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Dietary Supplement And Nonprescription Drug Consumer Protection Act

Rep. Joe L. Barton

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Mr. Speaker, I move to suspend the rules and pass the Senate bill (S. 3546) 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.

The Clerk read as follows:

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

This Act may be cited as the ``Dietary Supplement and Nonprescription Drug Consumer Protection Act''.

(a) In General.--Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:

(a) In General.--Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:

(a) In General.--Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following: ``(ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 760 or 761) or the falsification of a serious adverse event report (as defined under section 760 or 761) submitted to the Secretary.''. (b) Effective Date.--The amendment made by this section shall take effect 1 year after the date of enactment of this Act.

(a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended-- (1) in subsection (a), by inserting after the third sentence the following: ``If such article is subject to a requirement under section 760 or 761 and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 760 or 761) has not complied with a requirement of such section 760 or 761 with respect to any such article, or has not allowed access to records described in such section 760 or 761, then such article shall be refused admission, except as provided in subsection (b) of this section.''; and (2) in the second sentence of subsection (b)-- (A) by inserting ``(1)'' before ``an article included''; (B) by inserting before ``final determination'' the following: ``or (2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 760 or 761) can take action that would assure that the responsible person is in compliance with section 760 or 761, as the case may be,''; and (C) by inserting ``, or, with respect to clause (2), the responsible person,'' before ``to perform''. (b) Effective Date.--The amendments made by this section shall take effect 1 year after the date of enactment of this Act.

Pursuant to the rule, the gentleman from Texas (Mr. Barton) and the gentleman from New Jersey (Mr. Pallone) each will control 20 minutes.

The Chair recognizes the gentleman from Texas.

Rep. Joe L. Barton

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Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in support of Senate 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, and urge its adoption.

Mr. Speaker, I reserve the balance of my time.

Rep. Frank Pallone

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Mr. Speaker, could I ask for a copy of the legislation at this time? We seem to be concerned about the fact that changes have been made that we were not aware of on the Democratic side.

Rep. Joe L. Barton

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Mr. Speaker, if the gentleman will yield, there are no changes on this bill that I am aware of.

Could the gentleman provide the gentleman a copy of the bill?

Rep. Joe L. Barton

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We will provide a copy, Mr. Speaker.

Rep. Frank Pallone

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Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in support of S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act. By some estimates, the dietary supplement industry is a $20 billion industry. Over half the American population regularly uses dietary supplements, with as many as 60 percent of Americans using dietary supplements daily in an effort to maintain or improve their healthy lifestyles.

Many responsible dietary supplement companies and manufacturers already voluntarily report serious adverse events associated with their products to the FDA. However, in order to ensure the safety of consumers, all companies should be required by law to report such events. This bill accomplishes that goal.

The legislation before us today would amend the Food, Drug, and Cosmetic Act to require that the manufacturer, packer or distributor of a dietary supplement or over-the-counter drug notify the FDA within 15 business days of any serious adverse event reports it receives that are associated with one of their dietary supplements or over-the-counter products.

A serious adverse event is described as a health-related event that results in death, a life-threatening experience, in-patient hospitalization, a persistent or significant disability or incapacity, or congenital anomaly or birth defect.

Adverse event reports provide an early warning signal to the FDA about potential product problems, like product contamination or adulteration, tampering, bioterrorism and ingredient safety issues. By requiring that this information be submitted to a single source, manufacturers increase the likelihood that problems will be identified more quickly and fewer consumers will be affected.

Although the FDA currently receives adverse event reports from consumers, health care providers, poison control centers and even many manufacturers on a voluntary basis, this legislation will ensure that a greater number of serious adverse event reports are transmitted to the FDA for review.

Consumers should be assured that when a serious incident happens, the manufacturer will be held responsible for informing the Federal agency that regulates these products. Adverse event reporting by the manufacturer is already required for other FDA regulated products, such as medical devices, prescription drugs and certain over-the-counter-drugs. It is time that we require the same reporting standards for dietary supplements, and this change will help protect consumers and build greater confidence in the safety of dietary supplements.

Again, I would like to thank Senators Hatch, Harkin and Durbin, as well as all the industry and consumer groups who worked hard on developing this legislation, and I urge my colleagues to join me in supporting it.

Mr. Speaker, I reserve the balance of my time.

Rep. Joe L. Barton

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Mr. Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Price).

Rep. Tom Price

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Mr. Speaker, I appreciate the chairman yielding me time.

Mr. Speaker, I rise in opposition to this bill. Having just seen this legislation within the last hour, this is a significant change to current law. It is one that has had no House hearings during this session. This is what we used to describe at the State level as the dangerous time for legislation, and this is clearly one of those instances.

I don't think that anybody is opposed to decreasing the number of adverse events or of serious adverse events. But when you read through the bill, the level of problem that can occur that would result in an adverse event can be relatively minor; an adverse event occurring from the abuse of a drug, which would require companies to report to the FDA, adverse event occurring from the withdrawal from a drug, any failure of expected pharmacologic action of the drug itself. This is just a huge reach right at this point for the FDA and the Secretary.

So I would encourage the House to not support this bill. I would encourage the House to go through regular order on this piece of legislation, which is a significant change, and would ask for the House to turn down this suspension bill.

Rep. Frank Pallone

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Mr. Speaker, I reserve my time.

Rep. Joe L. Barton

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Mr. Speaker, I yield 2 minutes to the distinguished gentleman from Texas (Mr. Sessions).

Rep. Pete Sessions

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Mr. Speaker, I appreciate Chairman Barton allowing me time to speak on this bill.

Mr. Speaker, I rise opposing this Dietary Supplemental and Nonprescription Drug Consumer Protection Act. The bill would replace the current system of adverse event reporting by medical professionals through the MedWatch Program with a mandatory system that would require manufacturers and retailers to keep records and to report to the FDA when they received reports of adverse events.

The bill redirects complaints of adverse effects away from local health responders, health care professionals, to manufacturers and retailers and then to the FDA. Consumers who are injured should be directed to medical professionals trained to determine whether the condition is caused by ingredients in the supplement or by other factors, not by self-diagnosis.

Secondly, this bill depends on those who may be responsible for types of drugs or drug supplements to report adverse effects to the FDA. Those guilty of violating the law are less likely to report adverse effects to the government and to follow the law.

I think this is a bad bill. I hope that we reject it.

Rep. Frank Pallone

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Mr. Speaker, I yield back the balance of my time, and urge support of the bill.

Rep. Joe L. Barton

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Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, just in closing, I would urge support of the bill. The dietary supplement industry is a mature industry now, and I would estimate over 90 to 95 percent of those in the industry support passage of this bill. There are some segments of the industry that do oppose it.

This is a Senator Orrin Hatch bill. I know that Congressman Cannon here in our body strongly supports it. I would hope that we would pass it.

Rep. Christopher B. Cannon

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Mr. Speaker, I rise in support of S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act. I am the sponsor of the companion bill, H.R. 6168, here in the House.

S. 3546 would require mandatory adverse event reporting of serious events for dietary supplements and over-the-counter drugs, OTCs, within the FDA.

Currently, an adverse event reporting system for supplements and some OTCs exists, yet it is strictly voluntary. Under the proposed system, manufacturers, packers or distributors of OTC drugs or dietary supplements in the United States must report to the FDA within 15 business days any serious adverse event associated with their products. Serious events include those that result in death, a life-threatening experience, inpatient hospitalization, disability or incapacity, birth defect, or medical/surgical intervention to prevent one of these outcomes.

S. 3546 brings needed regulation to guarantee consumer protection from non-legitimate companies. This legislation will expose corrupt businesses that are misleading consumers and breaking the law, as well as protecting individuals from serious health risks.

S. 3546 would not restrict nor limit access to dietary supplements but in fact would strengthen the regulatory structure for dietary supplements building greater consumer confidence in this category of FDA-regulated products.

Mandatory adverse event reporting would not affect the regulation of dietary supplements under DSHEA. Although manufacturers would be required to report serious adverse events to FDA, the Food Drug and Cosmetic Act clearly distinguishes dietary supplements from drugs.

S. 3546 would actually counter critics who believe dietary supplements are under-regulated and should be treated as drugs.

The dietary supplement industry is a $20 billion industry. It is estimated that over 60 percent of Americans regularly use dietary supplements to improve health. Consumers should be confident that these dietary supplements are legitimate.

S. 3546 is supported by the major consumer and trade associations. Including 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 the United Natural Products Alliance.

The Dietary Supplement and Nonprescription Drug Consumer Act is necessary legislation to safeguard Americans and uncover illegal manufacturers who are jeopardizing consumer's health.

Rep. Joe L. Barton

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Mr. Speaker, I yield back the balance of my time.

The question is on the motion offered by the gentleman from Texas (Mr. Barton) that the House suspend the rules and pass the Senate bill, S. 3546.

The question was taken.

In the opinion of the Chair, two-thirds of those voting have not responded in the affirmative.

Rep. Joe L. Barton

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Mr. Speaker, on that I demand the yeas and nays.

The yeas and nays were ordered.

Pursuant to clause 8 of rule XX and the Chair's prior announcement, further proceedings on this question will be postponed.