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TAGline Fall 2014


Fall 2014

A Drug by Any Other Name
The basics of generic medications, bioequivalence, and the push for good manufacturing practices

By Tim Horn

Securing access to generic drugs to treat HIV, hepatitis C virus (HCV), and tuberculosis (TB) is now one of the most prominent strategies of global health care and treatment activism. The ongoing development, regulatory approval, and evaluation of generic drugs are dependent on activism. This requires a basic understanding of the science and policies of generics, particularly the practices that must be followed to help ensure equivalence and quality control.

The Road to Treatment Access
Generic drug registration, licensing, and a trip to Gilead’s islands
By Karyn Kaplan and Tracy Swan

Access to essential medicines is part of the human right to health. The HIV/AIDS epidemic has demonstrated that generic competition is key to massive antiretroviral treatment (ART) scale-up in low- and middle-income countries (LMICs). But several steps are needed to create access to generics, including registration and licensing. Understanding these steps is critical for effective advocacy.

Safeguarding against Stock-Outs
The time has come for U.S. tuberculosis programs to have full access to the Stop TB Partnership’s Global Drug Facility procurement and stockpile safety nets

By Kenyon Farrow

Generic drugs can be credited with saving millions of lives by allowing for life-threatening infectious diseases to be treated and cured affordably. However, access to these drugs still leaves a lot to be desired in many countries. These include the United States, where low-prevalence diseases like tuberculosis (TB) are at the mercy of limited market competition among generic drug makers, which can result in drug shortages when manufacturing or distribution problems arise.

Generics vs. the Giant
For people with drug-resistant tuberculosis (DR-TB), generic linezolid may be a lifesaver. But only if quality-assured versions are available and affordable
By Erica Lessem

As new drugs bedaquiline and delamanid offer renewed hope of treating DR-TB, doctors and programs are faced with the challenge of finding companion drugs to create regimens to which patients’ TB is still susceptible. Without other effective drugs, resistance may develop to bedaquiline or delamanid, and patients and communities have fewer chances of overcoming DR-TB. For this reason, interest in procuring linezolid has been increasing.