3.0.0 5874 2023-01-11T13:25:09Z 2023-01-11T13:25:09Z House H HR 2014-12-11 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. ISRAEL:H.R. 5874.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3 of the United StatesConstitution[Page H9304]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2014-12-11T14:02:35Z 2014-12-11 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2014-12-11 Introduced in House IntroReferral Intro-H 9 Library of Congress 2014-12-11 Introduced in House IntroReferral 1000 9 Library of Congress I000057 Rep. Israel, Steve [D-NY-3] STEVE ISRAEL D NY 3 N Health Administrative law and regulatory procedures Administrative remedies Criminal investigation, prosecution, interrogation Criminal justice information and records Department of Health and Human Services Department of Justice Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Fraud offenses and financial crimes Government information and archives Government studies and investigations Health information and medical records Health programs administration and funding Manufacturing Marketing and advertising Prescription drugs Retail and wholesale trades Health 00 2014-12-11 Introduced in House 2015-03-18T20:32:36Z Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for a drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Department of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred.

Deems a drug to be misbranded if it is not manufactured using technologies that HHS determines are technically feasible and assist in preventing such violations.

Authorizes additional appropriations for Food and Drug Administration (FDA) inspections, examinations, and investigations.

Requires HHS to educate the public and health care professionals on counterfeit drugs.

Directs HHS, upon a finding that a drug intended for human use may constitute a threat to the public health, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering, distributing, selling, or prescribing the drug. Requires HHS, after providing the person with an opportunity for an informal hearing, to amend the order to include a recall, if appropriate.

Requires HHS and the Attorney General to establish a procedure through which the FDA is authorized to issue subpoenas.

]]> Counterfeit Drug Enforcement Act of 2014 Display Title Counterfeit Drug Enforcement Act of 2014 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to establish recall authority regarding drugs, and for other purposes. Introduced in House IH Short Titles as Introduced Counterfeit Drug Enforcement Act of 2014 Short Titles as Introduced Tim Fagan's Law Introduced in House 2014-12-11T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr5874ih/xml/BILLS-113hr5874ih.xml 2014-12-11 Referred to the House Committee on Energy and Commerce. 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. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.