Pharmaceutical Law & Industry Report® Index-Summary

MAINE

– Sales ban on prescription data invalid (D. Me.), 9; state appeals, 232

MARKETING

See also ADVERTISING; CONFLICTS OF INTEREST
– “Academic detailing” programs described at Senate hearing, 293
– Accera, In Brief, 1319
– Afresa, In Brief, 1064
– Azor co-promotion, In Brief, 587
– Baycol, deceptive marketing alleged (D.N.J.), 540
– Behind-the-counter status, GAO probe sought, 101
– BiDil maker to end promotion, 107
– Cardizem maker settles marketing allegations, 611
– Compounded hormone drug claims, FDA issues warning letters, 48
– Continuing Medical Education, firms to disclosure contributions, 450
– Diastat AcuDial, In Brief, 1245
– Discounts

See DISCOUNTS

– Elotuzumab, In Brief, 974
– Enbrel marketing probed by N.J. Atty. Gen., 110
– Erythropoiesis-stimulating agents, Dingell (D-Mich.) and Stupak (D-Mich.), seek marketing materials, 395
– Fenoglide launched, In Brief, 246
– Fosrenol promotional materials called false and misleading by FDA, 585
– Gifts to MDs and medical students

See PHYSICIANS

– HRT, Nev. Atty. Gen. alleges deceptive trade practices (Nev. Dist. Ct.), 1336
– Infergen, In Brief, 30; commercial rights, In Brief, 1064
– KW0761, In Brief, 305
– Labor law and drug sales reps, Special Report, 368
– Leukine, In Brief, 614
– Lilly to disclose payments to MDs online, 1095
– Luvox CR, In Brief, 459
– Merck plans more transparency, 1126
– Merrem IV, In Brief, 808
– Nexium aggressive marketing, drugstores antitrust suit dismissed (D.D.C.), 228
– Off-label promotion and use

See OFF-LABEL USE

– Overtime pay

– – Outside salesman not entitled to overtime (C.D. Cal.), 67
– – Sales reps probably exempt (S.D.N.Y.), 703

– Prescribing data use for marketing, Senators ask AMA for details, 511
– Prices

See PRICING

– Pristiq, In Brief, 614
– Protonix promotional practices, In Brief, 912
– Pulmicort Respules, In Brief, 1318
– Quotas and wholesale distributors, France closes probe of GSK and Pfizer, 28
– Safety may be risked by marketing drugs faster, 1352
– Sancuso, In Brief, 1269
– Seroquel drug maker accused of deceptive marketing, RICO claim dismissed (M.D. Fla.), 1306
– Spam and fraudulent direct mail (N.D. Ga.), In Brief, 708
– Takeda and Abbot joint venture ends, In Brief, 362
– Trends

– – Constraints on promotion may drive up drug or device prices, 137
– – Growth in sales slowed in 2007, 300
– – Samples used mainly for marketing not as safety net for poor, 28

– Unapproved product use

– – Bayer accused of marketing unapproved drugs, 1239
– – Colchicine, FDA seeks to stop marketing of unapproved drug, 158
– – Comments on guidance sought by FDA, 207
– – Seroquel maker accused of promoting unapproved use, 1383

– Vermont

– – Oversight program, fee challenged by drugmakers (D. Vt.), 733
– – Spending by drug firms reported, 806

– Viadur maker to discontinue marketing, 27
– Vioxx marketing questions, maker will settle, 611
– Wyeth cuts 1,200 sales jobs, 410
– Xenazine, In Brief, 1064
– Zetia aggressive marketing, Kohl (D-Wis) seek details from drug maker, 328
– Zyprexa, Conn. Atty. Gen. alleges illegal marketing (E.D.N.Y.), 288

MARYLAND

– PBM oversight bill signed, 517

MASSACHUSETTS

– False claims, inflated prices, maker to settle with state (D. Mass.), 1084
– Gifts to MDs, limits bill approved, 918; signed, 945; rules anticipated, 1036; rules proposed, 1380
– Hospitals' drug errors, effect reported, 214
– Provider-supplier interface, BNA audioconference, In Brief, 973

MAXIPIME

– Antibiotic, FDA reviewing safety data, 580

MEDICAID

– Dual-eligibles, CMS agrees to drug benefits (N.D. Cal.), 733
– Fraud

See FRAUD AND ABUSE

– Multiple source drug definition revised by CMS, 327; criticized by pharmacy groups, 449; challenged (D.D.C.), 507; final rule revised, 1149
– Pricing

– – Administrative record, CMS must produce (D.D.C.), 911; pharmacies amend complaint, 1286
– – Average manufacturer price rule blocked, CMS will not appeal (D.D.C.), 208
– – Baucus (D-Mont) bill

See LEGISLATION, FEDERAL, S 3101

– – Kan. Atty. Gen. alleges false reporting of price data (Kan. Dist. Ct.), 1336

– Rebates

– – Accounting rules, guidance updated by FDA, 581
– – Hike

See LEGISLATION, FEDERAL, HR 1424

– Safety-net hospitals challenge CMS drug reporting rules (D.D.C.), 996
– State developments

– – Ala. pricing suit against drug makers settled (Ala. Cir. Ct.), 41; Atty. Gen. announces offer to settle with makers on pricing, 795
– – Cal., Medi-Cal cuts challenged (Cal. Super. Ct.), 705; TRO denied, 798; vacated and remanded (9th Cir.), 824; injunction denied (Cal. Super. Ct.), 882; cuts blocked (C.D. Cal.), 961
– – Colo. drug assistance plan, House votes to extend, 106
– – Kan. Atty. Gen. alleges overcharging by drug firms (Kan. Dist. Ct.), 1236
– – La. e-prescriptions program launched, 454
– – Miss. payment cut for generics challenged (Miss. Ch. Ct.), 545; rule reversed, 738
– – Mo. pricing suit, Schering-Plough to settle (Mo. Cir. Ct.), 1256
– – New York

– – – Budget proposal would reduce pharmacy payments, 106
– – – Mental health, state senator seeks data on children and psychiatric drugs, 214

– – TennCare contract awarded, In Brief, 517

– Switching prescriptions

See FRAUD AND ABUSE

– Tamper-resistant prescription pads, guidance sought, 70

MEDICARE DRUG COVERAGE

– Ed. Note: Entries at this heading refer to Medicare Part D unless otherwise indicated.
– Anemia drug coverage

See ANEMIA DRUGS

– Appeals, GAO urges improvements at CMS, 242
– Arbitration award to pharmacy chain over copayments upheld (D. Minn.), 658
– Baycol user cannot recover Medicare expenses for services needed after adverse reaction (8th Cir.), 46
– Cholesterol drug usage affected by coverage gap, 1127
– Compendia

– – Cancer drug coverage, CMS adds compendium, 805
– – Conflict of interest, opportunities for impartiality outlined, 1244
– – Updated by CMS, 684

– Competitive Acquisition Program, some participants have difficulties, 1093
– Doughnut hole reached by one-quarter of enrollees, 1011
– Draft call letter, CMS issues 2009 guidance, 103
– Dual-eligibles, CMS agrees to drug benefits (N.D. Cal.), 733
– E-prescriptions

See E-PRESCRIPTIONS

– Financial ties of drug firms to MDs, MedPAC to urge disclosure, 1287
– Formulary

– – Penalty pricing at issue, 1353
– – Unapproved drugs dropped, 608
– – Updates, CMS and U.S. Pharmacopoeia agree, 634

– Generics

– – Cuts

See LEGISLATION, FEDERAL, HR 6331

– – Drug prices down in 2007, 613
– – Market pricing data, HHS IG urges inclusion of generics, 1003

– Higher enrollment and lower cost projections reported by CMS, 159
– Home infusion drugs recommended for coverage, 519
– Inhalation drug alternative payment policy blocked (D.D.C.), 1205
– Markup expected on new Medicare bill, 157
– Medicaid paying less for some drugs, report says, 887
– Nursing home residents need more help, HHS IG says, 686
– Off-label use, Feinstein (D-Cal) and Brownback (R-Kan) want to expand, 633
– Outpatient drug codes in second quarter of 2007, 8 percent exceeded cost threshold that allows CMS to adjust prices, 21
– Overfill issues, Analysis & Perspective, 863
– Oversight criticized by HHS IG, 1264
– Premium increase announced for 2009, 969
– Prices

See PRICING

– Proposed changes

See LEGISLATION, FEDERAL, S 3101

– Protected drug class requirement may push up costs, survey finds, 1267
– Reimbursements

See LEGISLATION, FEDERAL, HR 6331

– Release of claims information, MedPAC report address privacy concerns, 357
– Safety, CMS final rule allows sharing of claims data, 632
– Standing lacking for pharmacy groups seeking payment from HHS (D.D.C.), 63
– Stark (D-Cal) criticizes CMS on bidding and oversight, 1315
– Subpopulations, CMS report on differences in drug use, 1263
– Technical corrections and clarifications finalized by CMS, 452

MENTAL HEALTH

– Medicaid

– – N.Y. state senator seeks data on children and psychiatric drugs, 214
– – Utah proposal would give patients new override option for drugs, 266

– Parity in insurance coverage

See LEGISLATION, FEDERAL, HR 1424

MERGERS AND ACQUISITIONS

– Alzheimer's drugs, In Brief, 1319
– Arisyn buys therapies from UAF, In Brief, 1097
– Biovitrum buys biologics, In Brief, 1065
– Bristol-Myers Squibb

– – ImClone offer made, 919; offer defended, 1063
– – Kosan, In Brief, 666

– Copaxone, In Brief, 691
– Covance buys Lilly lab, In Brief, 920
– Cyclofluidic, In Brief, 1222
– Encysive, In Brief, 691
– Fresenius to buy APP, In Brief, 808
– GSK

– – Biotene purchase, In Brief, 1222
– – Bristol Egyptian firm, In Brief, 1223
– – Genelabs, In Brief, 1270
– – Reliant purchase, In Brief, 31

– ImClone, In Brief, 1042
– J&J and Omrix, In Brief, 1355
– King makes offer for Alpharma, In Brief, 1066; King buys Alpharma, In Brief, 1356
– Lilly

– – ImClone purchase, In Brief, 1155; completed, In Brief, 1355
– – SGX purchase, In Brief, 807

– Mylan and Somerset, In Brief, 891
– Nastech name change, In Brief, 691
– NitroMed and Archemix, In Brief, 1318
– Novartis

– – Alcon, In Brief, 807
– – Nektar business, In Brief, 1221
– – Speedel, In Brief, 837

– Ondansetron, In Brief, 753
– Orphan Medical merger proxy, claims dismissed (8th Cir.), 940
– Pfizer

– – CovX purchase, In Brief, 31
– – Encysive purchase, In Brief, 219

– Roche

– – Genentech stock purchase planned, 861; Roche and Genentech stock, In Brief, 948
– – Memory pharmaceuticals, In Brief, 1355

– Shionogi to buy Sciele Pharma, In Brief, 1012
– Sun divests three generic drugs (FTC), 997
– Tadalafil, In Brief, 1319
– Takeda to buy Millennium, 459
– Teva

– – Barr purchase planned, 860; FTC seeks data, 1011; shareholders vote, In Brief, 1356
– – CoGenesys purchase, In Brief, 112
– – Watson to get some generics, 1347

– ViroPharma to buy Lev, In Brief, 836; buys Lev, 1220

METFORMIN ER

– Diabetes drug, infringement claim over generic settled (N.D. Cal.), 446

METOCLOPRAMIDE

– Brand name maker liable for neurological condition blamed on generic (Cal. Ct. App.), 1281
– Gastrointestinal drug blamed for dyskinesia, failure-to-warn claim preempted (D. Minn.), 734
– Heartburn drug, failure-to-warn claims, preemption ruling appealed (Cal.), 1371

MICHIGAN

– Fraud by drug makers, no preemption of Mich. law (U.S., brief filed), 95
– Immunity for drug makers

– – Governor seeks to repeal, 161
– – N.Y. Lipitor suits dismissed (N.Y. App. Div.), 1338

MIFEPREX

– Abortion pill, GAO reports on FDA postmarket oversight, 968

MINNESOTA

– E-prescriptions, MDs required to use, law signed, 688
– Monopolistic practices by NeoProfin maker alleged (D. Minn.), 1396

MINORITY HEALTH CARE

– Clinical trial disparities, Baylor College report addresses, 431
– Phenytoin, skin reactions shown in Asian patients, 1343

MIRALAX

– Laxative, tortious interference and antitrust claims dismissed (D. Del.), 903

MIRAPEX

– Compulsive gambling blamed on drugs, jury awards $8.2M (D. Minn.), 933
– Patent invalid, generic may proceed (D. Del.), 761
– Restless leg drug, generic approval, In Brief, 220

MIRCERA

– Anemia drug patent infringement, sales enjoined (D. Mass.), 254; special master ordered, 387; appeal planned, 443; industry group files amicus brief (Fed. Cir.), 796; Analysis & Perspective, 977; sales ban upheld (Fed. Cir.), 1173
– ITC has jurisdiction over patent dispute (Fed. Cir.), 315

MISSISSIPPI

– Medicaid payment cut for generics challenged (Miss. Ch. Ct.), 545; rule reversed, 738

MISSOURI

– Controlled substances monitoring, House approves bill, 299
– Medicaid drug pricing, Schering-Plough to settle (Mo. Cir. Ct.), 1256

MK-0524A

– Cholesterol drug not approvable, 518

MONISTAT

– Vaginal cream generic to be launched (D.N.J.), 1085

MOTRIN

– Blindness blamed on drug, jury verdict for maker (Cal. Super. Ct.), 346

MYOBLOC

– Adverse reactions, FDA urged to increase warnings, 135

MYOZYME

– Pompe disease biologic, FDA wants new application, 490
– Reviewed by FDA panel, 1218
– Update from maker, In Brief, 1319