Adverse Event Reports (AERs) need to be a major consideration for dietary supplement formulators, labelers, and marketers. Adverse events can happen at any time, even associated with the best of companies. And, they can be alarming for any natural products company. Nonetheless, if these reports are processed appropriately, formulators and consumers will have an invaluable resource on a wide range of compounds.
First, it is important to understand the difference between a common side effect or non-serious adverse event (such as temporary constipation), and a serious adverse event. Only serious AEs must be reported. The FDA regulations define “serious” as an adverse event that:
- Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or
- Requires—based on reasonable medical judgment—a medical or surgical intervention to prevent an outcome described above.
Reporting and documenting serious adverse events in a timely manner for the Food and Drug Administration (FDA) is crucial. It is important to understand what caused these serious events. For this reason, a system is in place for a healthcare practitioner, or the responsible company to send in a particular MedWatch form, specific to supplements, along with its own narrative and explanation. In this way, the FDA can accept reports of adverse events. By analyzing these reports, the FDA may be able to identify products or product ingredients that present a health concern, and take action to protect consumers from potential harm.
Since the Dietary Supplement Health and Education Act (DSHEA) of 1994 was signed into law more than 20 years ago, many individuals, consumer protection groups and members of Congress became concerned that the FDA was not receiving sufficient information regarding adverse events associated with taking dietary supplements. Relying on a voluntary reporting system to detect a harmful dietary supplement was wishful thinking at best. In December of 2006, at the urging of industry trade associations such as AHPA, Congress passed the Dietary Supplement and Non-prescription Drug Consumer Protection Act. Later that same month George W. Bush signed it into law. This law established a definition for serious adverse events and set both labeling and mandatory adverse event reporting requirements for the dietary supplement industry.
Thankfully, in 1993, the FDA created MedWatch, its reporting system for an adverse or sentinel event. This system of voluntary reporting allows information to be shared with the medical community or the general public. Consumers, health care providers, and natural products industry members submitting a non-serious adverse event can report an AER to the FDA office via phone, e-mail, letter or on-line using MedWatch.
In theory, this all sounds great. Ironically, dietary supplement AERs have been consistently on the rise since 2008. But this is not necessarily a bad thing. The increase is an indication of genuine progress companies are making toward the implementation of best practices, part of which is driven by the FDA’s public focus on compliance with AER reporting in its cGMP inspections. Prior to this, there was no mandate on AER reporting, so, it was, for the most part, ignored. Not anymore.
The FDA now generates weekly, monthly, biannual and annual reports from information stored in its electronic database of adverse events to help to identify trends and patterns that would otherwise not be seen. These types of reports help the FDA determine whether there is an association between a specific product and/or compound or ingredient, and certain types of adverse events. Although serious adverse events often garner immediate attention, as was the case in the 2003 death of Baltimore Orioles pitcher Steve Bechler that was linked to ephedra, a non-serious adverse event can still be a signal that a serious adverse event could arise from taking a dietary supplement.
These reports have helped FDA identify several problematic dietary supplements over the years, leading to a number of FDA actions intended to protect consumers, including the 2004 banning of the sale of products containing ephedra.
Interestingly, in the pharmaceutical arena, drug makers have done a less than stellar job of reporting drug side effects. And we all know drugs and side effects go hand in hand. All you have to do is watch a 30-second TV commercial on any drug. Half of the spot is dedicated to the side effects. That long list is also required by FDA, as the balancing requirement for the freedom to advertise Rx drugs direct to consumer, or DTC.
A new report on adverse event reporting by drug makers says pharmaceutical companies in general do a bad job of getting basic information. This makes it next to impossible for the FDA to track the safety of drugs after approval, post-market. The report points out that pharmaceutical companies account for 96% of the AE reports the FDA gets, but fewer than half are considered complete. In comparison, the FDA-collected reports are complete 85% of the time. The study looked at 847,000 reports made during the 12 months that ended March 31, 2014.
It goes without saying that it is the supplier’s responsibility to ensure that all of its products are safe for consumption before marketing them. However, the FDA’s review of adverse events provides a much needed additional measure of protection for consumers. By tracking and analyzing adverse events, the FDA may be able to identify potentially harmful ingredients and warn both consumers and the industry of possible problems. This system is a win-win-win for the FDA, the consumer and our industry so that potential problems may be avoided. The combination of mandatory serious AERs by our industry and encouraging consumers and health care professionals to do their part will significantly help the FDA continue to develop a robust resource from which it can better serve the public’s best health interests, as a Consumer Protection agency.
Mark Becker is the EVP, Sales and Marketing for Allied BioNutrition Corp., a global biotechnology leader, based in Los Angeles, CA. He has worked as a natural products sales and marketing executive for 20 years. Mark has written more than 300 articles and has hosted or been a guest on more than 500 radio shows. He obtained a bachelor’s in journalism from Long Beach State University and did his Master’s work in communications at Cal State Fullerton. For more than 30 years he has participated in numerous endurance events, including more than 150 triathlons of Olympic distance or longer, 103 marathons and numerous other events including ultramarathons and rough water swims from Alcatraz to the mainland. He has relied on a comprehensive dietary supplement and homeopathic regimen to support his athletic, professional and personal endeavors. Follow Allied BioNutrition on Facebook at https://www.facebook.com/AlliedBioNutrition11/?fref=ts. Follow Mark on Twitter at @AlliedMbecker. For more information, access www.AlliedBioNutrition.com.
DISCLAIMER: THE MATERIAL ABOVE AND ON THIS PAGE IS FOR CONSUMER INFORMATIONAL PURPOSES ONLY. NOTHING ON THIS PAGE IS INTENDED AS, OR SHOULD BE CONSTRUED AS, LEGAL ADVICE. SUPPLEMENT COMPANIES SHOULD CONSULT WITH THEIR OWN FDA LAW REGULATORY ATTORNEYS FOR SPECIFIC LEGAL ADVICE ABOUT DSHEA AND AS TO REGULATORY COMPLIANCE.