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“After the FDA’s second rejection of fast-track status, in September 2007, ReGen asked lawmakers from New Jersey, its home turf, for help. Supporters included Democrats Sen. Robert Menendez; Rep. Frank Pallone, chairman of the Health Subcommittee of the House Energy and Commerce Committee; Rep. Steve Rothman of Hackensack; and Sen. Frank Lautenberg.

Messrs. Menendez, Lautenberg and Rothman signed a letter to the FDA in December 2007 asking for Dr. von Eschenbach, the FDA commissioner, to review the issue personally. Mr. Menendez talked with the commissioner by phone, his office said.

The four lawmakers defend their actions, saying they were simply assisting a constituent tangled up in government bureaucracy. "Our effort to help them was solely to ensure they received a fair and unbiased FDA review," Rep. Rothman said in a statement.

Congressional support helped ReGen land a meeting with Dr. von Eschenbach on Jan. 23, 2008. Two days later, ReGen in a letter called on Dr. von Eschenbach to put the matter in the hands of Dr. Schultz, head of the FDA’s device division.

In the same letter, ReGen also asked that the FDA staffers who previously had opposed Menaflex be excluded from the decision-making process.

Dr. von Eschenbach wrote back, "I believe it is imperative that FDA follow its well-developed procedures."

In subsequent months, ReGen got much of what it wanted. Dr. Schultz confirms that he took personal charge of the decision-making process”

http://online.wsj.com/article/SB123629954783946701-search.html

So what is to prevent this in the future? State tort laws, the right for patients to sue, is the one last recourse that people have over power and money.

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“Both GAO and FDA, however, have identified shortcomings in FDA’s postmarket oversight. For example, in 2006 FDA reported that the agency’s ability to understand the risks related to the use of medical devices is limited by the fact that the volume of submitted reports exceeded FDA’s ability to consistently enter or review the reports in a routine manner. In 2008, FDA officials told us that while they have a number of strategies to prioritize their reviews of adverse event reports, they still cannot review all the reports they receive. Finally, GAO has found that FDA has not conducted required inspections of manufacturing establishments, another key FDA responsibility for medical devices marketed in the United States. In 2008, GAO reported that FDA has not met a statutory requirement to inspect certain domestic manufacturing establishments every 2 years. Instead, FDA officials estimated that the agency has inspected domestic establishments every 3 years (for class III devices) or 5 years (for class II devices). There is no comparable requirement to inspect foreign establishments, and FDA officials estimate that they have been inspected every 6 years (for class III devices) or 27 years (for class II devices).”

http://www.gao.gov/products/GAO-09-370T