II 

108TH CONGRESS 

2D SESSION S. 2445

To amend the Federal Food, Drug, and Cosmetic Act relating to directto-consumer prescription drug advertising. 

IN THE SENATE OF THE UNITED STATES 

MAY 19, 2004

Mr. EDWARDS introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL

To amend the Federal Food, Drug, and Cosmetic Act 

relating to direct-to-consumer prescription drug advertising.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Direct to Consumer 

5 Prescription Drug Advertising Act of 2004’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 

8 (1) The pharmaceutical industry spent 

9 $2,700,000,000 on direct to consumer advertising in 

10 2001, nearly a 60 percent increase since 1997. 
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1 (2) Direct to consumer prescription drug adver2 tisements can significantly increase the number of 

3 sales. In 2000, almost $2,500,000,000 was spent on 

4 direct to consumer advertising to promote 50 dif5 ferent drugs. The following year, retail sales for 

6 these drugs skyrocketed by 21.4 percent. 

7 (3) According to the Government Accounting 

8 Office, pharmaceutical companies have increased 

9 spending on direct to consumer advertising more 

10 rapidly than they have increased spending on re11 search and development. 

12 (4) New prescription drugs that are introduced 

13 into the market are generally more expensive than 

14 older drugs in the same class. Consequently, direct 

15 to consumer advertising may lead consumers to 

16 spend more money on new prescription drugs than 

17 those of similar quality. 

18 (5) Although direct to consumer prescription 

19 drug advertisements aid consumer awareness, they 

20 are often misleading as the benefits are more acces21 sible than the risks. 

22 (6) There has been a sharp increase in sales for 

23 direct to consumer advertised prescription drugs, 

24 which is disproportionate to the growth in the mar25 ket. 
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1 (7) Due to a revision of procedure within the 

2 Department of Health and Human Services, the 

3 Food and Drug Administration is often too late to 

4 act on misleading direct to consumer advertisements 

5 by the pharmaceutical industry. By the time they re6 voke an advertisement, many consumers have al7 ready viewed the misleading information. 

8 SEC. 3. PRESCRIPTION DRUG COMPARATIVE EFFECTIVE9 NESS. 

10 (a) IN GENERAL.—With respect to each prescription 

11 drug that is covered under a plan offered under the Fed12 eral Employees Health Benefits Program under chapter 

13 89 of title 5, United States Code, the Director of the Na14 tional Institutes of Health shall conduct research that 

15 compares the effectiveness and safety of such prescription 

16 drug relative to other prescription drugs used to treat the 

17 same condition or disease. 

18 (b) RULE OF CONSTRUCTION.—The results of the re19 search conducted under subsection (a) shall not be con20 strued to be a condition of approval under section 505 of 

21 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 355). 

23 SEC. 4. DIRECT-TO-CONSUMER ADVERTISING. 

24 (a) IN GENERAL.—Not later than 180 days after the 

25 date of enactment of this Act, the Secretary of Health and 
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1 Human Services shall promulgate amended regulations 

2 governing prescription drug advertisements. 

3 (b) CONTENTS.—In addition to any other require4 ments, the regulations under subsection (a) shall require 

5 that—

6 (1) any advertisement present a fair balance, 

7 comparable in depth and detail, between—

8 (A) information relating to effectiveness of 

9 the drug (including, if available, effectiveness in 

10 comparison to other drugs for substantially the 

11 same condition or conditions); and 

12 (B) information relating to side effects and 

13 contraindications; 

14 (2) any advertisement present a fair balance, 

15 comparable in depth, between—

16 (A) aural and visual presentations relating 

17 to effectiveness of the drug; and 

18 (B) aural and visual presentations relating 

19 to side effects and contraindications, except 

20 that nothing in this section shall require explicit 

21 images or sounds depicting side effects and con22 traindications; 

23 (3) prohibit false or misleading advertising that 

24 would encourage a consumer to take the prescription 

25 drug for a use other than a use for which the pre-
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1 scription drug is approved under section 505 of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 355); and 

4 (4) require that any prescription drug that is 

5 the subject of a direct-to-consumer advertisement in6 clude in the package in which the prescription drug 

7 is sold to consumers a medication guide explaining 

8 the benefits and risks of use of the prescription drug 

9 in terms designed to be understandable to the gen10 eral public. 

11 SEC. 5. CIVIL PENALTY. 

12 Section 303 of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 333) is amended by adding at the end the 

14 following: 

15 ‘‘(g) DIRECT-TO-CONSUMER PRESCRIPTION DRUG

16 ADVERTISING.—

17 ‘‘(1) IN GENERAL.—A person that commits a 

18 violation of section 301 involving the misbranding of 

19 a prescription drug (within the meaning of section 

20 502(n)) in a direct-to-consumer advertisement shall 

21 be assessed a civil penalty if—

22 ‘‘(A) the Secretary provides the person 

23 written notice of the violation; and 

24 ‘‘(B) the person fails to correct or cease 

25 the advertisement so as to eliminate the viola-
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1 tion not later than 180 days after the date of 

2 the notice. 

3 ‘‘(2) AMOUNT.—The amount of a civil penalty 

4 under paragraph (1)—

5 ‘‘(A) shall not exceed $500,000 in the case 

6 of an individual and $5,000,000 in the case of 

7 any other person; and 

8 ‘‘(B) shall not exceed $10,000,000 for all 

9 such violations adjudicated in a single pro10 ceeding. 

11 ‘‘(3) PROCEDURE.—Paragraphs (3) through (5) 

12 of subsection (f) shall apply with respect to a civil 

13 penalty under paragraph (1) of this subsection to 

14 the same extent and in the same manner as those 

15 paragraphs apply with respect to a civil penalty 

16 under paragraph (1) or (2) of subsection (f).’’. 

17 SEC. 6. REPORTS. 

18 The Secretary of Health and Human Services shall 

19 annually submit to the Committee on Health, Education, 

20 Labor, and Pensions of the Senate and the Committee on 

21 Energy and Commerce of the House of Representatives 

22 a report that, for the most recent 1-year period for which 

23 data are available—

24 (1) provides the total number of direct-to-con25 sumer prescription drug advertisements made by tel-
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1 evision, radio, the Internet, written publication, or 

2 other media; 

3 (2) identifies, for each such advertisement—

4 (A) the dates on which, the times at which, 

5 and the markets in which the advertisement 

6 was made; and 

7 (B) the type of advertisement (reminder, 

8 help-seeking, or product-claim); and 

9 (3)(A) identifies the advertisements that vio10 lated or appeared to violate section 502(n) of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

12 352(n)); and 

13 (B) describes the actions taken by the Secretary 

14 in response to the violations. 

15 SEC. 7. REVIEW OF DIRECT-TO-CONSUMER DRUG ADVER16 TISEMENTS. 

17 (a) IN GENERAL.—The Secretary of Health and 

18 Human Services shall expedite, to the maximum extent 

19 practicable, reviews of the legality of direct-to-consumer 

20 drug advertisements. 

21 (b) POLICY.—The Secretary of Health and Human 

22 Services shall not adopt or follow any policy that would 

23 have the purpose or effect of delaying reviews of the legal24 ity of direct-to-consumer drug advertisements except—
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1 (1) as a result of notice-and-comment rule2 making; or 

3 (2) as the Secretary determines to be necessary 

4 to protect public health and safety.

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