Pharmaceutical Regulation Conflict of Interest Act

“VI Special requirements for pharmaceutical regulators

“601. Definitions

“(a) In general—In this title, the terms designated agency ethics official and executive branch have the meanings given those terms under section 109.

“(b) Other definitions—In this title:

“(1) Covered pharmaceutical regulator—The term covered pharmaceutical regulator means an officer or employee of a covered pharmaceutical regulatory agency who occupies—

“(A) a supervisory position classified at or above GS–13 of the General Schedule;

“(B) in the case of a position not under the General Schedule, a supervisory position for which the rate of basic pay is not less than the minimum rate of basic pay for GS–13 of the General Schedule; or

“(C) any other supervisory position determined to be of equal classification by the Director.

“(2) Covered pharmaceutical regulatory agency—The term “covered pharmaceutical regulatory agency”—

“(A) means an agency whose primary responsibility is to regulate the manufacture, distribution, or sale of drugs (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) or biological products (as defined in section 351 of the Public Health Service Act (42 U.S.C. 262)); and

“(B) includes—

“(i) the Drug Enforcement Administration; and

“(ii) the Food and Drug Administration.

“(3) Director—The term “Director” means the Director of the Office of Government Ethics.

“(4) Former client—The term “former client”—

“(A) means a person for whom the covered pharmaceutical regulator served personally as an agent, attorney, or consultant during the 2-year period ending on the date (after such service) on which the covered pharmaceutical regulator begins service in the Federal Government; and

“(B) does not include—

“(i) instances in which the service provided was limited to a speech or similar appearance; or

“(ii) a client of the former employer of the covered pharmaceutical regulator to whom the covered pharmaceutical regulator did not personally provide such services.

“(5) Former employer—The term “former employer”—

“(A) means a person for whom a covered pharmaceutical regulator served as an employee, officer, director, trustee, or general partner during the 2-year period ending on the date (after such service) on which the covered pharmaceutical regulator begins service in the Federal Government; and

“(B) does not include—

“(i) any entity in the Federal Government, including an executive branch agency;

“(ii) a State or local government;

“(iii) the District of Columbia;

“(iv) an Indian tribe, as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); or

“(v) the government of a territory or possession of the United States.

“602. Conflict of interest and eligibility standards for pharmaceutical regulators

“(a) In general—A covered pharmaceutical regulator shall not make, participate in making, or in any way attempt to use the official position of the covered pharmaceutical regulator to influence a particular matter that provides a direct and substantial pecuniary benefit for a former employer or former client of the covered pharmaceutical regulator.

“(b) Recusal—A covered pharmaceutical regulator shall recuse himself or herself from any official action that would violate subsection (a).

“(c) Waiver

“(1) In general—The head of the covered pharmaceutical regulatory agency employing a covered pharmaceutical regulator, in consultation with the Director, may grant a written waiver of the restrictions under subsection (a) if, and to the extent that, the head of the covered pharmaceutical regulatory agency certifies in writing that—

“(A) the application of the restriction to the particular matter is inconsistent with the purposes of the restriction; or

“(B) it is in the public interest to grant the waiver.

“(2) Publication—The Director shall make each waiver under paragraph (1) publicly available on the Web site of the Office of Government Ethics.

“603. Negotiating future private sector employment

“(a) Prohibition—Except as provided in subsection (c), and notwithstanding any other provision of law, a covered pharmaceutical regulator may not participate in any particular matter which involves, to the knowledge of the covered pharmaceutical regulator, an individual or entity with whom the covered pharmaceutical regulator is in negotiations of future employment or has an arrangement concerning prospective employment.

“(b) Disclosure of employment negotiations

“(1) In general—If a covered pharmaceutical regulator begins any negotiations of future employment with another person, or an agent or intermediary of another person, or other discussion or communication with another person, or an agent or intermediary of another person, mutually conducted with a view toward reaching an agreement regarding possible employment of the covered pharmaceutical regulator, the covered pharmaceutical regulator shall notify the designated agency ethics official of the covered pharmaceutical regulatory agency employing the covered pharmaceutical regulator regarding the negotiations, discussions, or communications.

“(2) Information—A designated agency ethics official receiving notice under paragraph (1), after consultation with the Director, shall inform the covered pharmaceutical regulator of any potential conflicts of interest involved in any negotiations, discussions, or communications with the other person and the applicable prohibitions.

“(3) Publication—The Director, after receiving notice under paragraph (1), shall make publicly available on the Web site of the Office of Government Ethics the name of the covered pharmaceutical regulator and the name of the private person involved in the negotiations or arrangement concerning prospective employment of the covered pharmaceutical regulator.

“(c) Waivers only when exceptional circumstances exist

“(1) In general—The head of a covered pharmaceutical regulatory agency may only grant a waiver of the prohibition under subsection (a) if the head determines that exceptional circumstances exist.

“(2) Review and publication—For any waiver granted under paragraph (1), the Director shall—

“(A) review the circumstances relating to the waiver and the determination that exceptional circumstances exist; and

“(B) make the waiver publicly available on the Web site of the Office of Government Ethics, which shall include—

“(i) the name of the private person involved in the negotiations or arrangement concerning prospective employment of the covered pharmaceutical regulator; and

“(ii) the date on which the negotiations or arrangement commenced.

“(d) Scope—For the purposes of this section, the term negotiations of future employment is not limited to discussions of specific terms or conditions of employment in a specific position.

“604. Recordkeeping

“The Director shall—

“(1) receive all employment histories, recusal and waiver records, and other disclosure records for covered pharmaceutical regulators necessary for monitoring compliance with this title, and make those records publicly available on the Web site of the Office of Government Ethics;

“(2) promulgate rules and regulations, in consultation with the Director of the Office of Personnel Management and the Attorney General, to implement this title;

“(3) provide guidance and assistance where appropriate to facilitate compliance with this title;

“(4) review and, where necessary, assist designated agency ethics officials in providing advice to covered pharmaceutical regulators regarding compliance with this title; and

“(5) if the Director determines that a violation of this title may have occurred, and in consultation with the designated agency ethics official and the Counsel to the President, refer the compliance case to the United States Attorney for the District of Columbia for enforcement action.

“605. Penalties and injunctions

“(a) Criminal penalties

“(1) In general—Any person who violates section 602 or 603 shall be fined under title 18, United States Code, imprisoned for not more than 1 year, or both.

“(2) Willful violations—Any person who willfully violates section 602 or 603 shall be fined under title 18, United States Code, imprisoned for not more than 5 years, or both.

“(b) Civil enforcement

“(1) In general—The Attorney General may bring a civil action in an appropriate district court of the United States against any person who violates, or whom the Attorney General has reason to believe is engaging in conduct that violates, section 602 or 603.

“(2) Civil penalty

“(A) In general—Upon proof by a preponderance of the evidence that a person violated section 602 or 603, the court shall impose a civil penalty of not more than the greater of—

“(i) $100,000 for each violation; or

“(ii) the amount of compensation the person received or was offered for the conduct constituting the violation.

“(B) Rule of construction—A civil penalty under this subsection shall be in addition to any other criminal or civil statutory, common law, or administrative remedy available to the United States or any other person.

“(3) Injunctive relief

“(A) In general—In a civil action brought under paragraph (1) against a person, the Attorney General may petition the court for an order prohibiting the person from engaging in conduct that violates section 602 or 603.

“(B) Standard—The court may issue an order under subparagraph (A) if the court finds by a preponderance of the evidence that the conduct of the person violates section 602 or 603.

“(C) Rule of construction—The filing of a petition seeking injunctive relief under this paragraph shall not preclude any other remedy that is available by law to the United States or any other person.”