February 5, 2018
“Postmarketing studies are critical to ensuring that questions that could impact a drug’s risk-benefit profile are adequately addressed. These requirements are a key part of the agency’s efforts to ensure the safety of products. Postmarket studies often enable the agency to answer certain questions that can’t be adequately evaluated in reasonably-sized premarket approval studies. They allow further evaluation of potential safety issues or enable a better characterization of risk factors for known concerns. This is important because once a drug is approved, a larger population and more diverse range of patients will typically use the drug than were studied before approval. With this larger patient experience, new potential safety issues may emerge that weren’t seen in the studies conducted prior to approval, or that may require additional evaluation after the drug is marketed and used by patients for a period of time. Moreover, the experience from using a drug in diverse, real world settings can often provide valuable information to better inform providers and the FDA about the safe and effective use of new products. We’ve made clear that we’re committed to holding companies accountable for completing these important studies on time. The FDA provides guidance and oversight of firms to ensure the studies are completed, and we communicate directly with companies when requirements are missed,” said FDA Commissioner Scott Gottlieb, M.D. “As we made clear in our fiscal year 2017 report on the performance of firms conducting postmarketing requirements, most companies honor their requirements and complete these important studies in a timely fashion. But there are situations where companies disregard these legal obligations. Today, we posted a warning letter to Lymol for failing to submit their final postmarketing requirement report without demonstrating good cause for the delay. We take the need to fulfill these requirements seriously. The timely conduct of these studies is essential to our ability to protect public health. When we see deficiencies in a company’s progress, we can and will continue to take action. This sends a message not only to one company, but others who may delay conduct of these studies. We’ll continue to hold companies accountable in ensuring these studies are conducted and reported as required.”
The FDA has issued a warning letter to Lymol Medical Corporation explaining that the agency considers their Sterile Talc Powder to be misbranded because the company failed to comply with its postmarketing requirement (PMR). Specifically, Lymol Medical Corporation did not submit a final report for a study intended to assess the lead content in its product by the agreed upon deadline. Failure to comply with PMR milestone dates without demonstrating good cause for the delays is a violation of the Federal Food, Drug, and Cosmetic Act (“the Act”) and renders the product misbranded within the meaning of the Act. This violation is concerning from a public health perspective because the FDA is aware of lead content in sterile talc. Failure to conduct the postmarketing requirement impedes the evaluation of neurological, reproductive, developmental, immune, cardiovascular and renal toxicities from lead exposure through use of Sterile Talc Powder.
- Warning Letter to Lymol Medical Corporation
- Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
- FY 2017 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.