{ "id": "R44620", "type": "CRS Report", "typeId": "REPORTS", "number": "R44620", "active": true, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 599909, "date": "2019-06-06", "retrieved": "2019-12-20T18:57:06.334586", "title": "Biologics and Biosimilars: Background and Key Issues", "summary": "A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation.\nA biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is highly similar but not structurally identical, to a brand-name biologic (i.e., the reference product). This is in contrast to a generic chemical drug, which is an exact copy of a brand-name chemical drug (i.e., the reference listed drug). Because biologics are more complex than chemical drugs, both in composition and method of manufacture, biosimilars will not be exact replicas of the brand-name product, but may instead be shown to be highly similar. However, for many years, the drug industry and the Food and Drug Administration (FDA) have coped with the inherent variability in biological products from natural sources. FDA maintains that the batch-to-batch and lot-to-lot variability that occurs for both brand-name biologics and biosimilars can be assessed and managed effectively. \nThe FDA regulates both biologics and chemical drugs. Before a biologic or biosimilar may be marketed in the United States, it must be licensed (i.e., approved) by FDA. To obtain licensure of a new biologic, the sponsor (generally the manufacturer of the product) submits to the agency a biologics license application (BLA) with data demonstrating that the biologic, and the facility in which it is manufactured, processed, packed, or held, meet standards to assure that the product is safe, pure, and potent. The Biologics Price Competition and Innovation Act (BPCIA)\u2014enacted as Title VII of the Patient Protection and Affordable Care Act (ACA, P.L. 111-148)\u2014established an abbreviated licensure pathway for biosimilar biological products or biosimilars. To obtain licensure of a biosimilar, the sponsor submits to FDA a BLA that provides information demonstrating, among other things, biosimilarity based on data from analytical studies (structural and functional tests), animal studies (toxicity tests), and/or a clinical study or studies (tests in human patients).\nSince enactment of the BPCIA, as of May 29, 2019, 19 biosimilars\u2014for nine reference products\u2014have been licensed in the United States. However, many of these licensed biosimilars are not yet available to patients, primarily due to ongoing litigation, although various factors may impact uptake of biosimilars. \nBiologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs. The cost of specialty drugs, including biologics, can be extremely high.\nThe high costs of pharmaceuticals in general\u2014and biologics in particular\u2014has led to an increased interest in understanding the federal government\u2019s role in the development of costly new therapeutics. In the case of many biosimilars approved by FDA, the associated brand-name biologic was originally discovered by scientists at public-sector research institutions. These brand-name biologics\u2014Remicade, Enbrel, Humira, Avastin\u2014are among the top-selling drugs in the United States and worldwide.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R44620", "sha1": "e9461a9ed75e52a2ac0891d81be82163baab48a4", "filename": "files/20190606_R44620_e9461a9ed75e52a2ac0891d81be82163baab48a4.html", "images": {} }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R44620", "sha1": "95cb826e2625cc3433d6ee7954407cfbe4f8dec2", "filename": "files/20190606_R44620_95cb826e2625cc3433d6ee7954407cfbe4f8dec2.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 575293, "date": "2017-10-27", "retrieved": "2017-11-09T14:15:17.261739", "title": "Biologics and Biosimilars: Background and Key Issues", "summary": "A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation.\nA biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is similar but not structurally identical to the brand-name biologic made by a pharmaceutical or biotechnology company. In contrast, a generic chemical drug is an exact copy of a brand-name chemical drug. Because biologics are more complex than chemical drugs, both in composition and method of manufacture, biosimilars will not be exact replicas of the brand-name product, but may instead be shown to be highly similar. The Food and Drug Administration (FDA) regulates both biologics and chemical drugs.\nBiologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs. The cost of specialty drugs, including biologics, can be extremely high.\nIn April 2006, the European Medicines Agency (EMA) authorized for marketing in Europe the first biosimilar product, Omnitrope, a human growth hormone. The EMA lists a total of 40 biosimilars on its website; 2 products were refused authorization and 3 were withdrawn, leaving a total of 35 biosimilars authorized for the European market. The introduction of biosimilars in Europe has reduced prices for biologics overall, in some cases by 33% compared with the original price of the brand-name product. For one drug in Portugal, the price reduction was 61%.\nIn contrast, the pathway to marketing biosimilars in the United States has had several barriers. FDA approved Omnitrope in June 2006, following an April 2006 court ruling requiring the FDA to move forward with consideration of the application. At the time Omnitrope was approved, FDA indicated that this action \u201cdoes not establish a pathway\u201d for approval of other follow-on biologic drugs and stated that Congress must change the law before the agency can approve copies of nearly all other such products.\nFour years later, in March 2010, Congress established a new regulatory authority for FDA by creating an abbreviated licensure pathway for biological products demonstrated to be \u201chighly similar\u201d (biosimilar) to or \u201cinterchangeable\u201d with an FDA-licensed biological product. The new authority was accomplished via the Biologics Price Competition and Innovation Act (BPCIA) of 2009, enacted as Title VII of the Affordable Care Act (ACA, P.L. 111-148). Congress authorized FDA to collect associated fees via the Biosimilar User Fee Act of 2012 (BsUFA, P.L. 112-144). The five-year biosimilars user fee authority was set to expire on September 30, 2017. Congress reauthorized the biosimilar user fee program via the Food and Drug Administration Reauthorization Act of 2017 (FDARA, P.L. 115-52). \nAs more biosimilars enter the U.S. market, analysts expect to see U.S. price reductions similar to those that have occurred in Europe. However, of the seven biosimilars approved by FDA, sales of five biosimilars have been delayed, or (allegedly) adversely impacted, by actions of the brand-name manufacturers. Three biosimilars (Erelzi, Amjevita, and Cyltezo) have had their marketing launch delayed by patent infringement lawsuits filed by brand-name manufacturers. In addition, Pfizer has sued Johnson & Johnson (J&J) alleging that J&J has entered into anticompetitive contracts with insurers that prevent coverage of Pfizer\u2019s biosimilar (Inflectra), a less expensive substitute for J&J\u2019s best-selling biologic (Remicade). The alleged anticompetitive practices would be expected to have a negative impact on another recently approved biosimilar (Renflexis).\nThe high costs of pharmaceuticals in general\u2014and biologics in particular\u2014has led to an increased interest in understanding the federal government\u2019s role in the development of costly new therapeutics. In the case of six of the seven biosimilars approved by FDA, the associated brand-name drug was originally discovered by scientists at public-sector research institutions. Several of these brand-name biologics (Remicade, Enbrel, Humira, Avastin) are among the top-selling drugs in the United States and worldwide.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44620", "sha1": "c2d0776b0f485f079b8719e9f7c77e6412e9e74c", "filename": "files/20171027_R44620_c2d0776b0f485f079b8719e9f7c77e6412e9e74c.html", "images": {} }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44620", "sha1": "02addfccfc1a72461690a54c9c4b48925c4c4f5c", "filename": "files/20171027_R44620_02addfccfc1a72461690a54c9c4b48925c4c4f5c.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 462431, "date": "2017-06-29", "retrieved": "2017-08-22T14:04:56.631475", "title": "Biologics and Biosimilars: Background and Key Issues", "summary": "A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation.\nA biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is similar but not structurally identical to the brand-name biologic made by a pharmaceutical or biotechnology company. In contrast to the relatively simple structure and manufacture of chemical drugs, biosimilars, with their more complex nature and method of manufacture, will not be identical to the brand-name product, but may instead be shown to be highly similar. The Food and Drug Administration (FDA) regulates both biologics and chemical drugs.\nBiologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs. The cost of specialty drugs, including biologics, can be extremely high.\nIn April 2006, the European Medicines Agency (EMA) authorized for marketing in Europe the first biosimilar product, Omnitrope, a human growth hormone. The EMA lists a total of 33 biosimilars on its website; 2 products were refused authorization and 2 were withdrawn, leaving a total of 29 biosimilars authorized for the European market. The introduction of biosimilars in Europe has reduced prices for biologics overall, in some cases by 33% compared with the original price of the brand-name product. For one drug in Portugal, the price reduction was 61%.\nIn contrast, the pathway to marketing biosimilars in the United States has had several barriers. FDA approved Omnitrope in June 2006, following an April 2006 court ruling that the FDA must move forward with consideration of the application. At the time Omnitrope was approved, FDA indicated that this action \u201cdoes not establish a pathway\u201d for approval of other follow-on biologic drugs and stated that Congress must change the law before the agency can approve copies of nearly all other such biotech products.\nFour years later, in March 2010, Congress established a new regulatory authority for FDA by creating an abbreviated licensure pathway for biological products demonstrated to be \u201chighly similar\u201d (biosimilar) to or \u201cinterchangeable\u201d with an FDA-licensed biological product. The new authority was accomplished via the Biologics Price Competition and Innovation Act (BPCIA) of 2009, enacted as Title VII of the Affordable Care Act (ACA, P.L. 111-148). In addition, Congress authorized FDA to collect associated fees via the Biosimilar User Fee Act of 2012 (BsUFA, P.L. 112-144). The five-year biosimilars user fee authority will sunset on October 1, 2017. FDA held meetings with industry during March through May 2016 to renegotiate the user fee agreement. The draft BsUFA agreement on FDA performance goals and procedures for FY2018 through FY2022 was posted on the FDA website in September 2016. The public had an opportunity to express its views on the draft during a public meeting on October 20, 2016, and a 30-day comment period after which the agreement was presented to Congress.\nFDA has approved five biosimilars for marketing in the United States: Zarxio (filgrastim-sndz) in March 2015, Inflectra (infliximab-dyyb) in April 2016, Erelzi (etanercept-szzs) in August 2016, Amjevita (adalimumab-atto) in September 2016, and Renflexis (infliximab-abda) in April 2017. As more biosimilars enter U.S. market, price reductions similar to those that have occurred in Europe will likely occur.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44620", "sha1": "b70bb084e5a6ab6775b89a654a48eefbc8db53ed", "filename": "files/20170629_R44620_b70bb084e5a6ab6775b89a654a48eefbc8db53ed.html", "images": {} }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44620", "sha1": "c711062fbf8573fda507363e8b37d8174e779176", "filename": "files/20170629_R44620_c711062fbf8573fda507363e8b37d8174e779176.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 456200, "date": "2016-09-30", "retrieved": "2016-10-17T19:21:58.687458", "title": "Biologics and Biosimilars: Background and Key Issues", "summary": "A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation.\nA biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is similar but not structurally identical to the brand-name biologic made by a pharmaceutical or biotechnology company. In contrast to the relatively simple structure and manufacture of chemical drugs, biosimilars, with their more complex nature and method of manufacture, will not be identical to the brand-name product, but may instead be shown to be highly similar. The Food and Drug Administration (FDA) regulates both biologics and chemical drugs.\nBiologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs. The cost of specialty drugs, including biologics, can be extremely high.\nIn April 2006, the European Medicines Agency (EMA) authorized for marketing in Europe the first biosimilar product, Omnitrope, a human growth hormone. The EMA has authorized a total of 21 biosimilars for the European market. The introduction of biosimilars in Europe has reduced prices for biologics overall, in some cases by 33% compared with the original price of the brand-name product. For one drug in Portugal, the price reduction was 61%.\nIn contrast, the pathway to marketing biosimilars in the United States has had several barriers. FDA approved Omnitrope in June 2006, following an April 2006 court ruling that the FDA must move forward with consideration of the application. At the time Omnitrope was approved, FDA indicated that this action \u201cdoes not establish a pathway\u201d for approval of other follow-on biologic drugs and stated that Congress must change the law before the agency can approve copies of nearly all other biotech products.\nFour years later, in March 2010, Congress established a new regulatory authority for FDA by creating an abbreviated licensure pathway for biological products demonstrated to be \u201chighly similar\u201d (biosimilar) to or \u201cinterchangeable\u201d with an FDA-licensed biological product. The new authority was accomplished via the Biologics Price Competition and Innovation Act (BPCIA) of 2009, enacted as Title VII of the Affordable Care Act (ACA, P.L. 111-148). In addition, Congress authorized FDA to collect associated fees via the Biosimilar User Fee Act of 2012 (BsUFA, P.L. 112-144). The five-year biosimilars user fee authority will sunset on October 1, 2017. FDA held meetings with industry during March through May 2016 to renegotiate the user fee agreement. The draft BsUFA agreement on FDA performance goals and procedures for FY2018 through FY2022 was posted on the FDA website in September 2016. The public will have an opportunity to express its views on the draft during a public meeting on October 20, 2016, and a 30-day comment period after which the agreement will be presented to Congress.\nFDA has approved four biosimilars for marketing in the United States: Zarxio (filgrastim-sndz) in March 2015, Inflectra (infliximab-dyyb) in April 2016, Erelzi (etanercept-szzs) in August 2016, and Amjevita (adalimumab-atto) in September 2016. The entry of such products on the U.S. market may result in price reductions similar to those that have occurred in Europe.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44620", "sha1": "961bb0ea020891972f7fd7aa2f4bc482911ef21b", "filename": "files/20160930_R44620_961bb0ea020891972f7fd7aa2f4bc482911ef21b.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44620", "sha1": "78f9e07772b6b3f8824729cea1a9a8e87ae56689", "filename": "files/20160930_R44620_78f9e07772b6b3f8824729cea1a9a8e87ae56689.pdf", "images": null } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 455951, "date": "2016-09-20", "retrieved": "2016-09-23T18:02:42.446161", "title": "Biologics and Biosimilars: Background and Key Issues", "summary": "A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation.\nA biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is similar but not structurally identical to the brand-name biologic made by a pharmaceutical or biotechnology company. In contrast to the relatively simple structure and manufacture of chemical drugs, biosimilars, with their more complex nature and method of manufacture, will not be identical to the brand-name product, but may instead be shown to be highly similar. The Food and Drug Administration (FDA) regulates both biologics and chemical drugs.\nBiologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs. The cost of specialty drugs, including biologics, can be extremely high.\nIn April 2006, the European Medicines Agency (EMA) authorized for marketing in Europe the first biosimilar product, Omnitrope, a human growth hormone. The EMA has authorized a total of 21 biosimilars for the European market. The introduction of biosimilars in Europe has reduced prices for biologics overall, in some cases by 33% compared with the original price of the brand-name product. For one drug in Portugal, the price reduction was 61%.\nIn contrast, the pathway to marketing biosimilars in the United States has had several barriers. FDA approved Omnitrope in June 2006, following an April 2006 court ruling that the FDA must move forward with consideration of the application. At the time Omnitrope was approved, FDA indicated that this action \u201cdoes not establish a pathway\u201d for approval of other follow-on biologic drugs and stated that Congress must change the law before the agency can approve copies of nearly all other biotech products.\nFour years later, in March 2010, Congress established a new regulatory authority for FDA by creating an abbreviated licensure pathway for biological products demonstrated to be \u201chighly similar\u201d (biosimilar) to or \u201cinterchangeable\u201d with an FDA-licensed biological product. The new authority was accomplished via the Biologics Price Competition and Innovation Act (BPCIA) of 2009, enacted as Title VII of the Affordable Care Act (ACA, P.L. 111-148). In addition, Congress authorized FDA to collect associated fees via the Biosimilar User Fee Act of 2012 (BsUFA, P.L. 112-144).\nFDA has approved three biosimilars for marketing in the United States: Zarxio (filgrastim-sndz) in March 2015, Inflectra (infliximab-dyyb) in April 2016, and Erelzi, (etanercept-szzs) in August 2016. The entry of such products on the U.S. market may result in price reductions similar to those that have occurred in Europe.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44620", "sha1": "b8e49a8abdf6b63bdb635dc9b90088ec57689986", "filename": "files/20160920_R44620_b8e49a8abdf6b63bdb635dc9b90088ec57689986.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44620", "sha1": "be82315de3d5a3416888d639a61b7b9b4be1e7c1", "filename": "files/20160920_R44620_be82315de3d5a3416888d639a61b7b9b4be1e7c1.pdf", "images": null } ], "topics": [] }, { "source": "EveryCRSReport.com", "id": 455592, "date": "2016-09-07", "retrieved": "2016-09-09T18:30:38.230974", "title": "Biologics and Biosimilars: Background and Key Issues", "summary": "A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation.\nA biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is similar but not structurally identical to the brand-name biologic made by a pharmaceutical or biotechnology company. In contrast to the relatively simple structure and manufacture of chemical drugs, biosimilars, with their more complex nature and method of manufacture, will not be identical to the brand-name product, but may instead be shown to be highly similar. The Food and Drug Administration (FDA) regulates both biologics and chemical drugs.\nBiologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs. The cost of specialty drugs, including biologics, can be extremely high.\nIn April 2006, the European Medicines Agency (EMA) authorized for marketing in Europe the first biosimilar product, Omnitrope, a human growth hormone. The EMA has authorized a total of 21 biosimilars for the European market. The introduction of biosimilars in Europe has reduced prices for biologics overall, in some cases by 33% compared with the original price of the brand-name product. For one drug in Portugal, the price reduction was 61%.\nIn contrast, the pathway to marketing biosimilars in the United States has had several barriers. FDA approved Omnitrope in June 2006, following an April 2006 court ruling that the FDA must move forward with consideration of the application. At the time Omnitrope was approved, FDA indicated that this action \u201cdoes not establish a pathway\u201d for approval of other follow-on biologic drugs and stated that Congress must change the law before the agency can approve copies of nearly all other biotech products.\nFour years later, in March 2010, Congress established a new regulatory authority for FDA by creating an abbreviated licensure pathway for biological products demonstrated to be \u201chighly similar\u201d (biosimilar) to or \u201cinterchangeable\u201d with an FDA-licensed biological product. The new authority was accomplished via the Biologics Price Competition and Innovation Act (BPCIA) of 2009, enacted as Title VII of the Affordable Care Act (ACA, P.L. 111-148). In addition, Congress authorized FDA to collect associated fees via the Biosimilar User Fee Act of 2012 (BsUFA, P.L. 112-144).\nFDA has approved three biosimilars for marketing in the United States: Zarxio (filgrastim-sndz) in March 2015, Inflectra (infliximab-dyyb) in April 2016, and Erelzi, (etanercept-szzs) in August 2016. The entry of such products on the U.S. market may result in price reductions similar to those that have occurred in Europe.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44620", "sha1": "ca5e8e6725c1ca7098672751c3984aaf29ae7cbb", "filename": "files/20160907_R44620_ca5e8e6725c1ca7098672751c3984aaf29ae7cbb.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44620", "sha1": "d71a812f35685270053ab1b951e8b9ebae27e439", "filename": "files/20160907_R44620_d71a812f35685270053ab1b951e8b9ebae27e439.pdf", "images": null } ], "topics": [] } ], "topics": [ "Economic Policy", "Foreign Affairs", "Health Policy" ] }