The US House of Representatives has voted to approve a bill designed to help fund the US Food and Drug Administration, providing it with new authority to prevent drug shortages.
The bill also provides the US FDA with the power to collect higher fees from companies to fund inspections of foreign facilities, increasing the safety of drugs imported from overseas, whilst also incentivising the production of antibiotics for diseases with fewer available treatments.
The FDA will now have the power to reauthorise the fees it charges from drug makers, which is hoped to speed up the evaluation of new drugs. The new fees could contribute almost half of the proposed FDA annual budget of $4.5bn.
User fees contribute significantly towards the FDA's budget, allowing the organisation to conduct reviews of new drugs and medical devices. Although first established in 1992, a new version of user fees is due to come into force after the current version's expiry in September 2012, including the provision to collect fees from generic and biosimilar drug manufacturers.
Under the bill, the FDA will also have the power to force pharmaceutical companies to report supply disruptions, allowing the FDA to increase production at other manufacturers in order to avoid drug shortages. Manufacturing disruptions have caused shortages in anaesthetics and cancer drugs in particular over the last few years, most notably in Canada after a Sandoz manufacturing facility was forced to part-close in order to address issues raised by the FDA.
The bill, which was passed with a vote of 387-5, was also passed by the US Senate in late May 2012. The only remaining hurdle requires both sides of Congress to resolve any differences, with house leaders confirming that an agreement should be reached by 4 July 2012.
Current disagreements between the Senate and house versions of the bill include specific details of which antibiotics should qualify for incentives depending on the condition they treat, as well as other medical device safety provisions.