Reauthorization of FDA user fees is on track to be adopted well before the programs expire this fall following Senate passage of the Food and Drug Administration Safety and Innovation Act on May 24 and plans for the House to take up its version of the bill this week.

The Senate bill, which, like the similar House legislation, contains numerous reforms to FDA’s regulatory regime, was approved 96-1 after 10 amendments were added by the chamber.

The bill retains the user fee reauthorization agreement previously negotiated between FDA and the medical device industry, including $595 million (plus inflation) in industry user fees to be paid to the agency between 2013 and 2017, about double the total of the past five years. In return, FDA has agreed to pre-market review performance goals intended to increase early interaction between reviewers and device application sponsors, to hold FDA responsible for the total time to market for a device, and to make sure that FDA follows up with sponsors on reviews that take longer than the performance goal timelines. (See Also see "Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees" - Medtech Insight, 6 February, 2012..)

The new user fees will support 35% of FDA’s medical device pre-market review activities, up from 20% supported by the current fee program, which expires Sept. 30, according to the agency.

Both FDA and device industry groups are pushing for a continued quick pace to enactment.

Additional reforms in the approved bill target FDA’s device pre-market programs, including provisions to streamline the de novo application process, clarify the “least-burdensome” standard and better define FDA’s policy for "custom" devices. It addresses FDA’s post-market authorities, as well, including a requirement to add devices to the Sentinel initiative for active post-market product safety tracking, and to keep FDA on a statutory timeline for implementing mandatory unique device identification regulations. (See Also see "Senate Committee Moves Bipartisan FDA Reform Bill Toward Floor" - Medtech Insight, 30 April, 2012..)

“FDA is pleased that the Senate has voted to reauthorize the prescription drug and medical device user fee programs and create new user fee programs for biosimilar biological products and generic drugs,” FDA Commissioner Margaret Hamburg said in a May 24 statement.

“The vote signals support for innovation and access to safe and effective medical products and FDA looks forward to working with Congress as this legislation moves forward."

AdvaMed said it is pleased with how quickly the bill moved through the Senate, and hopes the House will move with similar speed.

“We believe the strong bipartisan support this measure received today reflects the acknowledgement that this legislation will benefit not only FDA and the medical technology industry, but most importantly, American patients,” AdvaMed CEO Steve Ubl said in a statement.

House leaders plan to bring a similar bill, albeit with some substantive differences, to the floor this week. Senate and House committee leaders have said they want the bill to be signed into law before July 4. (See Also see "Fireworks Kept At Bay As Congress Pushes To Enact FDA Reforms By July 4" - Medtech Insight, 14 May, 2012..)

Sen. Bernie Sanders, I-Vt., cast the lone vote against the bill. He said in a statement that the bill didn’t go far enough to address high prescription drug prices.

Few Device-Relevant Amendments

The Senate faced several days of delay in reaching agreement amendments to be considered on the floor, but the chamber moved quickly May 24 once the logjam was cleared.

The majority of the 10 amendments approved by the chamber did not address FDA’s device program, but three of the measures targeted FDA-wide policy issues with some potential impact on the device space. (See related chart, Also see "Senate FDA Bill: Device Provisions" - Medtech Insight, 28 May, 2012..)

An approved amendment from Sen. Chuck Grassley, R-Iowa, would protect individuals working at FDA who are officers with the Public Health Service Commissioned Corps under federal whistleblower statutes. Currently, Public Health Service officers are exempt from such protections. At least one of the CDRH employees who went to Congress with allegations about wrongdoing by device center management a few years ago was a Public Health Service officer who, Grassley has charged, was targeted with retaliatory action in part because of his exempt status. (See Also see "Regulatory News In Brief" - Medtech Insight, 20 February, 2012..)

Grassley was also successful in adding a provision requiring the Department of Health and Human Services to issue proposed and final regulations that have yet to be released relating to ClinicalTrials.gov registration requirements enacted by the FDA Amendments Act of 2007. (See Also see "ClinicalTrials.gov: NIH Busy Educating Sponsors On Mandates While Regs Remain In The Works" - Medtech Insight, 23 January, 2012..)

A third amendment from Sen. Ben Cardin, D-Md., would require FDA to submit a report to Congress on the status of the partnership efforts between the agency and the Small Business Administration, as well as other small business associations. Also the report should include the number of solicited and unsolicited grant applications from small businesses, and the barriers these firms face in the drug and device approval process.

Meanwhile, Sen. Orrin Hatch, R-Utah, attempted without success to add two amendments to the bill favored by the device industry. The first amendment called for a repeal of the 2.3% excise tax on U.S. device sales slated to begin Jan. 1, 2013. (See Also see "Public Hearing: IRS Tight-Lipped On Industry Device Tax Concerns" - Medtech Insight, 21 May, 2012..)

Hatch also attempted to change language in the bill in a second amendment that would have allowed FDA to reclassify a device to a higher or lower risk category with an administrative order instead of the more time-consuming rulemaking process.

Hatch’s unsuccessful amendment would have restricted FDA’s use of administrative orders only to down-classifying devices to lower risk categories, but would have retained the rulemaking standard for the agency to move a device into a higher risk class.

Also approved in the Senate bill were several new FDA-wide provisions added after committee action, but prior to legislation reaching the floor.

One such provision requires FDA to establish a “nanotechnology regulatory science program” to enhance scientific knowledge regarding nanomaterials included in products regulated by FDA. The bill also includes requirements for HHS to develop initiatives to address and reduce medication and device errors in clinical settings.

Concerns Over Mobile Apps Provision

Despite overall support for the Senate bill, FDA has expressed concern with a provision that would delay FDA from issuing its final medical mobile apps guidance until it submits a report to Congress on its strategy for regulating health information technology software. (See Also see "Latest Senate FDA Reform Bill Would Delay Guidance On Mobile Health Apps" - Medtech Insight, 21 May, 2012..)

CDRH Director Jeffrey Shuren has said that the delay would adversely affect investment in these apps and place undue regulatory burdens on device firms.

The Application Developers Alliance, a new coalition of app developers and firms, wrote a letter to the Senate May 24 supporting the report to Congress, but also opposing the delay on FDA guidance.

“Without clarity from the final guidance, many medical app investors and innovators may delay engagement as they await the outcome of a longer, more uncertain process,” wrote Jon Potter, president of the alliance.

FDA User Fee Reauthorization Charges Along With Senate Passage

More from Legislation

More from Policy & Regulation