Washington Drug Letter

The Senate plans to debate and vote on an omnibus FDA user fee bill this week, as lawmakers Tuesday substituted a new bill for the prior reauthorization bill.

The FDA is approving drugs faster than its regulatory peers in Europe and Canada, a new study finds, challenging criticism that the U.S. agency harps on safety at the expense of timely reviews.

PhRMA and the White House are under the congressional microscope for an alleged $80 billion deal crafted in secret during the 2010 Affordable Care Act negotiations.

Drugmakers looking to branch into biosimilars shouldn’t raise their hopes for quick FDA guidance on achieving interchangeability status.

Despite a Senate hearing Tuesday over the high price of HIV treatments, industry onlookers say any price controls on the drugs are unlikely in the near future.

CBER plans to rely heavily on the FDA’s new “Mini-Sentinel” surveillance pilot program to improve its ability to identify low-frequency adverse events involving licensed products.

Cardinal Health has agreed to halt distribution of controlled substances from its Lakeland, Fla., facility for two years and strengthen anti-diversion efforts as part of a settlement with the Drug Enforcement Agency (DEA), resolving claims that its controls over such drugs were too relaxed.

Gilead Sciences’ Quad HIV treatment has an acceptable benefit-risk profile and should be approved with robust postmarket strings attached, FDA reviewers say.

CDER has implemented new outreach programs that last year dramatically reduced the use of the agency’s ombudsman’s office — the main gateway for complaints against the center.