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Von Eschenbach: Funds needed to fulfill FDA mission

BY Michael Johnsen

WASHINGTON —Food and Drug Administration Commissioner Andrew von Eschenbach called for sweeping changes to the agency under his watch during a speech delivered at the National Press Club earlier this month.

And perhaps for the first time, von Eschenbach broke ranks with the Bush administration in acknowledging that the FDA is facing a budget crisis that will continue to impede the FDA’s ability to complete its mission—and that’s to protect the American public.

“The simple truth as I see it today is that the FDA of the 20th century is not adequate to regulate the food and drugs of the 21st century,” he said. “This is a time in which the winds of change in health care in terms of power and pace are not a gentle breeze but a jet stream. And the FDA must respond to these changes if it is to continue to fulfill its mission of protecting and promoting your health.”

And with that statement von Eschenbach affirmed FDA critics’ worst fears—the agency does not have the money to do its job today, and it’s not getting it tomorrow. Last month, the FDA received a 5.7 percent budget boost for fiscal 2009, bringing the agency’s total budget to $2.4 billion. A November 2007 Science Board report, a report actually commissioned by the FDA, called for a 15 percent increase for 2009, which would have brought the FDA total budget to $2.6 billion.

The sweeping changes that von Eschenbach called for would necessarily require a significant influx of capital to implement, and von Eschenbach publicly called for that need to bolster the FDA with additional funding. “It is no secret in Washington that as the FDA’s responsibilities have grown, the resources devoted to them have not kept pace,” he said. “Strengthening the FDA for this new century will require an investment, providing our agency with a budget and authorities that are commensurate with the scale and scope of our mission. We are on a trajectory of budget increases granted by Congress in 2007 and 2008 and those proposed by the president for 2009. This trajectory must continue and, as justified, must accelerate,” he said. “We cannot transform the agency ourselves.”

Already, von Eschenbach has re-engineered the internal processes at the FDA to make the agency more efficient and better prepared to rapidly respond to healthcare concerns with the implementation of a few guiding principles.

The principles of the systemic change process included focusing the FDA’s workflow to address the most immediate concerns—drug safety, food protection, FDA’s scientifically-inclined labor pool and infrastructure (including $250 million in the 2009 budget earmarked to improve the FDA’s dated information technology infrastructure). The principles von Eschenbach mentioned included a critical self-examination of the agency and whether the FDA is delivering on its mission. And those agency critiques are not only well under way, but have made plenty of headlines of late—including reports coming out of the Government Accountability Office and the highly critical Science Board report released in November, a report that the FDA itself commissioned to have done.

And finally, von Eschenbach sounded more like a chief executive officer than a commissioner when outlining an FDA principle of achievable outcomes, the journey toward those outcomes marked by milestones to ensure that the agency stays on course. “We were very honored to have launched such a plan—our Response to the IOM Drug Safety report—right here at the National Press Club last year and have already implemented many of the initiatives outlined in the report, such as creation of our Risk Communication Advisory committee,” he said.

Perhaps of greatest import to the drug industry, von Eschenbach announced a new FDA program, to be called the Sentinel Initiative, that will better capture post-marketing usage data.

“It is a collaborative effort with public and private partners that will create a distributed, nationwide system that will allow the FDA to analyze large databases of information about the safety of medical products as they are used by large diverse populations,” von Eschenbach said. It addresses the criticism that the FDA fails to regulate drugs once they’re approved for marketing.

And to help prevent the kind of regulatory oversights of foreign-based production facilities that contributed to the recall of Baxter Healthcare’s heparin products in February, von Eschenbach wants to establish satellite FDA offices in several regions of concern—China, first and foremost, but also India, Europe, central South America and the Middle East.

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MinuteClinic moves forward with Massachusetts plans

BY Antoinette Alexander

MINNEAPOLIS MinuteClinic, a clinic operator owned by CVS Caremark, has applied for its first 10 clinic sites in Massachusetts and expects the opening dates to be in late summer to early fall.

As previously reported by Drug Store News, in January, state health officials approved regulations allowing for limited service medical clinics, marking the end of a long review process that included two public hearings and the submission of hundreds of pages of testimony regarding the regulations.

MinuteClinic stated that it is working with the Massachusetts Department of Health and “is confident that the sites meet the regulatory requirements and will receive approval to move forward.”

The new in-store clinics are planned for CVS stores in Ashland, Beverly, Bridgewater, Danvers, Medford, Medway, Stoughton, Taunton, Tewkesbury and Westford.

The sites are the first of a total of 25 to 30 the company expects to open in Massachusetts by the end of 2008.

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Hallmark exits online flower and gift business

BY Doug Desjardins

KANSAS CITY, Mo. Hallmark is exiting the online gift and flower business, citing a less-than-acceptable return on investment. The move will result in the loss of about 100 jobs at its corporate headquarters and distribution center in Memphis, Tenn., though Hallmark said it would try to find new jobs in the company for those workers.

Hallmark started its online flower business in 2001 and its online and catalog gift and decor business in 2005. The decision will not affect its online business for greeting cards and stationery. A company spokeswoman said Hallmark decided to shutter the flower and gift divisions after determining they “couldn’t guarantee the results we needed.”

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