GPhA’s SVP sciences and regulatory affairs noted that GPhA and other industry associations have urged the FDA to avoid ambiguity in quality metrics and consider additional moves that would ensure that proposed changes won’t disrupt supply.
Read about 8 of the various civil cases that the Department of Justice and Federal Trade Commission have brought against supplement makers or individuals.
The Department of Justice announced the indictment of more than 100 manufacturers of illegal supplements as part of a yearlong effort that began last November.
CQ Roll Call profiled NACDS’ VP government affairs in a piece ahead of the Nov. 16 ceremony for the Professional Women in Advocacy Conference’s Excellence in Advocacy award, for which Kelly is a finalist.
Valeant Pharmaceuticals’ decision to raise the prices on a handful of drugs it has acquired over the past few years has led federal lawmakers and the Department of Justice to demand that the company explain its pricing policy.
A merger frenzy has hit the generics sector this year with a spate of acquisitions and hostile-takeover bids making headlines and reshaping the industry.
As 2015 draws to a close, the year is on track to be one in which the value of the branded drugs losing their patent protection approaches an all-time high. The dozens of drugs that will have lost their patent protection this year are estimated to have global sales of $44 billion a year — the highest total since $53 billion worth of medications went off patent in 2012.
Rapidly rising prices for many generics, regulations that could restrict patients’ access to these medications, a Food and Drug Administration backlog in getting new drugs approved and market consolidation that is reducing competition are all making some wonder how much longer generics will continue to be affordable.
New Jersey Gov. Chris Christie this week signed legislation allowing pharmacists to subsistute FDA-approved biosimilar products for biologics, and Generic Pharmaceutical Association voiced its support for the move.