[Congressional Record Volume 152, Number 81 (Wednesday, June 21, 2006)]
[Senate]
[Pages S6285-S6287]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HATCH (for himself, Mr. Durbin, Mr. Harkin, Mr. Enzi, and 
        Mr. Kennedy):
  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; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. HATCH. 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.

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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.

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  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.
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