Washington Drug Letter

CDER Director Janet Woodcock is urging House lawmakers not to overload their omnibus user fee draft with unfunded mandates that would add unneeded “work strain” to the resource-strapped FDA, including a requirement that would expedite manufacturing changes to speed shortage drugs to market.

Sen. Sherrod Brown (D-Ohio) had harsh criticism for FDA Commissioner Margaret Hamburg Thursday, questioning the agency’s lack of enforcement actions against companies’ with holes in their supply chain knowledge.

Drugmakers commenting on the FDA’s trio of biosimilars guidance documents are split on the need for certain clinical tests as part of the agency’s stepwise approach to showing biosimilarity.

The Supreme Court has unanimously ruled that generic-drug maker Caraco Pharmaceuticals can challenge Novo Nordisk’s “overbroad” patent listing for diabetes drug Prandin, reversing and remanding a lower court’s decision that critics called an existential threat to the generic industry.

The European Medicines Agency (EMA) has published question-and-answer guidance on marketing applications for biosimilars, providing advice on a number of pre-submission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.

ViroPharma is suing the FDA and is seeking a temporary restraining order for three newly approved generics of its gastrointestinal antibiotic Vancocin.

Drugmakers would need to submit pediatric study plans to the FDA sooner in the drug development process under a bipartisan Senate bill that would make three programs intended to encourage pediatric trials of medical products permanent.

BOSTON — Drugmakers need to lobby against price controls in Medicare Part D that have an estimated price tag upward of $100 billion, amounting to a tax on the industry, incoming PhRMA Chair John Lechleiter says.

The FDA has sent letters to physicians in 12 U.S. states, including nearly 30 in California, requesting they cease using and secure all products from a foreign distributor known for selling unapproved and counterfeit drugs, such as fake Avastin.

The FDA must develop a clear and unambiguous definition of crude heparin in light of inconsistent and confusing uses of the term in its draft guidance, Merck says.