Washington Drug Letter

President Barack Obama signed the FDA Safety and Innovation Act, S. 3187, into law July 9 reauthorizing the Prescription Drug User Fee Act (PDUFA) and creating new user fee programs for generic drugs and biosimilars.

A new study shows the U.S. outpaces Europe in approving new cancer drugs, but that lead could be in jeopardy under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), an expert tells WDL.

House Republicans, joined by a handful of Democrats, voted Wednesday to repeal the 2010 Affordable Care Act (ACA) — the 31st time the GOP has tried to take down or truncate the law, House Democrats said.

Sanofi, Ipsen and Eisai all took pipeline hits last week, with late-stage setbacks including Sanofi’s withdrawal of marketing applications for a blood-clot drug, Ipsen’s clinical hold for an investigational hemophilia drug and Eisai’s failed breast cancer trial.

The FDA has warned Spanish industrial giant and active pharmaceutical ingredient (API) maker Ercros S.A. for good manufacturing practice (GMP) nonconformities, including various validation lapses and building disrepair that invites pests.

The FDA is seeking public comment on an upcoming independent assessment of its new lengthened review program under the newly reauthorized Prescription Drug User Fee Act (PDUFA).

Exemplar Pharmaceuticals, a contract manufacturer of nasal sprays and other aerosol-based drugs, was handed a Form 483 for process control deficiencies tied to filling foul ups.

KV Pharmaceuticals has sued the FDA to force it to stop pharmacies from compounding KV’s preterm birth drug Makena.

Five retailers have sued Pfizer and Ranbaxy, alleging the drugmakers conspired to delay market entry of generic Lipitor in the U.S.

Eli Lilly’s antidepressant Cymbalta will remain patent protected until December 2013, now that the company has snagged an additional six months U.S. marketing exclusivity by conducting FDA-requested pediatric trials.

Companies manufacturing and distributing unapproved oxycodone products have until Aug. 20 to stop producing the pain meds and until Oct. 4 to cease shipping them or risk ramped up FDA enforcement.

Manufacturers of extended-release and long-acting (ER/LA) opioid pain relievers will need to have educational programs available for prescribers by March of next year, according to a new classwide risk evaluation and mitigation strategy (REMS) that has been in the works for years.