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For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.
For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change. This is “a watershed time” for FDA, says Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). The public is concerned about drug quality and imports, manufacturers are struggling with a productivity crisis, and the global financial meltdown may dry up investment for biomedical innovation, she observed in the fall. Her goals are to restore public confidence in the drug regulatory process, capitalize on advances in science and technology, improve postmarket oversight, and make FDA “the recognized leader in drug regulation.”
Such a turnaround may not be easy. Rep. Rosa DeLauro (D–Conn), who chairs the House Appropriations subcommittee overseeing FDA’s budget, asserted in April at a conference sponsored by the Institute of Medicine that FDA needs “urgent and dramatic reform” because it cannot perform basic functions, such as keeping track of clinical trials, conducting required inspections, and following up on commitments for postmarket studies. DeLauro also has expressed concern that FDA’s Critical Path Initiative may send the message to agency scientists that it’s more important to develop methods to support product approval than to objectively evaluate safety and efficacy data.
Anticipating new leadership
Efforts to change such opinions could be shaped by FDA’s next commissioner. Many names were circulating after the election, including those of Steven Nissen of Cleveland Clinic and Baltimore health chief Joshua Sharfstein. The recent naming of FDA science chief Dr. Frank Torti as acting director is likely to be accompanied by further speculation until a permanent commissioner is named.
The head of FDA needs management and leadership skills, and some familiarity with FDA’s mission would be helpful, says former commissioner Mark McClellan, now at the Brookings Institution. “This is a complex agency,” he says, “and it can’t be run by command-and-control, but by providing support for staff to do outstanding science-based work.”
One priority for the new commissioner is likely to be justification of continued growth in appropriated funds for the agency’s 2010 budget. The Alliance for a Stronger FDA has called for a 20% increase in FDA appropriations to $2.25 billion for next year. At less than $400 million in new money, this amount might be considered a drop in the bucket for most federal agencies.
Among some members of FDA and industry, there may also be hope that with Democrats in control of both the White House and Congress, there will be fewer attacks on the agency from Capitol Hill. An effective commissioner can provide “a heat shield from criticism for the agency,” says McClellan, adding that it’s easier to get financial support when there’s clarity about the direction FDA will take.
Fixing the field
Another likely priority for a new commissioner is the revival of FDA’s depleted field force. The Office of Regulatory Affairs (ORA), which inspects food- and drug-manufacturing facilities, is in disarray, a result of years of neglect and underfunding. FDA’s 70-year-old inspection model relies on generalists to cover a wide range of operations, an approach that doesn’t fit the high-tech world of biomedical production. The explosion in global manufacturing and the increased complexity of supply chains, moreover, have increased the potential for counterfeiting and terrorism. With a growing proportion of clinical trials conducted in other countries, new challenges arise in ensuring adherence to good clinical practices on a global basis. The recent crisis involving tainted heparin was “a wake-up call,” says Woodcock, one that “brought home the need for vigilance throughout the supply chain.”
One response is FDA’s Beyond Our Borders initiative, which is establishing overseas branches to better monitor foreign manufacturers of products destined for the United States. The agency opened offices in China in November and plans additional outposts in India, Europe, Latin America, and the Middle East to track local developments and to be on the spot if problems arise.
Field operations require innovative approaches, such as certification programs for foreign manufacturers, increased reliance on inspections by foreign regulatory authorities, improved risk management of inspection programs, and high-tech field laboratories. Even with more resources and foreign offices, FDA will never be able to inspect every manufacturer on a timely basis.
A major challenge for FDA’s field force is to oversee the U.S. food supply. Because food is regulated very differently from medical products, DeLauro and others propose to shift food regulation from FDA to a new federal agency.
The Department of Health and Human Services has opposed such a move, claiming that food safety is more of a public health issue than the province of agricultural interests.
FDA officials also propose a less radical change that involves splitting FDA into two “directorates,” one for food and one for medical products. There is support for such a move from food operators, many of whom are likely to feel that food plays second fiddle to drugs at FDA, and also from medical product companies that may fear being hit by more restrictive food import policies.
The probable political reality is that a major change such as taking the “food” out of FDA is not likely to happen any time soon. The Obama administration has more pressing tasks at hand in the economic and health arenas, and most members of Congress appear unenthusiastic about altering committee oversight responsibilities. Former FDA official Wayne Pines notes that reorganizations end up “just moving boxes around and not increasing efficiency.” But if Congress follows through on proposals to authorize FDA regulation of tobacco, that process could provide an opportunity for broader changes in agency structure and operations.
As debates about the authority of FDA continue, a likely priority for the new administrator is to ensure that FDA has the resources to approve new drugs for market and to oversee product development, manufacturing, and marketing in a fair and efficient manner. The current preoccupation with drug safety has raised fears in some quarters about a slowdown in application reviews. But many observers recognize that FDA has been busy implementing new requirements and training new employees, says Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America (PhRMA). “It really is this upcoming year that will be critical in looking at performance and benchmarking against PDUFA goals.”
An encouraging sign is an increase in new drugs coming to market. The agency hit a low for approvals in 2007, and it looked as if 2008 would be just as bad or worse. FDA reviewers were missing review deadlines, demanding additional data, and imposing stiff postmarket monitoring requirements on those products that made it through the process. But in November, FDA surpassed the 2007 approval total of 18 NMEs/new biologics and acted on several more to bring approvals up to 24 NMEs/new biologics for the year. Although it’s always easier to show gains from a very low starting point, chances are that both industry and FDA will consider this a sign of hope for the new year.
For an agency that deals with cutting-edge biomedical science, FDA’s lack of basic electronic information storage and communication systems is remarkable. FDA’s IT infrastructure is “obsolete, unstable and lacks sufficient controls to ensure continuity of operations,” according to the Science Board. Most agency records are on paper and stored in vast document rooms where access is difficult.
A reliable, modern IT system could bring considerable efficiencies to FDA inspections, adverse event tracking, and clinical data assessment. PDUFA IV has mapped out a plan for using format and data standards to establish an all-electronic submission platform for drugs. FDA plans to spend approximately $2.5 billion over the next 10 years for IT and data-management services. Ensuring that new information systems fit FDA’s unique and complex operations and legal structure will require skilled oversight of vendors, another challenge for a new commissioner.