PHARMACEUTICALS

Amendments

Computers: improve regulation of Internet pharmacies (S. 980), S2301, S2307 [1AP]

Medicare/Medicaid: extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (S. 3101), S5634, S5635 [12JN]

Articles and editorials

AmerisourceBergen's Scrimp-and-Save Dave, E2173 [30SE]

Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease—A Systematic Review and Meta-analysis, S10863-S10875 [10DE]

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. 6635), H7306 [29JY]

American Pharmacists Month: designate (see H. Res. 1437), H8127 [15SE]

Children and youth: improve vaccination rates (see S. 2911), S3401 [24AP]

Commission on Affordable Health Care: establish (see H.R. 6319), H5729 [19JN]

Computers: improve regulation of Internet pharmacies (see H.R. 6353), H6009 [24JN]

Contraceptives: require equitable coverage of drugs, devices, and services under health insurance plans (see S. 3068), S4793 [22MY]

Controlled Substances Act: address use of intrathecal pumps (see S. 3568), S9415 [24SE] (see H.R. 7304), H10856 [20NO]

Dept. of HHS: establish a drug discount program for individuals without prescription drug coverage (see H.R. 6619), H7164 [24JY]

———expand authority to impose debarments in order to ensure the integrity of drug, biological product, and device regulation (see H.R. 6376, 6378), H6173 [26JN]

———revise the National Vaccine Injury Compensation Program (see H.R. 6391), H6174 [26JN]

Diseases: provide assistance to in-need countries to combat HIV/AIDS, tuberculosis, and malaria (see S. 2762), S2132 [13MR]

Drugs: improve safety (see H.R. 5839), H2486 [17AP]

———mandate early access by patients to new drugs under clinical investigation for a serious or immediately life-threatening condition for which no comparable or satisfactory drug or other therapy is available (see H.R. 6047), H3884 [14MY]

EPA: convene a task force to develop recommendations on the proper disposal of unused pharmaceuticals (see H.R. 6451), H6342 [9JY]

———study presence of pharmaceuticals and personal care products in U.S. drinking water supplies (see H.R. 6820), H7808 [1AU]

FDA: clarify priority review voucher laws (see S. 3151), S5753 [18JN]

———establish a program of fees relative to generic new animal drugs (see H.R. 6433), H6229 [8JY]

———implement safeguards in direct-to-consumer advertising following FDA approval of prescription drugs and medical devices (see H.R. 6151), H4830 [22MY]

———reverse policy eliminating access to medication containing estriol (see S. Con. Res. 88), S5447 [10JN] (see H. Con. Res. 342), H3108 [6MY]

———revise and extend the animal drug user fee program (see H.R. 6432), H6229 [8JY]

Federal Food, Drug, and Cosmetic Act: distribution and citation of scientific research in connection with foods and dietary supplements (see H.R. 7120), H10129 [26SE]

———ensure safety and quality of medical products and enhance authorities of FDA (see S. 3409), S7905 [31JY]

Health: ensure a sufficient supply of vaccines (see H.R. 4991), H294 [16JA]

———increase availability of vaccines (see H.R. 4993), H294 [16JA]

Health care facilities: provide for public disclosure of charges for certain hospital and ambulatory surgical center services and drugs (see H.R. 5033), H348 [17JA]

Health care professionals: provide grants or contracts to create prescription drug education and outreach academic detailing programs (see S. 3396), S7904 [31JY] (see H.R. 6752), H7787 [31JY]

Health care providers: authorize grants to States to establish and implement programs for registering pharmaceutical technicians (see H.R. 5491), H1073 [26FE]

Labeling: require country-of-origin labeling on prescription and over-the-counter drugs (see S. 3633), S9657 [26SE]

Medicaid: include all public clinics for the distribution of pediatric vaccines (see H.R. 4990), H294 [16JA]

———permit States to exclude earned income in determining eligibility for medical assistance for individuals with extremely high prescription drug costs (see H.R. 5748), H2150 [9AP]

———provide coverage of drugs prescribed for certain NIH research study child participants (see S. 2629), S970 [13FE] (see H.R. 5468), H994 [14FE]

Medicare: apply exceptions process for tiered formulary drugs to specialty tier drugs and limit cost-sharing for specialty tier drugs (see H.R. 6684), H7784 [31JY]

———coverage of clinical pharmacist practitioner services under part B (see H.R. 5780), H2224 [10AP]

———enhance beneficiary protections under parts C and D (see H.R. 6359), H6009 [24JN]

———improve access of beneficiaries to immune globulins (see S. 2990), S3891 [7MY]

———limit prescription drug program premium increases to no more than Social Security cost-of-living adjustment and require Dept. of HHS to negotiate lower prescription drug prices (see H.R. 5317), H812 [7FE]

———provide coverage for the shingles vaccine (see H.R. 5877), H2657 [23AP]

———provide coverage of federally recommended vaccines (see H.R. 4992), H294 [16JA]

———provide for consolidated coverage of home infusion drug therapy (see S. 3505), S8947 [17SE]

———replace the prescription drug benefit with a revised and simplified program for all beneficiaries (see H.R. 6800), H7807 [1AU]

Medicare/Medicaid: extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (see S. 3101), S5366 [6JN] (see H.R. 6212), H5110 [9JN] (see H.R. 6331), H5796 [20JN]

———reduce cost-sharing for certain dual eligible populations under the prescription drug benefit (see H.R. 5604), H1700 [13MR]

National Medicine Abuse Awareness Month: designate (see S. Res. 614), S6869 [16JY]

Schools: provide States with resources needed to rid schools of performance-enhancing drug use (see H.R. 6281), H5481 [17JN]

Social Security: provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under certain programs (see H.R. 5605), H1700 [13MR]

Tariff: bismuth subsalicylate (see H.R. 5047), H349 [17JA]

———bulk aspirin (see H.R. 5330), H813 [7FE]

———squaric acid (see H.R. 5050), H349 [17JA]

Cloture motions

Medicare/Medicaid: extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), motion to proceed, S6224, S6231 [26JN], S6489 [9JY]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (S. 3101), motion to proceed, S5431 [10JN], S5564 [12JN]

Letters

Animal Drug User Fee Act Performance Goals and Procedures: Michael O. Leavitt, Sec. of HHS, S8170 [9SE]

Determination of GlaxoSmithKline, PLC, action after receiving study on the potential health risks associated with diabetes drug Avandia: Senator Grassley, Committee on Finance (Senate), S486 [30JA]

Harvard University and Massachusetts General Hospital financial disclosure policies implementation: Senator Grassley, Committee on Finance (Senate), S5031-S5033 [4JN]

Investigation of Alan Schatzberg at Stanford University under the Physician Payments Sunshine Act: Senator Grassley, S5956-S5958 [23JN]

Investigation of Charles B. Nemeroff of Emory University relative to financial disclosure requirements: Senator Grassley, Committee on Finance (Senate), S10467 [2OC]

Investigation of Frederick Goodwin of George Washington University Medical Center under the Physician Payments Sunshine Act: Senator Grassley, Committee on Finance (Senate), S10642, S10643 [19NO]

Investigation of Physicians at University of Texas System under the Physician Payments Sunshine Act: Senator Grassley, S8166 [9SE]

Investigation under the Physician Payments Sunshine Act into payments made by several pharmacuetical companies to Dr. Alan Schatzberg of Stanford University: Senator Grassley, S7890-S7893 [31JY]

Medicare Improvements for Patients and Providers Act: Peter R. Orszag, CBO, S5562 [12JN]

NIH extramural funding program oversight and transparency: Senator Grassley, Committee on Finance (Senate), S5030 [4JN]

Preserve Access to Affordable Generics Act: Brian A. Benczkowski, Dept. of Justice, S1195 [26FE]

Lists

Organizations supporting H.R. 6331, Medicare Improvements for Patients and Providers Act, S6142 [25JN], S6229 [26JN]

Messages

Veto of H.R. 6331, Medicare Improvements for Patients and Providers Act: President Bush, S6705 [15JY], H6520 [15JY]

Proclamations

Rexam Prescription, Inc., Anniversary: Representative Space, E626 [16AP]

Remarks in House

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 (H.R. 6635), E1596 [30JY]

American Pharmacists Month: designate (H. Res. 1437), H10177 [27SE]

Buckhead Coalition: tribute for initiative to equip pharmacies with backup generators to be used in event of an emergency, E832 [6MY]

Caribbean nations: provide assistance to combat HIV/AIDS, H1898-H1901 [2AP]

Computers: improve regulation of Internet pharmacies (H.R. 6353), H8691, H8696 [23SE], E1969 [25SE]

Dept. of HHS: require parental consent before dispensing prescription drugs at residential programs, H5961 [24JN]

Diseases: increase assistance to countries for the prevention, treatment, and control of tuberculosis, H1909 [2AP], H7117 [24JY]

———link between child vaccinations containing mercury and autism, H1996 [3AP]

EPA: conduct a study on the presence of pharmaceuticals and personal care products in coastal recreation waters, H2423 [16AP]

FDA: revise and extend the animal drug user fee program (H.R. 6432), H7534-H7541 [30JY], E1683 [1AU]

Foreign countries: provide assistance to combat HIV/AIDS, H1949 [2AP]

Medicare: provide coverage for the shingles vaccine (H.R. 5877), E708 [23AP]

———reform the prescription drug program, H601 [6FE]

———replace the prescription drug benefit with a revised and simplified program for all beneficiaries (H.R. 6800), H10688 [2OC], E1695 [1AU]

———require physician utilization of electronic prescription drug program, H6015 [25JN]

———require physician utilization of electronic prescription drug program (S. 2408), H599 [6FE]

Medicare/Medicaid: extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6212), H5181 [10JN], H7132 [24JY]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), H5876-H5916 [24JN], H6013, H6015 [25JN], H6092, H6150 [26JN], H6235, H6237 [9JY], H6479 [15JY], H7127 [24JY], H10171 [27SE], E1346, E1352, E1354 [25JN], E1401 [8JY], E1417, E1419 [9JY], E1473, E1477 [16JY], E1490 [17JY]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), veto, H6494, H6521-H6531 [15JY], E1480 [16JY]

Rockville, MD: tribute to U.S. Pharmacopeial Convention (organization) new headquarters, E267 [28FE]

Sports: impact of professional athletes using performance enhancing drugs on children, H1033 [26FE]

Taxation: allow a deduction for amounts paid for health insurance and prescription drug costs of individuals (H.R. 227), H484 [29JA]

Tian-Li Yue: Pharmaceutical Research and Manufacturers of America, Inc., Discoverers Award recipient, E160 [12FE]

Tibotec Therapeutics (business): tribute for development of new FDA-approved HIV treatment drug, E64, E66, E71 [23JA]

Remarks in Senate

Children and youth: improve vaccination rates (S. 2911), S3405 [24AP]

Computers: improve regulation of Internet pharmacies (H.R. 6353), S10184, S10185 [30SE]

———improve regulation of Internet pharmacies (S. 980), S2307-S2310 [1AP]

Contraceptives: require equitable coverage of drugs, devices, and services under health insurance plans (S. 3068), S4804 [22MY]

Dept. of HHS: develop an antimicrobial resistance research strategic plan (S. 2313), S3847-S3849 [7MY]

Diseases: provide assistance to in-need countries to combat HIV/AIDS, tuberculosis, and malaria (S. 2762), S2148 [13MR]

Drugs: increase in prices for prescription drugs, S7440 [25JY]

———prohibit the sale of prescriptions for human growth hormone for illegitimate purposes (S. 877), S1345 [28FE]

Economy: national objectives priority assignments, S8909 [17SE]

FDA: clarify priority review voucher laws (S. 3151), S5760 [18JN]

———increase access to lower-cost, generic versions of drugs, S10862 [10DE]

———revise and extend the animal drug user fee program (H.R. 6432), S7983 [1AU], S8115 [8SE], S8170 [9SE]

Federal Food, Drug, and Cosmetic Act: ensure safety and quality of medical products and enhance authorities of FDA (S. 3409), S7968 [31JY]

Government regulations: importation of prescription drugs, S2087 [13MR]

Health: national policy to provide health care and reform insurance procedures, S1220, S1221 [27FE]

———promote modernization of the health care system through adoption of electronic prescribing technology, S2050 [13MR]

Health care professionals: provide grants or contracts to create prescription drug education and outreach academic detailing programs (S. 3396), S7952 [31JY]

International Convention Against Doping in Sport: ratification, S6980 [21JY]

Labeling: require country-of-origin labeling on prescription and over-the-counter drugs (S. 3633), S9715 [26SE]

Major League Baseball: use of performance enhancing drugs by players, S1033, S1034 [14FE]

Medicaid: provide coverage of drugs prescribed for certain NIH research study child participants (S. 2629), S975-S977 [13FE]

Medicare: ensure competitive pricing among Medicare Advantage plans, S4780 [22MY]

———expand part B income test provisions to the part D prescription drug benefit requiring wealthy beneficiaries to pay a greater share of the premium, S1972 [12MR], S2055 [13MR], S5547 [12JN]

———extend eligibility period for ``Welcome to Medicare'' physical examination and provide for the coverage and waiver of cost-sharing for preventive services, S5557 [12JN]

———implementation of Competitive Acquisition Program, S10618 [19NO]

———improve access of beneficiaries to immune globulins (S. 2990), S3900 [7MY]

———provide coverage of federally recommended vaccines (S. 2464), S5708 [18JN]

———provide for consolidated coverage of home infusion drug therapy (S. 3505), S8951 [17SE]

———provide incentives to physicians for writing electronic prescriptions, S1949 [12MR], S2050, S2094 [13MR]

———require physician utilization of electronic prescription drug program, S5512, S5516 [11JN]

Medicare/Medicaid: extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), S6004, S6006 [24JN], S6097, S6142, S6143 [25JN], S6212 [26JN], S6713 [15JY]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), motion to proceed, S6183, S6200-S6202, S6219, S6220, S6222, S6225-S6231 [26JN], S6310, S6311 [27JN], S6349 [7JY], S6378, S6379, S6420-S6424 [8JY], S6476-S6490, S6494 [9JY]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), unanimous-consent agreement, S6223 [26JN]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), unanimous-consent request, S6232-S6234 [26JN]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), veto, S6698, S6702, S6705-S6710 [15JY]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (S. 3101), S5376 [6JN], S5377 [9JN], S6320 [27JN]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (S. 3101), motion to proceed, S5467, S5506-S5509, S5512, S5514-S5516, S5530 [11JN], S5539, S5546-S5551, S5553-S5564, S5576-S5578 [12JN]

———extend expiring provisions to improve beneficiary access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (S. 3101), unanimous-consent request, S5431 [10JN], S5710 [18JN], S5794 [19JN]

———extend provisions to improve access to preventive and mental health services, enhance low-income benefit programs, and maintain access to care in rural areas (H.R. 6331), unanimous-consent agreement, S6451 [9JY]

National Medicine Abuse Awareness Month: designate (S. Res. 614), S6875 [16JY], S9179 [22SE]

Safety: potential health risks associated with anxiety drug Paxil, S5519 [11JN]

———potential health risks associated with diabetes drug Avandia, S486 [30JA]

Social Security: provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under certain programs, S7890 [31JY]

———provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under certain programs (S. 2029), S2319 [2AP], S5029 [4JN], S5956 [23JN], S8165 [9SE], S10467 [2OC], S10641 [19NO]

Reports filed

Animal Generic Drug User Fee Act: Committee on Energy and Commerce (House) (H.R. 6433) (H. Rept. 110-805), H7627 [30JY]

FDA Animal Drug User Fee Program Revision and Extension: Committee on Energy and Commerce (House) (H.R. 6432) (H. Rept. 110-804), H7627 [30JY]

International Convention Against Doping in Sport: Committee on Foreign Relations (Senate) (Exec. Rept. 110-11), S6327 [27JN]

Online Pharmacy Consumer Protection Act: Committee on Energy and Commerce (House) (H.R. 6353) (H. Rept. 110-869), H9082 [23SE]

———Committee on the Judiciary (Senate) (S. 980), S1998 [12MR]

———Committee on the Judiciary (Senate) (S. 980) (S. Rept. 110-521), S10578 [17NO]

Resolutions of ratification

International Convention Against Doping in Sport, S6327 [27JN], S6980 [21JY]

Statements

Animal Drug User Fee Act Performance Goals and Procedures: Dept. of HHS, S8170-S8171 [9SE]

Animal Generic Drug User Fee Act Performance Goals and Procedures: Dept. of HHS, S8172 [9SE]

Summaries

Setting Forth the Federal Budget for 2008-2013 (S. Con. Res. 70): Vitter Amendment on Importation of Prescription Drugs, S2299 [1AP]

Tables

Estimated President's Emergency Plan for AIDS Research (PEPFAR) treatment, testing, and prevention of mother-to-child transmission (PMTCT) costs and benchmarks, S2431 [3AP]

Selected disclosures by Dr. Alan Schatzberg and related information reported by pharmaceutical companies and device manufacturers, S5958 [23JN], S7891 [31JY]

Selected disclosures by Dr. Augustus J. Rush, Jr., and related information reported by pharmaceutical companies and device manufacturers, S8167 [9SE]

Selected disclosures by Dr. Karen Wagner and related information reported by pharmaceutical companies and device manufacturers, S8168 [9SE]

Selected disclosures by Frederick Goodwin and related information reported by pharmaceutical companies and device manufacturers, S10642, S10643 [19NO]

Speaker event and professional programs databases of Dr. Karen Wagner, S8169 [9SE]

Texts of

H. Res. 1437, American Pharmacists Month, H10177 [27SE]

H.R. 6331, Medicare Improvements for Patients and Providers Act, H5876-H5904 [24JN]

H.R. 6353, Online Pharmacy Consumer Protection Act, H8691-H8694 [23SE]

H.R. 6432, FDA animal drug user fee program revision and extension, H7534-H7539 [30JY]

S. 980, Online Pharmacy Consumer Protection Act, S2307-S2309 [1AP]

S. 2629, Medicaid coverage of drugs prescribed for certain NIH research study child participants, S976 [13FE]

S. 2990, Medicare IVIG Access Act, S3901 [7MY]

S. Con. Res. 88, reverse FDA policy eliminating access to medication containing estriol, S5455 [10JN]

S. Res. 614, National Medicine Abuse Awareness Month, S6875 [16JY], S9180 [22SE]