Pharmaceutical Law & Industry Report® Index-Summary

FABRAZYME

– Fabry disease patients seek access, 1088
– March-in rights, 1584

FALSE CLAIMS

– Aggressive recovery at DOJ, 750
– Amgen kickback claims (D. Mass.), 1275
– Aransep suit dismissal (D. Mass.), 581
– Average wholesale price suit, qui tam relator as original source (D. Mass.), 155
– BNA webinar, 931
– Botox settlement (N.D. Ga.), 1131
– Dey pricing settlement (D. Mass.), 1612
– Documents produced in state probe (S.D. Tex.), 982
– Effect of enforcement, 1026
– FOIA and False Claims Act (U.S., brief filed), 1551
– Forest settlement (D. Mass.), 1177
– Gathering qui tam evidence, 1590
– Genetech suit, grand jury transcripts (E.D. Pa.), 1308
– Kadian settlement (D. Md.), 352
– Lipitor marketing qui tam action (E.D.N.Y.), 208
– Medicaid

– – Defending state suits, BNA Insights, 1533
– – Eon Labs settlement (D. Mass.), 232
– – Intervention denied (Wis. Cir. Ct.), 1622
– – Overcharges

See PRICING

– – Pfizer off-label marketing and kickbacks suit dismissal (D. Mass.), 1214; appeal (1st Cir.), 1398
– – Pharmacy owner (D. Mass.), 1187
– – Raplon suit dismissal (3rd Cir.), 182
– – Rebate action dismissal (D. Md.), 1143
– – Woodhaven settlement (D. Md.), 1554

– Medicare

– – Raplon suit dismissal (3rd Cir.), 182
– – Woodhaven settlement (D. Md.), 1554

– Off-label use, Rapamune whistleblower suit (E.D. Pa.), 715; DOJ intervention, 1209
– OxyContin suit dismissal (4th Cir.), 417; (U.S., rev den), 1304
– Procrit, qui tam suit partial dismissal (U.S., rev sought), 37; Solicitor Gen. input sought, 231; (rev den), 810
– Public Citizen study, 1625
– Rebates and brand names (D. Md.), 918
– TOBI settlement, 586
– Unapproved drugs, Schwarz Pharma settlement, 585

FAMVIR

– ANDA approval challenge (D.D.C.), 1244
– Herpes drug, infringement settlement (D.N.J.), 207

FDA

See FOOD AND DRUG ADMINISTRATION (FDA)

FEDERAL EMPLOYEES

– FEHBP

See FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM (FEHBP)

FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM (FEHBP)

– CVS generic drug prices, 217
– Transparency in pricing

See LEGISLATION, FEDERAL, HR 4489

FEDERAL TRADE COMMISSION (FTC)

– Commissioners confirmation, 360
– Enforcement, FTC-DOJ reviews, 1348
– Reverse payments

See ANTITRUST

FEHBP

See FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM (FEHBP)

FENTANYL

– Identity of patch maker at issue (N.D. Ohio), 280
– Negligent misrepresentation and breach of warranty claims (N.D. Cal.), 650
– Pain drug overdose death punitive damages (D. Utah), 1248
– Recall announced, 1379
– Transdermal patch implied warranty and fraud claims (M.D. Fla.), 279

FILIGRASTIM

– Biologic infringement suit (E.D. Pa.), 1498

FLOMAX

– Generics

– – Boehringer prostate drug generic approval, 292
– – Caraco, 1000
– – Mylan generic approval, 568

– Shipped, 1000

FLONASE

– Allergy drug generic, “sham ” citizen petition allegations (E.D. Pa.), 153; off-the-record, 921
– Asthma drug generic, “brand maturation” (E.D. Pa.), 1464

FLORIDA

– Discount card available, 465
– Drug pricing website, 822
– Medicaid pricing, Merck settlement, 21

FOCALIN

– ADHD drug, infringement claims dismissal (D.N.J.), 156

FOOD AND DRUG ADMINISTRATION (FDA)

– Additional resources urged, 392
– Advancing regulatory science, 1314
– Agenda for guidance, 1558; 2011 agenda, 1585
– Budget

– – FY2011 funding

See LEGISLATION, FEDERAL, S 3606

– – Senate hearings, 327
– – Spending bill signed, 1282

– Commissioner

– – Rare diseases chief, 289
– – Senate panel approves, 19

– Conflicts of interest, CRS report, 361
– Consumer reps on advisory panel, 1630
– Criminal enforcement

– – GAO report, 324
– – Investigations chief retirement, 1520

– Enforcement power

See LEGISLATION, FEDERAL, S 3690

– FDA-TRACK launch, 1149
– FY2011 budget proposal, 164; House panel approval, 894; Senate bill, see LEGISLATION, FEDERAL, S 3606
– Generic drugs chief transfer, 328
– Improving agency, FDA chief counsel speaks, 163
– Labels and packaging

See LABELS AND PACKAGING

– Management planning, GAO report, 427
– Marketing and advertising, FDA reorganization plan, 243
– Overhaul

See LEGISLATION, FEDERAL, HR 4816

– Public meeting procedures, 1589
– Recall authority

See LEGISLATION, FEDERAL, HR 5740

– Recruitment and retention at FDA, GAO report, 286
– Regulatory science advancement, 392
– Safety office, Grassley urges, 558; authority expansion sought, 1316
– Science board nominations, 1349
– Strategic priorities draft, 1281
– Transparency initiative

– – Comments sought, 357
– – Draft guidance, 523
– – Industry concerns, 950
– – Proposals issued, 652
– – Website launch, 70

FOSAMAX

– Causation lacking (S.D.N.Y.), 1509
– Defense verdict in jaw osteonecrosis suit (S.D.N.Y.), 624
– Femur breaks, FDA review, 358
– Jury award for jaw deterioration (S.D.N.Y.), 855; reduced, 1344
– Osteoporosis drug and osteonecrosis of the jaw (S.D.N.Y.), 159; suit untimely, 388
– Victory for maker in osteonecrosis suit (2nd Cir.), 1466

FRANCE

– Generic drugs, efforts to block, 693

FRAUD AND ABUSE

– Aggressive enforcement at DOJ, 1347
– BNA webinar, 256
– Bristol-Myers, ex-exec alleged financial fraud (3rd Cir.), 491
– Counterfeit drugs

See COUNTERFEIT DRUGS

– Effective enforcement by FDA, 1375
– Elan promotions settlement, 1578
– Exclusions from federal programs, drug execs challenge (D.D.C.), 161; 12-year ban, 1575
– False claims

See FALSE CLAIMS

– Foreign Corrupt Practices Act

– – Merck data sought, 1094
– – Prosecution trends, 214
– – Vigilance by firms, 655

– Grassley whistleblower query, 895; anti-fraud funding, 1630
– Guidelines for sentencing, 593
– Human growth hormone unapproved use (D.R.I.), 1311
– Increased prosecution of executives, 1375
– Ind. health care fraud enforcement efforts, 1115
– Kickbacks

– – Amgen kickback claims (D. Mass.), 1275
– – Effect of enforcement, 1026
– – Foundation's assistance program, 1153
– – Kaletra kickback claims (D. Mass.), 943
– – Kos settlement (M.D. La.), 1550
– – Nonprofit's assistance program, 753
– – Pfizer off-label marketing and kickbacks suit dismissal (D. Mass.), 1214
– – Uninsured and copayments, 724

– Medicaid

– – Integrity issues for 2011, 1351
– – Miss. AWP misrepresentation suit (Miss.), 517
– – Pennsylvania

– – – Bristol-Myers AWP case (Pa. Commw. Ct.), 1305
– – – J&J AWP reporting (Pa. Commw. Ct.), 1612

– – Qui tam relator as original source (D. Mass.), 155
– – S.C. AWP settlements, pharmacies held harmless, 787
– – Teva pricing settlement, 960
– – Utah AWP suit against firms dismissed (Utah Dist. Ct.), 271

– Medicare

– – Billing, sentencing (S.D. Fla.), 1108
– – Invalid prescriber identifiers, 1227
– – J&J suit over Procrit and Remicade (D. Mass.), 1209

– Misconduct in research, anesthesiologist, pain drug data fabrication guilty plea (D. Mass.), 280; sentenced, 858
– Motives for whistleblowing, 662
– N.Y. financial relationships between providers and drug and device makers, 169
– Obstruction and false statements in FDA probe (D. Md.), 1427; not guilty plea, 1552
– Off-label use

See OFF-LABEL USE

– Overutilization of drugs, 1371
– Pricing

See PRICING

– Rebate checks targeted, 725
– Recoveries

– – DOJ for FY2010, 1519
– – HHS OIG report, 1586

– Seroquel illegal marketing settlement, 563
– Theft of drugs and devices, 562
– Wire fraud, InterMume ex-CEO (N.D. Cal.), 1019

FUZEON

– AIDS drug infringement settlement (E.D.N.C.), 1246