Washington Drug Letter

In contrast to their Senate counterparts, House Democrats say increasing the penalties for drug counterfeiters and thieves is unlikely to have a deterrent effect, and Congress should instead consider giving the FDA and federal law enforcement agencies additional resources.

An FDA advisory panel voted 17–6 Thursday to recommend requiring drugmakers to rule out cardiac risks of investigational obesity drugs, even if a theoretic risk or signal for harm is not present.

The FDA and HHS may need to weigh enforcement against drug shortage risks in the future as a draft Senate bill would make them evaluate enforcement actions beforehand.

Drugmakers should bear much of the responsibility for determining how consumers can safely use a new category of behind-the-counter OTC drugs, the Consumer Healthcare Products Association (CHPA) told the FDA March 22.

The FDA has yielded to a request from PhRMA, giving stakeholders until April 9 to submit additional comments on a proposed rule for presenting risk information in direct-to-consumer (DTC) TV and radio ads.

The FDA’s complete response letter for MAP Pharmaceuticals’ migraine drug Levadex could tack on another year before approval, but the company says the letter should be fairly easy to deal with.

A federal appeals court has agreed with a lower court that ViroPharma lacks standing to sue the FDA for changing bioequivalence testing standards for generic drugs referencing its gastrointestinal antibiotic Vancocin.

The FDA granted approval to Affymax and Takeda’s once-monthly anemia treatment Omontys, but has loaded the companies with postmarketing requirements, including two safety studies and a risk evaluation and mitigation strategy (REMS).

Two experts are calling on the FDA to require a drug facts box in prescription drug labeling, pointing to an erroneous Aricept label as a signal of wider problems with the label review process.

The FDA will probably take a more lenient approach in reviewing the recent mixed trial results for GlaxoSmithKline (GSK) and Theravance’s chronic obstructive pulmonary disease (COPD) drug Relovair when the pair file later this year, an analyst says.

A bevy of generic manufacturers have launched or plan to launch generic versions of AstraZeneca’s blockbuster antipsychotic Seroquel mere days after a federal judge dismissed the drugmaker’s attempts to block competition.

Teva plans to shake up the traditional nasal allergy market next month when it begins selling its newly approved “dry” nasal spray QNASL, the first nonaqueous product in a setting dominated by “wet” sprays.

The generic-drug industry’s freedom from liability for inadequate safety labeling could soon disappear if a key Democratic lawmaker has his way.