03.01.07
The first seminar to tackle implementation of the new adverse event reporting (AER) bill was held inSalt Lake City, UT, in mid-January by the United Natural Products Alliance (UNPA). According to the organization's executive director, Loren Israelsen, passage of this bill is a seminal development as it relates to the maturation of the dietary supplement industry. The bill, which Mr. Israelsen said was vigorously debated within the industry, represents a significant splitting of philosophies. On one side you have companies that believe robust regulation includes more funding for FDA, which in turn will foster future growth. The other side believes little or no regulation ensures consumer freedom of choice. The former philosophy seems to have won this battle.
Of particular importance, according to Mr. Israelsen, was the timing of the bill's passage. "It's very important that this legislation passed in the last Congress because it would have been far more difficult for it to pass in this one without extensive revisions," he commented.
The "Dietary Supplement and Nonprescription Drug Consumer Protection Act" cleared the 109th Congress in its final hours on December 9th. The new law, which will amend the federal Food, Drug and Cosmetic Act, requires the reporting of "serious" adverse events for both over-the-counter (OTC) drugs and dietary supplements to the FDA.
The bill passed the Senate by unanimous consent. However, it hit a few snags in the House, narrowly getting the two-thirds majority vote it needed to move on to President Bush for his signature. The bill was signed into law on December 22nd.
Early reaction to the bill has been positive, many believing the law will benefit consumers as well as responsible industry.
Supporters ultimately feel this legislation will re-affirm what they already believe-that supplements maintain a strong record of safety and that this confirmation will further bolster consumer confidence in products.
The first speaker at the UNPA AER seminar was self-described "compulsive dietary supplement legislator" Patricia Knight, chief of staff for Senator Orrin Hatch (R-UT). She addressed the origins of the bill.
"There has been a lot of misinformation surfacing about how this legislation came to be," she said. Contrary to popular belief, she pointed out that the genesis of the legislation did not come from Senator Richard Durbin's (D-IL) interest in taking down stimulants.
In actuality, she said there was a string of events that led to the creation of the bill, including a Health & Human Services (HHS) Inspector General report from 2001, which highlighted the need for the government to obtain more information on adverse events as they relate to dietary supplements in order to generate stronger signals of public health concerns. The AER issue again surfaced in a 2002 Institute of Medicine (IOM) report, which underlined the importance of establishing an AER system as part of its framework for evaluating the safety of dietary supplements.
Following these developments, Ms. Knight said, "Congress started holding a lot of hearings regarding the safety of dietary supplements, many believing FDA needed to 'up' enforcement efforts for dietary supplements and put GMPs in place." Senator Durbin, an outspoken critic of dietary supplements, in the meantime also introduced a couple of pieces of legislation, but they did not come to fruition. By 2004 Senator Durbin decided to work with Sens. Hatch and Tom Harkin (D-IA) on the AER issue together.
When Sens. Hatch and Harkin started discussions with Senator Durbin in 2004, Ms. Knight said industry outliers automatically became nervous. "Outliers claimed the AER effort was being driven by 'big pharma' in an effort to undermine supplements. Some also viewed this as an FDA power grab," she said. "The reality is that this bill was the result of thoughtful, bipartisan efforts, and was not politically motivated. We went through 22 drafts of this bill in order to get it right"
At the conclusion of the process, she said Senator Durbin was very clear that this wasn't the only thing he wanted done with regard to supplements, but that the AER bill was a good first step.
Major provisions of the AER bill that were key to its passage were that it (1) include non-prescription drugs, (2) be limited to "serious" events only, (3) pre-empt any state and/or local adverse event reporting laws, (4) provide penalties for false reporting, (5) give the authority to modify the MedWatch form for supplements, (6) allow companies to outsource reporting capabilities and (7) consolidate multiple reports. The presentation offered by Peter Reinecke, former chief of staff for Senator Harkin, laid out the nuts and bolts of the new legislation, which included more detailed discussion on many of these points.
The "responsible parties" for reporting adverse events include the manufacturer, packer or distributor of a dietary supplement whose name appears on the label. If companies do not want to set up a AER system internally they have the option of outsourcing reporting efforts to a third party. However, it is crucial to remember that it is the "responsible parties" that maintain the ultimate responsibility for reporting to FDA.
It is important to note that retailers are exempt from reporting adverse events that come from customers. Even retailers that sell products under their own label will not be required to report adverse events to the FDA. However, a retailer by agreement may authorize the manufacturer or packer to submit required reports. All reports received by the retailer through the address or telephone number on the label must be included in such an agreement.
All dietary supplement labels must include an address or phone number through which the responsible party can receive a report of a serious adverse event with the product. Products not containing this label information will be considered misbranded. Only reports received through the labeled address or phone number must be reported to the FDA.
Serious adverse event reports must be filed with FDA no later than 15 business days after the report is received. Any additional information on such reports received within one year of the reporter's submission must also be filed with the FDA no later than 15 days after receipt. FDA is responsible for developing systems to ensure that duplicate reports and new medical information submitted on an existing report are consolidated into one single report.
For those companies worried about false reporting of adverse events, Ms. Knight and Mr. Reinecke said not to worry. "We worried about false reporting when we designed the legislation and that's why we included penalties for both individual and company false reporting," they said.
According to Mr. Reinecke, the new law makes it illegal to falsify a report to be provided to the manufacturer, packer or distributor. It is also illegal for the manufacturer, packer or distributor to falsify a report submitted to the FDA. The intent is that these provisions do not apply to inadvertent errors in reporting, but rather to deliberate false reporting. Falsification could lead to an injunction or criminal penalties, including possible fines.
Another important part of the legislation is the state and local preemption provision. In order to create a level playing field and to prevent unnecessary duplication or inconsistent reporting requirements, the law pre-empts state and local laws regarding adverse event reporting.
The AER bill will become effective within one year of its passage into law (December 22, 2007) and requires that FDA issue a guidance to industry addressing the reporting requirements within nine months of enactment. According to Mr. Reinecke's presentation, this includes providing guidelines for minimum data elements that should be included in any report. In the case of prescription drugs, for example, FDA lists four things that represent the minimum knowledge needed to submit an adverse event report-an identifiable patient, identifiable reporter, a suspect product and an adverse experience or fatal outcome suspected to be due to the product in question. This guidance does not require that a reporter share contact information, however.
Companies should keep in mind that submitting a report received does not constitute an admission that the event occurred or that the product(s) named caused or contributed to the alleged event. Reports are treated as protected medical records and may not be released unless all personally identifiable information is redacted.
The law also requires that reports be made using the FDA MedWatch form; the Secretary of HHS has the authority to modify the form if he/she determines it is not appropriate for reporting serious adverse events associated with dietary supplements. Congress has urged the HHS Secretary to promptly review the form for its appropriateness and to entertain public comment on any proposed changes to the form.
Using the MedWatch form to document adverse events sparked some debate at the seminar. Some feel the existing MedWatch form used for drugs would suffice so long as the questions/details are tweaked to pertain to dietary supplements. Others like Michael McGuffin, president, American Herbal Products Association (AHPA), Silver Spring, MD, feel the MedWatch form is too cumbersome and mostly irrelevant to dietary supplements. "I'm worried about using the MedWatch form because it is a little clumsy and you can never leave a field blank," he said. "It is really important that we put more thought into what questions need to be asked. When we are all asking the same questions, I will stop worrying."
While companies are required to keep records of ALL adverse events reported for a period of six years, it's only the "serious" ones that get reported to FDA. But therein lies the problem.
Many attendees at the seminar expressed concern about when to know whether an adverse event is serious enough to report. For now, Ms. Knight said, "Companies should err on the side of reporting." In other words, if the consumer submitting the report believes they have experienced a serious adverse event consistent with the law's definition, the event should be reported. This rule applies even if the responsible party disagrees with this determination and whether or not proof is provided or medical care was sought.
To make things a bit clearer, Mr. Reinecke said serious adverse events include those that either: result in death, a life threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital abnormality or birth defect. A serious adverse event could also require, based on reasonable medical judgment, a medical or surgical intervention to prevent one of these outcomes. Any new information regarding a report filed that is received by the responsible party within one year of the filing of the report must also be submitted to the FDA.
In addition to a records retention period of six years, Mr. Reinecke said companies must also make sure that records are maintained at a location, which allows timely access by government inspectors. This includes the reports themselves, records containing submissions to FDA and records containing communications between the responsible person and those making the report to them.
According to speaker Rick Kingston, president, SafetyCall International, Minneapolis, MN, if an applicant fails to establish and maintain records and make reports, FDA may pull the product from the market. Penalties could also include injunction and/or civil/criminal penalties.
Of particular importance, according to Mr. Israelsen, was the timing of the bill's passage. "It's very important that this legislation passed in the last Congress because it would have been far more difficult for it to pass in this one without extensive revisions," he commented.
The "Dietary Supplement and Nonprescription Drug Consumer Protection Act" cleared the 109th Congress in its final hours on December 9th. The new law, which will amend the federal Food, Drug and Cosmetic Act, requires the reporting of "serious" adverse events for both over-the-counter (OTC) drugs and dietary supplements to the FDA.
The bill passed the Senate by unanimous consent. However, it hit a few snags in the House, narrowly getting the two-thirds majority vote it needed to move on to President Bush for his signature. The bill was signed into law on December 22nd.
Early reaction to the bill has been positive, many believing the law will benefit consumers as well as responsible industry.
Supporters ultimately feel this legislation will re-affirm what they already believe-that supplements maintain a strong record of safety and that this confirmation will further bolster consumer confidence in products.
The Genesis of the Bill
The first speaker at the UNPA AER seminar was self-described "compulsive dietary supplement legislator" Patricia Knight, chief of staff for Senator Orrin Hatch (R-UT). She addressed the origins of the bill.
"There has been a lot of misinformation surfacing about how this legislation came to be," she said. Contrary to popular belief, she pointed out that the genesis of the legislation did not come from Senator Richard Durbin's (D-IL) interest in taking down stimulants.
In actuality, she said there was a string of events that led to the creation of the bill, including a Health & Human Services (HHS) Inspector General report from 2001, which highlighted the need for the government to obtain more information on adverse events as they relate to dietary supplements in order to generate stronger signals of public health concerns. The AER issue again surfaced in a 2002 Institute of Medicine (IOM) report, which underlined the importance of establishing an AER system as part of its framework for evaluating the safety of dietary supplements.
Following these developments, Ms. Knight said, "Congress started holding a lot of hearings regarding the safety of dietary supplements, many believing FDA needed to 'up' enforcement efforts for dietary supplements and put GMPs in place." Senator Durbin, an outspoken critic of dietary supplements, in the meantime also introduced a couple of pieces of legislation, but they did not come to fruition. By 2004 Senator Durbin decided to work with Sens. Hatch and Tom Harkin (D-IA) on the AER issue together.
When Sens. Hatch and Harkin started discussions with Senator Durbin in 2004, Ms. Knight said industry outliers automatically became nervous. "Outliers claimed the AER effort was being driven by 'big pharma' in an effort to undermine supplements. Some also viewed this as an FDA power grab," she said. "The reality is that this bill was the result of thoughtful, bipartisan efforts, and was not politically motivated. We went through 22 drafts of this bill in order to get it right"
At the conclusion of the process, she said Senator Durbin was very clear that this wasn't the only thing he wanted done with regard to supplements, but that the AER bill was a good first step.
The Details
Major provisions of the AER bill that were key to its passage were that it (1) include non-prescription drugs, (2) be limited to "serious" events only, (3) pre-empt any state and/or local adverse event reporting laws, (4) provide penalties for false reporting, (5) give the authority to modify the MedWatch form for supplements, (6) allow companies to outsource reporting capabilities and (7) consolidate multiple reports. The presentation offered by Peter Reinecke, former chief of staff for Senator Harkin, laid out the nuts and bolts of the new legislation, which included more detailed discussion on many of these points.
The "responsible parties" for reporting adverse events include the manufacturer, packer or distributor of a dietary supplement whose name appears on the label. If companies do not want to set up a AER system internally they have the option of outsourcing reporting efforts to a third party. However, it is crucial to remember that it is the "responsible parties" that maintain the ultimate responsibility for reporting to FDA.
It is important to note that retailers are exempt from reporting adverse events that come from customers. Even retailers that sell products under their own label will not be required to report adverse events to the FDA. However, a retailer by agreement may authorize the manufacturer or packer to submit required reports. All reports received by the retailer through the address or telephone number on the label must be included in such an agreement.
All dietary supplement labels must include an address or phone number through which the responsible party can receive a report of a serious adverse event with the product. Products not containing this label information will be considered misbranded. Only reports received through the labeled address or phone number must be reported to the FDA.
Serious adverse event reports must be filed with FDA no later than 15 business days after the report is received. Any additional information on such reports received within one year of the reporter's submission must also be filed with the FDA no later than 15 days after receipt. FDA is responsible for developing systems to ensure that duplicate reports and new medical information submitted on an existing report are consolidated into one single report.
For those companies worried about false reporting of adverse events, Ms. Knight and Mr. Reinecke said not to worry. "We worried about false reporting when we designed the legislation and that's why we included penalties for both individual and company false reporting," they said.
According to Mr. Reinecke, the new law makes it illegal to falsify a report to be provided to the manufacturer, packer or distributor. It is also illegal for the manufacturer, packer or distributor to falsify a report submitted to the FDA. The intent is that these provisions do not apply to inadvertent errors in reporting, but rather to deliberate false reporting. Falsification could lead to an injunction or criminal penalties, including possible fines.
Another important part of the legislation is the state and local preemption provision. In order to create a level playing field and to prevent unnecessary duplication or inconsistent reporting requirements, the law pre-empts state and local laws regarding adverse event reporting.
The AER bill will become effective within one year of its passage into law (December 22, 2007) and requires that FDA issue a guidance to industry addressing the reporting requirements within nine months of enactment. According to Mr. Reinecke's presentation, this includes providing guidelines for minimum data elements that should be included in any report. In the case of prescription drugs, for example, FDA lists four things that represent the minimum knowledge needed to submit an adverse event report-an identifiable patient, identifiable reporter, a suspect product and an adverse experience or fatal outcome suspected to be due to the product in question. This guidance does not require that a reporter share contact information, however.
Companies should keep in mind that submitting a report received does not constitute an admission that the event occurred or that the product(s) named caused or contributed to the alleged event. Reports are treated as protected medical records and may not be released unless all personally identifiable information is redacted.
The law also requires that reports be made using the FDA MedWatch form; the Secretary of HHS has the authority to modify the form if he/she determines it is not appropriate for reporting serious adverse events associated with dietary supplements. Congress has urged the HHS Secretary to promptly review the form for its appropriateness and to entertain public comment on any proposed changes to the form.
Using the MedWatch form to document adverse events sparked some debate at the seminar. Some feel the existing MedWatch form used for drugs would suffice so long as the questions/details are tweaked to pertain to dietary supplements. Others like Michael McGuffin, president, American Herbal Products Association (AHPA), Silver Spring, MD, feel the MedWatch form is too cumbersome and mostly irrelevant to dietary supplements. "I'm worried about using the MedWatch form because it is a little clumsy and you can never leave a field blank," he said. "It is really important that we put more thought into what questions need to be asked. When we are all asking the same questions, I will stop worrying."
What Constitutes a 'Serious' Adverse Event?
While companies are required to keep records of ALL adverse events reported for a period of six years, it's only the "serious" ones that get reported to FDA. But therein lies the problem.
Many attendees at the seminar expressed concern about when to know whether an adverse event is serious enough to report. For now, Ms. Knight said, "Companies should err on the side of reporting." In other words, if the consumer submitting the report believes they have experienced a serious adverse event consistent with the law's definition, the event should be reported. This rule applies even if the responsible party disagrees with this determination and whether or not proof is provided or medical care was sought.
To make things a bit clearer, Mr. Reinecke said serious adverse events include those that either: result in death, a life threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital abnormality or birth defect. A serious adverse event could also require, based on reasonable medical judgment, a medical or surgical intervention to prevent one of these outcomes. Any new information regarding a report filed that is received by the responsible party within one year of the filing of the report must also be submitted to the FDA.
In addition to a records retention period of six years, Mr. Reinecke said companies must also make sure that records are maintained at a location, which allows timely access by government inspectors. This includes the reports themselves, records containing submissions to FDA and records containing communications between the responsible person and those making the report to them.
According to speaker Rick Kingston, president, SafetyCall International, Minneapolis, MN, if an applicant fails to establish and maintain records and make reports, FDA may pull the product from the market. Penalties could also include injunction and/or civil/criminal penalties.
