Lawmakers are working to reach consensus on FDA reforms in preparation for markups of user fee reauthorization bills.

The Senate Health, Education, Labor and Pensions Committee has scheduled a full committee executive session on April 25 to mark up a draft “committee print” of a user fee bill. The House Energy & Commerce Health Subcommittee hopes to mark up its own version as early as this week, Chairman Joe Pitts, R-Pa., indicated, though a date has not yet been scheduled.

The latest versions of the draft bills in both chambers, posted last week, include the specific reauthorization language for user fees for devices and other FDA programs negotiated between the agency and the device, drug and biotechnology industries. FDA sent the official device user fee agreement to Congress on April 20. In addition, the packages include an array of additional reforms intended to supplement the user fee agreements.

Additions and revisions to the draft bills are expected in advance of and during the markups in the Senate and House. For instance, sections associated with reauthorization of certain provisions intended to increase the availability of pediatric devices and drugs are in active negotiation in both chambers. (See in this issue, Also see "Negotiations Continue On Pediatric Device Reauthorization Provisions" - Medtech Insight, 23 April, 2012..)

But the Senate committee print, which has bipartisan sponsorship, is likely more settled than the latest House discussion draft, which primarily reflects the priorities of the Republican majority. Compared to the Senate version, which includes a mix of provisions to enhance FDA device safety oversight and to streamline FDA reviews and make the agency more accountable, the House version focuses mostly on streamlining and accountability goals.

Members of the House Energy & Committee Health Subcommittee signaled at an April 18 hearing that they are still working to reach bipartisan compromise.

“There are still key concerns that remain, but the process has been a good one to date and I’m hoping that we can come together to address those outstanding issues” – Rep. Frank Pallone

“We have not yet reached full agreement on the discussion draft at the time of this hearing,” said Rep. Frank Pallone, D-N.J., the ranking Democrat on the subcommittee.

The House draft issued last week is nearly identical to a version issued by Energy and Commerce Committee Republicans in March. (See Also see "Draft User Fee Bills Aim To Streamline And Strengthen Device Regs" - Medtech Insight, 19 March, 2012..) But Pallone pointed to one notable difference: the inclusion of brackets around most of the legislative language, except for the FDA-industry negotiated core user fee reauthorization sections.

“These brackets indicate that the bill is a work in progress, and we continue to make headway,” Pallone said. “It’s important to note that there are still key concerns that remain, but the process has been a good one to date and I’m hoping that we can come together to address those outstanding issues and generate consensus on a bipartisan product that both sides can support.”

Subcommittee Chairman Pitts also referred to “outstanding issues that the staff continues to work on” that he hopes can be settled before markup. His goal is to have the bill signed into law by June, well before the current user fee agreements expire Sept. 30.

House Dems Push For 510(k) Predicate Restrictions

One issue not addressed in the current discussion draft that is a priority for some House Democrats is FDA’s lack of authority to prevent device companies from relying on predicates with documented safety problems to support 510(k) substantial equivalence determinations.

Rep. Edward Markey, D-Mass., introduced the Safety of Untested New Devices Act in February, which would prevent companies from using predicates that have been recalled from the market due to safety problems. (See Also see "Markey Bill Would Bar 510(k) Clearances Of Devices With Recalled Predicates" - Medtech Insight, 6 February, 2012..) Markey argued during the April 18 hearing that it was bad policy for FDA not to be able to reject a 510(k) submission because the claimed predicates have been recalled.

“When it comes to medical devices that are implanted in patients’ bodies, companies can and do base their products on faulty medical predecessor technologies. The definition of insanity is doing the same thing over and over again, and expecting different results. But when it comes to medical devices, we have an insane policy that makes no sense,” Markey said.

“Devices have been recalled because they severely injure patients and they are used again and again as models for new devices, with devastating, life-altering consequences for patients who are injured by them,” he stressed.

Device companies oppose Markey’s bill, arguing that it is unnecessary. FDA, meanwhile, has signaled interest in some additional authority to restrict use of certain predicates; however, the agency has not explicitly expressed support for Markey’s language.

Markey asked CDRH Director Jeffrey Shuren, who testified before the subcommittee, if he would like the authority to reject certain devices if they have the “same dangerous design flaws as other previously recalled devices.”

Shuren responded that CDRH would like to have “appropriately tailored authority.”

Also, Rep. Lois Capps, D-Calif., said that she seeks to add language to the House legislation to improve CDRH post-market oversight by requiring the inclusion of devices in FDA’s Sentinel post-market surveillance program, matching a provision currently in the Senate draft bill.

Further, Illinois Democratic Rep. Jan Schakowsky suggested she would push for changes to language in the current draft revising FDA’s mission statement to include an explicit focus on advancing medical innovation and promoting economic growth and job creation.

Schakowsky’s concerns were supported during the hearing by Shuren, who said he was worried about the unintended consequences this new FDA mission statement would have on device companies. When it comes to job creation, “whose jobs are we talking about – the job of the company coming in with the product, who may get some more jobs, or the competitors, who may lose jobs? In fact, when there’s a disruptive technology, many of the competitors can’t come to the market,” he said.

“Those are things our scientists shouldn’t be dealing with. They should focus on science and ensuring products that come on the market are safe and effective.”

Republican questions to Shuren, meanwhile, often focused on two issues: complaints from device companies about a July 2011 draft guidance on 510(k) modifications and concerns about FDA authority to reject investigational device exemptions.

Shuren told lawmakers that CDRH planned to issue a revised draft 510(k) modifications guidance in response to industry concerns with the original version. (See in this issue, Also see "CDRH Plans To Redraft Maligned 510(k) Modifications Proposal" - Medtech Insight, 23 April, 2012..)

The IDE issue, meanwhile, came up in the context of industry concerns with a November 2011 FDA draft guidance. The draft includes language that some companies worry would establish a new authority by FDA to deny an IDE if the agency does not believe the trial will support clearance or approval. The House draft legislation includes a provision explicitly precluding that standard for IDE approval from the law. (See [A#01120326010].)

Updated Senate Draft Includes UDI Deadline

The Senate Health Education Labor & Pensions Committee posted its committee print April 18 in the lead up to its April 25 markup. Most of the device reforms match language that was included in an earlier discussion draft released by the HELP committee March 16. (See Also see "Draft User Fee Bills Aim To Streamline And Strengthen Device Regs" - Medtech Insight, 19 March, 2012..)

The updated Senate discussion draft includes a new Dec. 31 deadline for FDA to issue a final regulation for unique device identifiers.

As with the earlier draft, the Senate language includes reforms to the de novo review and humanitarian device exemption program, and other changes focused on streamlining reviews and increasing FDA accountability. It also includes multiple measures to strengthen CDRH’s safety oversight, including providing FDA explicit authority to order section 522 post-market surveillance studies for devices at the time they are cleared or approved.

One notable change from the earlier draft is the addition of a specific deadline, Dec. 31, 2012, for FDA to issue a final regulation for unique device identifiers, in addition to a mandate included in the earlier version to simply implement a mandatory UDI “as soon as practicable.” A draft regulation for UDI is currently under review at the White House Office of Management and Budget.

In addition, the new Senate draft language removes time deadlines for CDRH guidance development. The previous draft, under a section on “good guidance practices,” would have mandated an 18-month deadline for finalizing most draft guidances, or the drafts would be considered “null and void.”

Although the Senate bill is bipartisan, members on both sides of the aisle are likely to raise amendments at the markup. For example, on April 18, Republican Sens. Richard Burr, from North Carolina, and Tom Coburn, from Oklahoma, introduced the PATIENTS’ FDA Act, with an emphasis on transparency and accountability from FDA, which, they said, is “designed to complement the proposed agreements negotiated between the FDA and the drug and device industries.”

The legislation includes a broad array of FDA-wide and device-specific reforms, including some concepts already contained in the House user fee bill focused on streamlining the IDE process and clarifying the 510(k) modifications issue, as well as new provisions, including more leeway for the agency to exempt some devices from clinical testing if the product is already approved in Western countries, and reforms to FDA’s custom-device regulations.

Consumer Group Complaints

As lawmakers move towards consensus language on FDA reforms, many consumer groups are urging caution or outright opposition to the current proposals.

Public comments were due April 16 to FDA on the draft commitment letter and legislative language agreed on with the device industry. More than a dozen patient and consumer advocates commented to the FDA docket, expressing concerns that echoed those raised at a March 28 public stakeholder meeting on device user fee reauthorization. (See Also see "Patient, Consumer Groups Decry Lack Of User Fee Funding For Post-Market Surveillance" - Medtech Insight, 2 April, 2012..)

The primary recommendations addressed in both the written comments and at the meeting were complaints that: device user fees amounts agreed to were too low; fees should be allocated to strengthening CDRH’s post-market surveillance; the third party review program should be scrapped; and patient and consumer representatives should be full partners in future MDUFA reauthorizations.

Some of the same groups are also engaging publicly in the legislative process, highlighting major concerns with the draft bills.

“While the Senate legislation is stronger than the House version, neither bill includes critical reforms needed to protect patients from dangerous or defective devices,” Consumers Union noted in an April 19 statement. Consumers Union is the advocacy arm of Consumer Reports, which recently published a scathing account of the FDA device oversight process.

Public Citizen also wrote an April 17 letter to Reps. Pitts and Pallone opposing its latest discussion draft.

[Editor's note: This story was updated on April 23, 2012, to clarify that the House Energy & Commerce Health Subcommittee markup has not yet been scheduled. The original version erroneously reported that the subcommittee would begin markup on April 24.]

Senate Plans FDA User Fee Markup This Week; House Not Far Behind

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