Washington Drug Letter

Drugmakers must dole out nearly $2 million in fees for drug applications requiring clinical data in fiscal 2013, while companies submitting applications without such data, or supplemental drug apps, will need to fork over half that amount.

A U.S. appeals court has ruled HHS was “unambiguously” justified in excluding three former Purdue Pharma executives from federal healthcare programs after they pleaded guilty to charges the company illegally marketed and promoted its painkiller Oxycontin.

A key Republican lawmaker is calling for more thorough government probes into the FDA’s monitoring of nine of its scientists as new information shows the agency may have broken more laws than congressional investigators previously believed.

While drugmakers should not rely on a “Plan B” for validating suppliers, there are some steps they can take if they can’t conduct sufficient quality audits — primarily beefing up incoming acceptance activities, compliance experts say.

The FDA’s recent complete response letter (CRL) on Salix’s sNDA for opioid-induced constipation (OIC) drug Relistor likely cites safety concerns and signals increased scrutiny for all makers of these drugs, analysts say.

Pfizer’s rheumatoid arthritis (RA) candidate tofacitinib could see its review date pushed back thanks to an FDA request for an additional analysis.

In ruling on what it called a “close question,” a federal court has backed a 2008 FDA request that a Colorado medical practice be ordered to cease marketing its cultured cell product that regenerates bone and cartilage, saying such therapies are drugs subject to agency enforcement.