Notice & Comment

Race and Regulation: Getting Evidence into the Record

The government might always struggle to determine, on its own, whether its regulatory choices reinforce racist structures and systems, such as those at work in the provision of health care. But the public need not passively wait for an agency to pay attention to these issues. The public comment process for rulemaking under the Administrative Procedure Act offers a way to place evidence in an agency’s record that it might not otherwise consider, including information about whether a proposed policy is racist or fails to be anti-racist. (If this language catches you off guard, the links might help.)

While sending information in response to an agency’s proposed rule does not guarantee any specific outcome, it triggers an agency’s responsibility to consider the information provided and to respond to it. Commenting also lays the foundation for subsequent litigation, should that be appropriate. Commenting on rules can only ever be an incremental tool, because any given rule only covers so many programs and policy choices, but it leverages a durable, institutionalized framework for policymaking that, over time, touches vast numbers of federal programs.

Last year I filed a public comment with the Food & Drug Administration (FDA) in response to their proposed rule on mammography. This rule, which was not expressly about race, ignored a pocket of literature suggesting the breast density notification portion of the rule may fail to achieve its objectives for Black and Hispanic patients. The public comment process allowed me to bring that literature to FDA and encourage them to reckon with it.

FDA’s Proposed Rule on Mammography

FDA proposed, among other changes, to add a new patient notification about breast density on the report that accompanies mammogram results. As I wrote for Health Affairs:

The issue of breast density, and what it means for cancer risk, is nuanced. As the FDA says in its proposal, “Mammograms of breasts with higher density are harder to interpret than those of less dense breasts, because the dense tissue can obscure cancers.” The Mayo Clinic explains that breast density “increases…risk of breast cancer, though doctors aren’t certain why.” 

This makes it hard for doctors and patients to know … what to do. But patient advocates have argued that patients should be informed of their density finding, so they can discuss options, including additional screening if appropriate, with their doctors.  

Bridget C.E. Dooling, The FDA’s Opaque Approach To Breast Density Communications, Health Affairs Blog (Dec. 13, 2019)

The two proposed notifications (84 Fed. Reg. 11,685) are as follows. For low-density breasts: “Some patients have high breast tissue density (more glands than fat in the breasts), which makes it harder to find breast cancer on a mammogram. Your breast tissue density is low, not high. Follow the recommendations in this letter, and talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” 

For high-density breasts: “Some patients have high breast tissue density (more glands than fat in the breasts), which makes it harder to find breast cancer on a mammogram. Your breast tissue density is high. Some patients with high breast density may need other imaging tests in addition to mammograms. Follow the recommendations in this letter, and talk to your healthcare provider about high breast density and how it relates to breast cancer risk, and your individual situation.”

The goal of any public health message is to help people make informed decisions. The risk with breast density notifications is that patients won’t know what to make of them and that their doctors might not either. Together, doctor and patient might pursue extra testing and procedures that the patient doesn’t need and which carry their own risks. Patients might also be spooked by the ambiguity of the language, leaving them to question the value of getting mammograms in the first place.

In my comment, I expressed several concerns about FDA’s lack of analysis and testing of the proposed breast density notifications. It is routine and good practice for public health agencies like FDA to put public health messages through rigorous testing, to make sure that messages are received the way they are intended. In its proposed rule for mammography, FDA noted only that they sought input from an advisory group. This is no substitute for the testing that FDA’s own risk-based communication policy encourages.

This skipped step is especially worrisome because of some evidence that Black and Hispanic women respond differently than white women to certain mammogram-related messages.

Evidence about False Positive Mammograms 

In 2008, a peer-reviewed study in Radiology showed that a false positive on a mammogram decreased patient willingness to return for screening mammograms in the future. The effect was stronger for Black and Hispanic women. The authors wrote:

After a false-positive result, only 80% of black women and 71% of Hispanic women were likely to continue with screening in the future, compared with 93% of white women (P < .0001). Only 54% of black women and 59% of Hispanic women were willing to return for a second noninvasive procedure despite the possibility of a higher cancer detection rate, compared with 76% of white women (P < .0001). Black women (53%) were also more reluctant to be recalled for invasive studies, and Hispanic women (65%) were slightly less willing to take this risk than were white women (75%) (P < .0001).

Nazia F. Jafri, Rama S. Ayyala, Al Ozonoff, Jacqueline Jordan-Gray, Priscilla J. Slanetz, Screening Mammography: Does Ethnicity Influence Patient Preferences for Higher Recall Rates Given the Potential for Earlier Detection of Breast Cancer?, Radiology (Dec. 1, 2008).

The possibility that the FDA’s proposed breast density notifications could discourage Black and Hispanic patients from getting future mammograms is a red flag. But FDA didn’t discuss this possibility, nevermind test for it.

And the effects of these messages may endure. In 2013, a different peer-reviewed study concluded that three years after a false positive, respondents “reported greater negative psychosocial consequences compared with women with normal findings.”

False positive mammograms are obviously not the same thing as a confusing or alarming breast density notification, but the point is that this research signals that patients can have significant and lasting reactions to the ways their mammography results are communicated.

Studies like this reinforce why testing public health messages is so important. The stakes are very high.

The Importance of Public Participation in Rulemaking

In the example above, FDA missed some studies. I found some of them, and sent them in a comment. To date, FDA has not finalized its mammography rule, and I don’t know if they’re revising the rule to address the concerns I raised. At a minimum, they have a legal obligation to consider them.

Getting good studies into the record is something that anyone can do, particularly the authors of them. Just as a study author might consider writing an op-ed, blog post, or tweet about a study, they should also consider a public comment on a rule as another vector to communicate their findings. The same goes for advocates who are working on any number of issues, including racism.

It’s always hard for an agency to envision all of the potential consequences that a proposed rule might unleash. That’s part of why the public comment process is so critical: it gives the public an opportunity to shine a light on what an agency missed or omitted.