PHARMACEUTICALS related term(s) Drugs

Amendments

FDA: modernize (S. 830), S9219, S9236 [11SE], S9298 [12SE], S9338, S9340, S9341, S9342, S9343, S9344, S9345, S9346, S9350 [15SE], S9428 [16SE], S9705, S9707 [19SE], S9739, S9763, S9766, S9767 [23SE], S9849 [24SE]

Appointments

Conferees: S. 830, FDA Modernization and Accountability Act, S11018 [23OC], H8978 [22OC]

Bills and resolutions

Children and youth: incentives for testing the safety of drugs for use by children (see S. 713), S4106 [7MY]

Contraceptives: require equitable coverage of drugs, devices, and services under health insurance plans (see S. 743, 766; H.R. 2174), S4479 [14MY], S4748 [20MY], H5401 [16JY]

Dept. of Defense: include certain beneficiaries in National Mail Order Pharmacy Program (see S. 1273; H.R. 1773), S10631 [8OC], H3273 [3JN]

Dept. of HHS: prepare and publish a consumer guide to prescription drug prices (see H.R. 183), H145 [9JA]

Diseases: coverage of prostate cancer screening and drug treatments under Medicare and Dept. of Veterans Affairs programs (see H.R. 301), H149 [9JA]

———coverage of prostate cancer screening and drug treatments under Medicare and Dept. of Veterans Affairs programs and expansion of research and education programs (see H.R. 383), H151 [9JA]

———Medicare coverage and research funding for amyotrophic lateral sclerosis (see H.R. 2009), H4221 [23JN]

———prostate cancer research programs (see H.R. 297), H148 [9JA]

———provide information relative to prostate cancer screening and drug treatments and expand research programs (see S. 902), S5620 [12JN], S5694 [16JN]

Drugs: defer effective dates for approving certain drug applications (see H.R. 1727), H3202 [22MY]

———encourage consultation with pharmacists relative to purchase and use of over-the-counter drug products (see H. Res. 151), H2784 [15MY]

———rescheduling of flunitrazepam into schedule I of the Controlled Substances Act (see S. 1568), S12576 [13NO]

———specify the entities eligible to purchase pharmaceutical products from the Federal Supply Schedule (see H.R. 2197), H5486 [17JY]

———use of marijuana for medicinal purposes (see H.R. 1782), H3476 [4JN]

FDA: approval and development of new drugs and biological products (see H.R. 1411), H1793 [23AP]

———encourage consultation with pharmacists relative to purchase and use of over-the-counter drug products (see S. Res. 99), S5596 [12JN]

———modernize (see S. 830), S5341 [5JN]

———modernize (S. 830), corrections in enrollment (see S. Con. Res. 69), S12576 [13NO], H10955 [13NO]

Federal, Food, Drug, and Cosmetic Act: authorize compounding of certain drugs and devices (see H.R. 1060), H1017 [13MR]

Federal employees: encourage the use of generic drugs in health insurance plans (see H.R. 1073), H1017 [13MR]

Government regulations: improve the regulation of drugs (see H.R. 1094), H1111 [18MR]

———reporting requirements of deaths resulting from the prescribing, dispensing, and the administration of drugs (see H.R. 524), H283 [4FE]

Health: improve regulation of radiopharmaceuticals (see H.R. 2298), H6405 [30JY], H6797 [3SE]

Insurance: treatment of prescription drugs (see H.R. 1525), H2155 [1MY]

Medicaid: eligibility for payment for administration of pediatric vaccines (see H.R. 912), H724 [4MR]

Medicare: coverage of multiple sclerosis drug treatments (see H.R. 1329), H1541 [15AP]

———eliminate time limitation on benefits for immunosuppressive drugs (see S. 1481; H.R. 1061), S12119 [8NO], H1017 [13MR]

———limit payments for drugs or biological products (see H.R. 2851), H10171 [6NO]

———multiple sclerosis drug treatments (see H.R. 1018), H888 [11MR]

———payments for certain drugs relative to hospital outpatient department services (see H.R. 2687), H8928 [21OC]

———pharmaceutical care services (see H.R. 1201, 1218), H1260 [20MR], H1288 [21MR]

Senior citizens: establish a program of pharmacy assistance fee for elderly persons who have no health insurance coverage (see H.R. 2681), H8928 [21OC]

States: permit funding of prescription drugs for minors relative to parental consent (see H.R. 2941), H10419 [8NO]

Tariff: anticancer drug production (see H.R. 2041, 2042, 2043, 2044, 2045, 2046, 2049), H4645 [25JN]

———anti-HIV and anti-AIDS drug production (see H.R. 2047, 2048), H4645 [25JN]

Taxation: credit for clinical testing of certain drugs for rare diseases or conditions (see S. 293; H.R. 1169), S1191 [10FE], H1259 [20MR]

Chronologies

Advanced Breast Biopsy Instrumentation device application process, S9752 [23SE]

Cloture motions

FDA: modernize (S. 830), S8721 [3SE], S8821 [4SE], S8839 [5SE], S9146 [11SE], S9375 [16SE], S9632 [18SE]

Factsheets

Adverse Health Effects of Feminine Hygiene Products, S9149 [11SE]

FDA Modernization and Accountability Act and Preemption of Cosmetic Regulations by the States, S9149 [11SE]

Hazards of Skin Care Products Containing Alpha-Hydroxy, S9149 [11SE]

Talc May Pose a Risk of Ovarian Cancer, S9150 [11SE]

Letters

FDA Modernization and Accountability Act: Daniel E. Lungren and Theodora Berger, S8867 [5SE]

———Donna E. Shalala, Sec. of HHS, S8843 [5SE], S9817 [24SE]

———Tom Carper, Governor of Delaware, and Tom Ridge, Governor of Pennsylvania, S8855 [5SE]

FDA regulation of medical device approval process relative to labeling claims: George N. Hatsopoulos, Thermo Electron (business), S9749 [23SE]

———Monica Morrow, S9746 [23SE]

FDA regulation of medical device approval process relative to tracking or conducting of post-market surveillance: Elaine Levenson, Victims Against Lethal Valves (organization), S9708 [19SE]

FDA treatment of liability relative to adverse reaction reports or other certain information: Alan F. Holmer, Pharmaceutical Research and Manufacturers of America, S9765 [23SE]

Food and Drug Administration Modernization and Accountability Act: Donna E. Shalala, Sec. of HHS, S12654-S12656 [13NO]

Issuance of State warning labels or public warnings about over-the-counter drugs: James D. Cope, Nonprescription Drug Manufactures Association, S9845 [24SE]

National Center for Complementary and Alternative Medicine: Jordan J. Cohen, Association of American Medical Colleges, S9761 [23SE]

———several health care professionals and organizations, S9761 [23SE]

Pharmaceutical and biological prescription drug industries user fees: Donna E. Shalala, Dept. of HHS, H10887 [13NO]

Motions

FDA: modernize (S. 830), H8500 [7OC]

Papers

Human Costs of Regulation—The Case of Medical Devices and the FDA: David C. Murray, Hudson Institution, S9833 [24SE]

Remarks in House

Dept. of Defense: include certain beneficiaries in National Mail Order Pharmacy Program (H.R. 1773), H3958 [19JN]

Diseases: AIDS research funding, H2755, H2756 [15MY]

———Medicare coverage and research funding for amyotrophic lateral sclerosis (H.R. 2009), H4228 [24JN], E1298 [23JN]

———prostate cancer research funding, E1568 [31JY]

Drugs: defer effective dates for approving certain drug applications (H.R. 1727), E1093 [3JN]

FDA: approval and development of new drugs and biological products (H.R. 1411), H8454, H8455-H8500 [7OC], H8694 [8OC], E2009 [9OC]

———modernize (S. 830), H8482-H8500 [7OC], H8807 [9OC]

———modernize (S. 830), conference report, E2388 [13NO]

———modernize (S. 830), corrections in enrollment (H. Con. Res. 196), H10886-H10889 [13NO]

———modernize (S. 830), insert language of H.R. 1411 in lieu, H8500 [7OC]

Health care facilities: requirements relative to purchase of pharmaceuticals and medical devices at discounted prices, H8366 [6OC]

Insurance: treatment of prescription drugs (H.R. 1525), E855 [6MY]

Medicare: payments for certain drugs relative to hospital outpatient department services (H.R. 2687), E2033 [21OC]

———pharmaceutical care services (H.R. 1201), E547 [21MR], E810 [1MY]

Prescription Drug User Fee Act: reauthorize, H8475-H8482 [7OC]

Taxation: credit for clinical testing of certain drugs for rare diseases or conditions (H.R. 1169), E550 [21MR]

Remarks in Senate

Children and youth: establish financial incentives for testing the safety of drugs on children, S9823 [24SE]

———incentives for testing the safety of drugs for use by children (S. 713), S4276, S4281 [9MY]

Contraceptives: require equitable coverage of drugs, devices, and services under health insurance plans (S. 743), S4487, S4488 [14MY]

Dept. of Defense: include certain beneficiaries in National Mail Order Pharmacy Program (S. 1273), S10648 [8OC]

Dept. of HHS: State AIDS drug assistance programs funding, S9109, S9114, S9115 [11SE]

Diseases: funding for affordable drug program for the terminally ill, S7849 [22JY]

———provide information relative to prostate cancer screening and drug treatments and expand research programs (S. 902), S5620 [12JN]

FDA: approval process and development of new drugs and biological products, S2762-S2764 [7AP]

———drug manufacturing and pharmacy compounding regulations, S9839, S9840, S9849 [24SE]

———encourage consultation with pharmacists relative to purchase and use of over-the-counter drug products (S. Res. 99), S5626 [12JN]

———Federal requirements for labeling of nonprescription drugs, S9768, S9769 [23SE]

———modernize (S. 830), S5342 [5JN], S8162-S8170, S8205 [28JY], S8482 [31JY], S8721 [3SE], S8815 [4SE], S8837-S8869 [5SE], S8878-S8898 [8SE], S9133-S9157 [11SE], S9360-S9363, S9378-S9385 [16SE], S9553, S9694-S9697 [18SE], S9701-S9713, S9721 [19SE], S9737-S9754, S9755-S9759-S9769, S9771-S9775, S9781 [23SE], S9811-S9868 [24SE], S10469 [7OC]

———modernize (S. 830), conference report, S12482 [10NO], S12653 [13NO]

———modernize (S. 830), corrections in enrollment (S. Con. Res. 69), S12710 [13NO]

———modernize (S. 830), unanimous-consent agreement, S8819 [4SE], S9362, S9378 [16SE], S9600, S9626 [18SE], S9754, S9759, S9760, S9769 [23SE], S10777 [9OC]

———modify mission statement, S9764 [23SE]

———prescription drug user fee reauthorization, S7942 [23JY], S8854-S8855, S8860 [5SE], S9838, S9840, S9842, S9844 [24SE]

———regulation of medical device approval process, S8843-S8845, S8847-S8850, S8853, S8860-S8869 [5SE], S8888-S8890, S8895-S8898 [8SE], S9361, S9380-S9385 [16SE], S9701-S9705 [19SE], S9772-S9775 [23SE], S9831-S9835, S9848 [24SE]

———regulation of medical device approval process relative to conflict of interest standards of FDA employees, S9705-S9707 [19SE], S9737, S9738 [23SE]

———regulation of medical device approval process relative to labeling claims, S9710-S9712 [19SE], S9739-S9754, S9755 [23SE], S9814-S9819, S9827-S9831 [24SE]

———regulation of medical device approval process relative to tracking or conducting of post-market surveillance, S9708-S9710 [19SE], S9738, S9739 [23SE]

———revise drug approval process, S7992 [24JY], S8205 [28JY]

———treatment of liability relative to adverse reaction reports or other certain information, S9764, S9765 [23SE]

Medicare: eliminate time limitation on benefits for immunosuppressive drugs (S. 1481), S12146 [8NO]

NIH: establish National Center for Complementary and Alternative Medicine, S9759-S9762 [23SE]

States: issuance of warning labels or public warnings about over-the-counter drugs, S9844, S9845 [24SE]

Taxation: credit for clinical testing of certain drugs for rare diseases or conditions (S. 293), S1191 [10FE]

Treaties and agreements: extension of application of patent terms on prescription drugs relative to GATT implementation, S3979, S3987, S3989, S3990 [6MY]

Reports filed

FDA Modernization and Accountability Act: Committee on Labor and Human Resources (Senate) (S. 830) (S. Rept. 105-43), S6907 [7JY]

FDA Regulatory Modernization Act: Committee on Commerce (House) (H.R. 1411) (H. Rept. 105-310), H8632 [7OC]

Statements

FDA Modernization and Accountability Act (S. 830): Committee on Labor and Human Resources (Senate), S9835-S9838 [24SE]

———OMB, S9848, S9849 [24SE]

Regulation of Cosmetic Industry in Food and Drug Administration Modernization and Accountability Act: David Wallinga, Natural Resources Defense Council, S9148 [11SE]

Summaries

Medicare Pharmaceutical Care Services (H.R. 1201), E547 [21MR]

Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures, H10887-H10889 [13NO]

Texts of

H. Con. Res. 196, corrections in enrollment of S. 830, Food and Drug Administration Modernization and Accountability Act, H10886 [13NO]

H.R. 1411, FDA Regulatory Modernization Act, H8455-H8474 [7OC]

S. 293, tax credit for clinical testing of certain drugs for rare diseases or conditions, S1192 [10FE]

S. 830, FDA Modernization and Accountability Act, S9133-S9145 [11SE], S9850-S9867 [24SE], H8482-H8500 [7OC]

S. 902, Prostate Testing Full Information Act, S5621 [12JN]

S. 1273, include certain Dept. of Defense beneficiaries in National Mail Order Pharmacy Program, S10649 [8OC]

S. Con. Res. 69, corrections in enrollment of S. 830, Food and Drug Administration Modernization and Accountability Act, S12616, S12710 [13NO]

S. Res. 99, encourage consultation with pharmacists relative to purchase and use of over-the-counter drug products, S5626 [12JN]