Pharmaceutical Law & Industry Report® Index-Summary

MARKETING

See also ADVERTISING; CONFLICTS OF INTEREST
– Academic detailing program

See LEGISLATION, FEDERAL, HR 1859, S 767

– Aplenzin, In Brief, 24
– Authorized generics marketing ban

See LEGISLATION, FEDERAL, HR 380

– Bexra illegal marketing, Pfizer fined $1.2B, 1047
– Biogenerics, In Brief, 1208
– Caldolor, In Brief, 1053
– Cefazolin, In Brief, 191
– Centany, In Brief, 516
– Cerezyme, In Brief, 1116
– Cholesterol drug makers accused of deceptive promotion (E.D. Pa.), 678
– Colchicine not enjoined (C.D. Cal.), 1249
– Convenience drug kits, In Brief, 872
– Creon, In Brief, 811
– Cyanokit, In Brief, 1265
– Discount drug card marketing claims settled (Pa. Commw. Ct.), 179
– Edluar, In Brief, 1053
– Eisai and Pfizer, In Brief, 1150
– Embeda videos, FDA says risks omitted or minimized, 1235
– Emsam, In Brief, 656
– Epiduo Gel, In Brief, 50
– Exactacain, In Brief, 272
– Fabrazyme, In Brief, 1116
– Firmagon, In Brief, 926
– Gelnique launch, In Brief, 627
– Global outlook for industry reported, 1207
– Grassley (R-Iowa) queries medical journals on ghostwriting policies, 805
– Health care reform, drug firms may need to overhaul strategies, 717
– Hydrelle, In Brief, 811
– J&J fined over misleading materials for MDs (W.Va. Cir. Ct.), 283
– Kaletra promotional DVD overstated efficacy and minimizes risks, FDA says, 862
– Kapidex, In Brief, 238
– Keppra XR, In Brief, 451
– Letairis, FDA alleges misleading comments by maker, 295
– Lipitor deceptive promotion claims dismissed (S.D.N.Y.), 1161
– MDV3100, In Brief, 1265
– Medical education funding, GSK limits, 1113
– Megace maker target of DOJ, 381
– Mircera sales ban upheld (Fed. Cir.), 1097
– Moxatag, In Brief, 49
– Naprelan, In Brief, 78
– NTC-801, In Brief, 298
– Off-label promotion and use

See OFF-LABEL USE

– Opioids, FDA warns firms marketing unapproved drugs, 1206
– Overtime for salespersons

– – Bayer, guidance sought from Cal. court (9th Cir.), 555
– – Novartis, overtime denied (S.D.N.Y.), 121

– Oxycodone, In Brief, 486
– Prices

See PRICING

– Rapaflo, In Brief, 418
– Risperdal, In Brief, 656
– Savella, In Brief, 298; 486
– Seroquel false promotion suit remanded to state court (D.N.M.), 852
– State developments

– – Mass., licensing of drug and device agents, Senate bill amended, 688; dropped from budget, 743
– – Vermont

– – – Gift ban for drug firms, expansion approved, 592; signed, 688
– – – Spending by drug firms reported, 474

– Sumavel DosePro, In Brief, 927
– Surfaxin, In Brief, 1085
– Timoptic, In Brief, 237
– Toviaz, In Brief, 655
– Uloric, In Brief, 325
– Unapproved drugs

See SAFETY

– Uramaxin, In Brief, 516
– Uroxatral, FDA calls promotional materials misleading, 1262
– Valstar, In Brief, 1054
– Vaprisol, In Brief, 384
– Vyvanse, In Brief, 385
– Zometa not withdrawn for safety or effectiveness reasons, FDA says, 448

MASSACHUSETTS

– Conflicts of interest

– – Fees for covered firms due Jul. 1, 648
– – Gifts to MDs, limits criticized, 71; conferences moved from Boston, 129; creates controversy, 158; final rules adopted, 292
– – Hospital network to limit interaction with industry, 441

– E-prescriptions, Mass. leads states for third year, 746
– False claims, inflated prices, Mylan settles with state (D. Mass.), 40
– Licensing of drug and device agents, Senate bill amended, 688; dropped from budget, 743
– Medicaid

– – Pricing suit against drug maker, nationwide settlement does not bar suit (D. Mass.), 311
– – Recoveries reported by Atty. Gen., 130

MAXIPIME

– Antibiotic, no higher mortality risk reported by FDA, 716

MEDICAID

– Alabama

– – E-prescribing system announced in Ala., 648
– – Pricing suits

– – – 5 firms settle with state (Ala. Cir. Ct.), 40; jury awards $78.4M (Ala. Cir. Ct.), 227; more firms settle (Ala. Cir. Ct.), 610

– Cal., Medi-Cal cuts challenged by pharmacists (C.D. Cal.), 151; cuts enjoined, 256; hospital and pharmacy reimbursement cuts blocked (9th Cir.), 404
– Comments added to administrative record, HHS must produce (D.D.C.), 765
– Controlled substances, improper payments reported, 1144
– Del., Omnicare to settle overcharging claims, 638
– Drug reimbursement rule delayed (D.D.C.), 228
– Fraud

See FRAUD AND ABUSE

– FY2010 budget includes cuts, 560; pharmacy groups oppose, 1082
– Generic drugs

– – Payment revisions urged, 538
– – Reimbursement gap with Medicare reported by HHS IG finds, 268

– Iowa, HHS rejection of drug plan amendment upheld (8th Cir.), 890
– Ky., $16M awarded for price inflation (Ky. Cir. Ct.), 768
– Mass., pricing suit against drug maker, nationwide settlement does not bar (D. Mass.), 311
– Pharmacy groups sue over reimbursements (C.D. Cal., N.D.N.Y., W.D. Wash.), 1165
– PhRMA and Families USA unveil expansion campaign, 485
– Poor Medicare enrollees move to Medicaid could cut costs, 925
– Pricing

– – Average manufacturer price, reimbursement cuts opposed by pharmacy stakeholders, 1111
– – Ill. settles with drug maker over inflated prices, 821; recovery announced, 882

– Protonix overcharges alleged (D. Mass.), 582
– Rebate hike considered in Senate, 589
– Regulatory outlook 2009, 80
– Reporting mandate, safety-net hospitals settle with CMS, 1199
– TennCare dual eligibles reimubursed at 100 percent of Medicare charge, bill signed, 865
– Utah recovers overcharges from Dey, 1112
– Wash. pharmacy reimbursement cuts blocked (W.D. Wash.), 403; agency to reexamine cuts, 592; agency to cut reimbursements, 621

MEDICARE ADVANTAGE (MA)

– Policy and technical changes proposed by CMS, 1202

MEDICARE DRUG COVERAGE

– Ed. Note: Entries at this heading refer to Medicare Part D unless otherwise indicated.
– Adjusting reimbursements, HHS IG finds potential savings, 508
– Advate coding upheld (D.D.C.), 971
– Compendia, conflicts of interest seen as inherent, 625
– E-prescriptions

– – Implementation reported, 1233
– – Technical problems limit ability of sponsors to meet standards, HHS IG reports, 1233

– Executive agency status for MedPAC

See LEGISLATION, FEDERAL, S 1110

– Fee schedule for MDs, proposal would remove office drugs from formula, 804
– Formularies, lower total reported for 2010, 1203
– Gap in coverage

– – Discounts for some enrollees promised by drug makers, 744
– – Sickest beneficiaries, Democrats proposal may harm, 810

– Generic drugs

– – Biotech drugs pushed, savings predicted, 320
– – Reimbursement gap with Medicaid, HHS IG reports, 268

– Industry ties to MDs, MedPAC reports, 266
– Inhalation drugs, utilization shifts, 1044
– Negotiated prices

– – Cost sharing rule issued by CMS, 42
– – Opposed by ex-CMS chief, 207

– Off-label use

– – Conditions for coverage more complex for drugs than devices, 382
– – Ovarian cancer treatment, contractor to cover, 471
– – State Attys. Gen. support CMS proposal to block insurers' requirement, 345

– Oversight a challenge for HHS, 43
– Performance of program examined, 894
– Pharmacist accreditation

See LEGISLATION, FEDERAL, HR 3663

– Pharmacogenomic testing of anticoagulants covered only for clinical trails, CMS proposes, 531
– Policy and technical changes proposed by CMS, 1202
– Poor enrollees move to Medicaid could cut costs, 925
– Premium hike announced, 973
– Prices

See PRICING

– Protected drug classes. CMS issues rule, 100; managed care group opposes expansion, 346
– Roche bids for Genentech, 162
– Traditional program

See LEGISLATION, FEDERAL, HR 684

– Trends

– – Accessibility to drugs increased by program, 76
– – Biologics use limited, 412
– – Inhalation drug billings higher in Fla., 509
– – Outpatient drug spending reported, 412

– Utilization management data, CMS urges plan sponsors to outline of websites, 376
– Warfarin, Medicare to cover clinical trial, 948

MEGACE

– Eating disorder drug marketing, maker target of DOJ, 381

MENTAL HEALTH

– Grassley (R-Iowa) seeks information on Natl. Alliance for Mental Illness, 1257

MERGERS AND ACQUISITIONS

– Abbott and Solvay drug business, In Brief, 1149
– Alprostadil, In Brief, 163
– Astellas wants CV Therapeutics, In Brief, 134; bid rejected, 238; offer dropped, In Brief, 324
– Biogen makes bid for Facet Biotech, 1083
– Bristol-Myers and Medarex, In Brief, 896
– Caraco completes asset from Forest Labs, 1177
– Cephalon

– – Arana, In Brief, 272
– – BioAssets, In Brief, 1265
– – Ception, In Brief, 105

– CVS Caremark merger, FTC probe sought, 565; pharmacists group alleges monopoly, 565
– Degarelix, In Brief, 271
– Desonate and NeoBenz Micro, In Brief, 1054
– Endo and Indevus, In Brief, 50; 352
– Express Scripts to buy WellPoint PBMs, 448; community pharmacists oppose, 512
– Gilead to buy CV Therapeutics, 323
– GSK

– – Genelabs, In Brief, 49
– – Stiefel, In Brief, 486

– Helsinn and Sapphire, In Brief, 133
– Hisamitsu and Noven, In Brief, 837; complete, In Brief, 1055
– J&J

– – Cougar purchase planned, 624; FTC clears, 748; completed, 838
– – Investing in Elan, 809; Elan collaboration planned with Biogen, terms of Johnson & Johnson deal modified, 1082
– – Omrix purchase, In Brief, 51

– LFA-1 inhibitor, In Brief, 298
– Licensing

See PATENTS

– Lundbeck and Ovation, In Brief, 191
– Merck to buy Schering-Plough, 295; effect on innovation, FTC urged to examine, 449; shareholders approve, In Brief, 952
– Novartis seeks generic injectables business, In Brief, 627; purchase of EBEWE cleared, 1148
– Onyx to buy Proteolix, In Brief, 1208
– Pfizer

– – Insulin factory, In Brief, 297
– – Wyeth purchase, 131; FTC wants more data, 418; effect on innovation, FTC urged to examine, 449; under EU scrutiny, 657; EU requires divestitures, 868; merger challenged (N.D. Cal.), 991; FTC clears, 1193; pharmacists challenge dismissed (N.D. Cal.), 1223

– Pharmexa and Affitech, 271
– Piramal and Minrad, In Brief, 24
– PPD buys vaccine testing lab, 48
– Roche

– – Genentech purchase planned, 296; tender offer, In Brief, 385
– – Memory, In Brief, 51

– Sanofi and Fovea, In Brief, 1178
– Sanofi purchase of Zentivz, EU agencies require spinoffs, 214
– Sepracor, In Brief, 1054
– Takeda to buy IDM Pharma, In Brief, 595
– Teva, Barr purchase cleared by FTC, 23
– Tysabri maker breached collaboration pact (S.D.N.Y.), 1029
– Warner Chilcott and P&G drug business, In Brief, 1004
– Watson and Arrow, In Brief, 719; FTC seeks information, 953
– Wyeth

– – Pfizer merger agreement reached, 942
– – Thiakis purchase, In Brief, 25

– Zevalin, In Brief, 238

METOCLOPRAMIDE

– Brand name maker liable for neurological condition blamed on generic (Cal.), 117
– Failure to warn claims

– – Fla., preempted (W.D. Fla.), 231
– – Ky., preempted (W.D. Ky.), 231

– Gastrointestinal drug makers must add box warning on risks of long-term or high-dose use, 269
– Heartburn drug blamed for neurological injuries (MDL), 708

MEXICO

– Kaletra price cut, 387

MICHIGAN

– Immunity for drug firms, House approves repeal, 378

MINNESOTA

– Conflicts of interest

– – Forest Lab payment to MDs reported, 1080
– – Gifts to MDs, bill to ban withdrawn, 378

– Generic pricing law, union funds sue pharmacy chains (D. Minn.), 1029
– Psychiatric clinical trial limits, bill signed, 593

MINOCIN

– Anti-bacterial drug, failure-to-warn claim not preempted (N.D. Ill.), 364

MIRAPEX

– Anti-competititve tactics allegedly used to block generic (W.D. Pa.), 1035
– Restless leg drug blamed for compulsive gambling (D. Minn.), 341

MIRCERA

– Anemia drug, sales ban upheld (Fed. Cir.), 1097

MIRENA

– Heavy menstrual bleeding treatment approved by FDA, 1177

MISSOURI

– Medicaid fraud, state settles with pharmacy, 975

MUCINEX D

– Pseudoephedrine HCl, generic ANDA challenged by patent holder, 690

MULTAQ

– Irregular heartbeat drug, FDA panel favors approval, 350; approved, 810

MYFORTIC

– Organ rejection drug maker warns of anemia risk, 1051