Steve Mister, Esq.09.01.06
First, do no harm. For several thousand years, this has been the mantra of healthcare practitioners. As self-care products like dietary supplements play an ever increasing role in our understanding of healthcare, helping us shift the paradigm from curing diseases to staying healthy in the first place, it's only appropriate that supplement manufacturers take a similar oath to do no harm. And that includes supporting legislation for a mandatory system of reporting serious adverse events potentially associated with dietary supplements.
Why should manufacturers agree to accept this responsibility? Quite simply: it's the right thing to do. It's what a mature, responsible industry does to take ownership of the potentiality for harm. It's what companies that rely on a bond of trust with their customers do to help reduce the safety risks of their products.
Everyone in this industry would love to return to the days of double-digit growth. We want our products to be considered by new customers-not just those converted consumers already passionate about our products. We want to be seen as part of the future of healthcare, a "prevention" alternative to "curative" and "treatment" modalities of allopathic medicine. But all that requires credibility on the safety of our products.
Dietary supplements have wide margins of safety and relatively miniscule numbers of adverse events associated with their usage. As manufacturers of supplements know firsthand, there are ways to ascertain the safety of these products, including evidence from clinical trials, observational studies, risk assessments and even years (sometimes centuries) of safe use. Manufacturers assure news reporters, regulators, in-vestors and their customers that in this nearly $21 billion industry there are very few consumer complaints of serious adverse events connected with supplement usage, and of the few complaints received, the likely causes are generally not from the appropriate use of the supplements.
But if manufacturers are not required to tell the FDA when they receive a report of a serious health consequence considered to be associated with their product-or for that matter even keep any record of having received these reports-why should consumers have any faith that the products are really safe? The memory lives on of a marketer of ephedra-containing supplements routinely assuring both FDA and Congress in the late 1990s that it had re-ceived only a handful of health complaints from users of its products. When the agency finally obtained a court order to turn over the files, there were thousands. That may have been an anomaly in this industry, but how is a consumer or FDA to know who's telling the truth-or who's just not talking?
Let's face facts: consumer confidence in dietary supplements is really taking it on the chin these days. From the muckraking of network news programs and the misleading headlines of national newspapers to the bias toward pharmaceuticals displayed by medical organizations and government agencies, consumers are not hearing much these days to foster their trust in the safety or benefits of supplements. So the lingering suspicions about possible serious health concerns sitting in a manufacturer's files only compound our other problems.
That is the background against which the current effort to enact man-datory adverse event reporting (AER) is being played out. SB 3546, introduced by Senators Orrin Hatch (R-UT) and Richard Durbin (D-IL), will compel three things. First, it will require manufacturers, packagers and distributors (but not retailers) of dietary supplements to notify FDA when they re-ceive a report of a serious adverse event that may be associated with one of their products. Second, it will re-quire manufacturers to put an address or phone number on their labels where consumers can submit these reports. Existing federal regulations already require an address on the label of all dietary supplements, so this isn't really anything new, just something that appropriately serves the consumers' needs. And third, the law will require that manufacturers provide FDA with additional medical information that they receive about the purported adverse event even if it is obtained up to one year after the initial report.
Along with these proposed new requirements, there are a whole host of protections in the bill that will de-fend manufacturers from misuses of this information. The bill assures manufacturers that their reports will not be used by product liability attorneys as admissions that their products caused or even contributed to the alleged harms they report. It protects the identifiable information of the subjects of the complaints so lawyers can't use these reports to create lists of potential plaintiffs for their next class action. It also allows companies who submit reports to submit supplemental information (that becomes a permanent part of the report) that helps to exculpate the supplement from the complaint. So if an overweight chain smoker with high cholesterol and a history of heart disease blames his third heart attack on the echinacea he took when he felt a cold coming on, that medical history can become part of the adverse event report.
There are other protections too. The bill preempts states from enacting their own competing systems of AERs and restricts states that obtain the information from FDA from making improper use of this material. It also requires FDA to take steps to eliminate duplicate reports of the same incident, a problem that plagued the industry during the ephedra battle. If a consumer files a report with the manufacturer and the consumer's wife calls FDA's Medwatch line, and the doctor files another report with a poison control center that alerts FDA-all about the same incident-the records will be compiled into one report.
So why are AERs important to FDA anyway? FDA has long regarded ad-verse event reports as critical early signals of potential health hazards. Prescription drugs, medical devices and many OTC products have been required to file their serious AERs for years, while consumers, healthcare providers or manufacturers of cosmetics, dietary supplements and conventional foods submit them to FDA on a voluntary basis. Given the ag-ency's use of AERs in connection with the ban of ephedra-containing products in 2003, the industry seems to have a preoccupation that AERs are primarily used to remove an entire ingredient from the market. But that's not the case. AERs are just as often an early signal of a more limited issue. Perhaps it's a contamination problem in an individual plant-i.e., suddenly a variety of products all made in the same facility are showing heightened bacteria levels and making people sick. Or perhaps it's a raw ingredient contaminated with pesticides or heavy metals that is sold to multiple finished product marketers.
If each company keeps its reports to itself, no one would ever connect the dots and trace the common problem back to the supplier. It could even be an incident of bioterrorism or product tampering. The innocent, but nonetheless silent, manufacturer in a state of denial could allow the problem to continue much longer than it should because the reports are not turned over to an objective third party for review. These are the kinds of problems mandatory AERs may prevent.
There are those who oppose this effort to make AERs mandatory for manufacturers. Some say that this legislation will lead to a tsunami of AERs pouring into supplement manufact-urers, most of which will be illegitimate but calculated to defame the industry. And from whom will these reports come? As already explained, consumers have the ability now to report AERs to either the manufacturer or directly to FDA. If one wanted to discredit the industry, wouldn't they already be filing false reports with FDA? Where is the tsunami now?
Objectors to this bill seem to feel that requiring manufacturers to report these events will take away "health freedom," remove safe products from the shelves, and drive industry out of business. These are the same slogans of those who resist government regulation of any kind. But I've yet to hear anyone who can logically explain how mandating that manufacturers disclose to FDA possible adverse events associated with their products is going to dry up the supplement marketplace and deny consumers access to vitamins. In fact, quite the opposite should occur.
By publicly standing behind the safety of our products, we're building a stronger, more reliable industry in which consumers can have faith that if something goes wrong, FDA will have the opportunity to investigate and quickly correct the problem. Transparency behind safe products will lead to a more robust and growing industry.
Then there are those who oppose mandatory AERs by predicting that allowing FDA access to this information is the first step to eventually requiring pre-market approval for our products. As long as our products maintain their safety records, mandatory reporting of AERs will not serve that purpose. If anything, by opening our file cabinets that house adverse event reports-file cabinets that are largely empty because there are so few serious reports-the industry may very well be fending off further un-necessary regulation, like calls for pre-market approval of supplements, by demonstrating how safe these products really are.
Some have asked if the need for mandatory reporting of adverse events will become superfluous once the final rules on good manufacturing practices (GMPs) specific to dietary supplements are released. The industry has been waiting for GMPs for 12 years, ever since the passage of DSHEA. But GMPs and mandatory reporting of AERs are not an either/
or proposition. For one thing, the pharmaceutical and medical device industries already have both GMPs and AERs. GMPs won't prevent an adulteration that occurs after the product leaves the plant, as is the case with product tampering or bioterrorism events. GMPs and AERs are two different but necessary approaches to the same issue of product safety. GMPs are the pre-market assurance that the manufacturer is taking reasonable steps to make a quality product; AERs are the post-market sur-veillance further demonstrating that manufacturers take responsibility for their products once they enter the marketplace.
Let's be realistic. Even when final GMPs are released and even if reporting serious adverse events becomes mandatory, that doesn't mean all our industry's problems will disappear. But these two pieces of regulation and legislation will act as bookends supporting the safety of dietary supplement products and helping ensure the consumer that responsible companies take responsibility for their products.NW
About the author: Steven Mister is the president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C. He can be reached at 202-776-7929.
Why should manufacturers agree to accept this responsibility? Quite simply: it's the right thing to do. It's what a mature, responsible industry does to take ownership of the potentiality for harm. It's what companies that rely on a bond of trust with their customers do to help reduce the safety risks of their products.
Everyone in this industry would love to return to the days of double-digit growth. We want our products to be considered by new customers-not just those converted consumers already passionate about our products. We want to be seen as part of the future of healthcare, a "prevention" alternative to "curative" and "treatment" modalities of allopathic medicine. But all that requires credibility on the safety of our products.
Why the Industry Needs a Mandatory AER System
Dietary supplements have wide margins of safety and relatively miniscule numbers of adverse events associated with their usage. As manufacturers of supplements know firsthand, there are ways to ascertain the safety of these products, including evidence from clinical trials, observational studies, risk assessments and even years (sometimes centuries) of safe use. Manufacturers assure news reporters, regulators, in-vestors and their customers that in this nearly $21 billion industry there are very few consumer complaints of serious adverse events connected with supplement usage, and of the few complaints received, the likely causes are generally not from the appropriate use of the supplements.
But if manufacturers are not required to tell the FDA when they receive a report of a serious health consequence considered to be associated with their product-or for that matter even keep any record of having received these reports-why should consumers have any faith that the products are really safe? The memory lives on of a marketer of ephedra-containing supplements routinely assuring both FDA and Congress in the late 1990s that it had re-ceived only a handful of health complaints from users of its products. When the agency finally obtained a court order to turn over the files, there were thousands. That may have been an anomaly in this industry, but how is a consumer or FDA to know who's telling the truth-or who's just not talking?
Let's face facts: consumer confidence in dietary supplements is really taking it on the chin these days. From the muckraking of network news programs and the misleading headlines of national newspapers to the bias toward pharmaceuticals displayed by medical organizations and government agencies, consumers are not hearing much these days to foster their trust in the safety or benefits of supplements. So the lingering suspicions about possible serious health concerns sitting in a manufacturer's files only compound our other problems.
That is the background against which the current effort to enact man-datory adverse event reporting (AER) is being played out. SB 3546, introduced by Senators Orrin Hatch (R-UT) and Richard Durbin (D-IL), will compel three things. First, it will require manufacturers, packagers and distributors (but not retailers) of dietary supplements to notify FDA when they re-ceive a report of a serious adverse event that may be associated with one of their products. Second, it will re-quire manufacturers to put an address or phone number on their labels where consumers can submit these reports. Existing federal regulations already require an address on the label of all dietary supplements, so this isn't really anything new, just something that appropriately serves the consumers' needs. And third, the law will require that manufacturers provide FDA with additional medical information that they receive about the purported adverse event even if it is obtained up to one year after the initial report.
The Safeguards in the SB 3546
Along with these proposed new requirements, there are a whole host of protections in the bill that will de-fend manufacturers from misuses of this information. The bill assures manufacturers that their reports will not be used by product liability attorneys as admissions that their products caused or even contributed to the alleged harms they report. It protects the identifiable information of the subjects of the complaints so lawyers can't use these reports to create lists of potential plaintiffs for their next class action. It also allows companies who submit reports to submit supplemental information (that becomes a permanent part of the report) that helps to exculpate the supplement from the complaint. So if an overweight chain smoker with high cholesterol and a history of heart disease blames his third heart attack on the echinacea he took when he felt a cold coming on, that medical history can become part of the adverse event report.
There are other protections too. The bill preempts states from enacting their own competing systems of AERs and restricts states that obtain the information from FDA from making improper use of this material. It also requires FDA to take steps to eliminate duplicate reports of the same incident, a problem that plagued the industry during the ephedra battle. If a consumer files a report with the manufacturer and the consumer's wife calls FDA's Medwatch line, and the doctor files another report with a poison control center that alerts FDA-all about the same incident-the records will be compiled into one report.
So why are AERs important to FDA anyway? FDA has long regarded ad-verse event reports as critical early signals of potential health hazards. Prescription drugs, medical devices and many OTC products have been required to file their serious AERs for years, while consumers, healthcare providers or manufacturers of cosmetics, dietary supplements and conventional foods submit them to FDA on a voluntary basis. Given the ag-ency's use of AERs in connection with the ban of ephedra-containing products in 2003, the industry seems to have a preoccupation that AERs are primarily used to remove an entire ingredient from the market. But that's not the case. AERs are just as often an early signal of a more limited issue. Perhaps it's a contamination problem in an individual plant-i.e., suddenly a variety of products all made in the same facility are showing heightened bacteria levels and making people sick. Or perhaps it's a raw ingredient contaminated with pesticides or heavy metals that is sold to multiple finished product marketers.
If each company keeps its reports to itself, no one would ever connect the dots and trace the common problem back to the supplier. It could even be an incident of bioterrorism or product tampering. The innocent, but nonetheless silent, manufacturer in a state of denial could allow the problem to continue much longer than it should because the reports are not turned over to an objective third party for review. These are the kinds of problems mandatory AERs may prevent.
The Opposition
There are those who oppose this effort to make AERs mandatory for manufacturers. Some say that this legislation will lead to a tsunami of AERs pouring into supplement manufact-urers, most of which will be illegitimate but calculated to defame the industry. And from whom will these reports come? As already explained, consumers have the ability now to report AERs to either the manufacturer or directly to FDA. If one wanted to discredit the industry, wouldn't they already be filing false reports with FDA? Where is the tsunami now?
Objectors to this bill seem to feel that requiring manufacturers to report these events will take away "health freedom," remove safe products from the shelves, and drive industry out of business. These are the same slogans of those who resist government regulation of any kind. But I've yet to hear anyone who can logically explain how mandating that manufacturers disclose to FDA possible adverse events associated with their products is going to dry up the supplement marketplace and deny consumers access to vitamins. In fact, quite the opposite should occur.
By publicly standing behind the safety of our products, we're building a stronger, more reliable industry in which consumers can have faith that if something goes wrong, FDA will have the opportunity to investigate and quickly correct the problem. Transparency behind safe products will lead to a more robust and growing industry.
Then there are those who oppose mandatory AERs by predicting that allowing FDA access to this information is the first step to eventually requiring pre-market approval for our products. As long as our products maintain their safety records, mandatory reporting of AERs will not serve that purpose. If anything, by opening our file cabinets that house adverse event reports-file cabinets that are largely empty because there are so few serious reports-the industry may very well be fending off further un-necessary regulation, like calls for pre-market approval of supplements, by demonstrating how safe these products really are.
Some have asked if the need for mandatory reporting of adverse events will become superfluous once the final rules on good manufacturing practices (GMPs) specific to dietary supplements are released. The industry has been waiting for GMPs for 12 years, ever since the passage of DSHEA. But GMPs and mandatory reporting of AERs are not an either/
or proposition. For one thing, the pharmaceutical and medical device industries already have both GMPs and AERs. GMPs won't prevent an adulteration that occurs after the product leaves the plant, as is the case with product tampering or bioterrorism events. GMPs and AERs are two different but necessary approaches to the same issue of product safety. GMPs are the pre-market assurance that the manufacturer is taking reasonable steps to make a quality product; AERs are the post-market sur-veillance further demonstrating that manufacturers take responsibility for their products once they enter the marketplace.
The Reality
Let's be realistic. Even when final GMPs are released and even if reporting serious adverse events becomes mandatory, that doesn't mean all our industry's problems will disappear. But these two pieces of regulation and legislation will act as bookends supporting the safety of dietary supplement products and helping ensure the consumer that responsible companies take responsibility for their products.NW
About the author: Steven Mister is the president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C. He can be reached at 202-776-7929.
