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A process of negotiation

The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 and the fourth installment of Prescription Drug User Fee Act (PDUFA) need to be reauthorised by 30 September 2007. Many in and around the United States (US) Congress are working hard to ensure that these laws are extended for another five years. Negotiations on the medical device programme began in January 2006 and continue as this article goes to print; the outcomes will be reported in a later issue of this magazine. There are also other bills and draft bills being considered in Washington that will have a direct impact on the medical technology industry and may be included in the legislation reauthorising PDUFA and MDUFMA. This article provides insights into one of those and highlights some of the improvements the medical device industry is advocating to be included.

Paediatric devices

The US Congress required with the Medical Devices Technical Corrections Act of 2004 that the Secretary of Health and Human Services submit a “report on the barriers to the availability of devices intended for the treatment or diagnosis of diseases and conditions that affect children.” What followed was a series of public meetings and a public comment period to try to identify areas of need and develop solutions.

One issue that arose from that comment period was that many stakeholders believe that the prohibition on generating profits on devices approved under Humanitarian Device Exemption (HDE) applications is a significant disincentive to developing products for the paediatric population. An HDE is similar to a premarket approval application, but exempt from the effectiveness requirements of sections 514 and 515 of the Federal Food, Drug and Cosmetic (FFDC) Act (manufacturers do not need to demonstrate both safety and efficacy, only safety). Food and Drug Administration (FDA) approval of an HDE application authorises the company to market a Humanitarian Use Device (HUD).

As a result of the comments, Senator Chris Dodd (D-CT) introduced the Pediatric Medical Device Safety and Improvement (PMDSI) bill on 8 March 2007, which is now under consideration. This, among other things, removes the prohibition on making profits on devices cited in HDE applications that are designed to meet a paediatric need.

Encouraging new products

Many stakeholders would also like to promote the development of paediatric devices by increasing the HUD threshold. Currently, FDA defines a HUD as a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.” Increasing the threshold to 8,000 or 10,000 affected patients per year would provide a greater incentive for companies to develop those products and ultimately improve the quality of care for the paediatric population. However, the current version of the PMDSI bill does not increase the HUD threshold.

Other provisions of the PMDSI bill include a requirement for the National Institutes for Health (NIH) to designate a contact point or office to help innovators and physicians access existing funding for paediatric medical device development. The NIH, FDA and Agency for Healthcare Research and Quality are also required to identify gaps in paediatric medical device research and propose a research agenda to address those gaps. The bill would also establish grants for nonprofit consortia to promote paediatric device development, which would entail coordinating inventors, manufacturers and physicians.

Although the industry is generally supportive of the bill, there is one additional provision that it is working to improve. As currently worded, the proposed legislation would expand Section 522 of the FFDC Act to allow FDA to require, as a condition of clearance or approval, postmarket studies for any Class II or Class III medical device if, in addition to the existing criteria, the device is expected to have significant use in the paediatric population. The need for this provision is unclear. FDA already has the authority to require postmarket studies if necessary to provide reasonable assurance of safety and effectiveness. Moreover, there is a lack of reliable data on the need for paediatric devices and the affected paediatric populations. Thus, FDA would have no basis on which to determine whether a device is expected to have “significant” paediatric use.

Timing

Although these are busy times in Washington, the reauthorisations of MDUFMA and PDUFA before 30 September 2007 are priorities for Congress and the affected industries. Therefore, there is likely to be a strong push for passage before 28 May 2007, the Memorial Day recess. Time will tell if that push will be successful and what additional bills Members of Congress will try to include. At the time of writing, all indications are that the items above will be part of the discussion.

Mark Leahey is Executive Director at the Medical Device Manufacturers Association, 1350 I Street, NW, Ste. 540, Washington, District of Columbia 20005, USA, tel. +1 202 354 7174, e-mail: mleahey@medicaldevices.org; www.medicaldevices.org