91Â鶹ÌìÃÀ

The Senate Health, Education, Labor and Pensions (HELP) Committee released a large legislative package on May 17, 2022 that would reauthorize the Food and Drug Administration user fees. Supporters of the Verifying Accurate Leading-edge IVCT Development (VALID) Act in the Senate attached this legislation to the user fee package.

The VALID Act would establish a new category of in vitro clinical tests (IVCTs) comprised of test kits and laboratory developed tests (LDTs), and grant the FDA authority to review and approve them pre-market. If enacted, this legislation could have a significant impact on clinical microbiology laboratories. 91Â鶹ÌìÃÀ has been working independently and in partnership with peer organizations to share the infectious disease diagnostics perspective and express strong concerns about provisions in the bill.

91Â鶹ÌìÃÀ issued the following statement regarding the VALID Act to Congress on May 22, 2022. This statement follows a previous letter sent to Representative DeGette, Representative Bucshon, Senator Bennet and Senator Burr on May 16, 2022.

The American Society for Microbiology (91Â鶹ÌìÃÀ), one of the oldest and largest life science societies with 30,000 members in the U.S. and around the world, appreciates your commitment to ensuring that diagnostic tests developed and deployed in the United States are safe, accurate and reliable. Thank you for the opportunity to provide this feedback on the discussion draft of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. Our comments focus exclusively on the provisions in Subtitle C of Title VIII which includes the Verifying Accurate Leading-edge IVCT Development (VALID) Act, and which, to our disappointment, does not incorporate any of our previous recommendations.

Therefore, we reiterate concerns expressed about the initial bill and urge you to address these concerns before advancing the bill as part of FDASLA, which is a fast-moving legislative package. The VALID Act remains a complex bill that will have far reaching implications for clinical microbiology laboratories and infectious disease diagnostic testing. One size does not fit all when it comes to diagnostic testing, and it is crucial that the needs of infectious disease and academic, nonprofit and other noncommercial laboratories be taken into consideration.

Implementation of a User-Fee Program for IVCT Review

Instituting user-fee program for IVCT review should consider the vast differences between large commercial test developers and individual, nonprofit laboratories at academic and other medical centers that develop LDTs. Clinical microbiology laboratories already operate on a thin margin within the health care facilities and are not profit centers. It is unreasonable to include these laboratories in the same business category as commercial entities, and we urge you to include specific language that would exempt academic, non-profit and laboratory entities that meet similar criteria as determined by the Secretary, from the user fee program. If this is not done, the result could be that these laboratories completely cease infectious disease-specific test development, which will ultimately harm patients and critically reduce access to timely, accurate and reliable tests.

While we appreciate that the bill requires the Secretary to consult with scientific and academic experts, as well as health care professionals when developing a user fee program, the impact of fees associated with test review, if applied to the academic, non-profit and small hospital-based laboratories in which our members work, would be devastating financially. This would have the unfortunate consequence of limiting the innovation of new tests, would put patients at risk and would strain the public health system.

Registration Requirement for Grandfathered and Low-Risk IVCTs

Another area where we have concerns is in the registration of grandfathered and low-risk IVCTs, as this will pose a significant time and personnel burden on laboratories that are already stretched thin and short-staffed. 91Â鶹ÌìÃÀ supports the concept of “grandfathering" all tests in clinical use prior to the legislation’s enactment and lifting the requirement for premarket review if they meet the criteria for such. 91Â鶹ÌìÃÀ also understands that the FDA needs to know which tests are in use, even if they are not subject to review.

If the registration requirement for all grandfathered and low-risk tests remains as it is currently written in the VALID Act, it will present an unreasonable burden on academic, nonprofit and hospital-based laboratories who do not have dedicated regulatory staff and do not have the funding to hire new staff for these tasks.

Under Section 587(I)(c )(1)(a), grandfathered tests are given a 1 year timeframe to submit notification information for a medical device listing. 91Â鶹ÌìÃÀ respectfully requests this be amended to provide a period of 3 years for grandfathered tests and low-risk tests to be registered with the agency.

91Â鶹ÌìÃÀ recommends the following changes to Section 587(I)(c )(1)(a):

• "(A) For an in vitro clinical test that was listed as a device under section 510(j) prior to the date of enactment of this section, a person shall maintain a device listing under section 510 until such time as the system for submitting the notification information required under subsection (b)becomes available and thereafter shall submit the notification information no later than 1 year 3 years after the system for submitting the notification under this section becomes available."

Use of Web-based Test Menus in Test Registration

For laboratories to more effectively meet the listing requirements found in Section 587I(b)(2), we propose maintaining an electronic, internet-based test menu on the laboratory’s website and submitting the link to that test menu to the FDA. Rather than requiring laboratories to duplicate this information for the agency which contributes to the regulatory burden, FDA could access the test menu information as needed on a given laboratory’s website. Patients also could access the information, either through a laboratory’s website or by accessing a laboratory’s test menu through the FDA’s own website. We recommend keeping this requirement as simple as possible. For example, requiring laboratories to submit a summary of the analytical and clinical performance of a test is overly burdensome and seems unnecessary for the purposes of obtaining an inventory of tests.

91Â鶹ÌìÃÀ thus suggests the following revisions to Section 587I(b):

"(1) IN GENERAL.—Each person who—

• (A) is a developer, a contract manufacturer (including contract packaging), contract sterilizer, repackager, relabeler or distributor of an in vitro clinical test; and
• (B) introduces or proposes to begin the introduction or delivery for introduction into interstate commerce through an exemption under section 587A(f)(2)(b) or 587A(g) or through the filing of an application under section 587B or 587D, shall submit a listing to the Secretary containing the information described in paragraph (2) in accordance with the applicable schedule described under subsection (c) or a link to a page on the entity’s website that contains the same information. Such listing shall be prepared in such form and manner as the Secretary may specify in guidance. Listing information shall be submitted through the comprehensive test information system in accordance with section 587T, as appropriate.

We urge you to amend the draft legislation to alleviate the aforementioned financial, regulatory and administrative burdens found within the VALID Act that would, among other aspects of the bill, be detrimental to infectious disease diagnostic testing and laboratory capacity throughout the nation. Thank you for your attention to our views.