Diagnostics & Imaging Week Washington Editor

Some of FDA’s recent guidances have made it clear that the agency intends to play a larger role in its regulation of diagnostics, and a recent warning letter suggests that despite talks with the agency, a company can end up with a warning for an assay previously covered under the Clinical Laboratories Improvement Act (CLIA), which is typically regulated by the Centers for Medicare & Medicaid Services.

Among open issues that persist is the question of “home-brewed” diagnostics.

The Oct. 11 warning letter to Exact Sciences (Marlborough, Massachusetts) was brief, noting that data the agency obtained from CMS was regarding Exact’s PreGen Plus assay for colorectal cancer screening and that the assay was used by LabCorp (Burlington, North Carolina) in both its main facility and in its plant in Burlington, North Carolina.

The use of the assay outside of Exact’s plant evidently served as the red flag that sparked FDA’s interest.

The letter states that the CMS information indicates that the assay in question is “a test that was designed, developed, validated and marketed by Exact Sciences rather than a test that was designed and developed by LabCorp,” which puts the assay outside “the scope of laboratory developed tests over which the agency has traditionally applied enforcement discretion.”

Given the lack of PMA or 510(k) approval, the agency cited Exact for misbranding and adulteration.

Jeff Luber, president of Exact, told Diagnostics & Imaging Week that the company’s understanding was that the test “fell under the home brew regulations, and we had discussions about 15 to 18 months ago and thought the issues were resolved.”

He also said that the company is not going to contest the home brew issue and will instead focus on “get[ting] it taken care of.”

“We have met with them and proposed a 510(k) strategy ... and are waiting to hear back from FDA on that,” Luber added.

FDA urged to revise breast biopsy rules

The National Mammography Quality Assurance Advisory Committee (NMQAAC) has advised the FDA to lift the current exemption of stereotactic breast biopsy from the MQSA regulations.

Nine out of 14 members of the committee voted in favor of regulating stereotactic breast biopsy facilities, citing current variable quality, lack of voluntary participation in existing accreditation programs, and dose concerns. Those voting against the proposal cited access issues, no scientifically documented need, and that MQSA did not intend to address interventional procedures.

After testimony from the American College of Radiology (ACR; Reston, Virginia), the Society of Breast Imaging (SBI; Reston, Virginia), the American College of Surgeons (Chicago), the American Society of Breast Surgeons (Columbia, Maryland), the Medical Imaging and Technology Alliance (Rosslyn, Virginia), radiologists and consumer advocates, the panel openly discussed their views before voting.

All speakers and committee members agreed that regulations should not be written to effectively exclude any specialties. FDA said it would take this advice under consideration as they draft revisions to their mammography regulations.

Members chosen for new FDA committee

FDA has selected 15 voting members to serve on its Risk Communication Advisory Committee. The committee will advise the agency about how best to communicate to the public about the risks and benefits of FDA-regulated products so as to facilitate their optimal use.

FDA announced the committee on June 5 and requested nominations for individuals to serve as members. The agency said it received more than 240 nominations.

The establishment of the advisory committee was one of the recommendations of the Institute of Medicine’s 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

“Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of FDA,” said Randall Lutter, PhD, Deputy Commissioner for Policy. “We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope to address communication regarding all products regulated by the agency, including our food supply responsibilities.”

The advisory committee’s 15 voting members include independent experts and public members. Experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health care providers. For some meetings, one or more industry representatives may be invited to participate in a nonvoting capacity.

Members have been assigned to serve for periods ranging from one to four years. FDA expects to hold the committee’s first meeting in 1Q08. The list of members is available on FDA’s web site at http://www.fda.gov/oc/advisory/OCRCACRoster.htm.

FDA is currently amending the committee’s charter to incorporate the provisions of the recently passed Food and Drug Administration Amendments Act of 2007.