Lawyer Monthly Magazine - September 2021 Edition

recalls if hazards are discovered, as the FDA cannot order a recall unless there is reliable information indicating that the product is adulterated or misbranded to an extent that could cause serious harm or death. Pharmaceutical companies can register with the Voluntary Cosmetic Registration Program (VCRP), a post-market reporting system that assists the FDA in regulating cosmetics marketed in the United States. The FDA website states, “Information from the VCRP database also has been used by the Cosmetic Ingredient Review (CIR), an independent, industry-funded panel of scientific experts, to assist the CIR Expert Panel in establishing their priorities for assessing ingredient safety as part of their ingredient safety review”. But the VCRP is just that: voluntary. And the database is only as useful as the products registered. Leaving pharmaceutical companies to self-regulate their products is problematic because there is no guideline for how to test for safety; the definition of “safe” becomes subjective. In the case of Johnson & Johnson, it determined from their testing that the amount of asbestos found in earlier baby powder contaminations was not harmful enough to report — yet there is no known “safe” amount of asbestos. In this way, self- regulation makes it impossible to tell whether a pharmaceutical company is telling the whole truth about their product. Medical Devices — More Regulation, But Not Enough Medical devices are subject to more regulation than cosmetic products, but harmful medical devices still make it onto the market. Health complications from medical devices can be far more severe. Here are some of the ways the FDA regulates them, and where they fall short: Black Box Warnings, or “boxed warnings,” are printed on the labelling of a prescription drug or medical device if there is a risk of serious injury or death associated with using the product. The FDA mandated a black box warning for the female sterilisation device Essure in 2016 amid thousands of reports of complications following placement of the device. As of 2020, there have been over 16,000 medical device reports (MDRs) 54 WWW.LAWYER-MONTHLY.COM | SEP 2021 EXPERT INSIGHT It is time for us to prioritise the health and safety of women and not lining the pockets of companies. of abdominal pain, ectopic pregnancy, organ perforation, and other serious adverse side effects associated with Essure. FDA Adverse Events Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to the FDA. There is both voluntary reporting and mandatory reporting. Manufacturers, importers, and device user facilities are required to report certain device-related adverse events and product problems to the FDA, usually serious injury or death.