Regulatory Focus
This article was originally published in RAJ Devices
Executive Summary
Devices in the spotlight
Devices in the spotlight
For once, medical devices are making bigger headlines than pharmaceuticals in the US media. But it's all for the wrong reasons.
Johnson & Johnson's $25.4 billion planned takeover of Guidant is in jeopardy, the New York attorney general is suing Guidant for alleged fraud and Guidant, St Jude and Medtronic are being investigated by the US Department of Justice over their selling practices. It doesn't stop there. The medical device postmarket surveillance systems of the Food and Drug Administration (FDA) are under intense scrutiny and the agency has just lost an important lawsuit in which it had sought to have a company that was allegedly failing to comply with federal quality system regulations closed down until it was in compliance. On top of that, there are complaints that new public disclosure requirements concerning FDA advisory panel members with links to industry do not go far enough.
As we report on pages 378-379, several Guidant products - including its popular implantable Ventak Prizm 2 DR Model 1861 defibrillator - have been the subject of recalls in recent months and the company has been accused of withholding important safety information from doctors and patients in the US. Guidant has said its evaluations of product performance and its decisions about physician communications ‘are and have always been based on patient safety’1. Nevertheless, J&J announced on 2 November 2005 that the ‘previously announced recalls at Guidant and the related regulatory investigations, claims and other developments’ were serious matters affecting both Guidant's short-term and long-term outlook2. It claimed that the events had had a material adverse affect on Guidant and, as a result, J&J was not obliged under the terms of the merger agreement to close the acquisition. Guidant subsequently filed a lawsuit in an attempt to force J&J to complete the merger3.
The following day, Eliot Spitzer, the New York attorney general, filed his lawsuit alleging, among other things, that Guidant engaged in fraud by failing to inform doctors of a mechanical problem in the Prizm 1861 that could cause it to malfunction with potentially fatal consequences4,5. The lawsuit alleges that, by misrepresenting critical information concerning its Prizm 1861 defibrillators manufactured before April 2002, Guidant has engaged in repeated and persistent fraudulent conduct in violation of New York law. The fault has been implicated in at least 28 failures of the Prizm 1861 defibrillator, including one that resulted in the death of a patient.
Through the lawsuit, the attorney general is seeking a court order that will require Guidant to fully disclose to medical professionals relevant design and performance information about its medical devices. The lawsuit seeks disgorgement of Guidant's profits from the sale of defective Prizm 1861 defibrillators. It also seeks restitution for any patient who wishes to replace a Prizm 1861 defibrillator made before the 2002 manufacturing changes.
In June 2005, Guidant voluntarily recalled Prizm 1861 defibrillators manufactured before April 2002. At the time of the recall, some 13,900 defibrillators made before April 2002 were still in use by patients in the US.
Mr Spitzer is a force to be reckoned with. He has been variously named ‘crusader of the year', the ‘sheriff of Wall Street’ and ‘the Enforcer’ for the zeal with which he conducts his business6. He was typically forthright in his statement announcing the lawsuit against Guidant: ‘Concealment of negative facts that might influence a consumer to purchase another manufacturer's product is the essence of fraud,’ Mr Spitzer said. ‘We wouldn't permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device.’
Guidant told RAJ Devices that it does not comment on current or pending litigation as a matter of policy7. The company is also facing product liability litigation over the defects in the form of class action and individual lawsuits8.
The repercussions of the events leading up to and surrounding the Guidant recalls are far-reaching. As the New England Journal of Medicine has reported, ‘the fallout from the potentially preventable death of Joshua Oukrop has triggered a broad discussion about the propriety of Guidant's actions and the safety of ICDs and medical devices in general. It has also led to debate about the appropriate standards for informing physicians and patients about safety issues and the responsibilities of industry, the FDA, and the medical community9.’
For its part, Guidant says it is working with outside experts, physician societies and regulatory agencies around the world to establish guidelines relating to physician communications about product performance reporting and safety. It says it is providing more performance information with greater frequency to better serve patients and the medical community and notes that the benefits associated with the therapies it provides are exceptional.
The FDA and quality systems
To add to Guidant's woes, the FDA, following an inspection of the company's plant in St Paul, Minnesota that ended on 1 September 2005, concluded that there are deficiencies in Guidant's quality system (QS) methods for its cardiac rhythm operations10. Guidant says that, while its quality system is in substantial compliance with the federal Quality System Regulations (QSR), it fully recognises the significance of the FDA's inspectional observations and the important opportunity that they represent for continuous improvement11. It notes that, while many things can trigger an FDA inspection, it is not uncommon for one to follow a product recall.
Guidant has accepted that there is room for improvement in terms of its quality systems methods. Utah Medical, a much smaller device company than Guidant, when faced with FDA claims of non-compliance with the agency's QSR, chose to fight. The company won. On 24 October 2005, the federal district court in Salt Lake City found that Utah Medical was complying with the QSR and dismissed the FDA's lawsuit that sought to shut down the company12-15.
FDA budget and advisory panel experts
The bill containing the FDA budget for fiscal year 2006 (the FY 2006 Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill) has now been approved by the House of Representatives and the Senate. It contains over $222.7 million in funding for the agency's Center for Devices and Radiological Health. This, says AdvaMed, the Advanced Medical Technology Association, is an increase of over $7.8 million over the FY 2005 level to take into account the most recent inflation figures16.
AdvaMed praised Congress for fully funding the FDA device programme but said it remained concerned about a potential across-the-board budget cut this year. It noted that, if funding were to be reduced, the medical device user fee programme would be in danger of being terminated due to a funding trigger in the authorising law.
The bill also contains new conflict of interest disclosure requirements relating to the FDA's practice of using outside experts with links to industry on its advisory panels. The agency often waives conflict of interest prohibitions if the subject under discussion is of general interest. However critics say this practice needs to be tightened up in order to ensure that panel members always give objective opinions.
The bill says that the FDA can proceed with a waiver if the Health and Human Services (HHS) secretary discloses on the FDA website the nature of the conflict of interest and the nature of the waiver no later than 15 days before an advisory meeting takes place. If a conflict of interest is discovered less than 15 days before the meeting, the FDA may proceed with the waiver as long as it makes a disclosure as soon as possible, and in any event no later than the date of the meeting. Also, the FDA commissioner must make quarterly reports to the HHS Inspector General and the House and Senate Appropriations Committees on the efforts they have made to identify qualified people with minimal or no conflicts for appointment to advisory committees. The FDA cannot appoint new people unless these reports are made.
Congressman Maurice Hinchey (Democrat - New York) protested that the bill was ‘a do-nothing amendment and a lost opportunity for real progress’17. An earlier House of Representatives version of the bill had included an amendment from Rep Hinchey that would have prevented the FDA from spending any money on waivers for advisory committees, effectively ending the practice of including scientists on advisory panels with ties to the drugs and devices in question. The House approved that version in June 2005, by 218 to 210. A less strict measure approved by the Senate in September 2005 served as the foundation for the language that was finally agreed upon between House and Senate negotiators, Rep Hinchey said.
‘What this final version essentially says to the FDA is if you want to continue using doctors and scientists with conflicts of interest go right ahead, just let us know about it. That's unacceptable,’ Rep Hinchey said.
AdvaMed for its part said that the compromise provided for earlier public release of information without imposing burdensome new restrictions. The earlier amendment, it said, could have significantly limited the FDA's ability to obtain the most qualified scientific input for its advisory panels.
Medical Devices Directive review
The European Commission has given an insight into its response to the consultation procedure for its proposals for a directive amending the Medical Devices Directive. We report on pages 369-370 that, in light of comments received, the commission has decided to drop its original plan to upclassify reusable surgical instruments. It has also rejected the lobbying efforts of industry groups and has stuck to its original decision not to deal with the controversial issue of single-use devices in this particular review.
The commission is due to formally adopt its proposals in December 2005, after which they will go forward to the European Parliament and the Council of Ministers.
Correction
In our article on the proposed amendments to the EU Medical Devices Directive on page 238 of RAJ Devices 13(4) 2005, we stated that, with regard to reporting requirements for medical device clinical trials, all serious adverse events ‘as in the original [directive]’ are to be reported despite there being obvious causality. This is not the case. The original directive states in Article 10 that only those related to the characteristics and performance of the device are to be reported. This means that, to date, non-related SAEs are not required to be reported.
References
1. Guidant news release, 20 October 2005, www.guidant.com/news/500/web_release/nr_000585.shtml
2. J&J press release, 2 November 2005, www.jnj.com/news/jnj_news/20051102_093237.htm
3. Guidant news release, 7 November 2005, www.guidant.com/news/500/web_release/nr_000591.shtml
4. Press release, Office of New York State Attorney Eliot Spitzer, 3 November 2005, www.oag.state.ny.us/press/2005/nov/nov03a_05.html
5. The people of the state of New York by Eliot Spitzer, Attorney General of the State of New York against Guidant Corporation, 2 November 2005, Index No 403656/05, www.oag.state.ny.us/press/2005/nov/complaint%20-%20stamped%20&%20signed.pdf
6. Biography of Eliot Spitzer, www.oag.state.ny.us/bio.html
7. Personal communication, Guidant, 8 November 2005
8. Guidant Corp, Form 8-K, 7 November 2005
9. The controversy over Guidant's Implantable Defibrillators, New England Journal of Medicine, 21 July 2005, 353(3), 221-224
10. Guidant news release, 22 September 2005, www.guidant.com/news/500/web_release/nr_000577.shtml
11. www.guidant.com/physician/Form483/
12. US District Court for the district of Utah, central division, Case No. 2:04-CV-733 BSJ, 21 October 2005, www.utd.uscourts.gov/reports/media/img1021.pdf, pp 135-149
13. Utah Medical press release, 24 October 2005, www.utahmed.com/pr/pr102405(2).htm
14. Utah Medical press release, 24 October 2005, www.utahmed.com/pr/pr102405.htm
15. FDA press release, P04-77, 10 August 2004, www.fda.gov/bbs/topics/news/2004/NEW01102.html
16. AdvaMed news release, 4 November 2005, www.advamed. org/publicdocs/PR-303.htm
17. News release, Rep Maurice Hinchey, www.house.gov/apps/list/press/ny22_hinchey/morenews/102805fdaconflicts.html
Maureen Kenny
Deputy Editor
The Regulatory Affairs Journals