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FDA Investigative Hearing

Mark Marich

PDE staff were on hand for an investigative hearing by the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce on FDA Medical Device Regulation:

Highlights: Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce: Regulatory Reform Series #5 – Hearing entitled, “FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs”

To some of us who are not abreast with the activities of the US Food and Drug Administration (FDA), we might be wondering how on earth the FDA has an impact on businesses, and for that matter, American jobs. Well, it is time to start revising our notes as the FDA, on Wednesday July 20, came under intense bashing from members of the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce at an investigative hearing. The main bone of contention was that the FDA failed to approve the use medical devices in a timely manner, and thus having an adverse effect of patients’ health as well as negatively impacting medical innovation, leading to the loss of jobs. Though most of the House Members and the witnesses severely lashed out at the FDA, a few members and just one of the seven witnesses attempted to justify the bureaucratic processes the FDA went through in approving medical devices for patients’ use.

With the exception of a few members, the common theme that run through the opening statements of most members on the negative externalities of FDA regulations were that the regulations were “inefficient,” and were forcing businesses to go abroad. In his opening statement, Chairman Cliff Stearns (R-FL) said the regulations “played a key role in the national decline of medical innovation.” This is because, medical devices that are approved for use in other territories particularly Europe, took a longer time to be approved by the FDA and leads to most medical device companies moving their innovations out of America, thus leading to job losses. Sounding rather sober, Ranking Member of the committee, Rep Dianna DeGette (D-CO) stated that the issue at hand “hits close to home” as she has a daughter with Type 1 diabetes who uses a glucose monitor everyday. Rather than taking the hard line approach, Rep DeGette rather called for appropriate tools to be provided to the FDA to make sure that the medical device review process supports innovation, and is at the same time safe for patient’s use. Though some members chastised the FDA, they also sounded a note of caution in attempting to make the FDA approve devices in a timely manner as this may lead to the approval of unsafe medical devices. For example, Rep Waxman (D-CA) said the discussion should be focused on how device laws could be strengthened in order to ensure the safety and effectiveness of medical devices.

Most of the witnesses that appeared narrated their ordeals before the committee on how the FDA and its regulations made their lives ‘miserable.’ The first witness to testify was Dr. Robert Fischell, an American innovator who said that the FDA had approvals delayed for a long time. As a result, many patients were forced to go abroad to use medical devices. Dr. Fischell also said that the current review process at the FDA was weakening the US medical position in medical innovation. The next witness, Ms. Carol Murphy, a migraine sufferer for 40 years, corroborated the claims made by Dr. Fischell. Ms. Murphy said, among other things, that she had been on all kinds of medication for her migraine; however, those treatments were to no avail. Consequently, she got a Transcranial Medical Stimulator (TMS) that relieved her of her pain from her migraines. However, the device was taken back by the Ohio State in 2006 for it to go through FDA, and till date it she has not gotten it back. An exasperated Ms. Murphy said she wanted her device back and threatened to “rob Peter to pay Paul” to go to England (where its use has been approved) to get it. Four other witnesses: Ms. Marti Conger (a spine patient), Ms. Pam K. Sagan (a mother of a Type 1 diabetes patient), Michael Mandel (a Chief Economic Strategist at the Progressive Policy Institute), and Sean Ianchulev (a clinician and eye surgeon) narrated similar ordeals and testified that the FDA medical device regulation discouraged innovation and destroyed businesses. For instance, Mr. Ianchulev regretted that he had been unable to give the best eye care to his patients because of the delays in FDA’s approval of devices, which have been approved elsewhere in the world.

On the other hand, the last witness, Gregory D. Curfman (Executive Director of the New England Journal of Medicine) disagreed with the fact that the process adopted by the FDA should be ‘fast tracked’ because according to him, medical innovation was important and in order to protect it, the safety of the devices must be guaranteed so that confidence can be reposed in innovation. In his testimony, Dr. Curfman gave two recent examples of innovative medical devices that were approved by the FDA 510(k) fast-track process, but “were later found to be defective even while they were being implanted in many thousands of patients.” One of the examples, in the field of cardiology, is the Sprint Fidelis implantable cardioverter-defibrillator lead, which was manufactured by Medtronic. According to Dr Curfman, because the FDA fast-track process approved this device, it did not undergo clinical testing, and despite the “hype” it received as a major innovation in defibrillator technology, it caused about 13 deaths.

Of course, the debates can go on and on, and there is not a doubt that there is a problem with FDA’s medical device regulations in the sense that they inhibit innovation and negatively impact businesses. However, the main question here is how do we find the right balance between approving devices in a timely manner, and at the same time, making sure the devices are safe?

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