influences prescribing, it could move into not only the practice of medicine, but also the practice of marketing, since labeling itself is not likely the sole basis of doctors' choices.

Analyzing such information will be the task of the agency's relatively new Risk Communication Advisory Committee, which is urging FDA to be more aggressive in collecting data related to the issues (⁵ (Also see "FDA Risk Communication Research May Follow Critical Path To Avoid OMB" - Pink Sheet, 25 Aug, 2008.), p. 11).

Small Study, Potentially Big Impact

The study of pregnancy-prescribing habits is an example of slow data collection that the risk communications committee expressed concern about. The study was originally announced in December 2007 and then re-announced in August with a slightly expanded survey size after review by the White House's Office of Management and Budget.

For the study itself, trained interviewers will speak with up to 30 (instead of the original 24) health care providers from each of the two groups to assess factors that influence their treatment decisions. FDA interviewed six health care providers using the mental model design in pretests, to determine how best to perform the final version of the study.

- Carlene Olsen ([email protected])