In the FiercePharma weekly newsletter, George Miller reported on a significant boost the the FDA’s IT budget.
How would you spend a $364-million IT budget, up from $232 million a year earlier? That’s what the FDA needs to figure out between now and October, when it’s on the hook to deliver a draft plan.

It’s not quite ready to so yet, according to the Government Accountability Office. The FDA, although making progress via ongoing projects to modernize its IT infrastructure, “has considerable work to do” in instituting critical IT management capabilities as a step toward modernizing its IT systems, the GAO says in a report to Congress published this month.

“A comprehensive IT strategic plan, including results-oriented goals and performance measures, is vital for guiding and coordinating the agency’s numerous ongoing modernization projects and activities,” according to the report. Ongoing projects include at least 16 enterprise-wide efforts. Yet FDA lacks a strategic plan for coordination and management of these efforts, as well as overall high-level planning.

Although it might have felt like big brother was looking over its shoulder, FDA recognized that it got some good guidance from GAO in the 57-page report: the regulator agreed with GAO’s recommendations and plans to address them. The GAO guidance is well worth reviewing for anyone managing and IT budget.

- read the report (pdf)

©2012 An Inconvenient Woman. All Rights Reserved.

It’s no secret that the knives are out in Washington for the FDA. There’s just been too much bad publicity for the agency over the last few years. From drug safety snafus dating as far back as Vioxx to last year’s heparin scandal, from melamine in dog food to salmonella in peanut butter, the FDA has spent beaucoups hours fighting fires. Meanwhile, dispassionate observers such as the Government Accountability Office have advised big-time changes for the agency, and its own Science Board said it was so seriously understaffed and underfunded that it couldn’t ensure the safety of food or drugs in the U.S.

Frequent agency critic John Dingell succinctly describes his view for the Associated Press: “You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above. Bet yourself a new hat or a fine dinner that you are going to have a scandal a month. They are running around like a lot of headless chickens.”

Enter a new Congress and new administration. Some are eager to make changes at the agency. And fixing the FDA is one area where politicians on both sides of the aisle agree that change needs to come. “One area where we could see bipartisan cooperation might be the strengthening of the FDA,” Dr. Paul Stolley, who had a stint as a visiting scientist at the FDA, told the AP. “I don’t think ideological differences should interfere.”

What to do, though? Some say the FDA is “fundamentally broken,” so it needs to be replaced, rather than fixed: The Center for Science in the Public Interest is advocating an entirely new food-safety agency, for instance. But we probably won’t see the shape of a new FDA forming until a permanent commissioner is named. Now that HHS has a nominee, the FDA could–finally–be next.

©2012 An Inconvenient Woman. All Rights Reserved.

FiercePharma is reporting that the Obama administration wants to hike the FDA’s budget by 19 percent to $3.2 billion for fiscal 2010. That’s a whopping increase: In dollar terms, it amounts to about half a billion, Reuters reports. A good billion or so of the total comes from industry via user fees.

More than half of that amount would go to the “F” in FDA, however, as the administration seeks to follow through on promises to better regulate the food supply. And part of the “D”-in-FDA increase would come from levying additional fees on generic drugmakers, about $36 million worth. But given that the fees would help break the approvals logjam in FDA’s generics office, the drugmakers aren’t balking.

Will those many millions be enough? William Hubbard, a former FDA associate commissioner, told the Wall Street Journal that the boost–coupled with an emergency funding increase of $172 million last year–will help the FDA “begin to solve some problems.” That’s partly because the budget will allow hiring of more inspectors and scientists, both of which are sorely needed at the FDA, observers say.

Still, those numbers only allow enough hiring to take FDA back up to the same level as 1994, WSJ notes, the year before FDA’s budget started lagging. As you know, the Agency has watched its funding shrink repeatedly since the mid-1990s, so there’s a lot of ground to make up.

- read the Reuters news
- see the article in the Wall Street Journal

©2012 An Inconvenient Woman. All Rights Reserved.