FDA Turnaround Time - Pharmaceutical Executive


FDA Turnaround Time

Pharmaceutical Executive

Fixing the Field

Another priority for a new commissioner is to revive FDA's depleted field force. The Office of Regulatory Affairs (ORA), which inspects food and drug manufacturing facilities, is in disarray due to years of neglect and under-funding. 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. Many ORA officials have retired or moved to other jobs, leaving the organization without the leadership needed to deal with globalization, technical advances, and inadequate IT. Heparin was "a wake-up call," says Woodcock, 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 US. The agency opened offices in China in November, and has plans for additional outposts in India, Europe, Latin America, and the Middle East to track local developments and be on the spot if problems arise.

But even with more resources and foreign offices, FDA will never be able to inspect every manufacturer on a timely basis. 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.

The "F" in FDA

A major challenge for FDA's field force is to oversee about 80 percent of the US food supply, much of it now imported. Because food is regulated very differently from medical products, DeLauro and others propose to shift foods away from FDA to a new federal agency that would assume responsibility for multiple food-related programs now spread around a dozen government offices.

The Department of Health and Human Services has opposed such a move, claiming that food safety is more a public health issue than the province of agricultural interests. To back up the status quo, last month FDA issued a one-year progress report on its Food Protection Plan, describing the many initiatives underway for preventing and handling food contamination problems.

FDA leaders 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, who feel they play second fiddle to drugs at FDA, and also from medical product companies that fear being hit by more restrictive food import policies.

The political reality is that a major change like taking the "food" out of FDA is not likely to happen any time soon. The Obama administration has more crucial tasks at hand in the economic and health arenas, and most members of Congress are 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 to regulate tobacco, that could provide an opportunity for broader changes in agency structure and operations.

The bottom line for pharma is for FDA to have the resources to approve new drugs for market and to oversee product development, manufacturing, and marketing in a fair and efficient manner. All the focus on drug safety has raised fears about a more risk-averse attitude and a slowdown in application reviews. But industry recognizes that FDA has been busy tackling new authorities 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 [Prescription Drug User Fee Act] goals."

A bright light on the horizon is an increase in new drugs coming to market. The agency hit a low for approvals in 2007, and it looked like 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 new molecular entities, and by year-end was slated to approve 21 new drugs for the year. While it's always easier to show gains from a very low starting point, both industry and FDA are happy to consider this a sign of hope for the new year.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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