Drugmakers often complain about slow regulatory review times, pointing to specific drugs that were approved months, or even years, faster in one market than in others.
While the patent challenge that's delaying the launch of the first biosimilar approved in the U.S. is grabbing headlines, some lawmakers may be second-guessing the final act of the Biologics Price Competition and Innovation Act (BPCIA).
Questioning the FDA's authority to issue a rule that would ultimately put generic drugmakers on the legal hook for "failure-to-warn" claims, several brand and generic companies urged the agency Friday to consider their alternative, which would make the FDA responsible for drug labeling changes once there's generic competition.
Hoping to revitalize Regulation A as a viable route for small companies to raise much-needed early capital, the SEC Wednesday adopted final rules transforming the regulation into a two-tier path with raised caps and some relief from the overlapping burden of state and federal oversight.
Glitches in the law that created the 340B drug discount program for safety net health care providers are creating oversight problems and raising questions about the intent of the program.
The patent dance laid out in the Biologics Price Competition and Innovation Act (BPCIA) is merely a temporary safe harbor that biosimilar sponsors may opt out of, a federal district judge ruled last week in denying Amgen Inc.'s request for a temporary injunction and partial summary judgment to halt the U.S. launch of Sandoz Inc.'s Zarxio, a biosimilar to Amgen's blockbuster Neupogen.
The House Republicans' opening salvo in the fiscal 2016 budget war doesn't bode well for the stagnant research coffers at the National Institutes of Health (NIH) or the FDA's efforts to keep up with its growing mission.
