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Week Ending December 8, 2006
S.3546 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, and for other purposes.
Under this bill any manufacturer, packer or distributor appearing on a non-prescription drug or dietary supplement package in the US must submit to the Secretary of Health and Human Services within 15 business days of a serious adverse event associated with using the drug or supplement in the US. The person must also submit within 15 business days any medical information related to the incident received within a year of the initial incident and to maintain records related to each report for sic years. Inspection of records is mandatory. Retailers would be freed of the requirements and could refer the concerned to the distributor and others.
Access to the records may not be prohibited and failure to maintain the records and falsification of the records are not an option.
The report submitted can dispute and allegations that the drug or supplement had an adverse health affect. Submitting an adverse event report is not to be construed as an admission that the drug contributed to the adverse event.
State laws must b identical to this Federal law.
Sponsor: Senator Orin G. Hatch (R-UT)
Vote: Passed Senate by Unanimous Consent December 7, 2006. Passed House 203 to 98 (RC 543) December 7, 2006. Clearing the way for the President.
Cost to the taxpayers: No discernible cost.
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MORE INFORMATION
Millions of Americans daily rely on over-the-counter drugs and dietary supplements. The vast majority of these products are safe, but the public could benefit from a system to ensure that government officials are made aware of any serious problems that arise.
Although the Food and Drug Administration has a voluntary system to receive reports about adverse events with dietary supplements, and a mandatory system that covers some non-prescription drugs, there is no requirement for mandatory reporting for all of these products as there is with other FDA-regulated products such as prescription drugs and medical devices. This bipartisan bill would require manufacturers and distributors of these products to report all serious adverse events to the government.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 [Public Law 103-417] ensures that a broad array of dietary supplements, and information about the benefits of those products, is available to American consumers. With this new bill, DSHEA will continue to protect consumer choice and access to dietary supplements that are safe and properly labeled. At the same time, consumers will benefit from a new system to make certain problems that arise are identified quickly so that they can be addressed appropriately.
Dietary Supplements: Estimates are that up to 150 million Americans consume dietary supplements regularly in order to maintain or improve their healthy lifestyles. These products, defined as vitamins, minerals, herbs and other botanicals, amino acids, or other dietary substances used to supplement the diet, are regulated under DSHEA, which set up the regulatory framework governing how these products are sold in the United States. Generally, under this law, ingredients in supplements marketed in the United States prior to October 15, 1994 are `grandfathered,' that is, they may continue to be marketed in products without notification to or review by the agency prior to marketing. Also under DSHEA, most new ingredients are subject to a pre-notification system. The manufacturer of any supplement which contains a dietary ingredient not sold in the United States prior to October 15, 1994 can only sell that product if either the ingredient has been present in the food supply in the same form in which it is sold, or there is evidence that the ingredient is reasonably expected to be safe and the manufacturer provides evidence of that safety to the Secretary of Health and Human Services 75 days prior to marketing.
Critics of the regulatory scheme laid out by DSHEA argue that all, or at least some, dietary supplement products or ingredients (such as stimulants) should be subject to pre-marketing approval by the government. When approving DSHEA, this
committee and later the Congress rejected such a regulatory system given the history of safe use of the majority of supplement products and the inherent cost of any pre-approval marketing requirement. The committee is not reconsidering that decision with this legislation.
In 2003, the FDA announced a new system to track adverse incidents associated with the use of foods, dietary supplements and cosmetics. The agency noted that determining the cause of such incidents and helping to prevent their recurrence was the focus of the Center for Food Safety and Nutrition's (CFSAN's) new Adverse Event Reporting System or `CAERS.' CAERS became part of an agencywide effort using information-gathering, data management and collaboration with health care institutions to improve the government's response to problems with products such as medical devices, vaccines, blood products, radiation-emitting products and drugs for animals. In a letter to stakeholders announcing the CAERS, CFSAN noted that the agency `will use the CAERS system as a monitoring tool to identify potential public health issues that may be associated with the use of a particular product already in the marketplace. Information gathered in CAERS will also assist FDA in the formulation and dissemination of CFSAN's post-marketing policies and procedures.'
Over-the-Counter Drugs: Under current law, a nonprescription drug can be marketed in one of two ways. First, drugs previously sold by prescription may be sold over-the-counter if the FDA approves the `switch' through a New Drug Application (NDA). These drugs were subject to adverse event reporting when they had prescription status, and continue to be subject to those requirements as non-prescription drugs. In addition, drugs may be sold over-the-counter if the FDA has found them to be Generally Recognized as Safe and Effective (GRAS/GRAE). OTC drugs in this category must be manufactured, labeled, and marketed according to the monographs (regulations) promulgated by FDA. Although monographed OTC drugs are not currently required to file adverse event reports, many companies file AERs on a voluntary basis.
Monographed OTC drugs, as is true of other OTC drugs, have a very high margin of safety and most have been on the market for decades. They have been thoroughly reviewed by FDA for safety and effectiveness since the OTC drug review began in 1972, and they are manufactured, labeled, and marketed according to regulations established by the agency. Including monographed OTC drugs in FDA's adverse event reporting system provides consumers with additional assurance of OTC safety and enhances FDA's ability to ensure the public health.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act builds on the CAERS by requiring that manufacturers of dietary supplements and now all non-prescription drugs provide to the FDA on an expedited basis any reports they receive of serious adverse events associated with the use of their products. This new reporting system will enhance the agency's effort to identify potential public health issues associated with the use of these products, and will enable the government, manufacturers, and retailers to respond more quickly to problems which may be identified. A new, comprehensive system will also serve to enhance the public's confidence in the products they purchase, since there will be greater government monitoring of serious problems.
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