The US Food and Drug Administration (FDA) is expected to have approved at least 21 new drugs by the end of this year, compared to 18 in 2007, but in the first 10 months of the year it missed 20% of its review deadlines for new drugs and biological products.
However, the biggest factor driving the decline in drug approvals by the agency each year is the fall-off in numbers of New Molecular Entity (NME) applications submitted by companies, according to a senior FDA official.
“We cannot approve what we don’t have to review,” John Jenkins, director of the office of new drugs at the FDA’s Center for Drug Evaluation and Research (CDER), told a conference held by the agency with the Centers for Medicare and Medicaid Services (CMS) this month. Another major reason for the lower NME numbers, agency officials believe, is the fall-off in “me-too” – sometimes called “me-too late” – NMEs, he added.
Under the Prescription Drug User Fee Act (PDUFA), which was first enacted in 1992 and revised in 1997 and 2002, the pharmaceutical and biotechnology industries pay the FDA user fees in exchange for a set of performance standards aimed at reducing approvals time for New Drug Applications (NDAs) and Biological License Applications (BLAs).
During January 1–October 31, 2008, the agency missed 32 of its 159 PDUFA goals related to NDAs and BLAs, or 20% of the total, and 20 (63%) of its actions on overdue applications, Dr Jenkins reported.
Reasons for the missed goal dates in the past year include: issues related to the FDA Amendments Act (FDAAA), including the Risk Evaluation and Mitigation Strategy (REMS) and Premarket Report (PMR) programmes; workload/competing priorities; pending citizen petitions; inspection issues; and advisory committee scheduling, he said.
All these competing issues mean that, while the FDA continues to take PDUFA goals very seriously, it has been struggling to meet them. Therefore, this year it made a “management decision” that it would not be able to meet both its PDUFA goals and all of its other priorities, said Dr Jenkins, although he pointed out that the agency did meet 80% of its PDUFA goals this year.
The never-ending debate about whether the FDA is too fast or too slow in approving new drugs continues to rage but, in his 16 years at the FDA, said Dr Jenkins, he has never received or issued an order to “speed up” or “slow down.” Nor, he added, are there any “goals” at the agency for numbers of approvals by year – “we review each application on its merits and apply our best judgment with regard to the data, the science and the regulations.” Drugs that meet the standards for approval are approved, and those which do not are not, he said, and emphasized that the agency expects product sponsors to do their part, for example by submitting applications which are complete.
