FDA is urging companies establishing pregnancy registries to consider a collaborative, multiple-product approach to facilitate more useful data collection.

One of the agency's challenges in understanding how drugs affect pregnant women is "the multiplicity of individual product-focused registries," CDER Office of New Drugs Deputy Director Sandra Kweder, MD, said at a Drug Information Association conference in Washington, D.C. May 24.

"That model which exists today...over the long haul is going to limit the productivity of these kinds of studies," she said.

One reason single-product registries are of limited usefulness is the likelihood that a patient will need multiple medications for a chronic or severe condition during her pregnancy, Kweder said.

"Take a woman who has asthma. It's highly likely that she's going to need more than one medicine to treat her asthma, if she has severe asthma, over the course of her pregnancy," she said.

"How would she choose" which registry "to enroll in? She probably won't want to be bothered to enroll in both, if she knew about them at all. How do registries A and B interface?"

Kweder suggested different companies that make the same product should consider joint registries. "It might be a situation when there is an innovator product and one or two more generics," or "where there are actually two innovator products which are actually the same drug...a sort of typical NME and a 505(b)(2) who are ultimately...pretty darn similar and we expect them to behave in the same way."

"In those situations, it makes absolutely no sense to have separate" registries, she said.

In February, a joint Drug Safety & Risk Management/ Dermatologic & Ophthalmic Drugs Advisory Committee approved a risk management program for Roche's Accutane and generics that involves a single, centralized registry (¹ Also see "Accutane/Generics Risk Program Should Include Mandatory Follow-Up Survey" - Pink Sheet, 1 March, 2004., p. 21).

FDA has been grappling with how to collect and communicate data on drug use in pregnant women. A proposal on pregnancy labeling has been under development for several years and is still on the agency's 2004 regulatory agenda.

CDER's pregnancy labeling team is discussing moving birth defects out of the "adverse events" section of labeling (see ² Also see "Pregnancy Adverse Events Could Be Shown Separately Under Labeling Reform" - Pink Sheet, 31 May, 2004. ).

A guidance on establishing pregnancy registries is also ripe for an update, CDER Pregnancy Labeling Team Program Manager Dianne Kennedy told the DIA meeting. "We know that we will be updating the guidance at some point in time," she noted.

"I do have a list of problems that I know needs to be clarified or changed" including the timeliness of updates to the registries, Kennedy added.

FDA published a ³ final guidanceg on the registry in the fall of 2002 (⁴ Also see "Pregnancy Registries May Use External Comparison Groups – Final Guidance" - Pink Sheet, 30 September, 2002., p. 23).

Along with the questions on how to make registries more useful and efficient, the agency expects to address how to handle informed consent issues associated with Health Insurance Portability & Accountability Act regulations.

"It seems to me that with the advent of HIPAA that we are in a perfect situation to allow revision of that guidance," FDA Associate Chief Counsel for Drugs & Biologics Peter Beckerman said.

HIPAA allows for adverse event reporting without informed consent. However, pregnancy registries are generally considered to be research and thus require informed consent.

There is "concern that patients are in fact being potentially discouraged from enrolling in pregnancy registries because of the requirement of gaining informed consent," he said.

Women may be concerned about what will happen to data given to a registry, he noted. "This is precisely the sort of thing that I think is right for including in an updated pregnancy registry guidance."

Merck Senior Epidemiologist Kristine Shields countered that HIPAA's informed consent regs might be leading to more effective registries. Patients who enroll under an informed consent process might be more likely to comply with the registry, she said.

"It hasn't been long enough to collect data on the impact of HIPAA regs," Shields stated. "But its something that I think we can look at in the coming years."

"If you have experience" with registries, "I would encourage you to make your comments to FDA," Beckerman said.

A third area an updated registry guidance might address is promotion of the registry versus standard product promotions.

"Advertising is certainly an area where we are plagued as much as in the HIPAA realm by a lack of guideline rules," Beckerman said.

Kweder added, "this is a question we have struggled with, and it's interesting because oftentimes even within FDA we disagree about what constitutes promotion of the registry versus promotion of the drug."

"We've had a lot of heated discussions with FDA with our drug advertising and marketing people about where that threshold lies."

Overall, Kweder recommended manufacturers take an "arm's length" view on registry promotions. "We have seen some examples where the message that was getting out to clinicians really did cross a line and become promotion in tone."

"I think that kind of depends on how involved the staff is - if it's in the company, who is working on the registry, collecting the data - and we know it's other people in companies who write those pieces," she said.

"I think it's just a matter of taking an arm's length view and being careful."

[Editor's Note: A version of this story first appeared in ⁵ "The Pink Sheet" DAILY May 25. Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.]

Pregnancy Registry Guidance Could Stress Collaboration, Tackle HIPAA

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