Pharmaceutical Law & Industry Report® Index-Summary

HALAVAN

– Breast cancer drug approval, 1474

HEALTH AND HUMAN SERVICES DEPARTMENT (HHS)

– Budget

– – AIDS and HIV, FY2011 budget, 1109
– – FY2010 budget, effectiveness research, 187

– CMS

See CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

– FDA

See FOOD AND DRUG ADMINISTRATION (FDA)

– Open government plan, 460

HEALTH CARE REFORM, FEDERAL

– Accounting rules, 1632
– Annual drug company fee, 1518
– Biosimilars pathway, 688
– BNA webinar, 568
– Cal. drug rebates, 656
– Cost to drug makers, estimate, 430
– Delivery system reform proposals, 255
– Harkin on quality, 631
– Industry effects

– – Benefits, 901
– – Fees, 1120

– Life science firms, effect of reform, 727
– Lobbyists, spending up, 216
– Markets, effect on, 527
– Medicaid rebates and reform, 564; effect of new rules, 1114
– Overhaul

See LEGISLATION, FEDERAL, HR 3590

– Payment advisory board

See LEGISLATION, FEDERAL, S 3653

– Pricing effects, 1437
– Reconciliation bill

See LEGISLATION, FEDERAL, HR 4872

– Repeal sought, 1406
– Timeline from CBO, 1438
– Transparency and disclosure, BNA Insights, 503
– White House

– – Revamped proposal, 241
– – Simple majority sought, 287

HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT (HITECH) ACT

– BNA webinar, 931
– Privacy rules and drugmakers, BNA Insights, 1038

HEALTH INSURANCE

– Cal., step-therapy mandates, proposed ban, 956
– Cancer, bundled pay test, 1380
– Cost sharing and drug utilization, 1415
– New York

– – Copay limits, 1284
– – Formulary specialty tiers, 755; banned, 1284

– Reform

See HEALTH CARE REFORM, FEDERAL

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

– Privacy, Rite Aid HIPAA settlement, 992

HECTORAL

– Kidney drug, generic challenge (D. Del.), 682

HELIXATE FS

– Hemophilia drug patent settlement (E.D. Tex.), 273

HEPARIN

– Antitrust challenge (D.N.J.), 1083
– Blood thinner, less activity, 461
– Contamination, report, 596; recall, 1414; FDA criticized, 1436
– Design defect and strict liability (D.N.J.), 1556

HEXVIX

– Imaging agent, FDA panel approval, 22

HIPAA

See HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

HITECH ACT

See HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT (HITECH) ACT

HORIZANT

– Restless leg drug application denial, 253; FDA questions, 1443

HORMONE REPLACEMENT THERAPY (HRT)

– Knowledge of injury and breast cancer (Pa. Super Ct.), 64
– Premarin

See PREMARIN

– Prempro

See PREMPRO

– Provera and breast cancer (Pa. Super. Ct.), 64
– Punitive damages retrial (U.S. brief filed), 718; (rev den), 816
– Time-barred claims (D. Minn.), 1279
– Wyeth award upheld (Nev.), 1507

HRT

See HORMONE REPLACEMENT THERAPY (HRT)

HUMIRA

– Arthritis drug infringement damages and interest (E.D. Tex.), 6
– Lymphoma suit (N.D. Cal.), 857
– NYU infringement suit (E.D. Tex.), 6

HYLENEX

– Recombinant recall, 660

HYZAAR

– Generic

– – Mylan, 501; final approval, 1355
– – Teva, 451

– Hypertension drug exclusivity upheld (D.D.C.), 349; FDA supports, 414