Mr. President, I am proud to rise with my colleague, Senator Durbin, to introduce S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act. We are joined in this effort by…
Mr. President, I am proud to rise with my colleague, Senator Durbin, to introduce S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
We are joined in this effort by Senators Harkin, Enzi, and Kennedy.
As my colleagues are aware, over half our population regularly uses dietary supplements. In fact, one government survey in 2004 indicated that nearly 60 percent of Americans regularly use dietary supplements to maintain or improve their healthy lifestyles.
Nearly 12 years ago, Senator Harkin and I joined with then- Representative Bill Richardson to author the Dietary Supplement Health and Education Act, DSHEA, which sets out the framework by which the Food and Drug Administration, FDA, regulates dietary supplements.
Since that time, the industry has grown. By some estimates, it is a $20 billion industry today.
Critics of the industry see this growth as a negative, as an indication that the industry is ``unregulated.'' I disagree. I think the growth of dietary supplement sales is testimony to a vibrant industry that is producing positive benefits for our economy and our people.
This is an industry that is largely comprised of men and women of good will, who want to provide the public with healthy products.
Let me hasten to add that we all recognize there are bad actors in the supplement industry, those who break the law and mislead consumers. They should be the subject of swift and sure punishment by the FDA and the Federal Trade Commission. Their products should be removed from the marketplace and the full weight of the law should be brought down on these bad actors.
It is no secret that the FDA is a woefully underfunded agency, which will be the first to admit that its oversight of the dietary supplement industry has not been as aggressive as it could be, in part due to a lack of resources. For several years, Senator Harkin and I have worked to rectify that shortcoming, and we are gratified that our Utah colleague, Senator Bennett, chairman of the Agriculture Appropriations Subcommittee, has joined hands with us to infuse some badly needed resources into the FDA.
When DSHEA was being debated in the Congress, one of the major points of contention was the belief by some that dietary supplements should be subject to premarket approval by the government. That would sound the death-knell for this industry, an industry that is largely comprised of products which have been sold safely for decades, if not centuries in many cases.
In 1994, the Senate agreed not once, but twice, to approve DSHEA by unanimous consent. The House also passed this bill by UC. It was not controversial.
Members recognized that supplements are largely safe. But just to make doubly sure there was adequate regulation, we provided the FDA with an arsenal of tools to take action against problematic products.
Then comes ephedra.
I do not think it is a constructive exercise to rehash the history of ephedra. There were mistakes and problems all around in how this product's safety was evaluated and addressed.
But something did stand out: one company had literally hundreds, if not thousands, of reports about products with this product, none of which were revealed to Federal authorities.
There is no question in my mind that the too-long safety evaluation of ephedra would have been shortened considerably had we known earlier about these reports.
Two years ago, I began discussing with those who are interested in dietary supplement regulation whether it would be wise to implement a system of mandatory adverse event reporting, AER, for those products.
While as a general principle, I am usually reluctant to argue for greater government regulation, in this instance it seemed to me a case could be made that an AER system for supplements could complement the work we achieved with DSHEA and improve the government's ability to address the relatively few problems which arose.
Senator Durbin and Senator Harkin were also having similar thoughts.
We joined forces and after much study, discussion and negotiation, produced S. 3546.
It may be surprising to many of our colleagues that Senators Hatch, Durbin, Harkin, Enzi and Kennedy stand together on this legislation--we come from very different perspectives on dietary supplement regulation.
And while we are each very passionate about our views, we are united in a common goal: improving the public health.
The premise for this bill is simple: mandating a system to provide the government with information about serious adverse events associated with the use of two types of FDA-regulated products--dietary supplements and over-the-counter drugs--provides Federal authorities with a better tool to respond to any problems which might occur. This is an important public health initiative, which at the same time safeguards access to dietary supplements and over-the-counter drugs.
There is currently a voluntary reporting system for supplements and some OTC drugs--our bill would replace that with a mandatory system.
Senator Harkin and I have a longstanding interest in regulation of these products, stemming back to our work on DSHEA.
Senator Durbin, as the former chair of the House Agriculture Appropriations Subcommittee, is one of the most knowledgeable Senators in this body when it comes to FDA matters.
Our collaboration on this legislation, along with the distinguished chairman and ranking minority member of the committee of jurisdiction, the Health, Education, Labor and Pensions--HELP--Committee, both of whom were integral to this process, has produced a bill which strikes the right balance between necessary regulation and over-regulation.
This is how the new system will work:
Manufacturers, packers or distributors of OTC drugs or dietary supplements marketed in the United States must provide to the FDA within 15 business days any reports of a serious adverse event associated with their products. Accompanying that report must be a copy of the label on or within the retail packaging of the supplement.
The definition of serious event is proscribed within the legislation. It is either an event that results in a death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, or congenital anomaly or birth defect; or it is an event that requires based on reasonable medical judgment a medical or surgical intervention to prevent one of the outcomes I have just listed.
The bill requires that those reporting must, for 1 year, provide any new medical information related to the serious adverse event report. Again, that information must be submitted within 15 days.
In addition, manufacturers, packers and distributors must keep for 6 years records of any adverse event associated with the product, even though there is no reporting requirement unless the event meets the definition of serious.
For over-the-counter drugs, the definition of ``adverse event'' is a health-related event associated with the use of a nonprescription drug that is adverse, including: an event occurring from an overdose, whether accidental or intentional; an event occurring from abuse of the drug, or withdrawal from the drug; or any failure of pharmacological action.
For dietary supplements, an ``adverse event'' is defined as any health-related event associated with the use of a dietary supplement that is adverse.
The reports will be submitted on the current MedWatch form, unless the Secretary of Health and Human Services chooses to modify that form at some point.
The bill makes clear that State health officials may have access to the adverse event reports, but that the Federal reporting system would supersede any state reporting laws.
As we met to develop this legislation, one thing we struggled with was the need to encourage responsible reporting in a way that manufacturers could implement. Some manufacturers indicated to us, for example, that they were not medical experts and could not determine in every case if a reporter's problem met the definition of ``serious'' contained in the bill.
To address this, we allow manufacturers to contract with third parties to handle the collection of reports. The manufacturers, of course, would still be ultimately responsible for reporting.
We have also asked the FDA to issue guidance to help manufacturers interpret what a serious adverse event might be.
Another concern was making certain we appropriately defined the role of retailers, who are selling a range of products, some supplements, some OTCs, some not. We determined that retailers would not be considered reporting parties. If, however, a retailer contracts with manufacturers to distribute ``private label'' products, he or she may authorize the manufacturer or packer to submit reports, as long as the retailer directs to the manufacturer all reports it receives.
We also wanted to allow the FDA the flexibility to manage this program. At its request, we made the program self-implementing. We also included a provision to allow the Secretary, after notice and comment from interested parties, to establish an exemption to the reporting requirements if there would be no adverse effect on public health.
Finally, there are provisions in the bill to impose penalties for not reporting, not providing on the product label an address or phone number for reporting, and for providing a false report.
The law will go into effect 1 year after the date of enactment.
Before I close, I want to address some of the concerns that representatives of the dietary supplement industry have voiced with this legislation.
First, some have suggested there is no need for this legislation from a public policy or a consumer safety perspective. I disagree.
Many have unfairly criticized the industry over media reports that supplements are unsafe because there is no premarket approval. While I can never support any system that requires premarket approval for supplements, I have become convinced that having a system in place to identify problems quickly can only enhance the authorities we gave the FDA with DSHEA.
It is also good policy. As the industry matures, we need to separate out the good actors from the bad. This is one way to show that this industry is a respectable, mainstream industry. Other major industries--e.g. pharmaceuticals, devices--are subject to mandatory AER reporting. Supplements are only handled through the voluntary reporting system.
And, I disagree with those who avow there is no consumer safety benefit. Let's take an easy case--where there is a bad batch of a product. Enabling the FDA to know quickly there is a problem can help industry and the public.
Other critics note that the FDA fails to pursue egregious violations of DSHEA. They question why this program will help. As I discussed earlier, Senator Harkin and I have been working to increase FDA's funding for responsible enforcement of DSHEA. I recently discussed this with the Commissioner-nominee, Dr. Andrew von Eschenbach.
One of my constituents who opposes this effort suggested that the FDA's voluntary system, the CAERS system, should be able to handle any reports of problems. Public health experts will agree that a voluntary system is not as good a sentinel as a mandatory system. In addition, those who report under the voluntary system are more likely to be physicians. Encouraging consumers to report to manufacturers through a phone number or address on the product's label will ensure a more thorough reporting system.
Yet another concern I have heard is that this bill has a significant economic impact that has not been studied appropriately. One estimate I have heard is that it could cost tens of millions of dollars a year to industry and consumers.
I have to say that these estimates do not seem to be supported by other industry representatives, many of whom are already instituting reporting systems of their own. During the drafting of this bill, we worked very hard to keep requirements to the minimum that would be necessary for a complete and full reporting of serious adverse events.
In addition, I have heard a suggestion that a better alternative to this bill would be a 1-800 number that consumers can use to contact FDA directly to report complaints. I discussed this with my colleagues and the FDA and found little support for this idea. What this could do is shift onto FDA the majority of reports about product problems. In other words, FDA fears that consumers would start phoning the agency, rather than the manufacturer, to report complaints for things like broken bottles or tablets, or to answer questions about usage. It is easy to see how this could end up relieving manufacturers of some of their consumer-related responsibilities and shift that onto the FDA.
Let me hasten to add that I understand the motivation behind these concerns. I will keep a close watch on this new program as it is implemented, and pledge to reexamine it should problems with implementation arise.
In closing, I thank my colleagues for the spirit of collaboration which led to development of this legislation. In particular, I thank Senator Durbin for his leadership on this issue. While we may not have always agreed on every provision, we did forge a bill on which we can agree.
Senator Harkin is a steadfast supporter of the dietary supplement industry, and his guidance undoubtedly made this bill a better product.
Senator Enzi and Senator Kennedy, both longtime experts in food and drug law, have both been most generous in their time and in moving the process forward.
I must also note the groups that also support the bill--the Consumer's Union, the Center for Science in the Public Interest, the Consumer Healthcare Products Association, the National Nutritional Foods Association, the Council for Responsible Nutrition, the American Herbal Products Association, and finally and most importantly, the Utah Natural Products Association.
That these groups, not often united--at least on this subject--can rally around our bill today is a testament to good policy, good politics, and a surviving bipartisan spirit.
Chairman Enzi has placed this legislation on the HELP Committee agenda for the June 28 executive session. It is my hope the committee will give swift approval to this bipartisan measure and that the Senate will shortly thereafter do the same.
