The US Food and Drug Administration has struggled with a depleted work force, obsolete information technology, and a weak
science base, according to its advisory Science Board. A new administration and new FDA leadership provide an opportunity
for change. This is "a watershed time" for the FDA, says Janet Woodcock, director of the Center for Drug Evaluation and Research
(CDER). The public is concerned about drug quality and imports, industry is caught in a productivity crisis, and the global
financial meltdown may dry up investment for biomedical innovation, she observes. Her goal is to restore public confidence
in the drug regulatory process, capitalize on advances in science and technology, improve postmarket oversight, and make the
FDA "the recognized leader in drug regulation."
Such a turnaround will not be easy. Rep. Rosa DeLauro (D-CT), who chairs the House Appropriations subcommittee that oversees
the FDA's budget, asserted at a meeting sponsored by the Institute of Medicine in April, that the FDA needs "urgent and dramatic
reform." The agency cannot perform basic functions, she said, such as keeping track of clinical trials, conducting required
inspections, and following up on commitments for postmarket studies. "FDA is barely hanging on by its fingertips," attorney
Peter Barton Hutt told the House Energy & Commerce Committee a year ago, joining the chorus seeking increased resources for
the beleaguered agency.
Fixing the FDA may require a major overhaul to better fit the global world of pharmaceutical and food production. Because
the regulatory model for food is very different from that for drugs and biologics, DeLauro and others propose to transfer
the FDA's responsibility for food regulation to a new federal agency that would assume responsibility for multiple programs
now spread around dozens of government offices.
To avoid such a disruptive change, agency officials are taking steps to demonstrate their ability to prevent and deal with
food contamination problems. They also propose a less radical reorganization that would split the FDA into two "directorates,"
one for food and another for medical products. There is support for such a move from food operators, who feel they play second
fiddle to drugs at the FDA, and also from some medical product companies that fear being hit by more restrictive food import
Taking the "food" out of FDA is not likely to happen any time soon, as the new Obama administration has much more crucial
tasks at hand in the economic and health arenas. But if Congress follows through on proposals to authorize the FDA to regulate
tobacco, that could provide an opportunity for broader organizational changes.
Improvements in FDA operations, resources, and infrastructure will be shaped considerably by the next FDA commissioner. Lots
of names have been circulating in the last month, a sign of the agency's high visibility and importance to the new administration
and to Congress. There is considerable hope that the FDA's new leader will be named and confirmed by the Senate in a few months.
One priority for the new commissioner is to push for continued growth in appropriated funds in the agency's 2010 budget. The
Alliance for a Stronger FDA has called for a 20% increase in the FDA appropriations to $2.25 billion for next year. That's
less than $400 million in new money—a drop in the bucket for most federal agencies.
A prime goal for biotech and pharmaceutical manufacturers is for the FDA to approve new therapies for market and oversee product
development, manufacturing, and marketing in a fair and efficient manner. All the attention on drug safety has raised concerns
about a more risk-averse atmosphere at the agency that may slow authorization of new products.
But there's light on the horizon with an increase in the number of innovative therapies approved by the FDA in 2008. The agency
experienced a new low in approvals of new molecular entities (NMEs) in 2007, and it looked like this past year would be just
as bad or worse. But in November, the FDA passed the 2007 approval total of 18 NMEs and appeared on track to act on several
more before year-end. Although it's always easier to show gains from a very low starting point, both industry and the FDA
are happy to consider this a sign of hope for the new year.