A recent article in the Wall Street Journal lays out in detail how the healthcare industry and its political friends influence what happens at the FDA. While the article dealt only with medical devices, the activities described also apply to drugs approved by the agency. The medical device is a $200 billion-a-year industry. The Journal sets out how manufacturer ReGen sought full approval from the FDA of a new medical device intended to treat meniscus tears. The c-shaped pad made from cow collagen, named Menaflex, was designed to be inserted between the knee bones to serve as a shock absorber between the bones. To support its application for full approval with the FDA, ReGen initiated a $35 million clinical trial to prove the safety and efficacy of Menaflex.
In December 2005, after receiving the first of two FDA warning letters regarding its clinical trial, ReGen decided to seek fast-track approval of Menaflex. It should be noted that fast-track [510(k)] approval does not require the completion of a clinical trial. Instead, all it requires is a showing that the product to be approved is substantially equivalent to a device previously approved by the FDA. That leaves a serious loophole in the law which those in the industry have used to their advantage.
The FDA scientists who were involved with reviewing Menaflex rejected ReGen’s fast-track applications in August 2006 and September 2007, finding that Menaflex was a new kind of device that required a rigorous, full review. In December 2007, ReGen, a New Jersey company, called on New Jersey lawmakers to help. Senators Robert Menendez and Sen. Frank Lautenberg and Representatives Frank Pallone and Steve Rothman wrote the FDA Commissioner in December 2007 asking that he personally review the Menaflex issue.
In January 2008, as a result of Congressional intervention, ReGen met with the FDA Commissioner. Two days later, ReGen wrote the Commissioner and asked for the Menaflex application to be given to Dr. Dan Shultz, head of the FDA’s device division. ReGen also asked for all FDA scientists, who previously opposed Menaflex, to be excluded from the decision-making process. From that point forward, Dr. Shultz took personal charge of that critical process. In July 2008, ReGen announced what it described to be successful results with its clinical trial. FDA scientists disagreed with ReGen’s categorization of the trial results. They noted that patients needed additional operations after receiving the Menaflex pad, and in some cases the device had to be removed.
Also in July 2008, ReGen filed its third application for fast-track approval. FDA scientists again found the device to not be substantially equivalent to previously-approved devices. Their rejection letter was never sent. Rather, in an unusual move, and at the request of ReGen, Dr. Shultz set up a panel of outside doctors to determine if Menaflex met the 510(k) standards for fast-track approval. It’s reported that ReGen pushed the FDA on who should be on the panel. On October 28, 2008, a staffer to Rep. Pallone contacted the FDA integrity office director to discuss the Menaflex panel. ReGen specifically asked that FDA scientists, who previously objected to Menaflex, not be allowed to address the panel.
ReGen’s requests caused considerable debate within the FDA. In response, agency officials drafted a letter to ReGen, the language of which was objected to by FDA lawyers who said it would cause significant problems for the agency with other companies because other companies did not have the same opportunities, and it would document favorable treatment for ReGen. Per ReGen’s request, the Menaflex panel included eight sports-medicine experts. No FDA scientists who had objected to Menaflex spoke at the panel. Following the meeting, Dr. Shultz issued a letter stating that the panel “clearly and unanimously” found Menaflex to be as effective as other similar products. Interviews with the panel members reveal that their findings were not unanimous. One panel member, Dr. Mabry, said that it was important to note that the panel did not find that the Menaflex pad was substantially equivalent to other medical devices. He said further, that had they known that Dr. Shultz was going to approve the Menaflex pad citing their panel, he would have been a more vocal opponent of it.
In December 2008, after reviewing the 510(k) application for Menaflex, Dr. Larry Kessler, director of the FDA’s science and engineering laboratory, found that Menaflex was not similar enough to other devices to qualify for 510(k) approval. Dr. Kessler wrote, “There is no statistical basis demonstrating effectiveness for this product.” By letter, he told Dr. Shultz that he was concerned that fast-track approval of Menaflex sets a precedent “that concerns us.” On December 20, 2008, Dr. Shultz approved Menaflex, finding that it was similar enough to other devices to earn approval.
According to Dr. Kessler, who now heads the Health Services Department at the University of Washington, FDA’s handling of Menaflex “shows the FDA at its worst.” In January 2009, nine FDA scientists in the device division wrote Congress calling for the President to remove top FDA medical device regulators, stating that the device approval process was “corrupted and distorted by current FDA managers.” The above is an example of how industry literally controls the FDA. That’s wrong and it must be changed.
Source: Wall Street Journal
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