Congress gave final approval last week to a massive FDA bill that renews device and drug user fees for five years and strengthens product safety programs.

The ¹ FDA Amendments Act of 2007 was sent to President Bush after passing the House on a 405-7 vote Sept. 19 and the Senate, by unanimous consent, the next day.

It is strongly supported by the device industry, which helped shape the user fee reauthorization language during more than a year of negotiations with FDA.

The act allows FDA to collect, in total, $287 million in fees from device manufacturers over fiscal years 2008 through 2012. The fees "will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices," the legislation states.

In addition, the act authorizes congressional appropriations totaling $39 million over five years for FDA's device center to collect and evaluate postmarket safety information - a new earmark responding to growing sentiment that FDA needs to do more to monitor the safety of marketed devices.

The final measure (H.R. 3580) reflects work by House and Senate members to reconcile differing versions approved earlier this year by the two chambers (² Also see "FDA User Fee Reauthorization Passes House, Awaits Conference" - Medtech Insight, 16 July, 2007., p. 4; ³ Also see "Senate Passes User Fee Reauthorization With FDA/Industry Proposals Intact" - Medtech Insight, 14 May, 2007., p. 3).

Lawmakers had only until Sept. 21 to finish the job before FDA would have been forced to begin the process of laying off more than 1,700 staffers due to a lack of incoming user fee revenues (⁴ Also see "Congress Down To The Wire On FDA User Fee Reauthorization, SCHIP" - Medtech Insight, 17 September, 2007., p. 3). Passage of the measure puts worries about the layoffs to rest.

The bill is expected to be signed by President Bush before Sept. 30, when the current user fee program expires.

Act Establishes New Types Of User Fees

The act makes important changes to device user fees, originally established five years ago under the Medical Device User Fee and Modernization Act.

Fees will still be tied to individual premarket submissions, including PMAs and 510(k)s, but in the new program these submission-specific fees will be reduced and supplemented by four new fee categories (see chart: " ⁵ 2008 Rates For New Device User Fees ").

The new fee types include two annual fees that a broad segment of the industry will need to pay on a regular basis: an annual registration fee for all medical device manufacturers, set at $1,706 for fiscal 2008, and a fee for submission of periodic postmarket reports on PMA-approved devices.

Companies will also have to pay a fee when they file 30-day device modification notices and when they request device classification information.

The new structure will give FDA substantially more user fee revenue - a full 31% more in fiscal 2008 than in 2007 - but will not significantly raise, and in some cases could lower, the annual amount paid per company (see chart: " ⁶ FDA Amendments Act Of 2007: Device-Related Provisions', 'Premarket Submission User Fees: 2007-2008 Comparison").

In a provision particularly important to industry, the act sets annual user fee increases at 8.5%, lending predictability to the fee system. Annual fluctuations in user fee rates had proven one of the most frustrating aspects of the original law for businesses.

"The passage of the FDA Amendments Act of 2007 is good news for patients, the FDA and for medical technology," said AdvaMed President Steve Ubl. "It will ensure patients continue to have access to safe and effective medical devices without unnecessary delays."

The bill gives FDA's device program "the financial resources it needs to meet its medical technology review commitments, while protecting future FDA appropriations and providing manufacturers with predictability regarding user fee rates," Ubl added.

Stricter FDA Review Goals, More Informal Process

In return for paying user fees, device manufacturers are given assurance that FDA will meet specified ⁷ premarket review goals. The goals, enumerated in letters from HHS to congressional leaders, are documented in the Congressional Record and referenced in the legislation.

Slightly more rigorous than the current goals, the new set requires, for example, that FDA in 2008 make a decision on 60% of regular PMAs within 180 days - versus 50% under the current performance goals.

More significantly, the new scheme eliminates premarket review "cycle goals" pertaining to the number of days FDA has to take various interim actions, such as issuing a PMA "major deficiency letter" to a company.

Instead, the goals going forward emphasize FDA's deadlines for final decisions, and encourage a more informal, interactive process between FDA and industry. The arrangement envisions, for example, FDA reviewers simply calling or emailing a company when they have questions about a submission (⁸ Also see "FDA Device Center Working Out “Nuts And Bolts” Of Interactive Review" - Medtech Insight, 9 July, 2007., p. 3).

The new approach grew out of frustration on the part of both companies and the agency that the cycle goals were actually prolonging reviews by putting pressure on reviewers to take formal, interim actions and stop the review process while waiting for the company's response.

Additional Device Provisions

In other device-related provisions, the FDA Amendments Act requires the agency to establish a system under which manufacturers will be required to label their devices with unique identifiers unless they receive a waiver. This is intended to facilitate recalls and other postmarket safety activities.

Industry is against a mandatory unique device identification system. However, the inclusion of the waiver option, which was not in earlier versions of the bill, and the fact that Congress does not provide a deadline by which FDA needs to create the new system, prevented this language from becoming a major point of contention for device lobbyists.

Title III of the act, dealing with pediatric medical devices, contains provisions to spur the development and ensure the safety of devices used in children. It authorizes $6 million a year for pediatric device development projects, and allows FDA to order companies to conduct postmarket surveillance on devices expected to be used in pediatric patients.

Additionally, the legislation requires companies to register their clinical trials with the National Institutes of Health, and calls for studies on the 510(k) premarket notification process, the prevalence of device-related infections, and the safety and quality of genetic tests (see chart: " ⁹ Premarket Submission User Fees: 2007-2008 Comparison ").

- Mary Houghton (m.houghton@elsevier.com)

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