“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.