US House votes more support for generics

The US House of Representatives has approved, by 324 votes to 89, anamendment to the fiscal 2002 appropriations bill to increase funding for the US Food and Drug Administration's Office of Generic Drugs by $2.5 million, to speed up the approval process for generics. Representative Sherrod Brown's amendment would also set aside $250,000 for a national campaign to raise awareness about the safety and cost-effectiveness of generic drugs.

There are only 300 FDA scientists to review generic applications but over 2,100 to review New Drug Applications, said Rep Brown. Giving the OGD the resources it needs will make a tangible difference in easing the prescription drug spending burden, he said, adding that chances to reduce both public and private spending on prescription drugs without sacrificing access or quality are very hard to come by. On the awareness campaign, he said there is clearly an information gap with generics and a misperception that, as conditions become more serious, their use becomes more risky. The greatest bias against generics exists, unfortunately, when cost savings are potentially the greatest for serious conditions requiring long-term treatment, he added.

The House also approved, in a voice vote, Rep Brown's amendment requiring the FDA to exercise its existing authority to prevent blatant patent listing abuses under Waxman-Hatch. The industry knows the FDA does not actually enforce its regulations and weed out patents that under no circumstances should trigger an automatic 30-month delay, said Rep Brown. Companies are conjuring up patents that by no stretch of the imagination fit the FDA criteria just to trigger the 30-month delay, and these totally unnecessary delays cost consumers billions in lost savings, while the brand-name companies reap billions in additional profits, he noted.