Pharmaceutical Law & Industry Report® Index-Summary

H1N1 VIRUS

– Fraudulent H1N1/swine flu cures, FDA and FTC warn public, 537
– Funding for H1N1/swine flu sought by White House, 534
– Peramivir, FDA clears for emergency use, 1261

HEALTH AND HUMAN SERVICES DEPARTMENT (HHS)

– Comparative effectiveness panel members named, 343
– Daschle pledges to improve operation of FDA and other agencies, 69; withdraws name, 156; Sebelius nominated, 263; Senate action delayed, 407; finance panel approves, 470; Senate approves, 503
– FDA

See FOOD AND DRUG ADMINISTRATION (FDA)

– FY2010 budget includes Medicaid cuts, 560; more FDA drug and device funding, 560
– Stimulus funding office launched, 291

HEALTH CARE REFORM, FEDERAL

– Baucus (D-Mont) proposal includes rebates and drug maker fees, 1042; released, 1074; bill, see LEGISLATION, FEDERAL, S 1796
– Biosimiliars pathways sought by governors, 1142; Senators seek, 1201
– Boehner (R-Ohio) opposes White House deal with industry, 974
– Comparative effectiveness

See COMPARATIVE EFFECTIVENESS

– Daschle withdrawal may slow down reform efforts, 156
– Democrats bill analyzed, 777
– Device and drug makers urge coverage expansion, 776
– Finance panel clears Senate bill, 1199
– GOP senators drafting proposal, 711
– Hatch (R-Utah) expects bipartisan bill to pass in 2009, 472
– HELP panel releases draft Senate bill, 683; markup, 739; biosimilars pathway sought, 1201
– Marketing, drug firms may need to overhaul strategies, 717
– PBM transparency included in Senate bill, 1138
– Personalized medicine pushed by Merck CEO, 566
– Pharmacists offer reform principles, 210
– Public option

See LEGISLATION, FEDERAL, HR 3200

– Rationing

See LEGISLATION, FEDERAL, S 1259

– Stakeholders pledge savings, 652

HEPARIN

– Adverse reaction, suit remanded to state court (S.D. Ala.), 255
– Approvals, In Brief, 1055
– Blood thinner not tied to adverse events in 3 patients, maker says, 594
– Chinese firms get warning from FDA on contamination, 476
– Potency cut by manufacturing change, 1174

HIBERIX

– Flu vaccine gets accelerated approval, 1002

HORMONE REPLACEMENT THERAPY (HRT)

– Breast cancer blamed on HRT

– – Non-resident plaintiff, Minn. limitations period applies (Minn.), 1036
– – Summary judgment for maker (Minn. Ct. App.), 884

– Failure-to-warn claim against maker not preempted (Tex. App.), 464
– Ghostwriting by maker, documents unsealed (E.D. Ark.), 915
– Jurisdiction lacking over ad firms with insufficient W.Va. contacts (E.D. Ark.), 367

HRT

See HORMONE REPLACEMENT THERAPY (HRT)

HUMAN SUBJECT PROTECTION

– IRBs

See INSTITUTIONAL REVIEW BOARDS (IRBs)

– Pfizer study subject protection program accredited, 417

HUMIRA

– Arthritis drug maker alleges patent infringement (D. Mass.), 526
– Patent infringement alleged (E.D. Tex.), 41; summary judgment for plaintiff denied, 585; summary judgment for defendant denied, 671; $1.67M awarded, 767
– Psoriasis and arthritis drug ad broadens approved indication and minimizes risks, FDA says, 21

HYTRIN

– Hypertension and prostate drug monopoly claim remanded (9th Cir.), 91