US caucus to promote generics and biosimilars

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

US caucus to promote generics and biosimilars

Home/Policies & Legislation | Posted 27/05/2011 0 Post your comment

Two House members have established a group that they hope will produce legislation that leads to increased use of generic and biosimilar drugs and lower healthcare costs.

Representatives Ms Jo Ann Emerson and Mr Peter Welch, founded the Congressional Affordable Medicines Caucus on 12 May 2011 and plan to push for an expansion of FDA’s Office of Generic Drugs, as well as trying to reduce the growth in healthcare spending.

Hopefully this lobbying by House representatives will prevent or reduce the size of cuts to the Office of Generic Drugs budget announced by US Congress, which the Generic Pharmaceutical Association (GPhA) had stated ‘would further slow generic approvals at the very time we need more, not fewer affordable medicines on the market’.

The GPhA has expressed its support of the goals of the caucus to increase the use of generic drugs and increase funding for the FDA’s Office of Generic Drugs. The GPhA feels that the US medical insurance programs Medicare and Medicaid are currently failing to take advantage of the enormous savings offered by generic drugs.

It has been estimated that an increase in generic use by even as little as a 2% by Medicaid would save the program more than US$1.3 billion. A 5% increase could save nearly US$3.3 billion.

Meanwhile, there is a massive backlog at the FDA, with more than 2,000 generic drug applications awaiting action. Since as many as 365 of those applications are related to first-time generic drugs it is no wonder the Office of Generic Drugs needs extra funding to clear this backlog. Whether this funding comes from Congress or from the much-discussed generic user fees or both–it can only be good news for the generics industry.

Related articles

Still no word from FDA on generic user fees

Negotiations on generic drug user fees

FDA user fees for assessing generic drugs

Source: GPhA