Jill Wechsler The campaign has begun to enact new policies to "improve" the drug approval process through legislation to reauthorize the drug user fee program; that always carries multiple initiatives designed to spur biopharmaceutical innovation. After a year of consultation with all interest groups, regulators and manufacturers reached agreement last spring for renewing the Prescription Drug User Fee Act (PDUFA), on track to transmit the PDUFA V plan to Congress next January. The current user fee program expires September 30, 2012, and a new program has to be in place before then for the Food and Drug Administration (FDA) to be able to continue collecting industry payments. The debate will be shaped by growing pressure on the Obama administration and Congress to cut government spending, which promises to curb resources for the FDA and further squeeze drug reimbursement. Legislation adopted in August to extend the national debt ceiling established a new "super" deficit reduction committee to identify $1.5 trillion in spending cuts for the next 10 years. If the panel fails to reach agreement on a savings plan, the default is an 8% across-the-board reduction in government spending, a tough cut for agencies like FDA that are required by recent legislation to expand oversight programs. The situation makes it even more important for Congress to quickly approve user fees to offset anticipated curbs on appropriated funding. Even though user fees already support some 60% of FDA's expenditures on assessing new drugs and biologics, the demand for more resources will make policy makers less likely to complain that fees make FDA overly dependent on industry.
Applied Clinical Trials, Oct 1, 2011