Washington Drug Letter

A House committee on May 15 advanced legislation establishing a national track-and-trace system for pharmaceuticals despite vociferous Democratic objections over the bill’s immediate preemption of state laws and lack of a clear unit-level pedigree roadmap.

Blocking imports of every shipment of active pharmaceutical ingredient (API) intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court May 13, calling KV Pharmaceuticals’ claims it should have done so “absurd.”

The Obama Administration last week moved to block a lower court judge’s order requiring the FDA to remove all age restrictions from the emergency contraceptive known as Plan B One-Step.

Generic drugmaker Ranbaxy announced May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York.

A federal judge handed Shire a victory May 9, ruling that Actavis’ generic version of Lialda, indicated for ulcerative colitis (UC), infringed the company’s ‘720 patent.

GOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier this month.

The FDA May 10 denied Endo Pharmaceuticals’ citizen petition requesting the agency acknowledge that its noncrush-resistant version of its opioid painkiller Opana ER was withdrawn from the market for safety reasons, a move that would have blocked generic versions of the drug.

In a case closely watched by the biotech and pharma industries, the Supreme Court May 13 ruled that farmers could not use Monsanto’s patented genetically altered soybeans to create new seeds without paying the company a fee.

Google searches, detailed contracts and audits-a-plenty: This is the recipe that one expert industry working group asks drugmakers to follow to guard against illegal drug diversion.

Eli Lilly has put the brakes on a Phase III trial of its non-Hodgkin’s lymphoma (NHL) drug enzastaurin after it failed to meet its primary endpoint.

French drugmaker Sanofi-Aventis was fined $52.6 million by the French competition authority May 14 for marketing practices that discouraged sales of generic versions of the company’s blood thinner Plavix.

Former U.S. trade officials and pharma industry experts May 14 called on Congress to investigate India’s trade policies that impede innovation.

Congressional carping that the FDA is taking too long to decide if hydrocodone combination products should be further restricted is well-intentioned but dismisses the fine line between enforcement and ensuring pain medications are available to those who need them, experts say.

All eyes will be on California May 20 as it joins a growing list of states trying to decide how to regulate the substitution of biosimilar drugs for their more costly brand counterparts.

The FDA is launching two studies examining how drug companies present composite scores in advertisements and what effect the composite score has on a consumer’s opinion of a drug.