Pharmaceutical Law & Industry Report® Index-Summary

FALSE CLAIMS

– Aventis to settle false price report charges, 637
– BNA audioconference, In Brief, 719; 781
– Caremark qui tam suit, state court must resolve counterclaim immunity issue (5th Cir.), 856
– Increased whistleblower suits possible, conference told, 779
– Inflated prices, Mylan settles with state (D. Mass.), 40
– Lipitor marketing qui tam action dismissed (E.D.N.Y.), 638
– Medicaid

– – Fla. pharmacy accuses drug maker of inflating prices (S.D. Fla.), 62
– – Ky. pharmacy (E.D. Ky.), In Brief, 1105
– – Tex. amends false claims complaint against Risperdal makers (Tex. Dist. Ct.), 14

– Modified liability

See LEGISLATION, FEDERAL, S 386

– Off-label use

– – Antidepressants, feds intervene in suit (D. Mass.), 226
– – Lovenox qui tam suit may proceed (N.D. Ill.), 501
– – Natrecor whistleblower suits, feds intervene (N.D. Cal.), 226

– Off-label uses, Forest Labs settles (D. Mass.), 1166
– Procrit, qui tam suit against maker partially dismissed (1st Cir.), 968
– Public disclosure jurisdiction limited (U.S., rev grant), 729
– Retaliatory firing by Pfizer alleged, summary judgment granted for firm (S.D.N.Y.), 1136

FAMPRIDINE

– MS drug cleared by FDA panel, 1235

FAMVIR

– Herpes drug, infringement claim against generic maker may proceed (D.N.J.), 254; jury trial disallowed, 553

FANAPT

– Schizophrenia drug approved for adults with warning, 539

FEDERAL TRADE COMMISSION (FTC)

– Antitrust

See generally ANTITRUST

– Leibowitz as FTC chair, more scrutiny predicted for drug industry, 261
– Mergers and acquisitions

See generally MERGERS AND ACQUISITIONS

FEN-PHEN

– Diet drug settlement, attorneys convicted of bilking plaintiffs (E.D. Ky.), 467
– Fee award for attorneys affirmed (3rd Cir.), 1226

FENTANYL

– Transdermal patch recall announced, 951

FENTORA

– Pain drug, infringement claim over generic may proceed (D. Del.), 436

FLOMAX

– Prostate drug, generic copy planned (N.D. Cal.), 1195

FLORIDA

– “Manufacturer,” definition revised, 778
– Medicare, inhalation drug billings higher in Fla., 509

FLUCLOXACILLIN

– Antibiotic associated with liver damage, 652

FLUTIFORM

– Application, In Brief, 627; FDA may need more data, In Brief, 691
– Asthma drug, additional clinical work urged, 1050

FOCALIN XR

– ADHD drug, infringement claim dismissed (D.N.J.), 95

FOLOTYN

– Lymphoma drug, FDA panel reports clinical benefit, 1049; approved, 1146

FOOD AND DRUG ADMINISTRATION (FDA)

– ANDAs

See ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)

– Applications

See APPLICATIONS

– Approvals

See APPROVALS

– Budget for FY2010

– – Funding bill

See LEGISLATION, FEDERAL, HR 2997, S 1406

– Civil penalties, In Brief, 234
– Commissioner

– – Ex-commissioner joins Center for Health Transformation, 1116
– – Nominee should be familiar with drug industry and have “impeccable qualifications,” health coalition says, 16; consumer groups comment, 183; President to nominate Hamburg, 317; hearings planned, 537; Hamburg approved by Senate panel, 562; approved by Senate, 589; begins work, In Brief, 620; urged to work with CMS, 646

– Conflicts of interest, panel member dismissed, Hinchey (D-NY) questions, 265
– Enforcement

– – Broader authority urged by MD group, 1147
– – Compliance discussed at conference, 1078
– – Increase predicted, 504

– FY2010 budget

– – Drug and device funding hiked, 560; deputy FDA chief testifies, 619
– – Generic biotech drugs pathway included, 260

– Grassley (R-Iowa) seeks clarification of employees right to discuss agency issues, 345
– IT contracting criticized by HHS IG, 70
– Labels and packaging

See LABELS AND PACKAGING

– Modernization projects, GAO urges comprehensive information technology program, 647
– Safety

See SAFETY

– Science, quality improvement discussed at conference, 654
– Splitting FDA, Sebelius says speculation premature, 374
– Transparency

– – Pushed at Senate panel, 862; new commissioner supports, 946
– – Task force announced, 645; industry and consumer groups comment, 740; more time for comments, In Brief, 1045; comments sought, 1174

– Warnings

See WARNINGS

– White House seeks regulatory review, 123

FORTAMET

– Diabetes drug, generic ANDA challenged (D. Del.), 97

FORTICAL

– Osteoporosis drug, generic blocked (S.D.N.Y.), 1028

FOSAMAX

– Defense attorney's trip to Australia for deposition, plaintiffs must defray costs (S.D.N.Y.), 315; summary judgment denied, 1069
– Degenerative jaw condition blamed on drug (S.D.N.Y.), 1037; mistrial after jury deadlock, 1069
– Osteoporosis drug product liability, amended claim to add second drug maker permitted (S.D.N.Y.), 118
– Sales rep, suit against remanded to state court (S.D.N.Y.), 1170

FOSRENOL

– Generic, brand-name maker seeks to block generic (S.D.N.Y.), 405
– Kidney disease drug maker alleges patent infringement (S.D.N.Y.), 312

FRAUD AND ABUSE

– Amgen accused of illegal marketing of Enbrel and Aransep (D. Mass.), 255
– BNA plans conference, In Brief, 24
– Discount drug card marketing claims settled (Pa. Commw. Ct.), 179
– Foreign Corrupt Practices Act

– – Compliance, Analysis & Perspective, 215
– – More cases reported, 807

– Fraud on agency claims, Analysis & Perspective, 1086
– Generic drugs, Ala. Atty. Gen. seeks to dismiss suits against pharmacies for deceptive trade practices, 1204
– Human growth hormone imports, Colo. pharmacy settles with DOJ (D. Colo.), 13
– Joint venture to sell cancer drugs, $3M award for negligent misrepresentation (5th Cir.), 799
– Kickbacks

See ANTI-KICKBACK LAWS

– Medicaid

– – Ky. inflated AWP suit settled (Ky. Cir. Ct.), 311
– – Mass. recoveries reported by Atty. Gen., 130
– – Mo. settles with pharmacy, 975
– – N.C. recoveries reported for 2008, 47
– – Rebates not paid, 4 drug makers settle (D.N.H.), 1224
– – Tex., immune system drug maker settles overcharge claims (Tex. Dist. Ct.), 969
– – Wis., Pharmacia defrauded program through inflated prices (Wis. Cir. Ct.), 200; forfeitures sought, 556

– Medicare Part D

– – Average wholesale price

– – – Inflated prices, $12.9M verdict affirmed (1st Cir.), 1125
– – – Overstating prices, dismissal vacated (1st Cir.), 1126

– Misconduct in research

– – Procedures to prevent revised by FDA, 947

– Mishandling controlled substances, Rite Aid settles (E.D. Cal.), 97
– Needy patients, drug maker assistance program cleared by HHS IG, 889
– Off-label use

See OFF-LABEL USE

– Oxycontin misbranding, Purdue Frederick ex-execs barred from federal programs, 119
– Recoveries predicted by HHS IG, 686
– Securities

See SECURITIES

– Viread maker accused of misrepresenting sales (N.D. Cal.), 679; some shareholder claims may proceed, 1229
– Walgreens accused of fraudulently switching dosage forms, dismissed (N.D. Ill.), 1030
– Zyprexa, S.C. Atty. Gen. settles fraudulent marketing suit (S.C. Cir. Ct.), 1249

FTC

See FEDERAL TRADE COMMISSION (FTC)