A December 9 hearing of the U.S. Senate Special Committee on Aging had senators looking closely at several possible solutions to the recent, massive price spikes for particular generic drugs, including having FDA speed approval for competitors for products with no competition.
U.S. Senators Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) recently reintroduced legislation that would make it illegal for brand-name drug manufacturers to pay-off other drug manufacturers to keep generic versions of brand-name drugs off the market.
That’s the allegation made in a potential class action lawsuit that claims CVS deliberately overcharged some customers for generic drugs by submitting claims to their insurance companies at inflated prices.
Rep. Steve Stivers (R-Ohio) and Rep. Peter Welch (D-Vt.) have re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to what they say will increase consumer access to generic drugs, boost market competition and ultimately save consumers money.
FDA’s approval of generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, from 4 different generic manufacturers, has industry insiders pondering the generic drug market.
Four generic manufacturers (Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals) received the go-ahead April 28 to market their generic versions for Abilify for the treatment of schizophrenia and bipolar disorder.
The Food and Drug Administration (FDA) has released its lists of approved biosimilar licensed products, called the “Purple Book”. The invaluable site includes the date a biological product was licensed under the PHS Act and whether FDA evaluated the biological product for reference product exclusivity.