As Sorensen and Drummond describe, in 2013 the FDA issued final regulations requiring manufacturers to use “unique device identifiers” (UDIs) to assist in tracking adverse events associated with devices that are in use. This will eventually provide better data on devices, but the FDA’s final rule gives manufacturers 3 additional years after most official deadlines to fully comply with the UDI regulations, even though the law requiring UDIs was first enacted in 2007. This is an example of the FDA’s underwhelming response to a recommendation in 2011 by a committee of the Institute of Medicine that the agency accord priority to “developing an integrated pre-market and post-market regulatory framework.”
Patients in many other industrial democracies have an important safeguard that US patients lack: their universal national health plans do not pay for devices unless they have been proven in clinical trials to benefit patients, which is a much higher standard than is required for either EU or FDA approval. In the United States, as soon as the FDA approves a device, it is likely to be covered by most public and private purchasers. This policy has contributed to the United States having the most expensive health care in the world and may put some American patients at greater risk of injury than are their counterparts in countries that apply more rigorous criteria for coverage and, hence, payment. Moreover, many devices are less expensive in Europe than in the United States because most EU member countries determine allowable wholesale prices, and hospitals and surgeons are reimbursed at lower rates than they are in the United States.
Sorenson and Drummond explain that the European Union began to utilize its full authority to regulate medical devices only with the reforms of 2012; prior to that, even when clinical trials were required for high-risk devices, they rarely were randomized or had a control arm; sample sizes were small; and outcomes focused on safety and “performance,” not whether the device benefits patients. The lack of transparency in the process reduced the opportunity for oversight or public outrage. In the United States, congressional hearings and media attention in the 1990s resulted in the FDA’s requiring clinical trials for breast implants and jaw implants, although it has not done so for many implants that are equally risky or pose even higher risks for patients. Only when similar congressional and media attention focused on metal-on-metal hip implants 20 years later did the FDA announce a plan to require clinical trials for them as well. Other implants, including numerous lifesaving cardiac devices, have been shown to be even more harmful when they fail but have received less attention from Congress and the media. The FDA has still not required clinical trials for many of those implants.
What accounts for the FDA’s reticence regarding more stringent regulation of medical devices? This is the same agency that Harvard political scientist Daniel Carpenter, in a history of its regulation of pharmaceuticals published in 2010, called the “most powerful regulatory agency in the world.” Sorenson and Drummond justifiably accuse the FDA and the EU of issuing regulations that “not only introduce risks to patients but also the wrong incentives to . . . evaluate the benefits and risk of new devices.” They offer some history of this failure in the EU, but hardly any for the FDA. This omission may be partly a result of the absence of scholarship on the recent history of device regulation comparable to Carpenter’s work on pharmaceuticals. Such timely scholarship would build on the article by Sorenson and Drummond and a review of recent literature by Christa Altenstetter.
Evidence has nevertheless accumulated about the impact of politics on device regulation in the United States. The presence of the device industry in every state and many congressional districts enhances its effectiveness in lobbying influential members of the House and Senate across the political spectrum. In addition, a lobbyist for AdvaMed, the device industry’s trade association, left this job to become deputy chief of staff for Speaker of the House John Boehner, and the current senior executive vice president of AdvaMed was previously a key health adviser to the late Senator Edward M. Kennedy. In the Senate, liberal Democrats Al Franken (MN), Patty Murray (WA), Barbara Mikulski (MD), and Elizabeth Warren (MA), for example, have joined with conservative Republicans such as Kelly Ayotte (NH), Tom Coburn (OK), Rand Paul (KY) and Marco Rubio (FL) to support initiatives promoted by device industry lobbyists, including a proposed delay or repeal of a 2.3% tax on medical devices in the ACA that helps pay for health insurance subsidies. AdvaMed and individual device companies make substantial contributions to Congressional candidates and spend tens of millions of dollars on lobbying every year. This makes it impossible to distinguish between the impact of Congressional concerns about the legitimate needs of device company constituents and the impact of campaign contributions. Regardless of causation, however, the result has been Congressional hearings that criticized FDA efforts to improve scientific standards for devices, and legislation that fails to ensure that most devices are either safe or effective.
The device industry and AdvaMed have, moreover, thwarted legislation to require price transparency for devices, arguing that prices are a trade secret under the US Commercial Code. They also have resisted attempts by investigative reporters to obtain information about adverse events associated with implants and conflicts of interest among physicians who select those devices. Exceptions include notable stories by Barry Meier of the New York Times and Peter Whoriskey of the Washington Post.
Sorenson and Drummond write that the FDA’s decisions have frequently benefited device manufacturers rather than the public. We augment their conclusions by emphasizing the influence of interest-group politics on the agency’s regulatory reticence. The device industry wields enormous influence at the FDA as well as in Congress. For example, the last four directors of the FDA’s Center for Devices and Radiological Health subsequently worked for the device industry as consultants or full-time employees, starting with James Benson, who left the FDA in 1992 to head the trade association that preceded AdvaMed.[24-27] But the revolving doors between industry and government, which have been widely criticized at the Pentagon and other agencies, have rarely captured public attention when they benefit the medical device industry. Regardless of FDA conflict-of-interest and regulatory policies, revolving doors undermine the quality and integrity—and add to the costs—of the US healthcare system because the relationships involved could contribute to the agency’s failure to require solid scientific evidence of the safety and effectiveness of most moderate-risk and high-risk medical devices upon which patients rely.
- Sorenson C, Drummond M. Improving medical device regulation: the US and Europe in perspective. Milbank Q. 2013;92(1):114- 150.
- US Department of Health and Human Services, assistant secretary for legislation. Testimony on FDA’s medical device program by Michael Friedman MD. Accessed December 2, 2013.
- Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European Union? A systematic review. PLOS Med. 2012;9(7):e1001276. doi:10.1371/journal.pmed.1001276.
- Federal Register. Cardiovascular devices; reclassification of external counter-pulsating devices for treatment of chronic stable angina; effective date of requirement for premarket approval for external counter-pulsating devices for other specified intended uses: docket no. FDA-2013-N-0487: May 2013. Accessed December 2, 2013.
- American Academy of Orthopaedic Surgeons. The 510(k) process—it’s not broken, so why “fix” it? Accessed December 2, 2013.
- Association for Medical Ethics. Who is already reporting payments to physicians? Accessed December 2, 2013. http://www.ethicaldoctor.org/medical-ethics/articles/physician-payments-sunshine-act/who-is-reporting-payments-to-physicians/
- Patient, Consumer, and Public Health Coalition. Comments on proposed order “Cardiovascular devices; Reclassification of intra-aortic balloon and control systems (IABP) for acute coronary syndrome, cardiac, and non-cardiac surgery, or complications of heart failure; Effective data of requirement for premarket approval for IABP for other specific intended uses.” http://patientsandconsumers.org/iabp-reclassification/. Accessed December 2, 2013.
- Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171(11):1006– 1011. doi:10.1001/archinternmed.2011.30.
- Zuckerman DM, Brown P, Nissen SE. Reply to “FDA recalls not as alarming as they seem” [commentary]. Arch Intern Med. 2011;171(11):1045-1046.
- Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.JAMA. 2014; 311(4):385- 391.
- National Research Center for Women & Families. Testimony of Dr. Anna E. Mazzucco, senior fellow, at FDA Advisory Committee on premarket approval of nucleus hybrid L24 system cochlear implants. https://center4research.org/public-policy/testimony-briefings-statements/testimonycochlearimplant/. Accessed December 2, 2013.
- Fox DM. The Convergence of Science and Governance: Research, Health Policy, and American States. Berkeley: University of California Press; 2010.
- Federal Register. Unique device identification system: Section G: General exceptions from the requirement for the label of a device to beat a unique device identifier—exception for existing inventories of finished devices that have been labeled prior to the applicable compliance data—final 801.30(a)(1). September 2013. Accessed December 2, 2013. https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system
- Institute of Medicine. Medical Devices and the Public’s Health: The FDA 501(k) Clearance Process at 35 Years. Washington, DC: National Academies Press; 2011.
- Rosenthal E. In need of a new hip, but priced out of the U.S. New York Times. August 3, 2013. Accessed December 2, 2013. http://www.nytimes.com/2013/08/04/health/for-medical-tourists-simple-math.html?pagewanted=all&_r=0
- Zuckerman D, Booker N, Nagda S. Public health implications of differences in US and European Union regulatory policies for breast implants. Reprod Health Matters. 2012;20(40):102-111. doi:10.1016/S0968-8080(12)40662-0.
- Carpenter D. Reputation and Power: Organizational Image and Pharmaceutical Power at the FDA. Princeton, NJ: Princeton University Press; 2010.
- Altenstetter C. Medical device regulation in the EU, Japan and the US: commonalities, differences, and challenges. Innovation; Euopean Journal of Social Science Research. 2012;25(4):362-388. doi:10.1080/13511610.2012.723328.
- Young J. How did these five lobbyists become congressional staffers? The Nation. May 6, 2013. http://www.thenation.com/article/174003/how-did-these-five-lobbyists-becomecongressional-staffers#. Accessed December 2, 2013.
- Carey MA. AdvaMed’s Nexon: expect more health cost reduction. Kaiser Health News. June 14, 2012.Accessed December 2, 2013.
- Parmar A. Five medical device firms that spent the most in lobbying in 2012. Device Talk. April 2, 2013. Accessed December 2, 2013. http://www.mddionline.com/blog/devicetalk/five-medical-device-firms-spent-most-lobbying-2012
- Lerner J, Fox D, Nelson T, Reiss J. The consequence of secret prices: the politics of physician preference items. Health Aff (Millwood). 2008;27(6):1560-1565. doi:10.1377/hlthaff.27.6.1560.
- See many articles on all-metal implants by Barry Meier in the New York Times; most recently “Hospital studies link heart device to clots,” November 28, 2013, B1. Accessed January 21, 2014. http://www.nytimes.com/2013/11/28/business/3-hospital-study-links-heart-device-to-blood-clots.html An example of Peter Whoriskey’s articles on devices is, Whoriskey P. Rise in spinal fusion surgeries may be driven partly by financial incentives, study says. Washington Post. November 13, 2013. Accessed December 2, 2013. https://www.washingtonpost.com/business/economy/rise-in-spinal-fusion-surgeries-may-be-driven-partly-by-financial-incentives-study-says/2013/11/13/2c87188a-4c87-11e3-be6b-d3d28122e6d4_story.html?utm_term=.2cc333954e92
- Industry pioneer: James Benson. MedicalDeviceLink.com: Medical Device & Diagnostic Industry. August 2004. Accessed December 2, 2013.
- Former FDA Center Director Daniel Schultz joins Greenleaf Health as senior vice president. Business Wire. January 6, 2010. http://www.businesswire.com/news/home/20100106005346/en/FDA-Center-Director-Daniel-Schultz-Joins-Greenleaf. Accessed December 2, 2013.
- David Feigel, MD, MPH profile. NDA Partners LLC. http://www.ndapartners.com/consultants/index.php?cat=partners&page=feigal. Accessed December 2, 2013.
- D. Bruce Burlington: Curriculum vitae. Accessed December 2, 2013.