FEDERAL FOOD, DRUG, AND COSMETIC ACT

Bills and resolutions

Agriculture: prohibit open-air cultivation or use of human food or animal feed as host plant and establish tracking system to regulate genetically engineered pharmaceutical and industrial crops (see H.R. 3554), H8124 [2DE]

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (see S. 1855), S7368 [10NO] (see H.R. 2405), H4580 [28JN]

Drugs: ensure accurate, intelligible information on dosage delivery devices packaged with liquid over-the-counter medications (see H.R. 338), H354 [19JA]

———improve safety (see H.R. 1483), H2603 [12AP] (see H.R. 3026), H6413 [22SE]

———reschedule marijuana under the Controlled Substances Act and allow for medicinal use of marijuana in accordance with State laws (see H.R. 1983), H3644 (see H.R. 1983), H3682 [25MY]

FDA: allow fast track approval of certain orphan drugs (see H.R. 3737), H10013 [20DE]

———allow manufacturers to distribute and cite scientific research on health benefits of foods and dietary supplements without affecting regulatory category of the product (see H.R. 1364), H2326 [5AP]

———ensure appointments to advisory committees are made to promote scientific and technical expertise while minimizing conflicts of interest (see H.R. 3206), H6975 [14OC]

———ensure public participation in the drafting and issuance of certain guidance documents (see H.R. 3204), H6975 [14OC]

———ensure safe use of cosmetics (see H.R. 2359), H4573 [24JN]

———ensure valid generic drugs may enter the market (see S. 1882), S7612 [16NO]

———enter into agreements with certain countries regarding methods and approaches to harmonizing certain regulatory requirements on devices (see H.R. 3230), H6976 [14OC]

———establish a nanotechnology regulatory science program (see S. 1662), S6330 [6OC]

———establish and enforce a maximum somatic cell count requirement for fluid milk (see S. 458), S1120 [2MR]

———evaluate evidence on whether to add more folic acid to enriched grain products and expand folic acid fortification into cornmeal and corn-based food products to help prevent birth defects (see H. Res. 17), H41 [5JA]

———expedite process for requesting de novo classification of a device (see S. 1943), S8183 [5DE] (see H.R. 3203), H6975 [14OC]

———improve capacity to prevent drug shortages (see S. 296), S614 [7FE] (see H.R. 2245), H4363 [21JN]

———improve humanitarian device regulation (see H.R. 3211), H6976 [14OC]

———improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases (see S. 606), S1826 [17MR] (see H.R. 3059), H6456 [23SE]

———improve safety of dietary supplements by requiring manufacturers to register supplement products with the FDA and amending labeling requirements (see S. 1310), S4291 [30JN]

———improve the safety of Internet pharmacies (see S. 2002), S8679 [15DE]

———make clarifications relative to persons accredited to review reports and make recommendations for initial classification of devices (see H.R. 3205), H6975 [14OC]

———prevent approval of genetically-engineered fish (see S. 230), S359 [31JA] (see H.R. 521), H549 [8FE]

———promote development of medical devices for patients with rare diseases, improve medical device approval process, and lift profit cap on humanitarian use devices (see S. 1865), S7451 [15NO]

———provide additional quality control of drugs (see S. 1584), S5773 [20SE]

———provide for regulation of medical gases (see H.R. 2227), H4326 [16JN]

———provide incentives for the development of qualified infectious disease products (see S. 1734), S6764 [19OC] (see H.R. 2182), H4276 [15JN]

———provide predictability, consistency, and transparency to the premarket review process (see H.R. 3209), H6976 [14OC]

———reaffirm the Safe Medical Devices Act by requiring establishment of a schedule and issuance of regulations relative to device approval process (see H.R. 3208), H6975 [14OC]

———reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market (see S. 1700), S6505 [13OC]

———regulations concerning safe dietary ingredients in dietary supplements (see H.R. 3380), H7397 [4NO]

———require labeling of genetically-engineered fish (see S. 229), S359 [31JA] (see H.R. 520), H549 [8FE]

Food: amend inspection laws to notify consumers of products produced from crops, livestock, or poultry raised on sewage sludge-treated land (see H.R. 254), H135 [7JA]

———require labels on food that contains, or is produced with, a genetically engineered material (see H.R. 3553), H8124 [2DE]

Food industry: ban use of the arsenic compound known as roxarsone as a food additive (see H.R. 1487), H2603 [12AP]

Health: ensure the FTC bears the burden of proof in false advertising cases involving dietary supplements and dietary ingredients (see H.R. 2045), H3755 [26MY]

———review claims about effects of foods and dietary supplements on health-related conditions and diseases (see H.R. 2044), H3755 [26MY]

Pharmaceuticals: allow importation of prescription drugs (see S. 319), S642 [10FE]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (see S. 1211), S3813 [15JN] (see H.R. 965), H1664 [9MR]

———prohibit marketing of authorized generic drugs (see S. 373), S792 [16FE] (see H.R. 741), H1039 (see H.R. 741), H1070 [16FE]

———provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (see H.R. 147), H39 [5JA]

Product safety: ban use of bisphenol A in food and beverage containers (see H.R. 432), H469 [25JA]

———ban use of bisphenol A in food and beverage containers for children, baby food, and infant formula (see S. 136), S125 [25JA]

Tobacco products: clarify FDA jurisdiction over certain tobacco products and protect jobs and small businesses involved in the sale, manufacturing, and distribution of cigars (see S. 1461), S5191 [1AU]

Women: improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women (see S. 438), S1120 [2MR] (see H.R. 3526), H7998 [30NO]

Letters

Generating Antibiotic Incentives Now (GAIN) Act: B. Keith English, University of Tennessee Health Science Center and Le Bonheur Children's Hospital, S7029 [2NO]

———Meri Armour, Le Bonheur Children's Hospital, S7029 [2NO]

———several East Tennessee State University administrators and faculty, S7029 [2NO]

———William E. Evans, St. Jude Children's Research Hospital, S7028 [2NO]

Remarks in House

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 2405), H8153-H8159 [6DE], E2205 [7DE]

FDA: ensure regulations do not limit access to dietary supplements, H8266 [8DE]

———food safety activities funding, H4253-H4256 [15JN]

———prohibit funding for approval of genetically-engineered salmon, H4240 [15JN]

Health: review claims about effects of foods and dietary supplements on health-related conditions and diseases (H.R. 2044), E972 [27MY]

Pharmaceuticals: preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (H.R. 965), E437 [9MR]

———provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (H.R. 147), E7 [5JA]

Women: improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women, E2035 [14NO]

Remarks in Senate

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (S. 1855), S7382-S7384 [10NO]

FDA: ensure valid generic drugs may enter the market (S. 1882), S7616 [16NO]

———establish a nanotechnology regulatory science program (S. 1662), S6332 [6OC]

———improve capacity to prevent drug shortages (S. 296), S6901 [31OC]

———improve safety of dietary supplements by requiring manufacturers to register supplement products with the FDA and amending labeling requirements (S. 1310), S4294 [30JN]

———improve the safety of Internet pharmacies (S. 2002), S8684 [15DE]

———provide incentives for the development of qualified infectious disease products (H.R. 2182), S7028-S7030 [2NO]

Pharmaceuticals: allow importation of prescription drugs (S. 319), S644 [10FE]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (S. 1211), S3837-S3839 [15JN]

———prohibit marketing of authorized generic drugs, S1098 [2MR]

———prohibit marketing of authorized generic drugs (S. 373), S797 [16FE]

Product safety: ban use of bisphenol A in food and beverage containers for children, baby food, and infant formula (S. 136), S203 [25JA]

Reports filed

Dept. of HHS Programs To Protect Against Pandemics and Attacks From Chemical, Biological, Radiological, and Nuclear Weapons Reauthorization: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1855), S8733 [16DE]

Dept. of HHS Reauthorization of Programs To Protect Against Pandemics and Attacks From Chemical, Biological, Radiological, and Nuclear Weapons: Committee on Energy and Commerce (House) (H.R. 2405) (H. Rept. 112-286), H7712 [16NO]

Texts of

H.R. 2405, Dept. of HHS programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons reauthorization, H8153-H8157 [6DE]

S. 136, Ban Poisonous Additives Act, S204 [25JA]

S. 1211, Preservation of Antibiotics for Medical Treatment Act, S3839-S3841 [15JN]

S. 1310, Dietary Supplement Labeling Act, S4294 [30JN]

S. 1662, Nanotechnology Regulatory Science Act, S6333 [6OC]

S. 1882, Fair and Immediate Release of Generic Drugs (FAIR Generics) Act, S7616 [16NO]

S. 2002, Online Pharmacy Safety Act, S8685-S8687 [15DE]