Pharmaceutical Law & Industry Report® Index-Summary

SAFETY

See also FOOD AND DRUG ADMINISTRATION (FDA); WARNINGS
– Active pharmaceutical ingredients, manufacturing violations, 255
– Actos and bladder cancer risk, 1233
– Adulterated or misbranding products, BNA Insights, 1002
– Advair Diskus inhalers stolen, 963
– Adverse events

See ADVERSE EVENTS

– Anemia drugs

– – Cancer patients, 1377
– – FDA meeting, 70; approval of risk management program, 209

– Anzemet heart risk, 1632
– Apotex manufacturing violations, 499
– Aransep kidney disease risk, 1353
– ARBs and cancer, 952
– Authority expansion for FDA, 1316
– Avandia heart attack risk, Senate report, 242; access restricted, 1229
– Avon warning letters from FDA, 431
– Beehive Botanicals, unapproved drug seizure, 470
– Bisphosphoates and femur fractures, 1192
– Bristol-Myers P.R. facility, 1192
– Canada

– – Improvements urged, 1531
– – Side effect reporting, 830

– Cleviprex recall, 24
– Clinical trials reporting, FDA final rule, 1251
– Combination drugs, good manufacturing practices, FDA proposed rule, 186
– Communication, FDA practices, 1111
– Computerized order systems medication errors, 1063
– Contamination at Pfizer facility, jury award for fired scientist (D. Conn.), 458
– Coumadin recall, 929
– Counterfeit drugs

See COUNTERFEIT DRUGS

– Cubicin and pneumonia, 1030
– Diabetes drug risks, 1120
– Drugs.com collaboration with FDA, 725
– Electronic records and signatures, industry compliance, 925
– Enforcement

See LEGISLATION, FEDERAL, S 3690

– Epogen recall, 1258
– Evamist, adverse effects on children, 1030
– Fentanyl recall, 1379
– Final rules from FDA, 1625
– Foreign inspections increased by FDA, 1370
– FY2011 FDA budget proposal, 164
– Gabitril, 1355
– GammaGard lots withdrawn, 759
– Generic drug impurities, FDA guidance, 1517
– Genzyme manufacturing practices, FDA enforcement action, 399; draft consent decree, 527; final consent decree, 679; Allston operations end, 1525
– GlaxoSmithKline

– – Adulterated drugs, penalties (D. Mass.), 1363
– – Manufacturing deficiencies, settlement, 959

– Global drug safety, Democrats proposal, 1223
– Globalized drug production and FDA, 326
– GnRH and diabetes, 591
– Heparin contamination, report, 596; recall, 1414; FDA criticized, 1436
– Hospital admissions for drug-related conditions, 1372
– Hylenex recall, 660
– Imported drugs, Senate hearings, 327
– Inhalers and ozone-depleting substances, 496
– IriSys San Diego facility, 1232
– IUDs, unapproved sales (Tex. Dist. Ct.), 1368
– IV bag contamination, 730
– K-V Pharma return to drugmaking, 1190
– Kapidex name change, 333
– KV Pharmaceutical settlement over reporting (E.D. Mo.), 270
– Lamictal and aseptic meningitis, 1095
– Lipitor recall, 1414; another lot recalled, 1635
– Lipodissolve, FDA warning stars, 461
– Meridia

See MERIDIA

– Methotrexate injection recall, 1413
– Metozolv ODT, FDA warning on promotional materials, 469
– Metronidazole injection recall, 661
– Mont. drug maker, unapproved new drugs, 1346
– Mylotarg withdrawal, 824
– Names of drugs, FDA guidance, 186
– Nanotechnology

See LEGISLATION, FEDERAL, S 2942

– NeoProfen recall, 1034
– Nimodipine, FDA warning, 1029
– Nitroglycerin, FDA warning letters, 364
– Octagam recall, 1259
– Ohm Labs manufacturing practices, FDA warning letter, 189
– Opioids, proposed risk plan from FDA, 859; risk evaluation and mitigation strategy, 990
– Osteoporosis drugs and femur breaks, FDA review, 358
– Patient medication information, FDA framework, 1153
– Perrigo manufacturing practices, 728
– Physician information, FDA draft guidance, 1473
– Posting of safety reports by FDA, 784
– Postmarketing studies, IOM report, 925
– Pregnancy, FDA research collaboration, 42
– Procrit recall, 1258
– Promacta and liver disease, 659
– Propofol withdrawn, 730
– Propoxyphene withdrawal, 1523
– Proton pump inhibitor drugs and fracture risk, 685
– Qualaquin

See QUALAQUIN

– Radiofrequency ID for drugs, compliance guide, 1628
– Rapamune

– – Marketing unapproved uses, whistleblower suit (E.D. Pa.), 1342
– – Transplant drug, promotion for unauthorized uses, 784

– Regulatory agenda for FDA, 592; outlined, 630
– REMS, comments on FDA draft guidance, 41; FDA reviews comments, 209
– Safe Use Initiative, FDA program, 1471
– Sentinel Initiative, FDA safety monitoring system, 67; Harvard Pilgrim contract award, 67; workshop planned, 1559
– Seroquel

See SEROQUEL

– Shire inspection, 25
– Sodium bicarbonate injection recall, 1635
– Stakeholder seek clarity in risk evaluation and mitigation strategy, 991
– Stalevo

See STALEVO

– Standardized medication information, FDA approval, 1252; to move forward, 1315
– Standardized numerical identifier, FDA guidance, 432
– Statin risk, 867
– Sun Pharma N.J. facility, 1157
– Tainted drug imports, Grassley query to FDA, 211
– Tessalon accidental ingestion, 1593
– Transdermal delivery systems residual drug substances, 1030
– Tri-Med drug seizure, 1379
– Tygacil, mortality risk, 1158
– Tysabri infection risk, 216
– Unapproved drugs and manufacturing practices, FDA warnings, 1000
– Valcyte dosing recommendations, 1191
– Vytorin cancer link, 21
– Weight loss drugs and liver damage, 724
– Xibrom, FDA warning letters, 364; BNA Insights, 473
– Zocor and rhabdomyolysis, 400

SEASONALE

– Contraceptive license, 623

SEASONIQUE

– Contraceptive generic infringement claim (D. Nev.), 454

SECURITIES

– Biovail ex-execs, SEC fraud charges (S.D.N.Y.), 817
– Board minutes, access limits (N.J. Super. Ct. App. Div.), 1147
– Bristol-Myers, ex-exec alleged financial fraud (3rd Cir.), 491
– Celebrex, investors suit (U.S., rev den), 589
– Cephalon shareholder's suit (3rd Cir.), 1622
– Harvard Scientific misstatements (7th Cir.), 1250
– Hedge fund insider trading

– – French physician (S.D.N.Y.), 1401
– – Pharma exec (E.D. Pa.), 1148

– Lilly overseas marketing probe, 252
– Matrixx Initiatives fraud class action (U.S., rev grant), 856
– Medicis investor suit dismissal (D. Ariz.), 15
– Omnicare investor suit dismissal (U.S.), 1433
– Rigel Pharmaceuticals class suit dismissal (N.D. Cal.), 38
– Schering-Plough settlement approval (D.N.J), 39
– Vioxx shareholders' securities fraud suit (U.S.), 554

SEROQUEL

– Advertising, FDA says materials misleading, 1062
– Antipsychotic diabetes suits

– – Mass settlement agreement in place, 1062
– – Summary judgment for maker (11th Cir.), 521
– – Time-barred consolidated suits (Del. Super. Ct.), 1249
– – Verdict for maker (N.J. Super. Ct.), 387

– Illegal marketing settlement, 563
– Miss. fraud suit remanded (N.D. Miss.), 1343

SIMCOR

– Cholesterol drug generic (D. Del.), 623

SKELAXIN

– Attorneys fees denial (E.D.N.Y.), 1276
– Muscle relaxant method patent invalid as obvious (Fed. Cir.), 1014

SOLODYN

– Generics

– – Acne drug, Mylan generic settlement (D. Del.), 976
– – Ranbaxy generic settlement (D. Del.), 622

– New patent, 1160
– New strength, 1161

SOUTH CAROLINA

– AWP settlements, pharmacies held harmless, 787

SOUTH DAKOTA

– Prescription drug monitoring program, 429

SPRYCEL

– Blood cancer drug approval, 1411

STALEVO

– Generic, infringement settlement (D.N.J.), 813
– Parkinson's drug and cardiovascular events, 1119
– Prostate cancer link, 470

STATUTES OF LIMITATION

– Fosamax liability suit untimely (S.D.N.Y.), 388
– HRT time-barred claims (D. Minn.), 1279
– Paxil and heart defect (S.D. Ohio), 522
– Prempro class action (E.D. Va.), 857
– Seroquel consolidated suits (Del. Super. Ct.), 1249
– Zyprexa time-barred suit (E.D.N.Y.), 184

STRATTERA

– ADHD drug induced infringement claim (D.N.J.), 33; patent invalid, 1079

SULINDAC

– Anti-inflammatory blamed for blindness and skin reaction (D.N.H.), 1183

SUPREME COURT, U.S.

– AIDS/HIV drug evaluation methods (rev grant), 1394
– Ceiling prices, federally funded medical clinics (rev grant), 1243; (brief filed), 1618
– Celebrex, investors suit (rev den), 589
– False claims

– – FOIA and False Claims Act (brief filed), 1551
– – OxyContin suit dismissal (rev den), 1304

– Generic drugs

– – Cipro pay-for-delay settlement (rev sought), 1579
– – Metoclopramide failure to warn claims (U.S., rev sought), 677; (brief filed), 1086; DOJ position (brief filed), 1428; (rev grant), 1577

– HRT and breast cancer (brief filed), 718; (rev den), 816
– Marinol off-label promotion (rev den), 815
– Matrixx Initiatives

– – Adverse events (brief filed), 1143; (brief filed), 1470
– – Securities fraud class action (rev grant), 856

– Medicaid, Mass. BCBS AWP suit (dec.), 1272
– Nigeria, Trovan clinical trial injuries (brief filed), 719; (rev den), 852
– Omnicare investor suit dismissal, 1433
– Patents

– – Antitrust, unenforceable patents, direct buyer plaintiffs standing (rev den), 852
– – Benicar patent not invalid for obviousness (rev sought), 1615
– – Business method patent, machine-or-transformation test (dec), 847; industry and practitioners react, 850
– – Omnicef, no patent infringement (rev den), 59

– Procrit, qui tam suit partial dismissal (rev sought), 37; Solicitor Gen. input sought, 231; (rev den), 810
– Vt. data mining law (rev sought), 1614; BNA Insights, 1643
– Vioxx shareholders' securities fraud suit (dec), 554
– Yasmin patent invalid (rev den), 587

SURFAXIN

– Infant Respiratory Distress Syndrome drug patent extension, 1354

SWITZERLAND

– Price cuts for health insurance system, 295