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Vol. 7, Nos. 1-43 pp. 1-1268 Jan. 2-Oct. 30 , 2009 A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
LABELS AND PACKAGING
See also SAFETY; WARNINGS
– Acetadote, In Brief, 26 – Antibacterials, FDA issues guidance, 802 – Asthma drug makers asked by FDA to add precaution on adverse events, 718 – Botulism toxin drugs get boxed warnings, 919 – Comparative effectiveness, FDA urged to include data on label, 1148 – Epilepsy drug suicide risk, FDA approves warning labels, 532 – Erbitux label revision approved by FDA, 870 – Evolence, In Brief, 691 – Industry guidance issued by FDA, 1231 – Intelence labels revised due to skin reactions, 1051 – Kidney transplant drug, FDA requires updated labels, 835 – Libel, packaging product criticized in journal, suit dismissed (S.D. Ind.), 405 – Metoclopramide must add box warning on risks of long-term or high-dose use, 269 – Orencia, In Brief, 1056 – Pegintron, In Brief, 325 – Preemption of state laws, White House seeks review of rules, 618 – Promethanzaine hydrochloride injection gets boxed warning, 1077; Analysis & Perspective, 1151 – Propoxyphene, FDA orders boxed warning, 803 – Rebetol, In Brief, 325 – Smoking cessation products and serious mental health events, FDA orders boxed warning, 803 – Testosterone gel to get box warning, 565 – Toll-free number on medication guides, FDA issues guidance, 351 – Vyvanse, In Brief, 656
– Epilepsy drug sold at discount, no settlement breach (D.N.J.), 763
– Diabetes drug, FDA examines cancer risk, 809
– Antibiotic blamed for tendon rupture (D. Minn.), 1170
– Ed. Note: This heading covers bills with assigned numbers. For information on measures not yet assigned numbers, see specific subject headings.
– House
– – HR 1, American Recovery and Reinvestment Act, includes comparative effectiveness research, 126; House approves, 180; signed, 205; industry cautiously optimistic, 241
– – HR 380, Authorized generic drugs marketing ban, Emerson (R-Mo), 99 – – HR 684, Medicare Prescription Drug Savings and Choice Act, Berry (D-Ark), would create drug plan under traditional program, 125 – – HR 759, Food and Drug Administration Globalization Act, would require international parity in inspections, expand FDA powers, 128 – – HR 1260, Patent Reform Act, Conyers (D-Mich), would create first-to-file system, 262; House urged to conform bill to S 515, 535 – – HR 1427, Promoting Innovation and Access to Life-Saving Medicine Act, Waxman (D-Cal), Pallone (D-NJ), Deal (R-Ga), Emerson (R-Mo), would allow FDA to approve generic versions of expensive biotech drugs, 287; pressure high to pass, 472 – – HR 1450, Counterfeit Drug Prevention Act, Rogers (R-Mich), would create criminal penalties, 319 – – HR 1548, Pathway for Biosimilars Act, Eshoo (D-Cal), Inslee (D-Wash), Barton (R-Tex), would create regulatory path at FDA, 318; Johnson & Johnson supports, 407; New Democrat Coalition supports, 508; Eshoo wants quick action, 590; Eshoo to offer bill as amendment, 832; hearing addresses competition, prices, innovation, 832; industry groups comment, 859 – – HR 1706, Protecting Consumer Access to Generic Drugs, would bar brand-name firms from pay for delays, FTC chief supports, 371; House panel approves, 642; hearing held, 642 – – HR 1859, Independent Drug Education and Outreach Act, Waxman (D-Cal), Pallone (D-NJ), would create academic detailing program to provide MDs with unbiased drug information, S 767 is companion, 374 – – HR 2892, Homeland Security funding, amendment allows imports from Canada, 864 – – HR 2997, Agriculture Appropriation Act, House approves FDA funding hike, 834; FDA funding approved by Senate, In Brief, S 1406 is companion, 920; conference report approved, 1202; signed, 1257 – – HR 3200, America's Affordable Health Care Choices Act, Democratic bill to create public option, revise Medicaid and Medicare drug coverage, 830; will not reach floor before recess, 886; Stark (D-Cal) defends kidney drug provision, 889; House energy and commerce panel approves, 917; PBM transparency sought, 999; CBO reports, 1045; BIO supports, 1048; Waxman (D-Cal) seeks generic biologics pathway, 1108 – – HR 3663, Medicare pharmacist accreditation requirement delayed, Senate approves, 1173
– – SConRes 13, FY2010 budget resolution, Kyl (R-Ariz) amendment on research-based delays rejected, 409
– – S 1, American Recovery and Reinvestment Act, includes comparative effectiveness research, 126; Senate approves, 180 – – S 301, Physician Payment Sunshine Act, Kohl (D-Wis) and Grassley (R-Iowa), would require firms to report payments and gifts to MDs, 127 – – S 369, Preserve Access to Affordable Generics Act, Kohl (D-Wis) and Grassley (R-Iowa), would ban makers from paying firms to keep generics off market, 155; FTC says ban would produce savings, 738; Senate panel likely to modify, 1076; brand namer-generic settlements presumed illegal, 1139; Senate panel approves, 1230 – – S 386, Fraud Enforcement and Recovery Act (FERA) of 2009, expands False Claims Act liability, signed, 619 – – S 501, Fair Prescription Competition Act, Rockefeller (D-WVa), would bar sale of authorized generics by brand-name maker, 265 – – S 515, Patent Reform Act, Leahy (D-Vt) and Hatch (R-Utah), would create first-to-file system, 262; Senate action delayed, 344; compromise possible soon, 375; compromise approved, 408; HR 1260 is counterpart, 535; panel report, 563 – – S 525, Pharmaceutical Market Access and Drug Safety Act, importation amendment rejected, 773 – – S 610, Patent Reform Act, Kyl (R-Ariz), would rewrite provisions concerning conditions for patentability, 344 – – S 726, Promoting Innovation and Access to Life-Saving Medicine Act, Brown (D-Ohio), Schumer (D-NY), Collins (R-Maine), Martinez (R-Fla), Stabenow (D-Mich), Vitter (R-La), would allow FDA to approve generic version of biotech drugs, 372 – – S 767, Independent Drug Education and Outreach Act, Kohl (D-Wis), Kennedy (D-Mass), Durbin (D-Ill), would create academic detailing program to provide MDs with unbiased drug information, HR 1859 is companion, 374 – – S 882, Drug and Device Accountability Act, Kennedy (D-Mass) and Grassley (R-Iowa), would increase FDA resources to inspect drugs, 507 – – S 1110, Medicare Payment Advisory Commission (MedPAC) Reform Act, Rockefeller (D-WVa), would create executive branch agency, 620 – – S 1232, Pharmaceutical Market Access and Drug Safety Act, Dorgan (D-ND), Snowe (R-Me), McCain (R-Ariz), would allow importation of lower-cost drug, 1107 – – S 1259, Preserving Access to Targeted, Individualized, and Effective New Treatments, Kyl (R-Ariz) and McConnell (R-Ky), seeks to prevent rationing, 711 – – S 1315, Drug Price Competition Act, Nelson (D-Fla), would expand availability of 180-day exclusivity for generic firms that challenge patents, 773 – – S 1406, FDA funding approved by Senate, In Brief, HR 2297 is companion, 920 – – S 1778, Access to Affordable Medicines Act, Shaheen (D-NH) and Vitter (R-La), would block delays by brand name drug makers, 1232 – – S 1796, America's Healthy Future Act, Baucus (D-Mont), health reform bill include generic prescribing, 1143; markup, 1172 – – S 1859, Independent Drug Education and Outreach Act, Kohl (D-Wis), Kennedy (D-Mass), Durbin (D-Ill), would create academic detailing program to provide MDs with unbiased drug information, 374
– Hypertension drug, FDA alleges misleading comments by maker, 295
– Antibiotic patent term extension approved (D.N.J.), 607
– Discovery costs denied in patent dispute (Fed. Cir.), 702
– Erectile dysfunction drug, generic challenged (D. Del.), 798
– Antidepressant approved for adolescents, 350
– Competing patents, two claims invalidated by prior art (S.D.N.Y.), 673 – Declaratory judgment against generic maker dismissed (U.S., rev den), 227 – Destruction of electronic records alleged (E.D. Mich.), 462; settlement reached, 836
– Cholesterol drug infringement suit stayed over jurisdiction issues (N.D. Ill.), 703
– Deceptive promotion claims dismissed (S.D.N.Y.), 1161 – Marketing qui tam action dismissed (E.D.N.Y.), 638 – Technical fix on patent, In Brief, 50
– Diabetes drug cancer risk disputed, 414
– Schizoaffective disorder drug approved, 923
– Contraceptive, generic sales opposed (D. Del.), 1068
– Hypertension drug, low-dose ANDA challenged as infringement (D.N.J.), 13; dismissed, 201
– Infringement claim dismissed without prejudice (D.N.J.), 1068
– Anticoagulant off-label use, qui tam suit may proceed (N.D. Ill.), 501
– Blood clot drug patent not enforceable (U.S., rev sought), 171; (rev den), 495
– Pompe disease treatment, FDA seeks more information, 270
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