The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report last week.
The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Behind-the-scenes partnerships between the pharmaceutical industry and advocacy groups may work against lowering the cost of high-priced drugs.
In a statement, Grassley said the inquiry is “based on reporting from Kaiser Health News” and strong consumer concern about high drug prices.
A Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions.
Before 1983 only 10 drugs had been approved to treat a rare disease, but as of November 2015 over 450 additional new orphan indications (both new drugs and secondary indications for previously approved drugs) had been approved.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The orphan drug industry is somewhat static in growth, but significantly outpaces the mass market drug industry, according to a new report from EvaluatePharma.
Patara Pharma now has a total of $33 million - including private investment and loans.
It's not just noise. This is an issue that needs to be addressed.
Also, the narrative shifts for FDA nominee Robert Califf, good news on Merck's c. diff treatment, and here's one part of Obamacare everyone hates.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Clinical trials are three years away for this necrotising enterocolitis treatment.
By Kurt R. Karst – Since we started this blogging gig seven years ago (March 6th was our anniversary) we’ve strived to cover topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law. Among other things, this has meant compiling […]