Washington Drug Letter

Due to summer holidays, Washington Drug Letter will not be published July 9. The next issue will be published July 16.

With the final FDA user fee legislation lacking language to support a national track-and-trace system, Congress must now act fast to preempt California’s e-pedigree law, slated to go into effect in 2015, Sen. Michael Bennet (D-Colo.) says.

Drugmakers should view Thursday’s landmark Supreme Court ruling on the 2010 Affordable Care Act (ACA) as an overall victory, industry analysts and consultants say.

The bill reauthorizing the Prescription Drug User Fee Act (PDUFA) for another five years is sitting on President Barack Obama’s desk waiting to be signed into law after the Senate voted 92–4 to pass the FDA Safety and Innovation Act, S. 3187.

PHILADELPHIA — The FDA is calling on drugmakers to build new manufacturing plants as part of their contribution to preventing drug shortages.

PHILADELPHIA — Drugmakers will need to take extra care to submit complete marketing applications to the FDA under the pending omnibus user fee bill, as the agency plans to place more emphasis on this requirement, experts warn.

The House has passed H.R. 4223, the SAFE Doses Act, by voice vote, taking another step toward ramped-up penalties for medical product thefts.

A federal court has ruled that drugmakers shouldn’t have to pay product fees for drugs with an approved generic, even when that generic isn’t actively marketed, but this precedent will be short lived as the fifth authorization of the Prescription Drug User Fee Act (PDUFA) closes this loophole.

PHILADELPHIA — The FDA and international regulators must establish a much more collaborative framework in order to ensure the safety of the world’s drug supply chains, FDA Commissioner Margaret Hamburg says.

Watson has received an untitled letter for a journal advertisement for iron deficiency anemia drug Nulecit that shows impacts on parallel therapies that are not representative of clinical trial results.

In a pair of decisions delaying action on two blood-thinning drugs, the FDA has given Johnson & Johnson (J&J) a complete response letter (CRL) for its sNDA on Xarelto to treat acute coronary syndrome, and Pfizer and Bristol-Myers Squibb (BMS) received a CRL for their NDA on Eliquis.

The FDA has approved its first weight-loss drug in 13 years, giving the OK to Arena Pharmaceutical’s Belviq, while requiring a hefty dose of postmarket studies on cardiovascular events.

PHILADELPHIA — Drug and medical device companies are increasingly minimizing or omitting the risks associated with their products in advertising and promotional materials this year, an FDA official says.

PHILADELPHIA — The FDA and the European Medicines Agency (EMA) are ramping up their interactions so they can more easily share information on future regulatory challenges, including foreign clinical trials, pharmacovigilance and active pharmaceutical ingredients.