{
  "id": "R44810",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "R44810",
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  "source": "EveryCRSReport.com",
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      "source": "EveryCRSReport.com",
      "id": 579415,
      "date": "2018-03-16",
      "retrieved": "2018-04-03T13:39:37.060342",
      "title": "FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development ",
      "summary": "The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the Food and Drug Administration (FDA) to regulate the safety and effectiveness of drug products sold in the United States. The statutory standard for FDA approval is that a drug is safe and effective for its intended use. FDA\u2019s determination that a drug is safe does not signify an absence of risk but rather that the drug\u2019s clinical benefits outweigh its known and potential risks.\nFor most drugs, FDA has generally considered routine risk minimization measures to be sufficient; for example, updated labeling based on new information from postmarket surveillance. In certain cases, however, the agency has recommended or required additional measures to minimize drug risk. Early risk management programs at FDA included elements such as education for patients and providers, and restrictions on distribution. In 2007, the FDA Amendments Act (FDAAA) expanded the risk management authority of FDA, authorizing the agency to require for certain drugs, under specified conditions, risk evaluation and mitigation strategies (REMS). REMS is a required risk management plan that uses risk mitigation strategies beyond FDA-approved professional labeling. As part of a REMS, a drug manufacturer may be required to provide certain information to patients (e.g., a medication guide) and health care providers (e.g., a communication plan) or to impose restriction on a drug\u2019s distribution or use via one or more \u201cElements to Assure Safe Use\u201d (ETASU). \nA REMS-restricted distribution program controls the chain of supply so that the drugs are provided only to patients with prescriptions from authorized physicians or pharmacies under specified conditions. Although the law prohibits the holder of an approved drug application (generally the brand company) from using ETASU to block or delay approval of a generic drug application, FDA, the Federal Trade Commission, generic drug manufacturers, and some Members of Congress have expressed concern that brand companies are using REMS to prevent or delay generic drugs from entering the market. The Director of the Center for Drug Evaluation and Research (CDER) at FDA, for example, has testified that some brand pharmaceutical companies have used REMS and distribution restrictions to impede competition by (1) withholding or refusing to sell samples of the brand drug to the generic company for purposes of bioequivalence testing and (2) prolonging negotiations related to developing a single, shared system of REMS. Effectively, withholding samples prevents the generic company from obtaining data necessary to support an application for approval, while prolonging negotiations of a single, shared system REMS delays approval of the generic application. Others argue that REMS are rare, and that FDA requires REMS with restricted distribution only for drugs that would otherwise not be allowed on the market due to safety risks.\nA 2014 study sponsored by the Generic Pharmaceutical Association (GPhA; now called the Association for Affordable Medicines [AAM]) estimated that misuse of REMS and other restricted distribution programs costs the United States $5.4 billion annually, with the federal government bearing a third of this burden. \nIn the 115th Congress, legislation to keep brand companies from using REMS to prevent or delay generic drugs from entering the market has been introduced: the Fair Access for Safe and Timely Generics Act of 2017 (or the FAST Generics Act of 2017 [H.R. 2051]) and the Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (or the CREATES Act of 2017 [S. 974, H.R. 2212]). Legislation aimed at reforming REMS has been discussed as a means of reducing healthcare spending, although CRS is not aware of any formal cost estimates from the Congressional Budget Office (CBO) or other entities.",
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        {
          "source": "IBCList",
          "id": 4880,
          "name": "FDA Product Regulation & Medical Research"
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    {
      "source": "EveryCRSReport.com",
      "id": 460402,
      "date": "2017-04-11",
      "retrieved": "2017-08-22T15:10:48.400487",
      "title": "FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development ",
      "summary": "The Food and Drug Administration (FDA) regulates the safety and effectiveness of drug products sold in the United States. The statutory standard for FDA approval is that a drug is safe and effective for its intended use. FDA\u2019s determination that a drug is safe does not signify an absence of risk but rather that the drug\u2019s clinical benefits outweigh its known and potential risks.\nFor most drugs, FDA has generally considered routine risk minimization measures to be sufficient; for example, updated labeling based on new information from postmarket surveillance. In certain cases, however, the agency has recommended or required additional measures to minimize drug risk. Early risk management programs at FDA, voluntarily instituted by manufacturers, included elements such as education for patients and providers, and restrictions on distribution. In 2007, the FDA Amendments Act (FDAAA) expanded the risk management authority of FDA, authorizing the agency to require for certain drugs, under specified conditions, risk evaluation and mitigation strategies (REMS). REMS is a required risk management plan that uses risk mitigation strategies beyond FDA-approved professional labeling. As part of a REMS, a drug manufacturer may be required to provide certain information to patients (e.g., a medication guide) and health care providers (e.g., a communication plan) or to impose restriction on a drug\u2019s sale and distribution via one or more \u201cElements to Assure Safe Use\u201d (ETASU). \nA REMS-restricted distribution program controls the chain of supply so that the drugs are provided only to patients with prescriptions from authorized physicians or pharmacies under specified conditions. Although the law prohibits the holder of an approved new drug or biologics license application (i.e., the brand company) from using ETASU \u201cto block or delay approval of an application,\u201d FDA, the Federal Trade Commission, generic drug manufacturers, and some Members of Congress have expressed concern that brand companies are using REMS to prevent or delay generic drugs from entering the market. A 2014 study sponsored by the Generic Pharmaceutical Association (GPhA; recently renamed as the Association for Affordable Medicines [AAM]) estimated that misuse of REMS and other restricted distribution programs costs the United States $5.4 billion annually, with the federal government bearing a third of this burden. REMS have come up in the context of user fee reauthorization, with the Director of the Center for Drug Evaluation and Research at FDA testifying that some brand drug manufacturers have used REMS and distribution restrictions to delay or refuse to sell quantities of a brand-name drug to generic product developers, potentially delaying consumer access to less expensive generic drugs. Without the brand-name drug against which to test bioequivalence of the generic product, the generic product developer cannot complete the required application to FDA. Others argue that REMS are rare, and that FDA only requires REMS with restricted distribution for drugs that would otherwise not be allowed on the market due to safety risks. \nIn the 114th Congress, two bills were introduced to keep brand companies from using REMS to prevent or delay generic drugs from entering the market: the Fair Access for Safe and Timely Generics Act of 2015 (or the FAST Generics Act of 2015 [H.R. 2841]) and the Creating and Restoring Equal Access to Equivalent Samples Act of 2016 (or the CREATES Act of 2016 [S. 3056]). As of the date of this report, neither of these two bills has been reintroduced in the 115th Congress. However, in the 115th Congress, two bills have been introduced that address generic drug development: the Lower Drug Costs through Competition Act (H.R. 749) and the Increasing Competition in Pharmaceuticals Act (S. 297). Both bills contain a provision titled \u201cStudy on REMS,\u201d which would require GAO to conduct a study on REMS and its implementation; the study would examine, among other things, the \u201cburden associated with REMS,\u201d including on generic drug manufacturers.\u201d",
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      "typeId": "REPORTS",
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          "id": 4880,
          "name": "FDA Product Regulation & Medical Research"
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  "topics": [
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}