ARLINGTON, Va. The Generic Pharmaceutical Association has openly applauded Congress for approving a $6 million increase in the budget for the Food and Drug Administration’s Office of Generic Drugs. The increased funds were part of a group of appropriations bill.
The office is responsible for the review and approval of all generic drugs in the U.S. and they have been facing a backup that is now around 1,300 applications waiting to be reviewed. This has changed the approval time for an application from 180 days to 17 months.
“OGD plays a vital role in ensuring that safe, effective and affordable generic medicines are available to consumers,” said GPhA President and chief executive officer Kathleen Jaeger. “These additional funds are a good first step toward enabling OGD to hire more reviewers and process generic applications in a timely manner. Generics save consumers and federal and state governments billions of dollars a year. Investment in the timely approval of generics will reap significant dividends in terms of cost savings and improved health. And it’s an investment that Congress must continue to make as it grapples with escalating health care costs and a shrinking domestic federal budget.”
The GPhA went further to add that the generic pharmaceutical industry is willing to help the FDA any way they can to help speed up the review process, so more affordable drugs can reach the market.