Washington Drug Letter

Drugs and biologics “fast-tracked” by the FDA get to market about four months sooner than those that undergo standard approval, but saving time is not the main reason to seek the designation, a report by Tufts University’s Center for the Study of Drug Development (CSDD) finds.

U.S. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.), who have led an investigation into a possible cover up of a link between cancer and Merck and Schering-Plough’s Vytorin, have accused the companies of creating a secret report on their cholesterol drug for the FDA, in a letter to company executives.

Teva Pharmaceutical Industries will have to wait as much as a month to complete its proposed acquisition of Barr Pharmaceuticals now that the FTC has sent a second request to both companies for information about the deal.

CDER’s decision to replace approvable and not-approvable replies with complete response letters probably will change the way that drugmakers communicate with investors and analysts about the FDA review process, an expert says.

The FDA recommends harmonization of standards for nonclinical safety studies that support clinical trials, according to a draft guidance.

The integrated summary of effectiveness (ISE) required in NDAs and encouraged in BLAs should include a detailed analysis of study results rather than just a summary of individual trials, according to an FDA draft guidance.

The FDA told manufacturers of four tumor necrosis factor (TNF)-alpha blockers used to treat arthritis and other immune disorders to strengthen warnings on patients’ risk of developing opportunistic fungal infections after reports of 12 deaths of patients taking the drugs.

Abbott Laboratories has updated the label for its protease inhibitor Norvir to include a new precaution for patients with cardiac disease regarding a disturbance of heart rhythm or atrioventricular (AV) block called PR prolongation.

United Therapeutics anticipates an April 30, 2009, FDA action date for an inhaled formulation of its Remodulin pulmonary arterial hypertension (PAH) drug.

Hi-Tech Pharmacal has filed a complaint against the FDA requesting a declaratory judgment related to the company’s ANDA for a generic version of Merck’s Cosopt, a glaucoma treatment.

The FDA permanently debarred clinical investigator Anne Kirkman-Campbell from providing services to anyone with an approved or pending drug application.

Alleged violations of Section 340B drug-pricing agreements with the federal government are cited in a case against drugmakers by Santa Clara County in California, which was just reinstated after three years of amended complaints and appeals.

A review of safety recommendations by the FDA’s Pediatric Drugs Advisory Committee showed that one-third of 67 pediatric drugs given additional exclusivity in return for postmarketing surveillance demonstrated rare, serious or child-specific adverse events, a study finds.