FDA Chief Signals Public-Health Focus

by Lesley Politi on May 27, 2009



The FDA has a huge impact on Health Insurance in this country. Keeping Americans healthy is a way to lower costs all around, for the individual, the insurance carriers and the medical providers.

WASHINGTON — In her first day on the job, Food and Drug Administration Commissioner Margaret “Peggy” Hamburg signaled that she sees the FDA as a public-health agency, and not just an organization that helps the food and drug industry market products.

The agency’s success should be measured by its impact on promoting health, preventing illness and prolonging life, not the number of facilities inspected or drugs approved, she wrote in a New England Journal of Medicine editorial published Tuesday.

The article, co-authored by Deputy FDA Commissioner Joshua Sharfstein, also took the food industry and the agency to task over the salmonella outbreak linked to contaminated peanut products, saying it “represented more than a sanitation problem at one troubled facility.” The two FDA officials blamed the agency’s inability to enforce preventive controls and food manufacturers’ inadequate monitoring of products from the peanut processor.

Their article emphasized the FDA’s role as regulator and highlighted the 2007 laws that strengthened the agency’s ability to restrict use of medication at the time of approval, and to demand post-marketing studies.

Drug and device makers have drawn criticism from Congress, consumer groups and doctors for stalling costly post-market studies. The editorial held out the prospect of quicker approvals for medicines whose makers show they are undertaking rigorous, scientifically valid studies of drugs and devices already on the market.

Neither Dr. Hamburg nor Dr. Sharfstein was available for comment.

Dr. Sharfstein, who has been acting commissioner since March 30, said last week he was eager for Dr. Hamburg to take over. He has dealt with voluntary recalls of pistachio products and a widely sold antipsoriasis drug; problems with an independent review board that had been overseeing patient safety in hundreds of clinical trials; and the outbreak of swine flu. He said his young son asked him during the last crisis, “Daddy, when the flu is over, then will you come home?”

One of Dr. Sharfstein’s first acts was to accelerate the FDA’s reversal of a ban on the manufacture of liquid morphine. The prohibition, planned before Dr. Sharfstein joined the agency, was announced in early April and quickly undone after hospice workers and caregivers contacted the FDA to say their dying patients would suffer terrible pain without that medicine.

Gail Austin Cooney, president of the American Academy of Hospice and Palliative Medicine said Dr. Sharfstein called her at home the evening of the reversal, to assure her that the liquid morphine would remain available.

“He apologized for not taking the palliative patient population into consideration beforehand,” she said, adding, “I’m amazed at how fast they fixed this.”

Dr. Cooney said that many patients in their final months of life only need to take a tiny amount of liquid morphine to manage their pain.

Dr. Sharfstein also met for two hours with a group of whistleblowers from the medical-device division, who had written the Obama administration in January, urging that their division chiefs be replaced. Some attendees said that Dr. Sharfstein assured them their concerns would be addressed.

Some in the industry are wary of the sudden shifts at the agency. Two pharmaceutical lobbyists said they are concerned that Dr. Sharfstein’s recent review of the approval of a knee-surgery device through the division’s fast-track process suggests that process might be slowed down.

A lawyer whose clients include grocery outlets argued that the agency overreacted in the case of pistachios and a more recent warning on sprouts, which he worries indicates a more pre-emptive approach to food safety.


I think its a great idea to promote wellness, which will help keep medical costs down. The less you use your medical insurance the better.

source: http://online.wsj.com/article/SB124337618081555947.html?mod=dist_smartbrief

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