The first legislative salvos were launched last week in a battle that is sure to escalate in conjunction with device user fee reauthorization efforts next year.

On Oct. 13, Sen. Amy Klobuchar, D-Minn., introduced the industry-supported Medical Device Regulatory Improvement Act, which seeks to streamline FDA’s pre-market device oversight with guidelines directing the agency not to ask companies for more data than it needs.

The bill responds directly to complaints from device companies that FDA reviewers are increasingly relying on overly burdensome and inconsistent standards.

On the following day, 10 bills were introduced by House Republicans, most with the goal of speeding up and adding predictability to the FDA device review process.

Sen. Amy Klobuchar, D-Minn., introduced legislation to enhance FDA's “least burdensome” provisions. (Photo: Klobuchar's office)

Sen. Amy Klobuchar, D-Minn., introduced legislation to enhance FDA's “least burdensome” provisions. (Photo: Klobuchar's office)

None of the bills are necessarily expected to move forward independently. But they begin to shape the congressional debate over reauthorization of the FDA user fee program, which expires in September 2012.

Of note, the Senate legislation was sponsored by two Democrats – Klobuchar and Michael Bennet, of Colorado – and one Republican, North Carolina’s Richard Burr.

Representing a different viewpoint, leading Democrats on the House Energy and Commerce Committee on Oct. 12 publicly pleaded with their Republican counterparts to pay more attention to device safety issues, rather than focusing solely on the burdens of FDA regulation.

The divergence underscores that the debate over whether the device industry needs lighter or heavier regulation, compared to the status quo, will not likely be a simple partisan battle.

Doubling Down On “Least Burdensome”

Klobuchar’s bill seeks to put more meat on the bones of the “least burdensome” provisions enacted in the 1997 FDA Modernization Act.

Device companies have long pointed to that language – calling on FDA to consider only what is “necessary” to establish safety and effectiveness or substantial equivalence – to counter requests by reviewers for data that sponsors deem extraneous to statutory standards. FDA, meanwhile, contends that companies sometimes inappropriately point to the least burdensome provisions in an attempt to obtain regulatory leniency.

Klobuchar's bill tries to establish some ground rules for least burdensome principles. For both PMA and 510(k) reviews, it would prohibit FDA from requesting information that is “unrelated or irrelevant” to establishing a reasonable assurance of device safety and effectiveness or substantial equivalence.

It would also require FDA to consider time-saving, effort-saving or cost-saving alternatives for evaluating a device, and to use “all reasonable mechanisms to lessen review times and render regulatory decisions.”

Further, for PMAs, the bill would press agency reviewers to determine whether pre-clinical data, such as bench and animal testing, could meet the statutory threshold for approval. And if clinical data is necessary, FDA should accept, when possible, alternatives to randomized, controlled trials, the bill states.

For 510(k)s, the bill instructs FDA to focus exclusively on the statutory matters at hand: whether the device has the same intended use and is as safe and effective as a legally marketed predicate device. Further, it states, the agency “shall not evaluate issues that do not present a major impact on the intended use as set forth in the labeling."

Separate from the language clarifying the least burdensome provisions, the bill would require the Department of Health and Human Services to contract with a third party to conduct an “extensive review of the management and regulatory processes” at CDRH to ensure that the device center takes into consideration the impact on innovation of each of its actions.

Further, the legislation would remove restrictions on the advisory panel selection process, including current caps on the number of conflict-of-interest waivers that FDA may grant to advisory panel members per year. FDA has already signaled some support for revising the advisory panel restrictions based on the challenges they pose to finding qualified outside experts. (See “ Also see "Rep. Burgess Vows To Fight FDA Panel Conflict-Of-Interest Restrictions" - Medtech Insight, 3 October, 2011. ” – “The Gray Sheet” Oct. 3, 2011.)

An FDA spokeswoman said the agency does not comment on pending legislation.

House Republicans Charge Ahead

Meanwhile, Republicans on the House Energy and Commerce Committee, who have held several hearings this year highlighting the negative impacts of FDA regulations on patient health and U.S. jobs, took their next steps with the introduction of 10 pieces of legislation Oct. 14.

FDA’s “unpredictable, inconsistent, and non-transparent handling of the review process has threatened our nation’s medical device leadership, hurting patients, American jobs and innovation,” the committee majority said in a statement.

Among the bills is the Premarket Predictability Act, sponsored by John Shimkus, R-Ill., which dovetails to some extent with Klobuchar’s measure. According to a draft summary, it would “reaffirm” the least-burdensome provisions.

It would also require device reviewers to provide the scientific and regulatory rationale for major decisions; make FDA publish detailed review summaries for cleared or approved products; and add a tracking number to device submissions to make FDA more accountable for the calendar days during which an application is in the hands of agency reviewers. (See “ Also see "FDA Embraces Total-Time Pre-Market Review Goals, With Shared Accountability" - Medtech Insight, 10 October, 2011. ” – “The Gray Sheet” Oct. 10, 2011.)

Another provision would attempt to streamline the de novo device review process by removing the requirement that a sponsor must wait for a not-substantially-equivalent determination before submitting a de novo petition. (See “ Also see "FDA Unveils Proposal For Streamlined De Novo Reviews" - Medtech Insight, 10 October, 2011. ” – “The Gray Sheet” Oct. 10, 2011.)

Other House bills would seek to remove the profit restriction for products with a humanitarian device exemption; streamline the third-party 510(k) review process; require more public input for guidance development; and press FDA to enter into more regulatory harmonization agreements with foreign governments.

Further, Rep. Michael Burgess, R-Texas, is circulating legislation to address current moves by FDA to regulate laboratory-developed tests. His draft measure would specifically exclude LDTs and direct-to-consumer genetic tests from the FDA definition of a medical device, but at the same time would create a new notification and review process under CMS.

And one of the Republican bills, also from Shimkus, would seek to improve FDA’s recall authority by codifying recent recommendations from the Government Accountability Office. (See “ Also see "GAO Calls For Reforms In FDA Oversight Of Device Recalls" - Medtech Insight, 27 June, 2011. ” – “The Gray Sheet” June 27, 2011.)

House Dems As Counterweight

Democrats on the Energy and Commerce Committee anticipated the actions from their counterparts. On Oct. 12, Ranking Member Henry Waxman, D-Calif., and senior minority subcommittee leaders sent a letter to the Republican committee leaders urging them to look more closely at the failures of FDA-approved devices and the benefits of regulation, not just the economic impacts of regulation.

“As the Committee embarks on the reauthorization of the medical device user fee program, we write to urge that we hold hearings that examine medical devices that have developed serious defects after being implanted in patients,” the letter states.

In particular, the lawmakers point to the high-profile recall of Johnson & Johnson’s metal-on-metal hip products and to recent data showing that intracranial stents, despite having been used in thousands of patients, are associated with worse outcomes than medical management in stroke patients. (See “ Also see "Intracranial Stenting Doesn’t Make The Cut In NIH Study" - Medtech Insight, 12 September, 2011. ” – “The Gray Sheet” Sept. 12, 2011.)

“While working to reduce inefficiencies at FDA, it is critical that we also protect patient safety,” the Democratic representatives argue.

That position, with a focus on potentially adding new regulatory authorities, will likely serve as a counterweight during user fee debates to the innovation and competitiveness agenda forwarded in the bills introduced last week.

Meanwhile, industry representatives and FDA officials continue intense negotiations with the goal of arriving at a consensus user fee and FDA performance proposal that can be sent to Capitol Hill by Jan. 15.

How the subsequent legislative process revises or adds to that agreement remains to be seen.

By David Filmore

Flurries Of New Bills Advance Device Industry Interests In Congress

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