June 8, 2022
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Nina Zeldes, a senior fellow at the Center. We analyze scientific data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
In this session, the committee is asked to vote on whether you agree with FDA’s proposal that all drug products containing lorcaserin hydrochloride should be added to the “Withdrawn or Removed List”.
Since this list includes drug products that were withdrawn or removed from the market because they have been found to be unsafe or ineffective, and because BELVIQ (lorcaserin hydrochloride) has been withdrawn from the U.S. market for safety reasons, there is no reason why this product should still be available for compounding.
In fact, it has long been clear that BELVIQ poses a risk to patients. FDA already alerted the public more than 2 years ago, in January 2020, that the results from a postmarketing study, which evaluated the risk of cardiovascular problems, showed an increased risk of cancer. As a result, FDA asked the drug manufacturer to withdraw this drug from the U.S. market one month later. This trial showed that compared to placebo, patients taking lorcaserin hydrochloride had more total cancers, more cancer deaths, more patients with multiple primary tumors and more patients with metastatic disease. Even if the observed excess cancer risk was small, FDA announced that the risks of BELVIQ outweigh any potential benefits and withdrew the drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”. Delaying the inclusion of unsafe drug products poses an entirely avoidable risk for patients. This is unacceptable.
Unfortunately, this is not the first time that drug products that were deemed unsafe were not added to this list in a timely fashion. When the “Withdrawn or Removed List” was established in 1999, it included 59 drug products and has been updated only twice since then — once in 2016 to include an additional 24 products, and once in 2018, to add another two drug products. These added drugs had in most cases already been withdrawn or removed from market over concerns of safety or effectiveness several years before.
According to Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA shall “convene and consult” an Advisory Committee on compounding, as it does today, and it also allows “the issuance of such regulations before consultation” if the Secretary determines that this “is necessary to protect the public health.” For many of these drugs, including BELVIQ, we argue that an inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.
In addition to adding BELVIQ to the “Withdrawn or Removed List” as soon as possible, we agree with Public Citizen’s 2021 petition that the current regulations should be revised so that every time a drug product is withdrawn or removed from market over safety or effectiveness concerns, that product will also be included on this list at the same time. Such an amendment will reduce the time potentially harmful drugs continue to be available for compounding and will help eliminate this entirely unnecessary risk for patients.
The Advisory Committee voted 10:0 in favor of adding lorcaserin hydrochloride to the “Withdrawn or Removed List”.