110 HR 6151 IH: Responsibility in Drug and Device Advertising Act of U.S. House of Representatives 2008-05-22 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 110th CONGRESS 2d Session H. R. 6151 IN THE HOUSE OF REPRESENTATIVES May 22, 2008 Ms. DeLauro (for herself and Mrs. Emerson) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to drug and device advertising, and for other purposes.

1.

Short title

This Act may be cited as the Responsibility in Drug and Device Advertising Act of 2008.

2.

Direct-to-consumer drug or device advertising

(a)

In general

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended— (1)in section 301, by adding at the end the following: (oo)The conduct of direct-to-consumer advertising of a drug or device in violation of section 503C. ; and (2)in chapter V, by inserting after section 503B the following:

503C.

Direct-to-consumer drug or device advertising

(a)

Prohibitions

(1)

First three years

(A)

In general

Subject to subparagraph (B), no person shall conduct direct-to-consumer advertising of— (i)a drug for which an application is submitted under section 505(b) before the end of the 3-year period beginning on the date of the approval of such application; or (ii)a class II or class III device for which a premarket notification is submitted under section 510(k) or a class III device for which a premarket approval is sought under section 515, before the end of the 3-year period beginning on the date of the notification or approval, respectively. (B)

Waiver

The Secretary may waive the application of subparagraph (A) to a drug or device during the third year of the 3-year period described in such subparagraph if— (i)the sponsor of the drug or device submits an application to the Secretary pursuant to subparagraph (C); and (ii)the Secretary, after considering the application and any accompanying materials, determines that direct-to-consumer advertising of the drug or device would have an affirmative value to public health. (C)

Application for waiver

To seek a waiver under subparagraph (B), the sponsor of a drug or device shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (2)

Subsequent years

(A)

Extension of prohibition

The Secretary may prohibit direct-to-consumer advertising of a drug or a class II or class III device during the period beginning at the end of the 3-year period described in paragraph (1)(A) if the Secretary determines that the drug or device has significant adverse health effects based on post-approval studies, risk-benefit analyses, adverse event reports, the scientific literature, any clinical or observational studies, or any other appropriate resource. (B)

Fair balance of benefits and risks for drugs and devices for permitted DTC advertising

Any direct-to-consumer advertising of a drug or a class II or class III device permitted under this section shall include a fair balance, as supported by the evidence, of the benefits and the risks associated with the drug or device. (b)

Regulations

Not later than 1 year after the date of the enactment of this section, the Secretary shall revise the regulations promulgated under this Act governing advertisements of drugs and devices to the extent necessary to implement this section. (c)

Rule of construction

This section shall not be construed to diminish the authority of the Secretary to prohibit or regulate direct-to-consumer advertising of drugs or devices under other provisions of law.

. (b)

Effective date

The amendments made by subsection (a) apply only with respect to a drug for which an application is approved under section 505(b) of the Federal Food, Drug, and Cosmetic Act, a class II or class III device for which a notification is submitted under section 510(k) of such Act, or a class III device for which an application is approved under section 515 of such Act, on or after the date that is 1 year before the date of the enactment of this Act.

3.

Prominent display of information in advertising on side effects, contraindications, and effectiveness

(a)

Requirement for drugs

(1)

In general

Subparagraph (3) of section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended— (A)by striking such other information and all that follows through which shall be issued by and inserting such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations which shall require such information to be prominently displayed in terms of font size and location and shall be issued by; (B)by striking in the case of published direct-to-consumer advertisements and inserting in the case of direct-to-consumer advertisements (including an advertisement that accompanies video programming delivered by television broadcasting or by a multichannel video programming distributor (as defined in section 602 of the Communications Act of 1934)); and (C)by striking published after the effective date and inserting disseminated after the effective date. (2)

Discontinuance of study

The Secretary of Health and Human Services shall discontinue the study required by section 906(b) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85). (b)

Application of similar rules for devices

The first sentence of section 502(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(r)) is amended— (1)by striking (1) a true statement and inserting a true statement (1); (2)by striking a brief statement; and (3)by inserting before the period at the end the following: , and in the case of direct-to-consumer advertisements (including an advertisement that accompanies video programming delivered by television broadcasting or by a multichannel video programming distributor (as defined in section 602 of the Communications Act of 1934)) the following statement printed in conspicuous text: You are encouraged to report negative side effects of medical devices to the FDA. Visit www.fda.gov/medwatch, or call 1–800–FDA–1088.. (c)

Effective date

The amendments made by this section apply with respect to any advertisement or other descriptive printed matter that is issued or caused to be issued on or after the date that is 90 days after the date of the enactment of this Act. Not later than 90 days after the date of the enactment of this Act, the Secretary shall revise any regulations promulgated pursuant to subsections (n) and (r) of section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) to the extent necessary to implement this section.

4.

Civil penalty

Subsection (g) of section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended to read as follows: (g)

Drug or device advertising and promotion

(1)

Civil penalty

(A)

In general

Any manufacturer, packer, or distributor of a drug or device who violates section 505(n), section 503C, or any other requirement of this Act relating to the advertising or promotion of the drug or device shall be subject to a civil penalty in an amount not to exceed— (i)in the case of the first such violation by the manufacturer, packer, or distributor relating to the drug or device, $1,000,000; and (ii)in the case of each subsequent violation by the manufacturer, packer, or distributor relating to the drug or device, an amount that is twice the amount of the maximum civil penalty applicable under this subparagraph to the previous violation. (B)

Procedure

Paragraphs (3) through (5) of subsection (f) shall apply with respect to a civil penalty under subparagraph (A) to the same extent and in the same manner as those paragraphs apply with respect to a civil penalty under paragraph (1), (2), (3), or (4) of subsection (f). (2)

Distribution of materials

If the Secretary finds that a person committed a violation described in paragraph (1)(A), the Secretary may order the person to distribute materials in the same markets in which the violative advertisement or promotional material was distributed in a manner designed to notify the public and the medical community of the violation and to provide corrective information. (3)

Separate offense

For purposes of imposing a civil penalty under this subsection, each violation described in paragraph (1)(A), including each distribution of a direct-to-consumer advertisement in violation of section 503C, shall constitute a separate offense. (4)

Relation to other penalties

A civil penalty under paragraph (1) and an order under paragraph (2) shall be in addition to any other penalty applicable under this Act or other law to the violation involved. .

5.

Public education campaign on risks of certain drugs and devices

The Secretary of Health and Human Services shall conduct an education campaign to increase public awareness of risks that, for some patients, may outweigh the benefits of using a particular drug or device, whether such risks are known at the time of the approval of the drug or device or become known after the approval of the drug or device.

6.

Additional funding for regulation of direct-to-consumer drug and device advertising

There are authorized to be appropriated to the Food and Drug Administration such sums as may be necessary for each of fiscal years 2009 and 2010 for the purpose of regulating direct-to-consumer drug and device advertisements, including by carrying out the amendments made by section 2. The authorization of appropriations in the preceding sentence is in addition to any other authorization of appropriations for such purpose.