Cantor: Strict FDA Regulations Force Companies to Europe

House Majority Leader Eric Cantor (R-Va.) tells an audience at the United States Chamber of Commerce that the new FDA regulations force companies looking to innovate to go to Europe.  (1:12)

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UCS Director: Now Is The Time For Food Safety Reform

Francesca Grifo, director of the Scientific Integrity Program at Union of Concerned Scientists, and a team of experts discuss the results of a recent survey about political influence over the food safety industry, and the prospects for improvement. 

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FCC, FDA Partnership Will Change Face Of Medicine, Says Official

Philip Bunnell - Talk Radio News Service

Food and Drug Administration Commissioner Margaret Hamburg lauds efforts to expand broadband coverage and wireless technology to the healthcare industry. She says a partnership with the Fedeal Communcations Comission will “change the face of medicine forever.” (00:40)

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FCC Chairman Says He Hopes Government, Industry Relations Will Foster Innovation

Federal Communications Commission Chairman Julius Genachowski says streamlined partnerships between government agencies and private industries will lead to innovation and the production of “cutting edge and life-saving devices.” (00:20)

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Delayed Drug Approval Costs Drug Producers Billions Says Expert

Eric Sun, Ph.D at Stanford University says that drug producers could save billions of dollars by getting prescription drugs immediately approved instead of going through a delayed process. (0:26)
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Delayed Drug Approval Destroying Drug Producers' Sales Says Scientist

Tomas Philipson, Ph.D. at the University of Chicago says that the main cost for drug producers are the forgotten profits of delayed sales. (0:11)
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Patients Suffering The Most From FDA Regulations, Says Scientist

Tomas Philipson, Ph.D. at the University of Chicago says FDA regulations are causing delays in drug development, hurting patients more than it costs the producers. (0:17)
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Doctor Says Safety Concerns Over Med Devices May Still Remain Despite FDA Approval

William H. Maisel, MD, MPH, is a practicing cardiologist at the Beth Israel Deaconess Medical Center, and Assistant Professor of Medicine at Harvard Medical School. He is also the Founder and Director of the Medical Device Safety Institute. He says that unanswered questions regarding device safety and effectiveness sometimes linger even following FDA approval. He notes that this creates the potential for a large number of patients to be exposed to a newly approved product in the absence of long-term follow-up data. (0:17)
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Manufacturer-FDA Relations Need Change, Says Harkin

Sen. Tom Harkin (D-Iowa) says that the FDA conducts its approval process with minimal resources and does not have adequate funds to "genuinely ensure [medical] devices are safe, or to properly and effectively reevaluate approvals as new information becomes available." He says that the FDA expects manufacturers to provide information about their products and once those products are on the market, it expects the manufacturers to track and monitor for any problems. He believes that without the threat of product liability, there is not much incentive for manufacturers to report any problems found to the FDA or the public. (0:39)
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Killer Peanut Butter: What Can We do?

Coffee Brown, MD, University of New Mexico, for Talk Radio News Service

The Oversight and Investigations Subcommittee of the House Energy and Commerce Committee examined the current salmonella outbreak as a bellwether for food safety in America. Noting that "This is the ninth time we've had to do this in two years," Subcommittee Chairman Rep. Bart Stupak (D-MI) made clear that there will be new legislation in response. "It's Upton Sinclair ("The Jungle") all over again, 100 years later."
There have been nine deaths - the ninth was reported during the hearing- and 600-800 illnesses attributed to the same source: the Peanut Corporation of America (PCA). 1500 peanut based products have been added to the FDA's recall list, and consumers are likely to shun even those peanut products which are not implicated, because it's hard to know for sure. The cost in dollars and lost employment is not known.
Stupak said there were failures at every level, including oversight, monitoring, inspections, and lack of FDA authority, but he placed the blame squarely on PCA. He produced e-mails showing that Stewart Parnell, owner and president, was aware{, at least for 18 months prior to being sent out, that the lab tests showed salmonella.} of lab tests showing salmonella in the batch before he sent it out, and for at least 18 months prior.. Parnell and plant manager Sammy Lightsey both declined to answer questions, citing their fifth amendment rights. Stupak stated he had more evidence than could be made public, because of an ongoing criminal investigation of the matter by the Justice Department.
Families of the victims testified:
Jeff Almer's mother beat cancer twice: "Cancer couldn't claim her, but peanut butter did." He further stated that we need a system that is proactive, not reactive.
Lou Tousignant's father died after eating contaminated peanut butter. He presented an eloquent memorial DVD and list of recommendations very similar to those being considered.
Peter Hurley is a police officer and father of a three-year-old, Jacob, who was seriously ill for 11 days. His salmonella infection was proven by DNA match to be due to peanut butter snacks made from PCA products. "It was like they were playing Russian roulette with the very young and the elderly," he said.
Rep John Dingell (D-MI), chairman of the House Energy and Commerce Committee, is sponsoring the FDA Globalization Act, which would provide increased funding, authority, and responsibility for the FDA. It would empower the FDA to mandate recalls, increase some penalties, and add "other safety provisions."
It came to light during the hearing, that surveillance studies (testing samples for contamination), are ordered at the discretion of the food manufacturers, and collected by them. The testing lab knows nothing about the sample except what the manufacturer tells them. There is also no requirement, or routine process, for reporting contaminated samples to any health agency. The bill by Dingell would address these types of issues.

Sound: Chairman Bart Stupak (D-MI): PCA peanut products had tested positive for salmonella at least 12 times since June 2007.

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"Some very good people have left the government"

Director of the Office of Management and Budget Sally Katzen says that after the Bush administration placed conservative appointees in top positions at regulatory agencies, many important career employees have left (0:44).
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Special Agent Douglas Loveland of the Office of Criminal Investigation for the FDA discusses why they need to be used and be given reliable data

Mr. Loveland discusses that the FDA needs reliable data, and not sloppy data. He also states that Aventis knew to contact the FDA and did not.
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