"Dietary Supplement and Nonprescription Drug Consumer Act": New reporting and record-keeping requirements for dietary supplement and OTC drug companies
On December 22, 2006, President Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, P.L. 109-462 (the “Act”), into law. The purpose of the Act is to establish a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States. The Act amends Chapter VII of the Federal Food, Drug, & Cosmetic Act (“FFDCA”) by adding two parallel and mandatory reporting systems: one for nonprescription drugs and the other for dietary supplements. The Act requires a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the secretary of health and human services (the “Secretary”), within fifteen business days, any report received of a serious adverse event associated with such drug or supplement when used in the United States; (2) submit, within fifteen business days, any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years from the time the report is received by the company; and (4) permit inspection of such records.
History of the Act
Discussions in Congress regarding creation of a dietary supplement adverse-event reporting system began in the wake of the February 2004 Food and Drug Administration (“FDA”) announcement that it would remove products containing ephedrine alkaloids from the market. The FDA’s decision was based on the agency’s review of evidence about ephedra’s pharmacology, reports in the scientific literature, and adverse event reports, including some extremely serious adverse events. Around that time, Senators Richard Durbin, Tom Harkin, Orrin Hatch, Michael Enzi, and Edward Kennedy began discussions about how to craft a serious-adverse-event reporting system. As a result of their efforts, on June 21, 2006, the senators introduced Senate bill 3546— a bill to amend the FFDCA with respect to serious-adverse-event reporting for dietary supplements and nonprescription drugs. On September 25, 2006, Representative Chris Cannon introduced a parallel bill, H.R. 6168, in the House of Representatives. On December 9, 2006, the Senate passed S. 3546 and, on December 12, 2006, the House suspended the rules and passed the Senate bill. The bill was presented to the president on December 20, 2006, and signed into law two days later, on December 22, 2006.
The new reporting system was created to enhance FDA’s efforts to identify potential public-health issues associated with the use of nonprescription drugs and dietary supplements, and to enable the government, manufacturers, and retailers to respond more quickly to potential problems. The Act is also aimed at enhancing the public’s confidence in dietary supplements and nonprescription drugs.
The Senate report accompanying S. 3546 reports that an estimated 150 million Americans consume dietary supplements regularly to maintain or improve their healthy lifestyles. Before enactment of this law, there was no reporting requirement for adverse events relating to dietary supplements, and reporting requirements for adverse events relating to non-prescription drugs was limited to those instances in which the product was previously sold as a prescription drug.
The reporting requirements
The Act requires the manufacturer, packer, or distributor (“responsible party”) of a dietary supplement or nonprescription drug to submit, through a MedWatch form, any serious-adverse-event it receives, along with a copy of the labeling for the product to the FDA within fifteen business days after the report is received. To facilitate implementation of the reporting requirements and ensure adverse events are reported to the responsible party, the Act requires product labeling to include a continuously operating toll-free telephone number for reporting serious adverse events involving a product (whether or not the serious adverse event ultimately is found to be related to the product).
If a retailer’s name appears on the label as a distributor, the retailer may, by agreement, authorize the manufacturer or packer of the product to submit the required reports, as long as the retailer directs to the manufacturer or packer all adverse events associated with the product’s use that are reported to it through the address or telephone number required by the Act. A retailer that does not have a product bearing the retailer’s name does not have any reporting obligations under the Act.
A“serious adverse event” is defined as an adverse event that results in death, life-threatening experience, in-patient hospitalization, persistent or significant disability or incapacity, or congenital anomaly or birth defect, and/or an adverse event that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of these outcomes. This definition is based upon definitions contained in the FDA’s current Safety Information and Adverse Event Reporting Program (“MedWatch”). In addition, the definition of “serious adverse event” is modeled on nearly identical language for adverse experiences associated with drugs, which is set forth in 21 CFR 310.305(b).
The Act also imposes new requirements for records retention. A responsible party must maintain records of any adverse report it receives, whether serious or not, for six years from the date the report is received by the responsible party. Responsible parties must also give authorized government officials timely access to the records. Companies must maintain records containing the submission of serious-adverse-event reports to the Secretary of HHS, records containing submission to the Secretary of new medical information related to serious-adverse-event reports, and records containing communications by the responsible party with anyone reporting an adverse event to the company. Responsible parties must maintain the records regardless of the source and regardless of any determination that the adverse event was caused by, or associated with, the product.
Public disclosure of adverse-event reports
The FDA has stated to Congress that it does not intend to publish statistics based on serious adverse events reported pursuant to the Act, but records submitted in compliance with the Act may be released to the public, subject to protections of the Freedom of Information Act and the Privacy Act of 1974. To minimize potential liability, the Act specifically provides that submission of a serious-adverse-event report pursuant to the Act shall not be construed as an admission that the product caused or contributed to the adverse event. Responsible parties are permitted to submit a statement with a report, which shall be included in any public disclosure of the report, that denies that the report constitutes an admission that the product involved caused or contributed to the adverse event. While this is encouraging to companies, whether the event is related or associated with the product will remain an issue of dispute in any legal action.
The Act includes a state preemption provision intended to ensure that state requirements relating to serious-adverse-event reporting are consistent with the Act, and to preempt those state requirements that are contrary to, or different from, the reporting requirements under the Act. While this is also encouraging, the scope of preemption remains an issue that may ultimately need to be decided by the federal courts.
Penalties and prohibitions
Products distributed with labels that do not contain the required telephone number or address will be deemed to be misbranded, and responsible parties will be subject to the enforcement and penalty provisions related to the sale and distribution of misbranded products. The Act also prohibits falsification of adverse-event reports to responsible parties or by responsible parties to the government. Noncompliance with the Act is prohibited under the FFDCA, and a violation can trigger an injunction or criminal penalties.
Preparing for compliance
The Act becomes effective December 22, 2007, one year after being signed into law, and requires that the FDA issue guidance to industry within nine months of enactment. Over the next year, affected companies must become informed about to how to adopt adverse-event reporting systems in their manufacturing and distribution processes. The Committee Report accompanying S. 3546 provides some guidance and answers to common industry concerns. For instance, “it is the committee’s strong view that the industries affected by the Act should undertake as quickly as possible training for their staff so that they are aware of their surveillance, investigation, and reporting duties.
The committee also cautioned that the reporting system is designed to generate signals that require further evaluation and that a responsible party should forward reports from consumers to the FDA, even if the responsible party does not agree with the reporter about the seriousness of an event. On this point, the committee noted that the MedWatch form, which the company is required to use under the Act, explicitly directs consumers to “Report, even if you’re not certain the product caused the event” or “you don’t have all the details.”
The committee also addressed industry concerns about balancing the fifteen-day reporting requirement with the requirement that reports to the FDA must be complete, accurate, and nonduplicative. While the Act requires the FDA to issue guidance on the minimum data elements that should be included in the reports, the committee suggested that the FDA’s “Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products, Including Vaccines” (March 2001) may be helpful. That guidance indicates that there are four things that are requisite of minimum knowledge necessary to submit a report to the agency. These are an identifiable patient, an identifiable reporter, a suspect product, and an adverse experience suspected to be due to the product. Companies with this requisite knowledge must report within fifteen days of receipt and must not wait to perform further investigation.
The committee also noted that, although the Act does not require the label to make any statement other than providing the address or phone number, a company choosing to make a statement on the label about the address or phone number must ensure that the statement conforms to all requirements of the FFDCA. Companies are also permitted to include an e-mail address that consumers can use to make electronic reports, but the label must still include the telephone number or address, as required by the Act.
Affected industry members must use the next year to establish the processes and procedures necessary to come into compliance with the new law. This should include creation of policies and procedures for staff training, including receiving, investigating, and reporting adverse events. Companies also need to create standard operating procedures to cover all aspects of the new requirements, and should consider record-retention auditing procedures. In addition, companies will need to consider inclusion of required information in new labels and establish a hotline for reporting purposes. Companies should also make early assessments of their in-house capabilities for determining whether an adverse event is “serious” and begin negotiating any necessary third-party reporting contracts and record-keeping contracts.
Working through and beginning the process of establishing these procedures early in the year will permit the industry to raise questions with the FDA in anticipation of its guidance to the industry. For instance, the Act leaves open the issue of whether companies are required to perform independent investigations into adverse-event reports. The industry may ask FDA to address this issue in its guidance. Even with such guidance, companies will need to consider the pros and cons of further investigation, because failure to undertake an investigation and to act on investigative findings may lead to liability.
- Comm. on Health, Educ., Labor, and Pensions, Dietary Supplement and Nonprescription Drug Consumer Protection Act, S. Doc. No. 109-324 (2d Sess. 2006).
[Back to reference]