TB CAB, TAG open letter to Janssen regarding the FDA approval of bedaquiline
Determining a fair and affordable price of bedaquiline is essential for timely approval and appropriate domestic and global access to the best possible therapeutic options for people with DR-TB.
On March 14, 2013 the Global TB Community Advisory Board (TB CAB) and the Treatment Action Group (TAG) sent an open letter to Janssen congratulating the company on the U.S. Food and Drug Administration’s approval of bedaquiline for the treatment of drug-resistant TB (DR-TB) and asking the company to determine a fair and affordable price, essential for timely approval and appropriate domestic and global access to the best possible therapeutic options for people with DR-TB.
“Fair and affordable pricing means concessional pricing in both the low- and middle-income countries that disproportionately bear the burden of TB, and affordable pricing in low-incidence settings such as the United States where TB programs receive few resources.”
The letter also requests that Janssen expedite the conduct of further research necessary to determine bedaquiline’s safety and optimal use.
