Whither FDA?

FDA's role should not be overlooked as it has been in years past.
Feb 02, 2009


Michelle Hoffman
Amid the rush of reports about new appointees to the Obama administration, one appointment stands out for the lack of discussion around it: FDA commissioner. A blasé attitude toward the appointment of a commissioner to lead the US Food and Drug Administration seems to have become something of a tradition among modern administrations. For most of its recent history, FDA has been led by temporary acting directors who lack the mandate to overhaul the agency. I am disappointed that there has not been any public acknowledgment of high-level discussions around this appointment and hope that the next appointment will not once again be an afterthought.

Many will argue that in light of the current financial crisis, the new administration has the more immediate problem of putting in place a competent team of financial experts. Of course, that's a priority. However, the appointment of FDA commissioner might loom a little larger in that equation if one considers that the products regulated by FDA account for approximately 25% of the US economy. So there is more at stake in the way FDA is managed than the mere health of the American people and the safety of the country's food and drugs; part of the US economy's health is also dependent on this appointment.

The selection of a new commissioner also will address a growing philosophical issue at FDA: What, exactly, is the agency supposed to be? Some observers are asking whether food and drugs ought to be regulated by separate agencies (see Jill Wechsler's January column). And with the growth of the pharmaceutical industry overseas, FDA is not just for domestic use anymore. Already, the agency has set up outposts in Asia to inspect facilities producing drugs for US domestic consumption. There is also discussion about whether FDA should monitor the supply chain of ingredients used in overseas manufacture of drugs destined for the US. Finaly, there remains the question of whether FDA exists to speed drugs through the approval process or to take a longer time and avoid all possible risks once a drug enters the market (of course, FDA's regulations have expanded to include postmarket monitoring.)

The argument that favors rapid approval allows potentially life-extending and life-saving medicines to enter the market early, where they might improve the lives of thousands who have no other treatment option. A slower review, on the other hand, might delay the release of important drugs, but also might identify potential side effects in drugs before they can do harm to the general population.

Mandates under the Prescription Drug User Fee Act (PDUFA) favor speedy review, but some well-publicized drug failures put pressure on FDA to move more slowly before releasing drugs to market. It is interesting that in a recent performance report to Congress, FDA noted at least 21 instances since 2007 in which the agency took longer to approve a drug than is specified by the Act. Some reviews ran as much as seven months beyond the 6-to-10 month review period prescribed by PDUFA. It may be that the agency is merely understaffed and therefore needed more time to review applications (there were slightly more applications for new molecular entities and biopharmaceutical products than there have been in years past). Or, the delays may signal that FDA is giving greater scrutiny to drugs than can be accomplished within PDUFA timelines. If the latter reason pertains, it should serve as a rebuttal to critics who maintain that FDA is in the pocket of drug companies that provide PDUFA fees.

None of these issues will go away by ignoring them—not if history is any guide. In fact, it seems that the role of FDA continues to expand beyond premarket approval of drugs and beyond US borders. As these new roles pile on, the question of what the agency will be to whom only becomes more acute. So, when the new commissioner is chosen, we can only hope it is done purposefully and with a full understanding of all of the implications that appointment carries.

Additional reading

M. Hay, "FDA PDUFA Goals Missed," Nature Reviews Drug Discovery, 8, Jan. 2009, p. 1.

A. Maurer, "BIO President Sees Biotech Industry Challenges for New Administration," TechJournal South, Jan.14, 2009, http://www.techjournalsouth.com/news/article.html?item_id=6747

A. Goldhammer, "Selecting the next FDA Commissioner," Pharm. Technol. 33 (1) 2009, 121-122.

A. von Eschenbach, "Performance Report to the President and the Congress for the Prescription Drug User Fee Act," http://www.fda.gov/ope/pdufa/report2007/PDUFAFY2007perf.html

Michelle Hoffman is editor-in-chief of Pharmaceutical Technology. Send your thoughts and story ideas to