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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 29th January 2008, 12:01 PM
Pharma Newshound Pharma Newshound is offline
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Default FDA `Overwhelmed,' Threatens Lives, Adviser Testifies


By Justin Blum

Jan. 29 (Bloomberg) -- Consumers are likely to die and suffer injuries because of an ``overwhelmed'' U.S. Food and Drug Administration that lacks enough funding, an adviser to the agency told lawmakers.

The FDA isn't inspecting enough manufacturers, has too few scientists who understand new technologies, and regulates a food supply that grows riskier every year, said Gail H. Cassell, an agency adviser who is a member of the FDA's Science Board, in written testimony today to a House subcommittee.

The Science Board adopted a report in December that said the FDA needs more money and better computer systems, and should be restructured to include a scientific leader. The agency, with a budget of more than $2 billion, regulates the sale of more than $1 trillion of products annually, including food, drugs, cosmetics and medical devices.

``Without immediate action, injuries and deaths from an overwhelmed regulatory system are certain, and the costs to our society will be far greater than any dollar figure upon which we can arrive,'' Cassell, vice president of scientific affairs at Eli Lilly & Co., told the investigative subcommittee of the House Energy and Commerce Committee.

The Science Board report described rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and said the FDA fails to adequately monitor products because it can't keep up with the science. The FDA suffers ``serious scientific deficiencies,'' the report concluded.

Science Panel's Inquiry

Andrew von Eschenbach, the FDA's commissioner, requested the report. The Science Board formed a subcommittee that was headed by Cassell and consulted more than 25 specialists in industry, academics and government to prepare the report.

In discussions with the subcommittee, FDA employees and officials were almost unanimous in saying there was a shortage of science staff and an ``inability to recruit and retain needed expertise,'' according to the report.

The FDA has received an increasing number of reports of harmful side effects associated with prescription drugs over the past decade and hasn't had any increase in staff to review them, the report said.

Congress Blamed

The report blamed Congress for requiring the FDA to take on more responsibilities without providing enough funds to hire staff.

The House subcommittee also voted 12-0 today to subpoena documents and testimony from the FDA on its handling of Sanofi Aventis SA's Ketek, an antibiotic linked to liver damage and death. The panel is investigating whether the agency ignored its scientists' safety concerns in approving the drug in 2004.

In another report that found FDA failings, a government investigator said the agency isn't meeting requirements to inspect U.S. medical-device makers every two years, and it monitors overseas producers even less frequently.

Companies in the U.S. that make high-risk devices, such as pacemakers for the heart, are inspected for safety once every three years, said Marcia Crosse, director of health care for the Government Accountability Office, the investigative arm of Congress, in testimony prepared for the House hearing today. The FDA checks companies overseas that make the same type of devices for sale in the U.S. every six years.

``Americans depend on the FDA to ensure the safety and effectiveness of medical products, including medical devices, manufactured throughout the world,'' Crosse said in prepared testimony. ``However, our findings regarding inspections of medical device manufacturers indicate weaknesses that mirror those presented in our November 2007 testimony regarding inspections of foreign drug manufacturers.''

Inspecting Drugmakers

At a hearing in November before the same subcommittee, Crosse said that the FDA conducts annual inspections on about 7 percent of overseas drugmakers that ship to the U.S., a pattern suggesting it would take 13 years to visit them all. Some of the drugmakers were never inspected and the exact numbers were unclear, she said at the time.

Producers of medical devices deemed a ``medium'' risk, such as hearing aids, are inspected every five years in the U.S. and every 27 years overseas, Crosse said. The U.S. requires manufacturers of high and medium-risk products to be inspected every two years in the U.S., and there is no requirement for companies overseas.

More than 23,600 establishments that make medical devices were registered with the FDA as of September 2007, according to data provided by the agency to the GAO. Of those, 10,600 make high- and medium-risk devices. About 5,600 of the plants were in the U.S.

Domestic and Overseas

From fiscal 2002 through fiscal 2007, the FDA conducted an average of 1,494 domestic and 247 overseas inspections annually, mostly targeting high- and medium-risk devices, according to Crosse.

Data suggest the agency inspects about 27 percent of U.S. establishments a year that were registered to make high-risk and medium-risk products and 5 percent of overseas plants, according to Crosse.

In China, 64 inspections were conducted during the six-year period, while there were 675 establishments registered to make high-risk and medium-risk products, according to the GAO. Those numbers don't include Hong Kong or Taiwan.

The FDA is responsible for regulating the safety and effectiveness of medical devices sold in the U.S., including those manufactured in the country and overseas.

The agency doesn't have the power to require companies overseas to allow agency inspections. The FDA can block the importation of products from manufacturers that refuse to be inspected, according to the GAO.

FDA databases provided differing estimates on the number of overseas medical-device manufacturing operations, according to Crosse. Some may register with the FDA and not send products to the U.S.

To contact the reporter on this story: Justin Blum in Washington at
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