As health care across the globe shifts to a more patient-focused model, one of the challenges is getting patients to be more accountable for their own health.
The old adage "you get what you pay for" may not hold true for new cancer drugs. A study of cancer drugs approved by the FDA between 2009-2013 shows little correlation between the efficacy of a drug and its price tag.
The FDA is tweaking its plans to study how best to present price comparisons in physician and direct-to-consumer (DTC) ads without implying that two prescription drugs are interchangeable. While the research will focus on diabetes medications, the results could impact how drugmakers market biosimilars in the U.S.
It's one thing to listen to patients and understand what's important to them. But it's much more difficult to translate the patient voice into a science-based tool that can be used to measure meaningful risks and benefits of a drug in clinical trials.
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.