GPhA calls for feedback and dialogue on US generic legislation

The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User Fee Act (GDUFA) process and implementation can be strengthened.

In a statement yesterday it praised generics for providing life-saving drugs for millions of Americans, calling them a boon for patients, taxpayers, businesses, and government. In 2013 alone, generic drugs were responsible for $239 billion in savings for the US health system, according to the recently released 2014 Generic Drug Savings in the US report.

The GPhA statement paid tribute to how the generic industry works closely with the US Food and Drug Administration. Ralph Neas, president and chief executive of GPhA, said: “GDUFA is a historic achievement for both FDA and the generic pharmaceutical industry. The association and its members fully support GDUFA objectives with 10% industry-generated funds. In fact, last year the industry contributed $300 million to support the three core public health aims of GDUFA: safety, access and transparency. For GDUFA to be successful it must be implemented in a way that is mindful of the realities of the generic drug marketplace, and continues to incentivize the development of generic drugs for patients.”