Education Labor a Committee on Health

Generic Drug User Fee Amendments Education Labor a Committee on Health

Since 2012, the FDA has received nearly $1 billion in user fees, those are the fees that are negotiated between the FDA and the generic drug makers to give the agency additional resources intended to speed the review of safe and effective generic drugs. [The Generic Drug User Fee] does not seem to be living up to Congress or the patient's expectations, as the number of generic drugs approved each year remains about the same. The user fee agreements are due to be reauthorized, and so now seems to be a good time to take a look at what has happened. The Generic Drug Program was started 30 years ago by Senator Hatch and Representative Henry Waxman. It has increased competition and lowered drug prices. The program was created to make it easier for generic drugs to come in. Generic drugs are those drugs that are allowed to come into the market after a drug manufacturer's patent expires. Generic drugs have to have FDA approval also, but they do not have to have full clinical trials, and so a lot of expense is avoided. As a result, more generic drugs on the market create competition and lower prices for consumers. Today, 88 percent of prescription drugs purchased in the United States are generic drugs. Thirty years ago, that number was zero.