November 20, 2024
I’m Dr. Diana Zuckerman, president of the National Center for Health Research. For those of you who don’t know us, our center is a nonprofit public health think tank that scrutinizes the safety and effectiveness of medical and consumer products, and we don’t accept funding from companies that make those products.
Thank you for the chance to share our views today. Prior to my current position, I was a post-doc in epidemiology and public health at Yale Med School, and was a faculty member and PI at Yale and Harvard. I then moved to Washington DC and was responsible for oversight hearings on FDA while working in the US House and Senate. I’m a founding Board member of the nonprofit Alliance for a Stronger FDA, which educates Congress about the need to financially support the essential work of the FDA.
I completely agree with the presentation of Dr. Brass, and I agree with most of what the previous panel stated as well. So that’s a good start.
We work closely with many other nonprofits and we are a member of the Patient, Consumer, and Public Health Coalition, and so we work closely with patients, consumers, researchers, and medical professionals and want to represent their interests today.
Our Center has strongly supported OMUFA and Monograph reform. We are concerned that OMUFA was being modeled on PDUFA, which we agree was successful in some ways, but not responsive to the needs of patients and consumers. We hope OMUFA will be more responsive to issues of safety, effectiveness, and the interests of consumers compared to PDUFA or MDUFA. For example, consumer groups have expressed concerns about the lack of data on these OTC products, and the reliance on GRASE for years after it was clear that a product was not safe and or not effective. We agree with all of you that scientific evidence is important, but in some cases GRASE relies on old assumptions, and for example we now know that phthalates, PFAS chemicals, and other endocrine disrupting chemicals are often very harmful, but valid tests don’t even exist for many of those thousands of chemicals.
We also agree with those who have expressed concerns about patients being unaware of the different ingredients of combination products such as cold medications, sometimes resulting in overuse of acetaminophen or other products that were in combination products and were also taken separately at the same time. Patients often are unaware that they are using much higher doses than are safe.
At last year’s meeting, we asked for OMUFA to be better than PDUFA and MDUFA in 2 essential ways:
- Performance goals that included metrics involving safety and effectiveness, not just speed of review.
- Negotiations between industry and FDA should be transparent: they should not be behind closed doors.
#2: I’ll address #2 first because it is easier:
Like PDUFA and MDUFA, OMUFA negotiations took place behind closed doors, and consumer advocates and public health advocates were not present. Equally disappointing, there were only 2 meetings with non-industry stakeholders during the year of meetings with industry, and the minutes of those meetings are the opposite of transparent. In almost every case where there was a proposal or a disagreement from either FDA or industry, there was no useful information about the content of those proposals or disagreements in the minutes.
#1: Safety and effectiveness are most important to me and my colleagues in the nonprofit community, but we can’t help but think if the negotiations were more transparent, that would result in metrics clearly related to safety and effectiveness. Instead, such metrics are missing from the commitment letter.
However, there are some mentions in the minutes that are relevant to consumer confidence and quality issues, so I want to take a few minutes to talk about those.
- When FDA tried to include ways to focus on quality at these meetings, the minutes indicate that industry came back with a counterproposal that would reduce the staff FTEs focused on quality issues. Finally, at the meeting on May 14, there were some details that FDA could use OMUFA fees to improve educational resources and a database that includes warning letters – these are useful, but not as important as staff whose job it is to focus on the safety and effectiveness of OTC products, which is what consumers want them to do. Even so, according to the May 20 meeting minutes, it seems even those quality efforts were overruled. The industry counterproposal included the kinds of activities that do not benefit patients or consumers, such as new registrant vetting, targeted fee recovery efforts, and FDA holding a workshop on compliance.
- As I mentioned, the meeting minutes are skimpy so I may have misunderstood. But I have read the commitment letter, and the only mentions of safety are regarding the logistics for safety change OMORs.
- We are very glad that the timeline for safety change OMORs is faster, the cost is free, and they can be initiated by the FDA. That’s the most important topic in the commitment letter for those of us who care about OTC products that benefit patients and consumers.
- What we don’t know, however, is how many staff, paid with OMUFA fees, will be able to dedicate any time to any efforts other than speeding up the reviews and meeting with industry. We want FDA staff to have time to initiate safety OMORs. Even PDUFA uses a proportion of their user fees for post-market surveillance – although MDUFA does not.
- We also ask that there be an easier mechanism for nonprofits and researchers to initiate safety OMORs – Citizens’ Petitions are very frustrating and it would be great if there was an easier process.
- And, 11 new FTE’s doesn’t seem like enough to do all the things that industry has requested in addition to the safety and quality focus that consumers want and deserve.